Altavant Sciences to Present Data at ISHLT Showing Potency and Distribution of Bronchiolitis Obliterans Candidate, ALTA-2530

CARY, N.C., and BASEL, Switzerland – April 25, 2022 – Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, announced today that the company will make an oral presentation on preclinical results supporting the development of ALTA-2530 for the treatment of bronchiolitis obliterans syndrome (BOS). Altavant will also share a poster presentation summarizing the research to understand patient insights in BOS/chronic lung allograft dysfunction (CLAD) at the International Society for Heart & Lung Transplantation (ISHLT) annual meeting, April 27-30, 2022, in Boston, MA.

The poster and oral presentation details are as follows:


Patients Living with Chronic Lung Allograft Dysfunction (CLAD) Provide Essential Insights for Drug Development

Session:

Date/time:

Location:

POSTER SESSION 2 – Pulmonology (LUNG)

April 28, 2022, 5:15 – 6:15 p.m. Eastern Time

John B. Hynes Memorial Convention Center, Poster Auditorium


An Investigational Inhaled rhIL-Ra (ALTA-2530) Demonstrates Distribution to Distal Regions of Lung and High Affinity IL-1 Receptor Blockade Supporting Development as a Treatment for Bronchiolitis Obliterans Syndrome

Session:

Date/time:

Location:

SESS 75 (Oral) — A Cure for CLAD? Update on CLAD Therapeutics

April 30, 2022, 11:00 – 11:15 a.m. Eastern Time

John B. Hynes Memorial Convention Center, R

In the April 28 poster presentation, key learnings from an advisory meeting of patients with BOS/chronic lung allograft dysfunction (CLAD) will be discussed. Altavant held a patient advisory meeting to seek patient views and considers such feedback as a critical step in the drug development process. At the advisory meeting, patients discussed their interactions with healthcare providers in regards to the prospect of rejection before and after transplantation as well as the emotional and practical impacts CLAD has on their lives. 

On April 30, Altavant will make an oral presentation summarizing results of in vivo preclinical studies measuring lung distribution of aerosolized ALTA-2530, an IL-1 receptor antagonist (IL-1Ra) in development for the treatment of BOS, a life-threatening form of CLAD. In addition, the presentation will include in vitro data showing the potency with which ALTA-2530 blocks the IL-1 receptor, thereby suppressing the expression of proinflammatory IL-6, which has been shown to be a driver of BOS.   

About bronchiolitis obliterans syndrome (BOS) 
BOS is commonly observed following lung transplantation. The condition is caused by an unchecked upregulation of pro-inflammatory chemical signals, including interleukin-1 (IL-1), which leads to fibrosis of the small airways (bronchioles) and eventual partial or total obstruction of the airways. ALTA-2530, a recombinant human IL-1Ra, binds competitively to the IL-1 receptor to attenuate the inflammatory response. ALTA-2530 is currently in preclinical development at Altavant for the treatment of BOS and chemical lung injuries.

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. For more information, please visit altavant.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 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 sumitovant.com or follow us on Twitter and LinkedIn.

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.

Contact:

Altavant Sciences
Aline Sherwood
Scienta Communications, LLC
asherwood@scientapr.com

Sumitovant Biopharma
Maya Frutiger 
Head of Corporate Communications
media@sumitovant.com

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Enzyvant Announces Plans to Expand Regenerative Medicine Manufacturing Capabilities

Enzyvant, a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases, announced today plans to develop a Good Manufacturing Practice (GMP)-compliant regenerative medicine manufacturing facility in Morrisville, NC, part of the Research Triangle Park area.

“Enzyvant is committed to ensuring scalable GMP manufacturing for RETHYMIC® (allogeneic processed thymus tissue-agdc), and we’re looking ahead to potential needs in other indications and in support of other advanced regenerative medicine technologies,” said Enzyvant CEO William Symonds. “This new facility, once completed, will give us the size, flexibility, and nimble processing capability to serve both commercial and research needs.”

The development of the 25,972-square-foot facility is expected to begin this summer and take approximately two and a half years to complete once construction begins. Enzyvant currently has research and development offices in Durham, NC.

“I am very pleased about the novel capabilities this new manufacturing facility will bring to Enzyvant and look forward to the progress ahead as we look to realize efforts,” said Myrtle Potter, CEO of Sumitovant. “This is a great example of three members of the Sumitomo Pharma family of companies working seamlessly together to address the most pressing issues affecting patients and families with the highest unmet medical needs.”

The new manufacturing facility is being co-developed by and operated with Sumitomo Pharma, which owns Enzyvant’s immediate parent company, Sumitovant Biopharma.

“We’re excited that this new site not only expands the range and scope of our manufacturing offerings, but also builds our presence in Research Triangle Park – leveraging our existing employee base and support the local area with new hires,” said Larry Weiner, VP of Pharmaceutical Development & Manufacturing at Enzyvant.

About Enzyvant
Enzyvant is a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases. The company’s first commercial product is U.S. Food and Drug Administration (FDA)-approved RETHYMIC (allogeneic processed thymus tissue-agdc), a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. Enzyvant has distinctive capabilities in expedited development of regenerative therapies for rare diseases. The company has obtained and leveraged multiple regulatory designations including Regenerative Medicine Advanced Therapy, Breakthrough, Fast Track, Rare Pediatric Disease, Orphan Drug, and Advanced Therapies Medicinal Product. Enzyvant is wholly owned by Sumitovant Biopharma Ltd. (wholly owned by Sumitomo Pharma). For more information about Enzyvant, visit Enzyvant.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 Pharma, is also the majority-shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovant.com

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, Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug. It also has been granted the Orphan Drug designation and the Advanced Therapy Medicinal Product designation by the European Medicines Agency. 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

Indication and Important Safety Information

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 hematopoietic cell transplantation (HCT) and maternal engraftment. GVHD may manifest as fever, rash, lymphadenopathy, elevated bilirubin and liver enzymes, enteritis, and/or diarrhea.

Autoimmune-related adverse events occurred in patients treated with RETHYMIC. 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 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 www.fda.gov/safety/medwatch

Media Contacts:

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

Sumitovant
Maya Frutiger
Head of Corporate Communications
media@sumitovant.com

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Sumitovant Biopharma and its Portfolio of Companies Announce Milestone Highlights from the Third Quarter of FY2021

LONDON and NEW YORK, March 25, 2022— Sumitovant Biopharma, Inc., today announced that its portfolio of four wholly-owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant (NYSE: MYOV), a publicly listed company that is majority-owned by Sumitovant, achieved several corporate milestones in the company’s third quarter of fiscal year 2021 ending in January.

“I am very pleased with the achievements Sumitovant and our family of companies have made in the third quarter of fiscal year 2021,” said Myrtle Potter, chief executive officer at Sumitovant. “We launched a phase 1 study with Sumitomo Dainippon Pharma to study a novel antibiotic. There is a high unmet medical need for effective treatments of complicated infections across the globe and developing novel antibacterial therapies has never been more important or urgent. In addition, Myovant presented at this year’s J.P Morgan Healthcare conference, Urovant’s vibegron showed efficacy and safety in two recent publications, and Spirovant presented data on an investigational gene therapy for Cystic Fibrosis.”

Highlights

Sumitovant/Sumitomo Dainippon Pharma
In January, Sumitomo Dainippon Pharma announced the launch of a phase 1 study in the U.S. on a new drug candidate (“KSP-1007”) for carbapenem-resistant bacterial infections. Sumitovant is leading the program of the compound in the U.S. targeting complicated urinary tract and intra-abdominal infections.

Myovant
At this year’s J.P. Morgan Healthcare Conference in January, Myovant’s Chief Executive Officer David Marek presented on the company’s achievements, goals, and products. In November, Marek also participated in a fireside chat at the Evercore ISI 4th Annual HealthCONx Conference to discuss Myovant’s products and business model. 

Also in November, Myovant announced the appointment of Nancy Valente, M.D., as an independent member of the company’s Board of Directors. Dr. Valente is a renowned expert in hematology and oncology drug development with over 20 years of experience leading global development programs at Genentech/Roche and other leading pharmaceutical companies involving novel first-in-class molecules. In addition to her Board appointment, Dr. Valente will chair the Board’s Nominating and Corporate Governance Committee and be a member of the Audit Committee.

Urovant
Urovant Sciences, Inc., announced in December that the journal Advances in Therapy had published patient-perception data supporting clinical meaningfulness of overactive bladder (OAB) symptom reduction for Urovant’s FDA-approved OAB therapy, GEMTESA® (vibegron), compared to placebo.

In addition, the journal Blood Pressure Monitoring published in November ambulatory blood pressure data on Urovant’s overactive bladder (OAB) therapy, GEMTESA® (vibegron) in the U.S. The study showed that once-daily treatment with GEMTESA® 75 mg was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate.

Spirovant
In November, Spirovant 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. 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.

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 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 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.

Contact:

Maya Frutiger
Sumitovant Biopharma
Head of Corporate Communications 
media@sumitovant.com

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

© 2022 Sumitovant Biopharma

Sumitovant is a trademark of Sumitomo Dainippon Pharma Co., Ltd.

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Urovant Sciences Announces Publication of New Review of Efficacy and Safety Data for GEMTESA® (vibegron) 75 mg in Overactive Bladder Patients in the Journal Therapeutics and Clinical Risk Management

IRVINE, Calif. & BASEL, Switzerland – March 22, 2022 – Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new review of data on GEMTESA (vibegron) 75 mg in the peer-reviewed journal, Therapeutics and Clinical Risk Management (https://bit.ly/Vibegron). Titled, ‘An evaluation of the efficacy and safety of vibegron in the treatment of overactive bladder,’ the paper reviews published data from studies conducted over the past three years.

“This new review highlights the fact that across all studies, vibegron was efficacious, safe and well tolerated, and is an option for the treatment of patients with overactive bladder, including older adults,” said lead author Jeffrey Frankel, MD, of Seattle Urology Research Center. “This product offers a promising alternative to anticholinergics, with a clinically meaningful impact for patients.

“Over a year after GEMTESA’s approval in the United States, this data further underscore vibegron’s potential clinical benefit for patients with OAB,” said Cornelia Haag-Molkenteller, MD, PhD, executive vice president and Chief Medical Officer of Urovant Sciences.

The Therapeutics and Clinical Risk Management paper points out that in the international phase 3 EMPOWUR trial, treatment with GEMTESA was associated with significant improvements compared with placebo in the efficacy outcomes of micturition frequency, urge urinary incontinence (UUI) episodes, urgency episodes, and volume voided. The 40-week EMPOWUR extension study evaluated safety in patients receiving GEMTESA for 52 weeks. Treatment with GEMTESA was also associated with improvements in patient-reported outcomes.

Serious adverse events (AEs) occurred at rates comparable with placebo (1.5% vs 1.1% for vibegron vs placebo, respectively) in EMPOWUR and with active control (3.3% vs 4.3% for vibegron vs active control, respectively) in the EMPOWUR extension study. In EMPOWUR, the most frequently occurring treatment-emergent AEs (TEAEs) with incidence greater for vibegron than placebo were headache and nasopharyngitis. Hypertension incidence was similar between vibegron and placebo treatment groups. In the EMPOWUR extension study, the most common TEAEs with vibegron were hypertension (incidence similar to active control), urinary tract infection and headache.

A separate, dedicated ambulatory blood pressure monitoring study showed that treatment with vibegron, similar to placebo, was not associated with clinically meaningful effects on blood pressure or heart rate. In this study, the most frequently occurring TEAEs with vibegron were hypertension, upper respiratory tract infection and headache.

Improvements in patient-reported outcomes suggest that vibegron achieves both objective measures of clinical efficacy and subjective measures of symptomatic improvement that may be perceived as more meaningful by patients, according to the paper.

The paper concludes that further investigation into the real-world effectiveness of vibegron is warranted based on the promising efficacy and safety data seen in clinical trials.

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 ER 4 mg administered orally once daily.

About the 40-Week EMPOWUR Extension
The EMPOWUR 40-week extension trial was a phase 3, randomized, double blind, active-comparator controlled multicenter study to evaluate the long-term safety and efficacy of vibegron in patients with symptoms of overactive bladder. The extension study enrolled approximately 500 EMPOWUR completers. The primary endpoint was safety, measured by incidence of adverse events. Secondary endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence.

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 or follow us on Twitter or 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 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.

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

Source: Urovant Sciences, Inc.

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Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902

March 7, 2022 at 11:30 AM EST

IRVINE, Calif. & BASEL, Switzerland – March 7, 2022 – Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced positive topline results from its Phase 2a, double-blind, placebo-controlled exploratory study of URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), in patients with overactive bladder (OAB), who were not well managed by oral therapies.

“URO-902 showed a clinically meaningful and statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration,” said Cornelia Haag-Molkenteller, MD, PhD, executive vice president and chief medical officer of Urovant Sciences. “URO-902 was well tolerated, compared to placebo. The most common adverse event was urinary tract infection, in both treatment groups.” We are encouraged by these positive results and pending the completion of the study in Fall 2022 and we look forward to discussing next steps for the URO-902 clinical development plan.”

The Phase 2a study included 80 female patients and was designed to evaluate the efficacy, safety, and tolerability of a single, physician administered dose of URO-902 of 24 milligrams (mg) and 48 mg, compared with placebo with a primary timepoint at week 12 post-administration. Patients were followed for up to 48 weeks post-administration. URO-902 has the potential to be the first gene therapy for patients with OAB.

“These promising results suggest that URO-902 could potentially offer a new treatment option for patients with overactive bladder who have been inadequately managed by oral pharmacologic therapy,” said Kenneth Peters, MD, principal investigator, and chief of the department of urology at Beaumont Hospital, Royal Oak; Medical director of the Beaumont Women’s Urology and Pelvic Health Center and professor and chair of urology of the Oakland University William Beaumont School of Medicine in Rochester, Michigan.

The company plans to present the topline results of the study at the American Urological Association annual meeting being held May 13-16, 2022 in New Orleans, LA.

About the Phase 2a Study 
The study was a randomized, double blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of a single physician administered dose of URO-902, a novel gene therapy being developed for patients with OAB who have not been adequately managed with oral or transdermal pharmacologic therapy for OAB. URO-902 is administered via direct intradetrusor injections into the bladder wall under local anesthesia in patients who are experiencing OAB symptoms and urge urinary incontinence (UUI).

The Phase 2a trial enrolled 80 female patients in two cohorts: the first cohort received either a single administration of 24 mg of URO-902 or matching placebo, and the second cohort received 48 mg of URO-902 or matching placebo into the bladder wall. Multiple outcome measures were explored, including the effect on the number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration, as well as an assessment of the safety and tolerability of this potential new therapy. Patients were followed for up to 48 weeks after initial administration.

About URO-902
URO-902 has the potential to be the first gene therapy for patients with OAB. If approved, this innovative treatment may address an unmet need for patients who have not been adequately managed by oral or transdermal pharmacologic OAB therapies and are concerned with potential urinary retention with other minimally invasive therapies or surgical interventions related to existing third-line OAB treatments.

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 or follow us on Twitter or 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 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.

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.

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 and Enzyvant Appoint Bill Symonds, CEO of Altavant Sciences, as Interim Chief Executive Officer of Enzyvant

CAMBRIDGE, Mass. & BASEL, Switzerland, March 2, 2022 – Sumitovant Biopharma and wholly-owned subsidiary Enzyvant, a biopharmaceutical company focused on developing transformative regenerative therapies for patients with rare diseases, today announced the appointment of Bill Symonds, Pharm.D., as interim chief executive officer, effective March 11, 2022.

Dr. Symonds has served as the chief executive officer of Altavant Sciences, a Sumitovant wholly-owned subsidiary, since its inception in August 2018. Previously, Dr. Symonds was a member of the founding management team at Roivant Sciences, Inc., where he served as chief development officer. Earlier in his career, Dr. Symonds held senior positions at a number of pharmaceutical companies, including Pharmasset, Inc. and Gilead Sciences, Inc., leading development efforts for several notable approved medicines. 

“The future of Enzyvant is at a critical juncture, and we are thrilled to have Dr. Symonds lead the company into a new phase on an interim basis,” said Myrtle Potter, chief executive officer of Sumitovant. “Bill is part of the Sumitovant family of companies and previously also worked with Enzyvant during its early stages. With his knowledgeable background of the company, expertise as a drug developer and biotech business leader, I’m confident Bill will be of significant benefit to the team and play a tremendous part in the path forward for the future CEO of Enzyvant.” 

Enzyvant received U.S. Food and Drug Administration (FDA) approval for its lead asset RETHYMIC (allogeneic processed thymus tissue-agdc) in October 2021. It is the first FDA-approved treatment for pediatric congenital athymia.

“I am excited to lead Enzyvant at this important moment in its history,” said Dr. Symonds. “The approval of RETHYMIC offers a revolutionary treatment to the congenital athymia patient community who face complex challenges with this condition on a daily basis. I look forward to working with the dedicated men and women of Enzyvant as we continue this critical journey.”

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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, 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

About Enzyvant
Enzyvant is a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases. The company’s first commercial product is U.S. Food and Drug Administration (FDA)-approved RETHYMIC (allogeneic processed thymus tissue-agdc), a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. Enzyvant has distinctive capabilities in expedited development of regenerative therapies for rare diseases. The company has obtained and leveraged multiple regulatory designations including Regenerative Medicine Advanced Therapy, Breakthrough, Fast Track, Rare Pediatric Disease, Orphan Drug, and Advanced Therapies Medicinal Product. Enzyvant is wholly-owned by Sumitovant Biopharma Ltd. (wholly-owned by Sumitomo Dainippon Pharma Co., Ltd.).

For more information about Enzyvant, visit www.enzyvant.com

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, Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug. It also has been granted the Orphan Drug designation and the Advanced Therapy Medicinal Product designation by the European Medicines Agency. RETHYMIC is the first and only treatment approved by the FDA for immune reconstitution in pediatric patients with congenital athymia.

Contact:
Maya Frutiger
Head of Corporate Communications
media@sumitovant.com

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Myovant Sciences Receives Positive CHMP Opinion for ORGOVYX® (relugolix) for the Treatment of Advanced Prostate Cancer

February 25, 2022

BASEL, Switzerland, Feb. 25, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormonesensitive prostate cancer. The European Commission (EC) will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

“This positive CHMP opinion represents another step toward positioning ORGOVYX® as a new standard of care for men with advanced prostate cancer,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We look forward to providing patients and physicians in Europe with the first oral, androgen deprivation therapy treatment to further advance our mission to redefine care for men with prostate cancer.”

The CHMP positive opinion recommending approval is supported by efficacy and safety data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix compared to leuprolide in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. ORGOVYX® received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with advanced prostate cancer in December 2020.

Myovant continues to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in prostate cancer. Myovant remains on track to reach an agreement with a partner by the anticipated EC approval of relugolix for advanced prostate cancer.

ABOUT PROSTATE CANCER
Prostate cancer is a leading cause of death in the European Union with about 65,200 men having died from the disease in 2016. The standardized death rate from prostate cancer stood at 38 deaths per 100,000 male inhabitants according to Eurostat.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued.

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. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of ORGOVYX®(relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The European Commission will review the CHMP recommendation. 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.

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; the expectations of commercialization and launch of ORGOVYX® for adultpatients with hormone sensitive advanced prostat cancer in Europe, if approved; the expectations of the European Commission’s review of the CHMP recommendation and the timeline of its final decision on the Marketing Authorization Application and the application of such decision in the European Union; Myovant’s expectations regarding partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in prostate cancer, including the timing of any potential agreement with a partner by the anticipated EC approval of relugolix for advanced hormone sensitive prostate cancer; and Myovant’s expectations regarding the potential benefits of ORGOVYX® and its potential to become the new standard of care androgen deprivation therapy for men with advanced hormone sensitive prostate cancer, if approved.

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 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.

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

Media Contact:
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

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Sumitomo Dainippon Pharma and Sumitovant Biopharma Initiate Phase 1 Study on New Drug Candidate for Carbapenem-Resistant Bacterial Infections

LONDON and NEW YORK, February 10, 2022 — Sumitovant Biopharma Ltd., in partnership with its parent company Sumitomo Dainippon Pharma Co., Ltd., recently announced the launch of a phase 1 study in the U.S. on a new drug candidate (“KSP-1007”) for carbapenem-resistant bacterial infections. The launch is a result of a joint research project between Sumitomo Dainippon Pharma and the Kitasato Institute in Japan. Sumitovant is leading the program of the compound in the U.S. targeting complicated urinary tract and intra-abdominal infections. 

“There is a high unmet medical need for effective treatments of complicated infections across the globe,” said Myrtle Potter, Chief Executive Officer of Sumitovant. “Developing novel antibacterial therapies has never been more important or urgent. I believe this drug candidate has the potential to be an effective treatment option against carbapenem-resistant bacterial infections that affect so many people in the U.S. and beyond.” 

Urinary tract infections are among the most common causes of sepsis. Complicated infections are those that have a higher risk of treatment failure and typically require longer antibiotic courses. Complicated intra-abdominal infections are infections that extend beyond the wall of a hollow viscus of origin into the abdominal cavity while being associated with an abscess or peritonitis. 

“It appears from nonclinical data that KSP-1007 broadly and strongly inhibits β-lactamases, which are enzymes that are produced by bacteria that can degrade carbapenem antibiotics,” said Salomon Azoulay, M.D. Chief Medical Officer and Head of Research & Development at Sumitovant, whose team has been leading the design and execution of the phase 1 study in the U.S. “We are studying KSP-1007 in combination with meropenem hydrate, a carbapenem antibiotic, already widely used to treat Gram (-) infections, to enhance efficacy in complicated urinary tract and intra-abdominal infections.” 

New antibiotic development is an urgent international issue. The emergence and spread of antimicrobial resistant (AMR) bacteria, which are resistant to antibiotics, is a growing global problem and concern. The World Bank estimates that 700,000 people die of AMR bacterial infections each year.1 The World Health Organization has been calling for urgent measures both at the national and global level to fight these infections and develop novel treatments. Because of an increase in the use of antibiotics related to COVID-19, there is concern that antimicrobial resistant bacteria will spread even further. 

1 https://www.worldbank.org/en/topic/health/brief/antimicrobial-resistance-amr

Sumitovant and Sumitomo Dainippon Pharma are committed to finding novel treatment options for the most challenging treatments and conditions across the globe. Developing new antibacterial treatments is one area of focus for the companies’ researchers. 

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. 

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

Forward-Looking Statements 
This press release contains “forward-looking statements” concerning the development and commercialization of Sumitomo Dainippon Pharma’s and Sumitovant’s products, the companies’ business development efforts, and expectations regarding their 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. Sumitomo Dainippon Pharma and Sumitovant undertake no obligation to update any forward-looking statements for any reason.

Contact:
Maya Frutiger
Head of Corporate Communications
media@sumitovant.com

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

info@sumitovant.com

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Myovant Sciences to Present at Upcoming Investor Conferences

BASEL, Switzerland, Feb. 07, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that David Marek, Chief Executive Officer of Myovant Sciences, Inc., and other members of the Myovant executive team will participate in a fireside chat at the following investor conferences:

Investors and the general public are invited to listen to the webcasts, which will be accessible on the Events page under the Investors & Media section of the Myovant website at www.myovant.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 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.

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 Appoints Johanna Rossell as Chief Commercial Officer

CAMBRIDGE, Mass. & BASEL, Switzerland, January 26, 2022 (GLOBE NEWSWIRE) — Enzyvant today announced the appointment of Johanna Rossell as Chief Commercial Officer.

Johanna Rossell has an extensive background in the pharmaceutical and healthcare sector, leading multifunctional teams across several geographic markets around the world. She has delivered strong business results for companies such as Novartis, Merck, Mallinckrodt, and Biogen, with a robust track record of bringing new products to market and creating integrated pre-and post-launch commercial plans including a Regenerative Medicine Advanced Therapy (RMAT)-designated tissue-based product and several therapies for rare diseases.

“We are pleased to have an industry veteran of Johanna’s caliber here to lead our commercial enterprise including the U.S. commercialization of RETHYMIC®,” said Rachelle Jacques, CEO of Enzyvant. “Johanna brings in-depth experience and an intimate understanding of tissue-based regenerative therapies to Enzyvant that will not only help us advance our first FDA-approved therapy but also pursue and execute our bold vision for growth into new markets, indications, and assets.”

Enzyvant received U.S. Food and Drug Administration (FDA) approval for its lead asset RETHYMIC (allogeneic processed thymus tissue-agdc) in October 2021. It is one of only three RMAT-designated products to be approved by the FDA since the program was implemented.

“I am thrilled to be joining the talented team at Enzyvant as the company advances a remarkable regenerative technology,” said Johanna Rossell. “While the growth potential of this company is attractive, I am most excited by the opportunity to bring truly transformative therapies to patients in need and make a meaningful difference in their lives.”

About Enzyvant
Enzyvant is a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases. The company’s first commercial product is U.S. Food and Drug Administration (FDA)-approved RETHYMIC (allogeneic processed thymus tissue-agdc), a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. Enzyvant has distinctive capabilities in expedited development of regenerative therapies for rare diseases. The company has obtained and leveraged multiple regulatory designations including Regenerative Medicine Advanced Therapy, Breakthrough, Fast Track, Rare Pediatric Disease, Orphan Drug, and Advanced Therapies Medicinal Product. Enzyvant is wholly-owned by Sumitovant Biopharma Ltd. (wholly-owned by Sumitomo Dainippon Pharma Co., Ltd.).

For more information about Enzyvant, visit Enzyvant.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 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.

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, Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug. It also has been granted the Orphan Drug designation and the Advanced Therapy Medicinal Product designation by the European Medicines Agency. 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 and important safety information.

Indication and Important Safety Information

INDICATION

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

RETHYMIC is not for use in patients who have been diagnosed with severe combined immunodeficiency (SCID).

 

IMPORTANT SAFETY INFORMATION

Infection Control: Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6-12 months after treatment with RETHYMIC. Immune reconstitution is needed for the body to produce cells in the immune system to fight infection. Your child’s doctor should advise you of infection control measures which should be followed immediately after treatment and until the immune system starts working at a sufficient level. Monitor your child closely for signs of infection, including fever. Your child should be maintained on immunoglobulin replacement and prophylactic antimicrobials until certain criteria are met as determined by your doctor.

Graft versus Host Disease (GVHD): RETHYMIC may cause or make pre-existing GVHD worse. Your child will be monitored for GVHD and treated if needed. Symptoms of GVHD may include fever, rash, enlarged lymph nodes, inflammation of the gastrointestinal system and/or diarrhea.

Autoimmune Disorders: Autoimmune-related adverse events occurred in patients treated with RETHYMIC. These events included: low platelets, low white blood cells, protein in urine, low red blood cells, hair loss, poor thyroid function, inflammation of liver, inflammation of the joints, inflammation of the spinal cord, loss of pigment in the skin, eyes and hair, overactive thyroid function, and loss of function of the ovaries. Your doctor will monitor your child regularly including performing blood tests.

Kidney Disease: Treatment with RETHYMIC is a risk factor for death in patients with pre-existing kidney disease.

Cytomegalovirus (CMV) Infection: In clinical studies with RETHYMIC, 3 out of 4 patients with pre-existing CMV infection prior to the implantation with RETHYMIC died. Talk to your doctor about the benefits/risks of treatment if your child has pre-existing CMV infection.

Cancer: Due to your child’s weakened immune system, there is increased risk of developing certain cancers. Your child’s doctor will monitor your child through testing for Epstein-Barr virus (EBV) and cytomegalovirus (CMV), which are two viruses that can cause cancer.

Transmission of Serious Infections: Because RETHYMIC is made from human tissue, and animal products are used in the manufacturing process, transmission of infectious diseases may occur.

Vaccinations: Your child should not receive any vaccinations until he or she has met certain requirements set by your doctor. Talk to your child’s doctor prior to any vaccinations.

Anti-HLA Antibodies: Prior to receiving RETHYMIC your child will be tested for HLA antibodies, which are proteins that may be present in your child’s blood. If your child has these antibodies, he/she will need to receive RETHYMIC from a donor that does not express those HLA proteins.

HLA Typing: If your child has received a hematopoietic cell transplantation (HCT) or a solid organ transplant, they will have a test to look for specific antibodies that could interfere with the effect of RETHYMIC. If they are present, then it will be necessary to receive RETHYMIC from a certain group of donors that do not have these proteins.

Deaths: 105 children participated in the clinical studies of RETHYMIC. 29 of the patients died, including 23 in the first year after implantation of RETHYMIC.

What are the most common side effects with RETHYMIC? The most common side effects with RETHYMIC are hypertension (high blood pressure), cytokine release syndrome, rash, hypomagnesemia (low magnesium), renal impairment / failure (decrease of kidney function), thrombocytopenia (low platelets), and graft versus host disease.

These are not all of the possible side effects of RETHYMIC. Talk to your child’s doctor about any side effect that bothers your child or does not go away.

You are encouraged to report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

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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