Myovant Sciences Announces Financial Results for Third Quarter of Fiscal Year 2021 and Corporate Updates

January 26, 2022 at 6:55 AM ESTPDF Version

BASEL, Switzerland, Jan. 26, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced financial results for the third quarter of fiscal year 2021 and other corporate updates.

“Our third fiscal quarter 2021 financial results reflect the continued strong momentum for the ORGOVYX and MYFEMBREE launches. ORGOVYX volume grew 40% sequentially, reflecting steadily increasing patient and clinician demand for its differentiated clinical profile compared to other androgen deprivation therapy alternatives. By December 2021, MYFEMBREE had captured 45% new-to-brand prescription share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids, significant progress only six months following launch. This notable performance for both brands reaffirms our belief that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively, and represent significant commercial opportunities over time,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc.

Mr. Marek added, “We anticipate 2022 will be a significant growth year with several important milestones that will support our mission of redefining care and position Myovant for long-term success. In addition to executing commercially, we look forward to submitting for FDA review the results of the LIBERTY randomized withdrawal study in women with uterine fibroids, completing the two-year SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain, and potentially launching MYFEMBREE in endometriosis in the U.S. pending FDA approval, while also expanding our pipeline by advancing relugolix lifecycle opportunities and pursuing business development.”

Third Fiscal Quarter 2021 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Ex-U.S. Rights to Relugolix in Oncology

Board of Director Appointment

Effective on November 5, 2021, Dr. Nancy Valente, M.D. was appointed by Myovant’s Board as an independent director following Ms. Kathleen Sebelius’ retirement from Myovant’s Board. Dr. Valente also became a member of the Audit Committee and the Chair of the Nominating and Corporate Governance Committee of Myovant’s Board.

Expected Upcoming Milestones

Third Fiscal Quarter 2021 Financial Summary

Total revenues for the three months ended December 31, 2021 were $54.4 million compared to $1.4 million for the three months ended December 31, 2020.

Cost of product revenue for the three months ended December 31, 2021 was $4.2 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such amounts recognized in the comparable prior year period.

Collaboration expense to Pfizer for the three months ended December 31, 2021, was $12.1 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such amounts recognized in the comparable prior year period.

Research and development (R&D) expenses for the three months ended December 31, 2021, were $25.7 million compared to $30.5 million for the comparable prior year period. The decrease in R&D expenses primarily reflects a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, as well as higher cost sharing with Pfizer for certain R&D expenses.

Selling, general and administrative (SG&A) expenses for the three months ended December 31, 2021, were $72.1 million compared to $49.2 million for the comparable prior year period. The increase was primarily due to higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces.

Interest expense was $3.5 million for the three months ended December 31, 2021, compared to $2.6 million for the comparable prior year period. The increase in interest expense was primarily driven by the higher balance under Myovant’s loan agreement with Sumitomo Dainippon Pharma (Sumitomo Dainippon Pharma Loan Agreement) and $0.6 million of accretion of the financing component of the cost share advance from Pfizer.

Foreign exchange gain for the three months ended December 31, 2020 was $5.9 million, primarily the result of the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.

Net loss for the three months ended December 31, 2021 was $63.4 million compared to $73.8 million for the comparable prior year period. On a per common share basis, net loss was $0.68 and $0.82 for the three months ended December 31, 2021 and 2020, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $569.1 million as of December 31, 2021, and consisted of $527.8 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, January 26, 2022, to discuss financial results for its third fiscal quarter ended December 31, 2021 and corporate updates. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. The webcast will be archived on Myovant’s investor relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX® (relugolix 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix (120 mg) is also under regulatory review in Europe for men with advanced prostate cancer. MYFEMBREE® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months, and by the European Commission and the Medicines and Healthcare products Regulatory Agency in July 2021 and August 2021, respectively, as RYEQO® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted Myovant’s supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively, as well as regulatory approvals by the European Commission and the Medicines and Healthcare products Regulatory Agency for women with symptomatic uterine fibroids. Additionally, Myovant has two regulatory submissions under review, a Marketing Authorization Application in advanced prostate cancer and a supplemental New Drug Application in endometriosis-associated pain. Myovant is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant is also developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including the U.S., Japan, China, and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through its unique portfolio of companies—wholly-owned Urovant, Enzyvant, Spirovant, Altavant, plus majority-owned Myovant Sciences (NYSE: MYOV)—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit Sumitovant’s website at www.sumitovant.com or follow Sumitovant on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including but not limited to: Myovant’s belief that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively; Myovant’s anticipation that 2022 will be a significant growth year with several important milestones that will support its mission of redefining care and position Myovant for long-term success; statements regarding Myovant’s intention to submit for FDA review the results of the LIBERTY randomized withdrawal study in women with uterine fibroids, completing the two-year SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain, and potentially launching MYFEMBREE in endometriosis in the U.S. pending FDA approval, while also expanding its pipeline by advancing relugolix lifecycle opportunities and pursuing business development; the statement about Myovant’s goal to reach agreement with a partner by the anticipated EC approval of relugolix for prostate cancer and the expected timeline; and the statements under the caption “Expected Upcoming Milestones.”

Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q to be filed on January 26, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

MYOVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)

 Three Months Ended December 31, 
2021
Three Months Ended December 31,
2020
Nine Months Ended December 31,
2021
Nine Months Ended December 31,
2020
Revenues:  
Product revenue, net $29,268$—$61,885$—
Pfizer collaboration revenue 25,1721,37979,8531,379
Richter license and milestone revenue —31,66733,333
Total revenues 54,4401,379173,40534,712
Operating costs and expenses:  
Cost of product revenue 4,2437,897
Collaboration expense to Pfizer 12,08625,912
Research and development (1) 25,72630,45382,886115,160
Selling, general and administrative (1)  72,12549,243192,118103,387
Total operating costs and expenses 114,18079,696308,813218,547
Loss from operations(59,740)(78,317)(135,408)(183,835)
Interest expense 3,4792,60910,4786,908
Interest income(70)(32)(248)(178)
Foreign exchange gain —(5,891)(16,178)
Loss before income taxes(63,149)(75,003)(145,638)(174,387)
Income tax expense (benefit) 296(1,154)1,058(616)
Net loss$(63,445)$(73,849)$(146,696)$(173,771)
Net loss per common share — basic and diluted$(0.68)$(0.82)$(1.59)$(1.94)
Weighted average common shares outstanding — basic and diluted 93,474,98590,096,55792,514,65789,715,160
(1) Includes the following share-based compensation:
Selling, general and administrative$4,173$3,699$18,131$10,686
Research and development3,0263,31112,19311,060
Total share-based compensation$7,199$7,010$30,324$21,746
Product revenue, net:
ORGOVYX$24,393$—$53,535$—
MYFEMBREE2,4294,133
Richter product supply and royalties2,4464,217
Total product revenue, net29,26861,885
Pfizer collaboration revenue:
Amortization of upfront payment20,9741,37962,9221,379
Amortization of regulatory milestone4,19816,931
Total Pfizer collaboration revenue25,1721,37979,8531,379
Richter license and milestone revenue31,66733,333
Total revenues$54,440$1,379$173,405$34,712

Revenue components are as follows:

MYOVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)

  December 31, 2021March 31, 2021
Assets  
Current assets:  
Cash and cash equivalents$457,742 $674,493
Accounts receivable, net18,910 3,570
Marketable securities70,020 10,435
Inventories6,737 2,611
Prepaid expenses and other current assets20,795 13,536
Amount due from related party550 —
Total current assets574,754 704,645
Property and equipment, net2,952 3,300
Operating lease right-of-use asset8,405 9,655
Other assets18,181 7,427
Total assets$604,292 $725,027
Liabilities and Shareholders’ Deficit  
Current liabilities:  
Accounts payable$12,130 $17,809
Accrued expenses and other current liabilities58,423 44,612
Share-based compensation liabilities2,724 21,636
Deferred revenue100,564 100,564
Amounts due to Pfizer37,727 1,954
Cost share advance from Pfizer55,026 92,415
Operating lease liability2,052 1,807
Amounts due to related parties391 543
Total current liabilities269,037 281,340
Deferred revenue, non-current400,849 397,369
Cost share advance from Pfizer, non-current 29,447
Long-term operating lease liability7,618 9,189
Long-term debt, less current maturities (related party)358,700 358,700
Other liabilities371 2,947
Total liabilities1,036,575 1,078,992
Total shareholders’ deficit(432,283)(353,965)
Total liabilities and shareholders’ deficit$604,292 $725,027

Investor Contact:
Ryan Crowe
Vice President, Investor Relations
+1 (650) 781-9106
investors@myovant.com

Media Contact:
Albert Liao
Director, Corporate Communications
+1 (650) 410-3055
media@myovant.com

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Urovant Sciences Announces Publication in Advances in Therapy of Analyses of Patient-Perceived Meaningfulness of Improvement in Symptom Reduction for Overactive Bladder Patients Treated with GEMTESA® (vibegron) 75 mg

December 20, 2021 at 12:11 PM EST —

IRVINE, Calif. & BASEL, Switzerland — (BUSINESS WIRE) — Dec. 20, 2021 — Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., announced today that the journal Advances in Therapy has published patient-perception data supporting clinical meaningfulness of overactive bladder (OAB) symptom reduction for its FDA-approved OAB therapy, GEMTESA® (vibegron), compared to placebo. The article entitled, “Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR” is available online and the print version will be published in an upcoming issue of the journal.

The analysis of 12-week data from the EMPOWUR study regarding patient perception supports that the reductions in OAB symptoms such as urinary frequency, urgency, and urinary incontinence were meaningful to patients after treatment with GEMTESA 75 mg compared with those receiving placebo. These data also were presented at sectional American Urological Association (AUA) and Urology-focused meetings this fall including SCS-AUA, NCS-AUA, ICS, NE-AUA, SUNA, and WS-AUA.

“Our findings suggest that the statistically significant improvements in bothersome symptoms of OAB seen in the 12-week EMPOWUR trial are indeed clinically relevant in terms of patient perceptions,” said lead author Jeffrey Frankel, MD, of Seattle Urology Research Center. “These significantly higher proportions of patients achieving pre-defined patient-perceived symptom improvements are likely to inform patients and providers in establishing realistic treatment goals.”

“The patient-centered analysis further supports that GEMTESA is an important treatment option with meaningful clinical benefit for patients with OAB,” said Cornelia Haag-Molkenteller, MD, PhD, executive vice president and Chief Medical Officer of Urovant Sciences. “The publication in a peer-reviewed journal is another example of Urovant’s commitment to informing the scientific – medical community about meaningful effects of GEMTESA.”

About the Analysis
Although OAB is highly prevalent among adults; large clinical studies often neglect to report patient perceptions of the meaningfulness of symptom improvement. The new publication describes a method to derive meaningful within-patient change using a patient-reported measure, the Patient Global Impression of Change (PGI-C). Based on patient interviews and PGI-C results applied to phase 2 and 3 studies, the authors established responder-based definitions of clinically meaningful improvement in reducing micturitions, urgency episodes, and UUI episodes. This analysis indicated that significantly more patients receiving vibegron vs. placebo achieved meaningful responder definitions: ≥15 percent reduction in micturitions (56.3 vs. 44.6 percent, respectively) (post hoc), ≥50 percent reduction in urgency episodes (39.5 vs. 32.8 percent), ≥75 percent reduction in UUI episodes (49.3 vs. 32.8 percent), and ≥90 percent reduction in UUI episodes (35.2 vs. 23.5 percent) (post hoc) at week 12 (P<0.05 each).

About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.1, 2

About GEMTESA®
GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?

GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology. The Company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant, a wholly-owned subsidiary of Sumitomo Dainippon Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovant.com or follow us on Twitter and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma is based on the 2005 merger between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

To read our news release, visit urovant.com/news-releases.

Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9

Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.

Contact:

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
alana.darden@Urovant.com 
media@urovant.com

Sumitovant Biopharma 
Maya Frutiger
Vice President, Corporate Communications 
media@sumitovant.com

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Sumitovant Biopharma Highlights Significant Clinical, Regulatory and Commercial Achievements Across its Portfolio of Companies in the Second Quarter of FY2021

LONDON and NEW YORK, Dec. 10, 2021 /PRNewswire/ — Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly-owned subsidiary companies (UrovantEnzyvantAltavant and Spirovant) and Myovant (NYSE: MYOV), a publicly listed company that is majority-owned by Sumitovant, achieved significant clinical, regulatory and commercial milestones during the company’s second quarter of fiscal year 2021 ending in October.

“The second quarter of 2021 was marked by progress on significant regulatory milestones. Enzyvant gained FDA approval of RETHYMIC® for pediatric patients with congenital athymia, a rare immune disorder. Also, majority-owned Myovant received FDA acceptance of MYFEMBREE®’s supplemental New Drug Application in pain associated with endometriosis,” said Myrtle Potter, CEO of Sumitovant Biopharma. “In addition, Sumitovant companies also made significant clinical contributions to the scientific community, with key data presentations at prominent medical meetings which continue to underscore the therapeutic potential of our collective pipeline in a variety of therapeutic areas with high unmet needs.” 

Milestone Highlights

Enzyvant
On October 8, Enzyvant announced the U.S. Food and Drug Administration (FDA) approved RETHYMIC® (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia.

Myovant
On September 9, Myovant and its partner, Pfizer, announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the investigational use of the management of moderate to severe pain associated with endometriosis. The FDA set a target action date of May 6, 2022 for the sNDA under the Prescription Drug User Fee Act (PDUFA).

Additional Highlights

Myovant 
On October 19, Myovant and its partner, Pfizer, presented data on relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) from clinical studies in uterine fibroids and endometriosis at the American Society for Reproductive Medicine (ASRM) 2021 Congress. The presentations included two-year efficacy and safety data in women with heavy menstrual bleeding associated with uterine fibroids and pooled safety and tolerability data.  

In August, the FDA informed Myovant that the partial clinical hold for the Phase 3 SERENE study evaluating relugolix combination therapy for the prevention of pregnancy was lifted following study protocol amendments. The amended SERENE study protocol will evaluate the contraceptive efficacy of relugolix-CT in women with heavy menstrual bleeding associated with uterine fibroids or endometriosis-associated pain who are 18 to 50 years of age and at risk for pregnancy, and includes bone mineral density monitoring for patients during and after treatment. Patient screening with this updated protocol began in September 2021, with initial patients dosed in October 2021.

Urovant
On September 13, Urovant presented at the 2021 American Urologic Association (AUA) annual meeting new data from a dedicated ambulatory blood pressure study showing that vibegron 75mg in overactive bladder patients was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate. In addition to this presentation, further data presented at AUA included a review of the efficacy of vibegron in the OAB dry population from the EMPOWUR phase 3 pivotal trial. Urovant also presented data collected from a Director of Nursing population related to the impact of overactive bladder on residents and caregivers in the long-term care community. These data highlights were presented at the National Association of Directors of Nursing Administration (NADONA) and the Gerontological Advanced Practice Nurses Association (GAPNA) annual meetings in September 2021.

Altavant 
On September 13, Altavant presented an e-poster at the European Respiratory Society annual congress highlighting the protocol design of the ongoing double-blind, placebo-controlled ELEVATE 2 (NCI NCT04712669) Phase 2b study of rodatristat ethyl (rodatristat) in patients with pulmonary arterial hypertension (PAH).

Enzyvant
On August 26, Enzyvant announced data from two first-ever studies revealing extreme clinical, emotional, social, and financial burdens on pediatric patients with congenital athymia and their families, and extraordinary costs of supportive care to healthcare systems. Posters of each of the studies were presented at the Clinical Immunology Society 2021 Annual Meeting.

On August 4, Enzyvant announced results from clinical trials of the Company’s investigational RVT-802 (allogeneic processed thymus tissue-agdc), engineered human thymus tissue implanted in 105 pediatric patients, published in The Journal of Allergy and Clinical Immunology.

Spirovant
On October 28, Spirovant announced plans to deliver oral and poster presentations highlighting pre-clinical data for its compound, SP-101, an investigational novel recombinant adeno-associated virus (AAV) gene therapy selected for its tropism to human airway epithelia, at the 2021 North American Cystic Fibrosis Conference in November.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of companies—wholly-owned Urovant, Enzyvant, Spirovant, Altavant, plus majority-owned Myovant (NYSE: MYOV)—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit our website at www.sumitovant.com or follow us on Twitter and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd. 
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma was formed pursuant to the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

About Urovant Sciences
Urovant is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology. The Company’s lead product, GEMTESA®(vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com

About GEMTESA®
GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA. Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

About Myovant Sciences
Myovant aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively, as well as a European Commission approval for women with symptomatic uterine fibroids. Additionally, Myovant has two regulatory submissions under review, a Marketing Authorization Application in advanced prostate cancer and a supplemental New Drug Application in endometriosis-associated pain. Myovant is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant is also developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About MYFEMBREE®
MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, please click here.

Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Important Safety Information
BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS
Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events. MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONS
MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONS
Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS
Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS
P-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.

Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION
Advise women not to breastfeed while taking MYFEMBREE.
For more information with respect to Myovant Sciences, including disclosure regarding the risks and uncertainties related to any forward-looking statements, please refer to Myovant Sciences’ filings with the United States Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on July 28, 2021, as such risk factors may be amended, supplemented or superseded from time to time.

About Enzyvant Therapeutics
Enzyvant, a wholly-owned subsidiary of Sumitovant Biopharma Ltd. (wholly-owned by Sumitomo Dainippon Pharma Co., Ltd.), is a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases. Enzyvant’s RETHYMIC® (previously RVT-802) is a one-time tissue-based regenerative therapy approved by the U.S. Food and Drug Administration for pediatric congenital athymia, an ultra-rare and life-threatening pediatric immunodeficiency. For more information about Enzyvant, visit Enzyvant.com. Follow @Enzyvant on Twitter, Facebook, and LinkedIn.

About RETHYMIC
RETHYMIC (allogeneic processed thymus tissue-agdc) is a novel one-time tissue-based regenerative therapy used for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC is engineered human thymus tissue designed to regenerate the thymic function children with congenital athymia are missing and does not require donor-recipient matching. RETHYMIC has been studied across 10 clinical trials for more than 25 years and was granted multiple U.S. Food and Drug Administration (FDA) designations including Regenerative Medicine Advanced Therapy (RMAT), Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug. It also has been granted the Orphan Drug designation and the Advanced Therapy Medicinal Product (ATMP) designation by the European Medicines Agency (EMA). RETHYMIC is the first and only treatment approved by the FDA for immune reconstitution in pediatric patients with congenital athymia. Please see full prescribing information.

Important Safety Information (ISI)

Indication
RETHYMIC® (allogeneic processed thymus tissue–agdc) is indicated for immune reconstitution in pediatric patients with congenital athymia.

Limitations of Use
RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

Important Safety Information
Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC. Given the immunocompromised condition of athymic patients, follow infection control measures until the development of thymic function is established as measured through flow cytometry. Monitor patients closely for signs of infection including fever. If a fever develops, assess the patient by blood and other cultures and treat with antimicrobials as clinically indicated. Patients should be maintained on immunoglobulin replacement therapy until specified criteria are met, and two months after stopping, IgG trough level should be checked. Prior to and after treatment with RETHYMIC, patients should be maintained on Pneumocystis jiroveci pneumonia prophylaxis until specified criteria are met.

RETHYMIC may cause or exacerbate pre-existing graft versus host disease (GVHD). Monitor and treat patients at risk for the development of GVHD. Risk factors for GVHD include atypical complete DiGeorge anomaly phenotype, prior HCT and maternal engraftment. GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea.

Treatment with RETHYMIC may increase the risk of autoimmune-mediated conditions. These events included: thrombocytopenia, neutropenia, proteinuria, hemolytic anemia, alopecia, hypothyroidism, autoimmune hepatitis, autoimmune arthritis, transverse myelitis, albinism, hyperthyroidism, and ovarian failure. Monitor for the development of autoimmune disorders, including complete blood counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function.

Pre-existing renal impairment is a risk factor for death.

In the clinical studies of RETHYMIC, 3 out of 4 patients with pre-existing cytomegalovirus infection died. The benefits/risks of treatment should be considered prior to treating patients with pre-existing CMV infection.

Because of the underlying immune deficiency, patients who receive RETHYMIC may be at risk of developing post-treatment lymphoproliferative disorder. Patients should be monitored for the development of lymphoproliferative disorder.

Transmission of infectious disease may occur because RETHYMIC is derived from human tissue and because product manufacturing includes porcine- and bovine-derived reagents.

Immunizations should not be administered in patients who have received RETHYMIC until immune-function criteria have been met.

All patients should be screened for anti-HLA antibodies prior to receiving RETHYMIC. Patients testing positive for anti-HLA antibodies should receive RETHYMIC from a donor who does not express those HLA alleles. HLA matching is required in patients who have received a prior hematopoietic cell transplantation (HCT) or a solid organ transplant. Patients who have received a prior HCT are at increased risk of developing GVHD after RETHYMIC if the HCT donor did not fully match the recipient.

Of the 105 patients in clinical studies, 29 patients died, including 23 deaths in the first year (< 365 days) after implantation.

The most common (>10%) adverse events related to RETHYMIC included: hypertension, cytokine release syndrome, rash, hypomagnesemia renal impairment / failure thrombocytopenia, and graft versus host disease. 

To report suspected adverse reactions, please contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/safety/medwatch.

About Spirovant Sciences
Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company’s current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant’s lead programs are in development for cystic fibrosis. Spirovant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd., which is itself a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Spirovant is located in Philadelphia, PA. More information is available at https://www.spirovant.com.

About Altavant Sciences
Altavant is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases. Altavant is currently developing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat ethyl is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension. By reducing serotonin production via TPH inhibition rodatristat ethyl may play a role in halting or reversing the vascular remodeling associated with PAH, offering a novel treatment option for patients living with this disease. ALTA-2530 is an inhaled interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening form of chronic lung allograft dysfunction (CLAD) that may present following lung transplantation. ALTA-2530’s unique mechanism of action may offer a novel treatment option for patients who suffer from BOS, a disease where there are currently no approved therapies. Altavant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd. For more information, please visit https://altavant.com

Sumitovant Biopharma, Inc.
151 W. 42nd Street, 15th Floor
New York, NY 10036

info@sumitovant.com

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Spirovant Presents Preclinical Data Showing SP-101 Restores CF Transmembrane Conductance Regulator Function at the 2021 North American Cystic Fibrosis Conference

Philadelphia, PA, November 4, 2021 – Spirovant Sciences, a gene therapy company developing treatments and cures for inherited respiratory diseases including cystic fibrosis (CF), today presented SP-101, an investigational novel recombinant adeno-associated virus (AAV) gene therapy selected for its tropism to human airway epithelia, at the 2021 North American Cystic Fibrosis Conference (NACFC 2021). In oral and poster presentations, Spirovant summarized recent pre-clinical data suggesting SP-101 functionally corrects human CF airway epithelia. In addition, the presentations showed that CFTR expression and CF correction exhibited by SP-101 are dose responsive and durable, demonstrating that SP-101 is a promising drug development candidate. SP-101 is intended for inhalation in patients with CF who do not benefit from treatment with small molecule CFTR modulators, which is approximately 20% of all patients with CF. A copy of the presentation slides and poster are available on the Spirovant website.

“These exciting data are the first preclinical models showing relevant levels of CFTR expression,” said Roland Kolbeck, PhD, Chief Scientific Officer of Spirovant Sciences. “With this information in hand, we believe that SP-101 holds great promise for the many patients living with CF, particularly those who have alleles with nonsense – or Class I – mutations or otherwise do not respond well to existing CFTR modulators.  As we continue to expand our scientific team, we plan to advance the development of this promising treatment and future programs for inherited respiratory disease.”

About Spirovant Sciences, Inc.
Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company’s current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant’s lead programs are in development for cystic fibrosis. Spirovant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd., which is itself a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Spirovant is located in Philadelphia, PA. More information is available at https://www.spirovant.com.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products including GEMTESA® for overactive bladder and RETHYMIC® for pediatric congenital athymia, and has advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is the majority-shareholder of Myovant (NYSE: MYOV) whose marketed products include ORGOVYX® for advanced prostate cancer and MYFEMBREE® for uterine fibroids. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit https://www.sumitovant.com.  

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com/.

Media Contacts:

Spirovant Sciences
Jennifer Guinan
Sage Strategic Marketing
610.410.8111
Jennifer@sagestrat.com

Sumitovant Biopharma
Maya Frutiger
VP, Corporate Communications
media@sumitovant.com

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Myovant Sciences to Host Second Fiscal Quarter 2021 Earnings Conference Call at 8:30 a.m. Eastern Time on October 26, 2021

BASEL, Switzerland, Oct. 12, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced it will host a webcast and conference call to discuss corporate updates and financial results for its second fiscal quarter 2021, ended September 30, 2021. The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on October 26, 2021.

Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

A replay of the webcast, along with the earnings press release and presentation materials, will be archived on Myovant’s investor relations website.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, we have two FDA-approved products. ORGOVYX® (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in 2021 in the U.S. as MYFEMBREE® as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, and by the European Commission as RYEQO® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. We have filed a supplemental New Drug Application (sNDA) for the management of moderate to severe pain associated with endometriosis, which was accepted for review by the FDA in September 2021. The therapy is also being assessed for the prevention of pregnancy. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

Investor Contact:
Ryan Crowe
Vice President, Investor Relations
+1 (650) 781-9106
investors@myovant.com

Media Contact:
Albert Liao
Director, Corporate Communications
+1 (650) 410-3055
media@myovant.com

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Enzyvant Receives FDA Approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

CAMBRIDGE, Mass. & BASEL, Switzerland, October 8, 2021 (GLOBE NEWSWIRE) – Enzyvant today announced the U.S. Food and Drug Administration (FDA) approval of RETHYMIC® (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia.

“For too long, families have faced a reality that the brutal journey for pediatric congenital athymia patients receiving supportive care only would end tragically. The FDA approval of RETHYMIC will help patients access this desperately needed therapy beyond clinical study,” said Rachelle Jacques, CEO of Enzyvant. “We are deeply grateful to the 105 patients who participated in clinical trials, their families, and all of the stakeholders who contributed to this pioneering regenerative medicine research program.”

Pediatric congenital athymia is ultra-rare with an estimated incidence of about 17 to 24 live births each year in the United States. Children who have this condition are born without a thymus and therefore have profound immunodeficiency, life-threatening immune dysregulation, and high susceptibility to potentially fatal infections. With only supportive care, children with congenital athymia typically die by age two or three.

“This therapy is the result of more than 25 years of research aimed at increasing survival for patients who previously had very little hope,” said Louise Markert, M.D, Ph.D., principal investigator for RETHYMIC clinical trials and Professor of Pediatrics and Immunology at the Duke University School of Medicine. “Our research program was inspired each and every day by the possibilities that exist for children who have congenital athymia with an FDA-approved treatment for this devastating condition.”

With this FDA approval, Enzyvant has obtained a Priority Review Voucher (PRV) under the Rare Pediatric Disease Program.

RETHYMIC Clinical Trial Data
Ten prospective single-arm, open-label studies with patient enrollment from 1993 to 2020 form the basis of the RETHYMIC data set. One hundred and five patients were surgically implanted with RETHYMIC under one of 10 Institutional Review Board (IRB)-approved protocols. Ninety-five patients were included in the Efficacy Analysis Set (EAS) and 105 patients were included in the Safety Analysis Set.

Survival rates were analyzed with the longest follow-up period of 25.5 years. In the EAS, Kaplan-Meier estimated survival rates (95% CI) were 77% (0.670–0.841) at one year and 76% (0.658–0.832) at two years. For patients who were alive at one year post implantation, the Kaplan-Meier estimated long-term survival rate was 94% at a median follow-up time of 10.7 years. For the patients in the clinical trials, naïve T-cell levels were measured using flow cytometry at six, 12, and 24 months after implantation with RETHYMIC. Patients in the clinical trials started out with very few naïve T cells but naïve CD4+ and CD8T cells began to reconstitute over the first year, with a durable increase through year two. Reductions in the number of infections over time during the first two years after treatment were statistically significant (p<0.001).

About the Thymus and Congenital Athymia
The “T” in T cell stands for thymus because it is where T cells are selected to fight infections or are destroyed if they have the potential to attack the body instead of invaders. Congenital athymia is an ultra-rare condition in which children are born without a thymus, causing profound immunodeficiency, vulnerability to potentially fatal infections, and life-threatening immune dysregulation. With only supportive care, children with congenital athymia typically die by age two or three. Congenital athymia is initially detected by T-cell deficiency observed in newborn screening for SCID (severe combined immune deficiency), which is now required in all 50 U.S. states. SCID and congenital athymia are both primary immunodeficiency disorders but they are distinct conditions. The estimated incidence of pediatric congenital athymia in the United States is 17 to 24 live births each year.

About RETHYMIC
RETHYMIC (allogeneic processed thymus tissue-agdc) is a novel one-time tissue-based regenerative therapy used for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC is engineered human thymus tissue designed to regenerate the thymic function children with congenital athymia are missing and does not require donor-recipient matching. RETHYMIC has been studied across 10 clinical trials for more than 25 years and was granted multiple U.S. Food and Drug Administration (FDA) designations including Regenerative Medicine Advanced Therapy (RMAT), Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug. It also has been granted the Orphan Drug designation and the Advanced Therapy Medicinal Product (ATMP) designation by the European Medicines Agency (EMA). RETHYMIC is the first and only treatment approved by the FDA for immune reconstitution in pediatric patients with congenital athymia.

Please see full prescribing information.

Important Safety Information (ISI)

Indication
RETHYMIC® (allogeneic processed thymus tissue–agdc) is indicated for immune reconstitution in pediatric patients with congenital athymia.

Limitations of Use:

RETHYMIC is not indicated for the treatment of patients with severe combined immunodeficiency (SCID).

Important Safety Information
Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC. Given the immunocompromised condition of athymic patients, follow infection control measures until the development of thymic function is established as measured through flow cytometry. Monitor patients closely for signs of infection including fever. If a fever develops, assess the patient by blood and other cultures and treat with antimicrobials as clinically indicated. Patients should be maintained on immunoglobulin replacement therapy until specified criteria are met, and two months after stopping, IgG trough level should be checked. Prior to and after treatment with RETHYMIC, patients should be maintained on Pneumocystis jiroveci pneumonia prophylaxis until specified criteria are met.

RETHYMIC may cause or exacerbate pre-existing graft versus host disease (GVHD). Monitor and treat patients at risk for the development of GVHD. Risk factors for GVHD include atypical complete DiGeorge anomaly phenotype, prior HCT and maternal engraftment. GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea.

Treatment with RETHYMIC may increase the risk of autoimmune-mediated conditions. These events included: thrombocytopenia, neutropenia, proteinuria, hemolytic anemia, alopecia, hypothyroidism, autoimmune hepatitis, autoimmune arthritis, transverse myelitis, albinism, hyperthyroidism, and ovarian failure. Monitor for the development of autoimmune disorders, including complete blood counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function.

Pre-existing renal impairment is a risk factor for death.

In the clinical studies of RETHYMIC, 3 out of 4 patients with pre-existing cytomegalovirus infection died. The benefits/risks of treatment should be considered prior to treating patients with pre-existing CMV infection.

Because of the underlying immune deficiency, patients who receive RETHYMIC may be at risk of developing post-treatment lymphoproliferative disorder. Patients should be monitored for the development of lymphoproliferative disorder.

Transmission of infectious disease may occur because RETHYMIC is derived from human tissue and because product manufacturing includes porcine- and bovine-derived reagents.

Immunizations should not be administered in patients who have received RETHYMIC until immune-function criteria have been met.

All patients should be screened for anti-HLA antibodies prior to receiving RETHYMIC. Patients testing positive for anti-HLA antibodies should receive RETHYMIC from a donor who does not express those HLA alleles. HLA matching is required in patients who have received a prior hematopoietic cell transplantation (HCT) or a solid organ transplant. Patients who have received a prior HCT are at increased risk of developing GVHD after RETHYMIC if the HCT donor did not fully match the recipient.

Of the 105 patients in clinical studies, 29 patients died, including 23 deaths in the first year (< 365 days) after implantation.

The most common (>10%) adverse events related to RETHYMIC included: hypertension, cytokine release syndrome, rash, hypomagnesemia renal impairment / failure thrombocytopenia, and graft versus host disease.

To report suspected adverse reactions, please contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/safety/medwatch.

About Enzyvant
Enzyvant, a wholly-owned subsidiary of Sumitovant Biopharma Ltd. (wholly-owned by Sumitomo Dainippon Pharma Co., Ltd.), is a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases. Enzyvant’s RETHYMIC® (previously RVT-802) is a one-time tissue-based regenerative therapy approved by the U.S. Food and Drug Administration for pediatric congenital athymia, an ultra-rare and life-threatening pediatric immunodeficiency. For more information about Enzyvant, visit Enzyvant.com. Follow @Enzyvant on Twitter, Facebook, and LinkedIn.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products including GEMTESA® for overactive bladder and RETHYMIC® for pediatric congenital athymia, and has advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is the majority-shareholder of Myovant (NYSE: MYOV) whose marketed products include ORGOVYX® for advanced prostate cancer and MYFEMBREE® for uterine fibroids. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit https://www.sumitovant.com.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com/.

Media Contacts:

Enzyvant
Eliza Schleifstein
6 Degrees
(917) 763-8106
Eliza@schleifsteinpr.com

Sumitovant Biopharma
Maya Frutiger
VP, Corporate Communications
media@sumitovant.com

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Sumitovant Biopharma Highlights Strong First Fiscal Quarter of 2021 with Significant Commercial and Clinical Achievements Across its Portfolio of Companies

LONDON and NEW YORK, September 16, 2021 – Sumitovant Biopharma’s portfolio of four wholly-owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant Sciences (NYSE: MYOV), a publicly-listed company that is majority-owned by Sumitovant, achieved significant clinical and corporate milestones in the Company’s first quarter of fiscal year 2021. 

“We were excited to see significant regulatory and clinical progress across the Sumitovant portfolio of companies during the Company’s first fiscal quarter, including both the commercial launch of GEMTESA® to treat overactive bladder and the FDA approval and commercial launch of MYFEMBREE® for women with uterine fibroids,” said Myrtle Potter, CEO of Sumitovant Biopharma. “In addition to bringing important therapies to market to address areas with high unmet patient need, we also made significant advancements in the clinical research program and scientific exchange area for rodatristat ethyl, Altavant’s lead candidate to treat pulmonary arterial hypertension (PAH).”

CLINICAL HIGHLIGHTS

Myovant Sciences 
On April 12, 2021, Myovant Sciences and its collaboration partner, Pfizer Inc., announced the first participant was dosed in the Phase 3 SERENE study evaluating MYFEMBREE for the prevention of pregnancy. On May 18, 2021, the U.S. Food and Drug Administration (FDA) informed Myovant that they placed a partial clinical hold on the SERENE study. In July 2021, Myovant provided to the FDA an amended study protocol for the SERENE study. Following Myovant’s discussions with the FDA, Myovant expects the partial clinical hold to be lifted in August 2021. 

Urovant Sciences
On April 15, 2021, Urovant Sciences announced the Journal of Urology published positive safety and efficacy data from the GEMTESA® (vibegron) double-blind 40-week extension study with patient data over a total exposure of 52 weeks. 

Altavant Sciences
On April 26, 2021, Altavant presented results of in vitro and in vivo studies for nebulized ALTA-2530, which is in nonclinical development for treatment of bronchiolitis obliterans syndrome (BOS). These studies demonstrated ALTA-2530 achieved and maintained pharmacologically-relevant exposure levels in lung epithelial lining fluid and distributed to epithelial cells of the lung’s distal airways.

In May 2021, Altavant presented an update on the clinical development of rodatristat ethyl, the company’s lead investigational candidate for the treatment of pulmonary arterial hypertension (PAH), at the annual meeting of the American Thoracic Society (ATS). This update included findings from a dose-response model, which simulated daily administration of rodatristat ethyl to identify optimal doses for the Phase 2b clinical trial.

On May 6, Altavant announced the company has initiated its ELEVATE 2 Study, a Phase 2b clinical trial of rodatristat ethyl for the treatment of patients with pulmonary arterial hypertension (PAH).  

Corporate Highlights

Urovant Sciences
On April 12, 2021, Urovant announced the commercial launch of GEMTESA® (vibegron) to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

Myovant Sciences
On May 26, 2021, Myovant and Pfizer announced that the FDA approved MYFEMBREE as the first and only once-daily oral treatment to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. MYFEMBREE was launched in the U.S. by Myovant and Pfizer in mid-June 2021. Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.

On July 6, 2021, Myovant submitted a supplemental New Drug Application (NDA) to the FDA for once-daily MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In April and June 2020 and January 2021, Myovant reported positive results from the two replicate Phase 3 SPIRIT studies and the SPIRIT long-term extension study.

On July 16, 2021, the European Commission approved RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. RYEQO is the first and only long-term, once-daily oral treatment for uterine fibroids in Europe and has no limitation on its duration of use. The approval was based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies (LIBERTY 1 and LIBERTY 2), a one-year extension study, and supportive bone mineral density data from a randomized withdrawal study. The commercial launch of RYEQO is being executed by Gedeon Richter, Myovant’s commercialization partner for RYEQO in Europe and certain other international markets.

Enzyvant Therapeutics
On April 27, 2021, Enzyvant announced the resubmission of the Biologics Licensing Application (BLA) to the FDA for RVT-802, cultured human thymus tissue. RVT-802 is a one-time tissue-based regenerative therapy for the treatment of pediatric patients with congenital athymia.

On May 3, 2021, Aceragen, Inc. announced the acquisition of Enzyvant’s RVT-801 (now ACG-801), an investigational enzyme replacement therapy for acid ceramidase deficiency presenting as Farber disease.

###

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company leveraging data-driven insights to rapidly accelerate development of new potential therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries—Urovant, Enzyvant, Spirovant, Altavant—and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved product GEMTESA® for overactive bladder and has advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant is the majority-shareholder of Myovant (NYSE: MYOV) whose marketed products include ORGOVYX® for advanced prostate cancer and MYFEMBREE® for uterine fibroids. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For more information, please visit https://www.sumitovant.com.

About Sumitomo Dainippon Pharma Co., Ltd. 
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com/.

About Altavant Sciences
Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases. Altavant is currently developing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension. By reducing serotonin production via TPH inhibition rodatristat may play a role in halting or reversing the vascular remodeling associated with PAH, offering a novel treatment option for patients living with this disease. ALTA-2530 is an inhaled interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening form of chronic lung allograft dysfunction (CLAD) that may present following lung transplantation. ALTA-2530’s unique mechanism of action may offer a novel treatment option for patients who suffer from BOS, a disease where there are currently no approved therapies.

Altavant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd. For more information, please visit https://altavant.com

About Enzyvant Therapeutics 
Enzyvant, a wholly-owned subsidiary of Sumitovant Biopharma Ltd. is a biotechnology company dedicated to developing novel, transformative regenerative therapies for people with devastating rare diseases. Enzyvant’s lead asset is the investigational tissue-based regenerative therapy, RVT-802, for congenital athymia, an ultra-rare and life-threatening pediatric immunodeficiency. RVT-802 has been granted multiple regulatory designations, including the U.S. Food and Drug Administration designation as a Regenerative Medicine Advanced Therapy (RMAT). The RVT-802 Biologics Licensing Application (BLA) was resubmitted this year and the expected action date provided by the FDA under the Prescription Drug User Fee Act (PDUFA) is October 8, 2021. The European Medicines Agency (EMA) has granted Orphan Drug designations and the Advanced Therapy Medicinal Product (ATMP) designation for RVT-802. For more information about Enzyvant, visit Enzyvant.com. Follow @Enzyvant on Twitter, Facebook, and LinkedIn.

About Spirovant Sciences, Inc.
Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company’s current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant’s lead programs are in development for cystic fibrosis. Spirovant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd., which is itself a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd.  More information is available at https://www.spirovant.com/.

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 to treat adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA is also being evaluated to treat OAB in men with benign prostatic hyperplasia (OAB+BPH). The company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has two FDA-approved products. ORGOVYX® (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in 2021 in the U.S. as MYFEMBREE® as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, and by the European Commission as RYEQO® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The therapy has also completed Phase 3 registration-enabling studies for women with endometriosis and is being assessed for the prevention of pregnancy. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is a majority shareholder. For more information, please visit Myovant’s website at www.myovant.com

About MYFEMBREE®
MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. 

MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, please click here.

Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Important Safety Information
BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.

MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONS
MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONS
Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS
Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS
P-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.

Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION
Advise women not to breastfeed while taking MYFEMBREE.

For more information with respect to Myovant Sciences, including disclosure regarding the risks and uncertainties related to any forward-looking statements, please refer to Myovant Sciences’ filings with the United States Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on July 28, 2021, as such risk factors may be amended, supplemented or superseded from time to time.

Contacts:

Sumitovant Biopharma
Maya Frutiger
Vice President, Corporate Communications 
media@sumitovant.com

Myovant Investor Contact:
Ryan Crowe
Vice President, Investor Relations
Myovant Sciences, Inc.
investors@myovant.com

Myovant Media Contact:
Albert Liao 
Director, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

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Altavant Sciences Highlights Ongoing Phase 2b ELEVATE 2 Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension at European Respiratory Society Annual Congress

CARY, N.C. and BASEL, Switzerland —  September 13, 2021 —  Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, presented an e-poster at the European Respiratory Society annual congress highlighting the protocol and design of the ongoing double-blind, placebo-controlled ELEVATE 2 (NCI NCT04712669) Phase 2b study of rodatristat ethyl (rodatristat) in patients with pulmonary arterial hypertension (PAH). 

Howard Lazarus, MD, Chief Medical Officer of Altavant and lead author of the ERS poster, explained, “Rodatristat is a novel molecule with a different mechanism of action than currently available PAH medications. It has been shown in animal models to reduce pulmonary vascular remodeling, which is characteristic of PAH, more effectively than was observed with a currently available treatment regimen. We are excited to be able to offer this experimental medicine to PAH patients in our clinical trial.”

Rodatristat acts by lowering synthesis of serotonin in the periphery. This is important as excessive serotonin production has been associated with the development of PAH. In an animal model of PAH in which the pulmonary vasculature is constricted using a combination of a vascular endothelial growth factor receptor antagonist and hypoxia, rodatristat was shown to reduce levels of peripheral serotonin synthesis, reduce PAH-like remodeling and lower mean pulmonary arterial pressure (mPAP) more effectively than ambrisentan plus tadalafil, a combination often prescribed for PAH. Peripheral serotonin lowering was substantiated in two dose-range finding studies in healthy volunteers where twice-daily oral administration of rodatristat reduced peripheral serotonin levels by up to ~60%. These findings were taken into consideration, along with results from a proprietary dose-response computer model, when selecting twice-daily doses of 300 mg and 600 mg of rodatristat for patients randomized into the treatment arms of ELEVATE 2. 

The e-poster, titled: “ELEVATE 2: A multicenter study of rodatristat ethyl in patients with WHO Group 1 pulmonary arterial hypertension (PAH)” and corresponding audio narration will be available on the ERS Congress platform until December 31, 2021 for registered participants. Following the society’s embargo policy, the e-poster will be made available on the publications page of the Altavant website. 

For more information on the ELEVATE 2 study, including eligibility and enrollment criteria, please visit ELEVATEPAHStudy.com.

About Altavant Sciences
Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases. Altavant is currently developing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat ethyl is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension. By reducing serotonin production via TPH inhibition rodatristat ethyl may play a role in halting or reversing the vascular remodeling associated with PAH, offering a novel treatment option for patients living with this disease. ALTA-2530 is an inhaled interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening form of chronic lung allograft dysfunction (CLAD) that may present following lung transplantation. ALTA-2530’s unique mechanism of action may offer a novel treatment option for patients who suffer from BOS, a disease where there are currently no approved therapies.

Altavant is a wholly-owned subsidiary of Sumitovant Biopharma Ltd. For more information, please visit https://altavant.com

About Sumitovant Biopharma Ltd.

Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sumitovant is the majority shareholder of Myovant, and wholly-owns Enzyvant, Spirovant, Urovant, and Altavant. Sumitovant’s pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant please visit https://www.sumitovant.com/

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and other Asian countries. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com/.

Forward-Looking Statements
This press release contains “forward-looking statements” concerning the development and commercialization of Altavant’s products, the company’s business development efforts and its expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Altavant undertakes no obligation to update any forward-looking statements for any reason.

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Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (vibegron) 75 mg in Overactive Bladder Was Not Associated with Statistically Significant or Clinically Meaningful Effects on Blood Pressure or Heart Rate

September 13, 2021 at 7:30 AM EDT

IRVINE, Calif. and BASEL, Switzerland – (BUSINESS WIRE) – Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today presented data on GEMTESA® (vibegron) 75 mg in patients with overactive bladder (OAB) at the 2021 Annual Meeting of the American Urological Association (AUA) held virtually from September 10-13, 2021.

“We are delighted to present these important additional data confirming the efficacy and safety profile of GEMTESA,” said Cornelia Haag-Molkenteller, MD, PhD, Chief Medical Officer of Urovant Sciences. “The data from the ambulatory blood pressure study demonstrating no statistically significant or clinically relevant effect on blood pressure with GEMTESA, a beta-3 agonist to treat OAB, will be important for physicians and patients suffering from OAB.”

In a randomized, double-blind study of patients with OAB, once-daily treatment with GEMTESA was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate. The study was described in a virtual podium presentation (#PD66) by Michael A. Weber, MD, Professor of Medicine at the State University of New York Downstate College of Medicine, Brooklyn, NY. The presentation was entitled, “Effects of Vibegron on Ambulatory Blood Pressure in Patients with Overactive Bladder: Results from a Double-Blind Study.” 

“This standalone study was conducted to understand the potential effects of GEMTESA on heart rate and blood pressure in a dedicated study using ambulatory blood pressure measurements,” said Dr. Weber. “The new data confirm that GEMTESA has no statistically significant or clinically relevant impact on blood pressure compared to placebo.” 

Results from Ambulatory Blood Pressure Study
The ambulatory blood pressure study enrolled 214 patients with OAB, aged between 40-75 years. The mean age was 59.3 years and 74.6% of all patients were female. Overall, 35% of patients had pre-existing hypertension, which was present in slightly more patients in the GEMTESA group than in the placebo group. Demographic characteristics were well balanced between the groups.

The primary endpoint was change from baseline to day 28 in mean daytime ambulatory systolic blood pressure and was evaluated against a criterion of 3.5 mmHg for the upper limit of the confidence interval. Key secondary endpoints were change from baseline to day 28 in mean daytime ambulatory diastolic blood pressure and heart rate and change from baseline to day 28 in mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, and heart rate. Safety was assessed through adverse event reporting and safety lab tests.

Individuals with valid 24-hour ambulatory blood pressure readings at baseline were randomly assigned 1:1 to receive once daily GEMTESA or placebo for 28 days. At day 28, patients returned to the clinic for a second 24-hour assessment. At baseline, in-clinic mean baseline systolic blood pressure, diastolic blood pressure, and heart rate were generally similar between groups. There were no statistically significant or clinically relevant differences in mean daytime or mean 24-hour ambulatory systolic blood pressure, diastolic blood pressure, or heart rate after 28 days of treatment with GEMTESA compared with placebo. 

Serious treatment-emergent adverse events occurred in 1 patient in each group (GEMTESA: postoperative pain; placebo: hypoglycemia). Hypertension was the most frequently reported treatment-emergent adverse event in both the placebo (4 patients) and the GEMTESA treatment group (5 patients); however, no event of hypertension with GEMTESA was considered related to study treatment. Of the 5 reported events of hypertension with GEMTESA, 1 occurred in a patient taking phentermine, which was a prohibited medication as it is known to increase blood pressure.

EMPOWUR Subgroup Analyses 
Post hoc subgroup analyses of data from the international, randomized, placebo- and active-controlled Phase 3 EMPOWUR trial were the subject of a virtual poster presentation (#MP63) by David Staskin, MD. The principal investigator of the EMPOWUR study, Dr. Staskin is a urologist with St. Elizabeth’s Medical Center, and Associate Professor of Urology at Tufts University School of Medicine, Boston. The virtual poster was entitled, “Vibegron for the Treatment of Patients with Dry Overactive Bladder: A Subgroup Analysis from the EMPOWUR Trial.” 

“The data from the subgroup analyses indicate that compared with placebo, once-daily GEMTESA 75 mg was associated with significant reductions in daily urgency episodes and urinary frequency also in patients with OAB who did not have urinary urge incontinence,” said Dr. Staskin. “These positive effects were seen in patients with OAB wet, who have urinary incontinence, and OAB dry, who do not. This suggests that GEMTESA is similarly effective for these endpoints in patients with OAB wet and dry.” 

About the EMPOWUR Trial
The EMPOWUR trial was an international, randomized, double-blind, placebo and active comparator-controlled Phase 3 clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. A total of 1,518 patients were randomized across 215 study sites into one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once daily; placebo administered orally once daily; or tolterodine extended release (ER) 4 mg administered orally once daily.

About Overactive Bladder 
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).2
Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.2, 3

About GEMTESA® 
GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:
•    urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
•    urgency: the need to urinate right away
•    frequency: urinating often
It is not known if GEMTESA is safe and effective in children. 

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?

GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full Product Information for GEMTESA.

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The Company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder of Myovant (NYSE: MYOV) and wholly-owns Urovant, Enzyvant, Spirovant, and Altavant. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. Sumitovant is a wholly-owned subsidiary of Sumitomo Dainippon Pharma. For further information about Sumitovant, please visit https://www.sumitovant.com.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo Dainippon Pharma is based on the 2005 merger between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

To read our news release, visit urovant.com/news-releases.

1.    Staskin, D., Frankel, J., Varano, S., Shortino, D., Jankowich, R., Mudd, P.N. Jr. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020 Aug;204(2):316-324. doi: 10.1097/JU.0000000000000807. Epub 2020 Feb 18. PMID: 32068484.
2.    Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13.  https://doi.org/10.1007/s11884-016-0344-9
3.    Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087.

Contact:

Urovant Sciences
Mary-Frances Faraji
1 908 334 7693
maryfrances@jeffwintonassociates.com
media@urovant.com

Sumitovant Biopharma 
Maya Frutiger
Vice President, Corporate Communications 
media@sumitovant.com

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Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis

September 9, 2021 at 6:58 AM EDT

BASEL, Switzerland and NEW YORK, Sept. 09, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. The FDA set a target action date of May 6, 2022 for this sNDA under the Prescription Drug User Fee Act (PDUFA).

“Women with endometriosis often experience debilitating symptoms that impact their daily lives – and unfortunately, many of them do not find relief with the medical options that are currently available,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “If approved for this indication, we believe MYFEMBREE has the potential to redefine care for women with endometriosis as an effective, one pill, once-a-day treatment option.”

The sNDA submission in endometriosis is supported by results from the Phase 3 SPIRIT program, which included two multinational, replicate pivotal clinical studies (SPIRIT 1 and SPIRIT 2) in over 1,200 women with pain associated with endometriosis for 24 weeks, and an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2 through one year.

“The submission of the sNDA for MYFEMBREE to treat endometriosis pain reflects our commitment to addressing areas of significant unmet need in women’s health,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We look forward to potentially bringing this important new treatment option to women with endometriosis.”

In the U.S., MYFEMBREE is currently available for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.

About Endometriosis
Endometriosis is an estrogen-dependent, inflammatory disease in which tissue similar to the uterine lining is found outside the uterine cavity, commonly in the lower abdomen or pelvis, on ovaries, the bladder, and the colon. This endometrial-like tissue outside the uterus results in chronic inflammation and can cause scarring and adhesions.

The symptoms associated with endometriosis include painful periods and chronic pelvic pain, painful ovulation, pain during or after sexual intercourse, heavy bleeding, fatigue, and infertility. Endometriosis can also impact general physical, mental, and social well-being, requiring a multi-disciplinary approach to care.

For endometriosis-associated pain, per current guidelines, initial treatment options include hormonal contraceptives and over-the-counter pain medications. In more severe cases, LHRH agonists such as leuprolide acetate are used for short-term treatment. An estimated six million women in the U.S. suffer from symptoms of endometriosis, and an estimated one million women are inadequately treated by current medical therapy and require further treatment. Almost 200 million women are affected globally.

About MYFEMBREE®
MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, please click here.

Indications and Usage
MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Important Safety Information

BOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.

MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONS

MYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsensIn women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONS

Most common adverse reactions for MYFEMBREE (incidence ≥3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONS

P-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.

Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATION
Advise women not to breastfeed while taking MYFEMBREE.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, we have two FDA-approved products. ORGOVYX® (relugolix) was approved by the U.S. Food and Drug Administration in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in 2021 in the U.S. as MYFEMBREE® as the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, and by the European Commission as RYEQO® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The therapy has also completed Phase 3 registration-enabling studies for women with endometriosis and is being assessed for the prevention of pregnancy. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients’ Lives 
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

Myovant Sciences Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including: statements regarding Myovant’s aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of MYFEMBREE for the management of moderate to severe pain associated with endometriosis; and Myovant’s expectations regarding the development and commercialization of MYFEMBREE by Myovant and Pfizer in the United States.

Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on July 28, 2021, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciencesundertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Pfizer Disclosure Notice
The information contained in this release is as of September 9, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when applications may be filed in any additional jurisdictions for MYFEMBREE for the management of moderate to severe pain associated with endometriosis or in any jurisdictions for any other potential indications for MYFEMBREE; whether and when the FDA may approve the supplemental new drug application for the management of moderate to severe pain associated with endometriosis and whether and when regulatory authorities in any jurisdictions may approve any such other applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether MYFEMBREE will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of MYFEMBREE; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Myovant Sciences Contacts
Ryan Crowe, Investors
+1 (650) 781-9106
investors@myovant.com

Albert Liao, Media
+1 (650) 410-3055
media@myovant.com

Pfizer Contacts
Media Relations
Steve Danehy
+1 (212) 733-1538
PfizerMediaRelations@pfizer.com  

Investor Relations
Bryan Dunn
+1 (212) 733-8917
Bryan.Dunn@Pfizer.com

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