Myovant Sciences Announces U.S. Availability of ORGOVYX™ for the Treatment of Advanced Prostate Cancer

BASEL, Switzerland, Jan. 05, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that ORGOVYX™ (relugolix), the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer, is now available through authorized specialty distributors.

“Myovant has been focused on ensuring access to ORGOVYX for men with advanced prostate cancer as quickly as possible following approval, and we are delighted to announce that it is now available,” said David Marek, chief executive officer of Myovant Sciences, Inc. “As part of our commitment to redefine care for women and for men, this is a critical step as we work to bring about a new standard of care for men with advanced prostate cancer.”

ORGOVYX was approved by the FDA on December 18, 2020. Myovant is committed to ensuring that men in the U.S. who are prescribed ORGOVYX can achieve fair and timely access and receive the support they may need throughout their treatment journey. As part of this commitment, Myovant has launched the ORGOVYX Support Program which provides insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to two months of therapy, and patient assistance for qualifying uninsured patients. For more information, please contact 833-ORGOVYX (833-674-6899), 8 a.m.–8 p.m. Eastern Time, Monday–Friday.

About ORGOVYX (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

For full prescribing information, including patient information, please click here.

Indication

ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information

Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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. .

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 and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of ORGOVYX; patient and provider reaction to ORGOVYX; Myovant’s goal of establishing ORGOVYX as the new standard of care in advanced prostate cancer; Myovant’s patient assistance program for patients; and the features of such patient assistance program, including insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to 2 months of therapy, and patient assistance for qualifying uninsured patients.

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’s dependence on the success of ORGOVYX; Myovant’s ability to sustain a commercial field organization and distribution network; the degree of acceptance of ORGOVYX among physicians, patients, healthcare payors, patient advocacy groups, and the general medical community; Myovant’s ability to obtain favorable coverage and reimbursement from third-party payors for ORGOVYX; and Myovant’s reliance on third parties for the manufacture of ORGOVYX. 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 November 12, 2020, 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
Albert Liao
Director, Corporate Communications
+1 (650) 410-3055
media@myovant.com

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Sumitovant Biopharma Announces the Appointment of Industry Veteran, David Marek, as Chief Executive Officer of Myovant Sciences

NEW YORK and LONDON, January 4, 2021 (GLOBE NEWSWIRE) – Sumitovant Biopharma Ltd., the majority shareholder of Myovant Sciences (NYSE: MYOV),  announced today that Myovant Sciences, a healthcare company focused on redefining care for women and for men and one of the five healthcare companies in the Sumitovant family of companies, appointed Mr. David Marek as chief executive officer of Myovant Sciences, Inc. Mr. Marek will also serve as principal executive officer of Myovant Sciences Ltd. and as a member of its board of directors. Mr. Marek succeeds Lynn Seely, M.D.

David Marek is a veteran biopharmaceutical executive with over 30 years of experience in the industry. He brings to Myovant the commercial expertise of a seasoned pharmaceutical executive, the strategic prowess from leading one of the world’s most successful healthcare advertising agencies, as well as the consumer and digital marketing know-how from one of the most popular health information portals, WebMD.  David joins Myovant from Axsome Therapeutics where he was chief commercial officer responsible for building out commercial capabilities in preparation for multiple expected launches.

Prior to Axsome, David served as general manager of Amgen’s Neuroscience Business Unit where, amongst other responsibilities, he oversaw the successful launch of AIMOVIG®, the first-of-its-kind migraine preventive therapy that became and remains the top drug in its class. In that role, David also co-led the AIMOVIG®commercialization partnership in the U.S. with Novartis. David joined Amgen as vice president of marketing for Amgen’s $9 billion Inflammation and Nephrology Business Unit that represented approximately 40% of Amgen’s total company revenue at that time. In this role, he was charged with transforming and modernizing the commercial capabilities as he oversaw the following therapeutic areas: rheumatology, dermatology, nephrology, and eventually, neuroscience.

Prior to Amgen, David was executive vice president, consumer services at WebMD where he led an organization of over 300 employees across marketing, sales, medical, editorial, programming, analytics, government relations, and other key areas. Prior to WebMD, David served as managing director at Saatchi and Saatchi Healthcare Advertising where his organization led the development and implementation of advertising strategies for some of the industry’s most important multi-billion-dollar brands, including NEXIUM®, ENBREL®, CRESTOR®, ELOXITIN®, SEROQUEL®, and AMBIEN® across global markets from launch to loss-of-exclusivity.

“We welcome David to this important role at Myovant. We are confident that he will provide the leadership to continue to expand Myovant’s clinical development strengths while guiding the company in its commercial endeavors,” said Myrtle Potter, chief executive officer of Sumitovant Biopharma and chairman of the board of Myovant Sciences. As the first member of the Sumitovant family of health care companies to reach commercialization, Myovant will set the precedent for the pace and approach of our pipeline development as well as our goal of becoming a high-performing commercial organization.”

“I am pleased to bring my years of experience to Myovant at this pivotal time as the company transitions to being a commercial-stage enterprise. Myovant has already earned a well-deserved reputation for developing therapies with the potential to redefine care for women and for men. I look forward to working with the experienced and talented Myovant team to further strengthen the company’s competitive position while driving growth and profitability,” said David Marek, chief executive officer of Myovant Sciences, Inc. “I am also committed to assuring Myovant’s drug development engine continues to grow the company as we pursue purpose-driven science, empowering medicines, and transformative advocacy.”

We sincerely thank Dr. Seely for her leadership in building Myovant. Dr. Seely is a true physician-scientist and business leader who understands and is deeply committed to the bench to bedside care of patients,” said Potter. “Under her leadership, in less than 5 years, Myovant built a high-performing clinical development engine that has conducted five successful global phase 3 trials, resulting in multiple NDA and other regulatory filings, with ORGOVYX™ earning priority review designation and approval from the FDA. Dr. Seely also led the effort that resulted in Myovant’s important strategic partnership with Pfizer. The Myovant employee team is excellent, passionate, and excited about the company’s potential to make a difference for patients and healthcare providers. Dr. Seely leaves a stellar foundation of success that will be built upon by David Marek.”

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYX for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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 Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London.  Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns 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 needs. 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 the U.S., Japan, China, and the European Union. 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 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

Investor Contact:

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

Media Contacts:

Sumitovant Biopharma
Mary Stutts
SVP, Corporate Relations
+1 (707) 373-0097
media@sumitovant.com

Myovant Sciences
Albert Liao 
Director, Corporate Communications
+1 (650) 410-3055
media@myovant.com

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Myovant Sciences Appoints Industry Veteran David Marek as Chief Executive Officer

BASEL, Switzerland, Jan. 04, 2021 (GLOBE NEWSWIRE) – Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the appointment of David Marek as chief executive officer of Myovant Sciences, Inc. Mr. Marek will also serve as principal executive officer of Myovant Sciences Ltd. and as a member of its board of directors. Mr. Marek succeeds Lynn Seely, M.D. 

Mr. Marek is a veteran biopharmaceutical executive with over 30 years of experience in the industry. He brings to Myovant the commercial expertise of a seasoned pharmaceutical executive, the strategic prowess from leading one of the world’s most successful healthcare advertising agencies, as well as the consumer and digital marketing know-how from one of the most popular health information portals, WebMD. Mr. Marek joins Myovant from Axsome Therapeutics where he was chief commercial officer responsible for building out commercial capabilities in preparation for multiple expected launches. 

Prior to Axsome, Mr. Marek served as general manager of Amgen’s Neuroscience Business Unit where, amongst other responsibilities, he oversaw the successful launch of AIMOVIG®, the first-of-its-kind migraine preventive therapy that became and remains the top drug in its class. In that role, Mr. Marek also co-led the AIMOVIG commercialization partnership in the U.S. with Novartis. He joined Amgen as vice president of marketing for Amgen’s $9 billion Inflammation and Nephrology Business Unit that represented approximately 40% of Amgen’s total company revenue at that time. In this role, he was charged with transforming and modernizing the commercial capabilities as he oversaw the following therapeutic areas: rheumatology, dermatology, nephrology, and eventually, neuroscience. 

Prior to Amgen, Mr. Marek was executive vice president, consumer services at WebMD where he led an organization of over 300 employees across marketing, sales, medical, editorial, programming, analytics, government relations, and other key areas. Prior to WebMD, Mr. Marek served as managing director at Saatchi and Saatchi Healthcare Advertising where his organization led the development and implementation of advertising strategies for some of the industry’s most important multi-billion-dollar brands, including NEXIUM®, ENBREL®, CRESTOR®, ELOXATIN®, SEROQUEL®, and AMBIEN® across global markets from launch to loss-of-exclusivity. 

“I am pleased to bring my years of experience to Myovant at this pivotal time as the company transitions to being a commercial-stage enterprise. Myovant has already earned a well-deserved reputation for developing therapies with the potential to redefine care for women and for men. I look forward to working with the experienced and talented Myovant team to further strengthen the company’s competitive position while driving growth and profitability,” said Mr. Marek, chief executive officer of Myovant Sciences, Inc. “I am also committed to assuring Myovant’s drug development engine continues to grow the company as we pursue purpose-driven science, empowering medicines, and transformative advocacy.” 

“Myovant is entering a critical phase of its growth where launch strategy, execution, and commercial performance are essential to the overall success of the company,” said Dr. Seely, former chief executive officer of Myovant Sciences, Inc. “We just received an important approval from the FDA for ORGOVYX™ for adult patients with advanced prostate cancer and we have another important New Drug Application for relugolix combination tablet under review with the FDA for the treatment of women with uterine fibroids. Seven days ago, we announced a transformational collaboration to develop and commercialize our relugolix franchise with our new partner, Pfizer. With the accomplishment of these important milestones, the board and I have decided to transition the leadership of Myovant to an executive with significant commercial expertise. I will be working closely with Dave and the rest of the Myovant board and executive team to ensure a seamless transition.” 

“The Myovant board and I welcome Dave to this important role at Myovant. We are confident that he will provide the leadership to continue to expand Myovant’s clinical development strengths while guiding the company in its commercial endeavors,” said Myrtle Potter, chairman of the board of Myovant Sciences. “The board and I sincerely thank Dr. Seely for her leadership in building Myovant. Dr. Seely is a true physician-scientist and business leader who understands and is deeply committed to the bench to bedside care of patients. Under her leadership, in less than five years, Myovant built a high-performing clinical development engine that has conducted five successful global Phase 3 trials, resulting in multiple NDA and other regulatory filings, with ORGOVYX earning priority review designation and approval from the FDA. Dr. Seely also led the effort that resulted in Myovant’s important strategic partnership with Pfizer. The Myovant employee team is excellent, passionate, and excited about the company’s potential to make a difference for patients and healthcare providers. Dr. Seely leaves a stellar foundation of success that will be built upon by Dave Marek.” 

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDAapproved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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 Sumitovant Biopharma Ltd. 
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns 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 needs. 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 the U.S., Japan, China, and the European Union. 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 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com

Investor Contact
Ryan Crowe
Vice President, Investor Relations
Myovant Sciences, Inc.
+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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Sumitovant Biopharma Announces Myovant Sciences and Pfizer Enter Collaboration to Develop and Commercialize Relugolix in Oncology and Women’s Health

NEW YORK and LONDON, Dec. 28, 2020 (GLOBE NEWSWIRE) — Sumitovant Biopharma Ltd., the majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that Myovant Sciences, a healthcare company focused on redefining care for women and for men, and one of the five healthcare companies in the Sumitovant family of companies, and Pfizer Inc. (NYSE: PFE) have formed a collaboration to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health in the U.S. and Canada. Pfizer will also receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.

“We have been anticipating and planning for the commercial launch of the first product in our family of companies”, said Myrtle Potter, Chief Executive Officer of Sumitovant Biopharma. “With the approval of ORGOVYX, we are now realizing that goal and have taken steps to position ORGOVYX for success by supporting Myovant in forming an empowering collaboration between Myovant Sciences and Pfizer.” 

“We are thrilled to partner with Pfizer to unlock the full potential of ORGOVYX in advanced prostate cancer and relugolix combination tablet in uterine fibroids and endometriosis, advancing our mission to redefine care for women and for men,” said Lynn Seely, M.D., Chief Executive Officer, Myovant Sciences, Inc. “Pfizer is the ideal partner for Myovant given its impressive capabilities and track record across both oncology and women’s health. This transformative collaboration will significantly strengthen the upcoming launch of ORGOVYX and the potential launches of relugolix combination tablet in women’s health, while substantially enhancing our financial position and enabling us to expand our pipeline of potential new medicines.”

Under the terms of the agreement, Myovant and Pfizer will jointly develop and commercialize ORGOVYXTM (relugolix) in advanced prostate cancer and, if approved, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health in the U.S. and Canada. Myovant and Pfizer will begin co-promoting ORGOVYX for advanced prostate cancer in early 2021. Myovant and Pfizer will equally share profits and certain expenses for ORGOVYX and relugolix combination tablet with Myovant recording revenues. Myovant will remain responsible for regulatory interactions and drug supply and continue to lead clinical development for relugolix combination tablet. Myovant will receive up to $4.2 billion, including an upfront payment of $650 million, $200 million in potential regulatory milestones for U.S. Food and Drug Administration (FDA) approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and also for the combined women’s health indications. If Pfizer exercises the option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries, Myovant will receive $50 million and be entitled to receive double-digit royalties on sales.

The FDA approved ORGOVYX on December 18, 2020 for the treatment of adult patients with advanced prostate cancer. ORGOVYX is the first and only oral GnRH antagonist for men with advanced prostate cancer. Relugolix combination tablet is currently under regulatory review by the FDA for women with uterine fibroids, with a target action date of June 1, 2021. Relugolix combination tablet is also under development for women with endometriosis, with a New Drug Application submission potentially anticipated in the first half of 2021.

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. Relugolix (120 mg) is FDA-approved as ORGOVYXTM for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.

About ORGOVYXTM (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. 

For full prescribing information, including patient information, please click here

Indication
ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information 

Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%). 

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmaxof ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. 

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYXTM for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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 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. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising 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 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 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com

Sumitovant Biopharma and Myovant Sciences Forward-Looking Statement
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 and quotes reflecting Sumitovant’s and Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of ORGOVYX and of other relugolix product candidates; the potential benefits of the collaboration with Pfizer, including Myovant Sciences’ upcoming and potential commercial launches, its financial position and potential expansion of new medicine pipeline; the timing and anticipated actions under the agreement and on Myovant Sciences’ regulatory filings. 

Sumitovant’s and 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’s dependence on the success of ORGOVYX and its other product candidates; Myovant’s ability to sustain a commercial field organization and distribution network; the degree of acceptance of ORGOVYX among physicians, patients, healthcare payors, patient advocacy groups, and the general medical community; Myovant’s ability to obtain favorable coverage and reimbursement from third-party payors for ORGOVYX and its other product candidates; and Myovant’s reliance on third parties for the manufacture of ORGOVYX and its other product candidates. Sumitovant and 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 November 12, 2020, 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 Sumitovant’s or Myovant Sciences’ management to predict all risk factors, nor can Sumitovant or 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, neither Sumitovant nor Myovant Sciences undertakes any obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Investor Contact:

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

Media Contacts:

Sumitovant Biopharma
Mary Stutts
SVP, Corporate Relations
media@sumitovant.com

Myovant Sciences
Albert Liao 
Director, Corporate Communications
media@myovant.com

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Myovant Sciences and Pfizer Announce Collaboration to Develop and Commercialize Relugolix in Oncology and Women’s Health

BASEL, Switzerland and NEW YORK, Dec. 28, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced a collaboration to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health in the U.S. and Canada. Pfizer will also receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.

“We are thrilled to partner with Pfizer to unlock the full potential of ORGOVYX in advanced prostate cancer and relugolix combination tablet in uterine fibroids and endometriosis, advancing our mission to redefine care for women and for men,” said Lynn Seely, M.D., Chief Executive Officer, Myovant Sciences, Inc. “Pfizer is the ideal partner for Myovant given its impressive capabilities and track record across both oncology and women’s health. This transformative collaboration will significantly strengthen the upcoming launch of ORGOVYX and the potential launches of relugolix combination tablet in women’s health, while substantially enhancing our financial position and enabling us to expand our pipeline of potential new medicines.”

Under the terms of the agreement, Myovant and Pfizer will jointly develop and commercialize ORGOVYX™ (relugolix) in advanced prostate cancer and, if approved, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health in the U.S. and Canada. Myovant and Pfizer will begin co-promoting ORGOVYX for advanced prostate cancer in early 2021. Myovant and Pfizer will equally share profits and certain expenses for ORGOVYX and relugolix combination tablet with Myovant recording revenues. Myovant will remain responsible for regulatory interactions and drug supply and continue to lead clinical development for relugolix combination tablet. Myovant will receive up to $4.2 billion, including an upfront payment of $650 million, $200 million in potential regulatory milestones for U.S. Food and Drug Administration (FDA) approvals for relugolix combination tablet in women’s health, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and also for the combined women’s health indications. If Pfizer exercises the option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries, Myovant will receive $50 million and be entitled to receive double-digit royalties on sales.

“We are excited to join forces with Myovant and combine our capabilities to bring ORGOVYX to patients with advanced prostate cancer,” said Andy Schmeltz, Global President, Pfizer Oncology. “This strategic collaboration builds on our leadership in serving prostate cancer patients in the U.S. and aligns with our goal to deliver more breakthroughs across the prostate cancer treatment paradigm.”

“There continues to be a high unmet need among the millions of women who experience the common and debilitating symptoms associated with uterine fibroids and endometriosis,” said Nick Lagunowich, Global President, Pfizer Internal Medicine. “We believe our deep heritage and leadership in women’s health combined with our experienced women’s health field force will enable us to maximize these opportunities with Myovant, potentially bringing valuable new treatment options to these women.”

The FDA approved ORGOVYX on December 18, 2020 for the treatment of adult patients with advanced prostate cancer. ORGOVYX is the first and only oral GnRH antagonist for men with advanced prostate cancer. Relugolix combination tablet is currently under regulatory review by the FDA for women with uterine fibroids, with a target action date of June 1, 2021. Relugolix combination tablet is also under development for women with endometriosis, with a New Drug Application submission anticipated in the first half of 2021.

Myovant Sciences Conference Call
Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time today, December 28, 2020. 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. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.

About ORGOVYX™ (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

For full prescribing information, including patient information, please click here.

Indication

ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information 

Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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 150 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 Statement
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 and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of ORGOVYX and of other relugolix product candidates; the potential benefits of the collaboration with Pfizer, including Myovant Sciences’ upcoming and potential commercial launches, its financial position and potential expansion of new medicine pipeline; the timing and anticipated actions under the agreement and on Myovant Sciences’ regulatory filings.

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’s dependence on the success of ORGOVYX and its other product candidates; Myovant’s ability to sustain a commercial field organization and distribution network; the degree of acceptance of ORGOVYX among physicians, patients, healthcare payors, patient advocacy groups, and the general medical community; Myovant’s ability to obtain favorable coverage and reimbursement from third-party payors for ORGOVYX and its other product candidates; and Myovant’s reliance on third parties for the manufacture of ORGOVYX and its other product candidates. 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 November 12, 2020, 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.

Pfizer Disclosure Notice
The information contained in this release is as of December 28, 2020. 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 ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer, relugolix combination tablet for women with uterine fibroids, relugolix combination tablet for women with endometriosis and a collaboration between Pfizer and Myovant Sciences to develop and commercialize relugolix in advanced prostate cancer and women’s health, including their 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 ORGOVYX; 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 the potential application for relugolix for women with endometriosis will be filed with the FDA and whether and when any applications may be filed for relugolix for advanced prostate cancer, for women with uterine fibroids or for women with endometriosis in additional jurisdictions or in any jurisdictions for any other potential indications for relugolix; whether and when the FDA may approve the pending application for relugolix for women with uterine fibroids and the potential application for women with endometriosis and whether and when regulatory authorities may approve any other applications that may be filed for relugolix in other jurisdictions, 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 relugolix 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 relugolix; 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, 2019 and 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
Chuck Triano
+1 (212) 733-3901
Charles.E.Triano@Pfizer.com 

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Sumitovant Biopharma Announces Urovant Sciences Receives U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

GEMTESA® is the second FDA approval for the Sumitovant Biopharma family of companies in the past week. GEMTESA® is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences

NEW YORK, LONDON, IRVINE, Calif. & BASEL, Switzerland, Dec. 23, 2020 (GLOBE NEWSWIRE) — Sumitovant Biopharma Ltd., today announced that Urovant Sciences (Nasdaq: UROV), a member of the Sumitovant family of companies, has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. GEMTESA is the first oral branded OAB medication to be approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.

“Sumitovant Biopharma welcomes the first drug approval for Urovant Sciences.  We look forward to providing GEMTESA® to patients with OAB whose needs often remain unsatisfied.  This is a drug category that has gone without a new branded entrant in eight years so we are pleased to bring a new option to those who can benefit from the advances we have made,” said Myrtle Potter, CEO of Sumitovant Biopharma.  GEMTESA is the second Sumitovant family product to be approved by the FDA within this past week.  GEMTESA’S approval follows the December 18th approval of ORGOVYXTMfor the treatment of advanced prostate cancer.

“The FDA’s approval of GEMTESA is an important milestone for the tens of millions of patients living with overactive bladder and for Urovant, as it is our first drug approval. We look forward to launching GEMTESA and believe that it will provide a compelling alternative for the many patients suffering from the burden of an overactive bladder. We also remain committed to bringing more new therapies to market that address unmet medical needs of patients suffering from urologic diseases,” said Jim Robinson, president and chief executive officer of Urovant Sciences.

“The clinical data for once-daily 75 mg GEMTESA demonstrated clear efficacy on the key symptoms of OAB, by reducing urinary frequency, urge urinary incontinence, and urgency.  In addition, data specifically showing reduction in urgency episodes are included in the Prescribing Information of GEMTESA, which is unique among currently- available OAB treatments. Urgency episode reduction data are particularly relevant for OAB patients and their health care providers, as they show GEMTESA’s direct impact on a hallmark symptom of the condition,” said Cornelia Haag-Molkenteller, M.D., Ph.D., chief medical officer of Urovant Sciences. “By successfully treating clinical symptoms, GEMTESA may allow patients to overcome the devastating impact that OAB can have on their daily lives.”

GEMTESA is an oral, once-daily tablet containing 75 mg of vibegron, a small-molecule β3 adrenergic receptor agonist therapy which helps relax the detrusor bladder muscle so that the bladder can hold more urine, thereby reducing symptoms of OAB.

“GEMTESA is the first beta 3-agonist available as a once-daily pill which does not require dose titration,” said David Staskin, MD, clinical trial investigator and a leading urologist with St. Elizabeth’s Medical Center in Boston. “Notably, GEMTESA did not have any increase in the adverse event of hypertension compared to placebo in the key EMPOWUR study and has no interactions with medications metabolized by CYP2D6, which is important since many common medications are metabolized by CYP2D6.” 

The FDA’s approval is based on results from an extensive development program involving more than 4,000 OAB patients, including the 12-week double blind, placebo-controlled Phase 3 EMPOWUR study with a dose of 75 mg and the double blind EMPOWUR long term extension study.1 These data show that treatment with GEMTESA resulted in statistically significant reductions in daily UUI, micturitions, and urgency episodes and an increase in the volume voided when compared to placebo in EMPOWUR.

The most common adverse reactions of GEMTESA from the double blind, placebo-controlled EMPOWUR study in ≥2% of patients were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. GEMTESA demonstrated the same rates for the adverse events of hypertension and increased blood pressure as placebo.

Urovant is planning to launch GEMTESA in the United States late in the first quarter of 2021. To learn more about GEMTESA, please visit GEMTESA.com.

About 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

More than 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.3,4

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 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA is also being evaluated for the treatment of 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 subsidiary of Sumitomo Dainippon Pharma Co., 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 a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising 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 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 6,000 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 within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the impact of vibegron on patients’ OAB symptoms and Urovant’s expectations regarding the planned commercial launch and footprint for vibegron. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success and cost of Urovant’s efforts to commercialize vibegron; Urovant’s ability to realize the anticipated benefits of the co-promotion agreement with Sunovion in the manner or timeline expected; Urovant’s reliance on Sunovion for the co-promotion and distribution of vibegron and Urovant’s ability to secure alternative access to commercial infrastructure or strategic collaborations for the commercialization or distribution of products if it is unable to continue the relationship with Sunovion; the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings with the SEC. Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

  1. Staskin, D., 2020. 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 | Journal of Urology. https://www.auajournals.org/doi/10.1097/JU.0000000000000807
  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. https://doi.org/10.1016/j.urology.2010.08.039
  4. 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

Media Inquiries: 
Mary Stutts
415-419-6705 
mary.stutts@sumitovant.com

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Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dec. 23, 2020– Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.

“The FDA’s approval of GEMTESA is an important milestone for the tens of millions of patients living with overactive bladder and for Urovant, as it is our first drug approval. We look forward to launching GEMTESA in the coming months and believe that it will provide a compelling alternative for the many patients suffering from the burden of an overactive bladder. We also remain committed to bringing more new therapies to market that address unmet medical needs of patients suffering from urologic diseases,” said Jim Robinson, president and chief executive officer of Urovant Sciences.

“The clinical data for once-daily 75 mg GEMTESA demonstrated clear efficacy on the key symptoms of OAB by reducing urinary frequency, urge urinary incontinence, and urgency. In addition, data specifically showing reduction in urgency episodes are included in the Prescribing Information of GEMTESA, which is unique among currently-available OAB treatments. Urgency episode reduction data are particularly relevant for OAB patients and their health care providers, as they show GEMTESA’s direct impact on a hallmark symptom of the condition,” said Cornelia Haag-Molkenteller, M.D., Ph.D., chief medical officer of Urovant Sciences. “By successfully treating clinical symptoms, GEMTESA may allow patients to overcome the devastating impact that OAB can have on their daily lives.”

GEMTESA is an oral, once-daily tablet containing 75 mg of vibegron, a small-molecule β3 agonist which helps relax the detrusor bladder muscle so that the bladder can hold more urine, thereby reducing symptoms of OAB.

“GEMTESA is the first beta 3-agonist available as a once-daily pill which does not require dose titration,” said David Staskin, MD, clinical trial investigator and a leading urologist with St. Elizabeth’s Medical Center in Boston. “Notably, GEMTESA did not have any increase in the adverse event of hypertension compared to placebo in the key EMPOWUR study and has no interactions with medications metabolized by CYP2D6, which is important since many common medications are metabolized by CYP2D6.”

The FDA’s approval is based on results from an extensive development program involving more than 4,000 OAB patients, including the 12-week double blind, placebo-controlled Phase 3 EMPOWUR study with a dose of 75 mg and the double blind EMPOWUR long term extension study.1 These data show that treatment with GEMTESA resulted in statistically significant reductions in daily UUI, micturitions, and urgency episodes and an increase in the volume voided when compared to placebo in EMPOWUR.

The most common adverse reactions of GEMTESA from the double blind, placebo-controlled EMPOWUR study in ≥2% of patients were headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. GEMTESA demonstrated the same rates for the adverse events of hypertension and increased blood pressure as placebo.

Urovant is planning to launch GEMTESA in the United States late in the first quarter of 2021. To learn more about GEMTESA, please visit GEMTESA.com.

About 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

More than 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.3,4

What is 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.

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 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA is also being evaluated for the treatment of 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 subsidiary of Sumitomo Dainippon Pharma Co., 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 a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising 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 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 6,000 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 within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the impact of vibegron on patients’ OAB symptoms and Urovant’s expectations regarding the planned commercial launch and footprint for vibegron. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success and cost of Urovant’s efforts to commercialize vibegron; Urovant’s ability to realize the anticipated benefits of the co-promotion agreement with Sunovion in the manner or timeline expected; Urovant’s reliance on Sunovion for the co-promotion and distribution of vibegron and Urovant’s ability to secure alternative access to commercial infrastructure or strategic collaborations for the commercialization or distribution of products if it is unable to continue the relationship with Sunovion; the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings with the SEC. Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

  1. Staskin, D., 2020. 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 | Journal of Urology. https://www.auajournals.org/doi/10.1097/JU.0000000000000807
  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. https://doi.org/10.1016/j.urology.2010.08.039
  4. 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

Media Contacts:

Urovant Sciences 
Ryan Kubota
ryan.kubota@urovant.com
949-769-2706

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Sumitovant Biopharma Announces Myovant Sciences receives FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer

NEW YORK, LONDON, BASEL, Switzerland, Dec. 18, 2020 (GLOBE NEWSWIRE) — Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that Myovant Sciences, a healthcare company focused on redefining care for women and for men, and one of five healthcare companies in the Sumitovant family of companies received U.S. Food and Drug Administration (FDA) approval of ORGOVYXTM (relugolix) for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available in January 2021.

“ORGOVYX’S approval after receiving Priority Review by the FDA is a significant milestone and the first approval for the Sumitovant family of companies that are focused on bringing treatment options more rapidly to patients in the U.S. and other countries,” said Myrtle Potter, CEO of Sumitovant Biopharma.

“I am enormously pleased by the approval of ORGOVYX and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy,” said Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO program steering committee member. “For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone, with a safety analysis showing a lower incidence of major adverse cardiovascular events compared to leuprolide injections, the current standard of care, as evaluated in the Phase 3 HERO study and published in the June 2020 New England Journal of Medicine. The COVID-19 pandemic has heightened the importance of oral treatments as men with prostate cancer continue to experience difficulties and risks traveling to receive injections.”

“Prostate cancer is a very personal journey, but a universal truth is that those of us living with this disease want better treatments and options. That is why the approval of ORGOVYX is such an exciting milestone that brings a long-awaited oral treatment option to men with advanced prostate cancer,” said Thomas Farrington, president and founder of the Prostate Health Education Network. “It is so important for men to speak with their doctor and explore what treatment is right for them as they focus on their overall health.”

“With the approval of ORGOVYX, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once-a-day,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. “We have successfully built our commercial capabilities to bring this newly approved treatment to the urologists and oncologists who care for men with advanced prostate cancer, with the goal of establishing ORGOVYX as the new standard of care. We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of ORGOVYX through its Priority Review pathway.”

In the Phase 3 HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care. ORGOVYX also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). ORGOVYX lowered prostate-specific antigen (PSA), on average, by 65% at Day 15 and by 83% at Day 29. In a substudy, 55% of men treated with ORGOVYX achieved normal testosterone levels (> 280 ng/dL) or returned to baseline within 90 days of treatment discontinuation. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. The HERO data were previously presented in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, with simultaneous publication in the New England Journal of Medicine.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men diagnosed with prostate cancer are alive in the U.S., and approximately 190,000 men are estimated to be newly diagnosed in 2020.

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. Approximately 300,000 men are treated with androgen deprivation therapy each year.

About ORGOVYXTM (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

For full prescribing information, including patient information, please click here.

Indication
ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information 
Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYXTM for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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 Sumitovant Biopharma Ltd.
Sumitovant Biopharma Ltd. is a global biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns 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.  Follow Sumitovant on 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 the European Union. 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 6,000 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 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 and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of ORGOVYX; Myovant’s expectation that ORGOVYX will become available in January 2021; Myovant’s expectations regarding the potential commercial launch of ORGOVYX in the United States, including launch timing; Myovant’s goal of establishing ORGOVYX as the new standard of care in advanced prostate cancer; Myovant’s plans to offer a patient assistance program for patients; and the features of such patient assistance program, including insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to 2 months of therapy, and patient assistance for qualifying uninsured patients.

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’s dependence on the success of ORGOVYX; Myovant’s ability to sustain a commercial field organization and distribution network; the degree of acceptance of ORGOVYX among physicians, patients, healthcare payors, patient advocacy groups, and the general medical community; Myovant’s ability to obtain favorable coverage and reimbursement from third-party payors for ORGOVYX; and Myovant’s reliance on third parties for the manufacture of ORGOVYX. 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 November 12, 2020, 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.

Media Contact:
Mary Stutts
Sumitovant Biopharma
703-373-0097
mary.stutts@sumitovant.com

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Myovant Sciences Announces FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer

BASEL, Switzerland, Dec. 18, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the U.S. Food and Drug Administration (FDA) has approved ORGOVYX™ (relugolix) for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available in January 2021.

Multimedia components are available with this press release here.

“I am enormously pleased by the approval of ORGOVYX and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy,” said Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO program steering committee member. “For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone, with a safety analysis showing a lower incidence of major adverse cardiovascular events compared to leuprolide injections, the current standard of care, as evaluated in the Phase 3 HERO study. The COVID-19 pandemic has heightened the importance of oral treatments as men with prostate cancer continue to experience difficulties and risks traveling to receive injections.”

“Prostate cancer is a very personal journey, but a universal truth is that those of us living with this disease want better treatments and options. That is why the approval of ORGOVYX is such an exciting milestone that brings a long-awaited oral treatment option to men with advanced prostate cancer,” said Thomas Farrington, president and founder of the Prostate Health Education Network. “It is so important for men to speak with their doctor and explore what treatment is right for them as they focus on their overall health.”

“With the approval of ORGOVYX, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once-a-day,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. “We have successfully built our commercial capabilities to bring this newly approved treatment to the urologists and oncologists who care for men with advanced prostate cancer, with the goal of establishing ORGOVYX as the new standard of care. We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of ORGOVYX through its Priority Review pathway.”

In the Phase 3 HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care. ORGOVYX also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). ORGOVYX lowered prostate-specific antigen (PSA), on average, by 65% at Day 15 and by 83% at Day 29. In a substudy, 55% of men treated with ORGOVYX achieved normal testosterone levels (> 280 ng/dL) or returned to baseline within 90 days of treatment discontinuation. The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. The HERO data were previously presented in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, with simultaneous publication in the New England Journal of Medicine.

Myovant is committed to ensuring that men in the U.S. who are prescribed ORGOVYX can obtain access and receive the support they may need throughout their treatment journey. As part of this commitment, Myovant is launching the ORGOVYX Patient Support Program which provides insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to two months of therapy, and patient assistance for qualifying uninsured patients. For more information, please contact 833-ORGOVYX (833-674-6899), 8 a.m.–8 p.m. Eastern Time, Monday–Friday.

Conference Call and Webcast
Myovant will hold a conference call on December 21, 2020 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the FDA approval of ORGOVYX™ for men with advanced prostate cancer. 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. 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 will be archived on Myovant’s investor relations website.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men diagnosed with prostate cancer are alive in the U.S., and approximately 190,000 men are estimated to be newly diagnosed in 2020.

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. Approximately 300,000 men are treated with androgen deprivation therapy each year.

About ORGOVYX™ (relugolix)
ORGOVYX (relugolix) is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

For full prescribing information, including patient information, please click here.

Indication
ORGOVYX is approved for the treatment of adult patients with advanced prostate cancer.

Select Important Safety Information 
Androgen deprivation therapy, such as ORGOVYX, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Most common adverse reactions (≥ 10%) in patients receiving ORGOVYX were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

Most common laboratory abnormalities (≥ 15%) in patients receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix (120 mg) is FDA-approved as ORGOVYX™ for adult patients with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 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.

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 and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of ORGOVYX; Myovant’s expectation that ORGOVYX will become available in January 2021; Myovant’s expectations regarding the potential commercial launch of ORGOVYX in the United States, including launch timing; Myovant’s goal of establishing ORGOVYX as the new standard of care in advanced prostate cancer; Myovant’s plans to offer a patient assistance program for patients; and the features of such patient assistance program, including insurance verifications, prior authorizations, copay support for commercially-insured patients, free trial for up to 2 months of therapy, and patient assistance for qualifying uninsured patients.

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’s dependence on the success of ORGOVYX; Myovant’s ability to sustain a commercial field organization and distribution network; the degree of acceptance of ORGOVYX among physicians, patients, healthcare payors, patient advocacy groups, and the general medical community; Myovant’s ability to obtain favorable coverage and reimbursement from third-party payors for ORGOVYX; and Myovant’s reliance on third parties for the manufacture of ORGOVYX. 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 November 12, 2020, 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.

SOURCE: Myovant Sciences

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

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

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Urovant Sciences Announces Topline Data from Phase 2a Study of Vibegron for the Treatment of Irritable Bowel Syndrome (IBS) Pain Did Not Meet Primary Endpoint

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Nov. 24, 2020– Urovant Sciences (Nasdaq: UROV)today reported topline data from the Phase 2a randomized, double blind, placebo-controlled clinical trial evaluating once-daily vibegron 75 mg in women with abdominal pain due to irritable bowel syndrome (IBS) with IBS-D (diarrhea) and IBS-M (mixed IBS).

A total of 222 female IBS patients were enrolled at 35 sites in the United States, 189 of whom completed the 12-week study. In the primary efficacy analysis, the study did not meet the primary endpoint with 40.9 percent of vibegron IBS-D patients achieving at least a 30 percent improvement in average worst abdominal pain over the week 12 period, compared to 42.9 percent in the placebo group. A responder was defined as a subject with at least a 30 percent decrease in “worst abdominal pain in the past 24 hours” compared to the weekly baseline average over the 12-week period.

The most important secondary endpoint demonstrated 42.4 percent of Global Improvement Scale (GIS) responders at Week 12 for IBS-D patients in the vibegron group, compared with 33.3 percent for placebo but this was not statistically significant for the IBS-D, IBS-M or the overall IBS population. Urovant will continue to analyze the full data set of this study.

Vibegron was very well tolerated in the study and did not lead to any worsening of IBS symptoms. Discontinuation rates due to adverse events were 0 percent in the vibegron group and 2.7 percent in placebo. The frequency of serious adverse events was similar across treatment arms with 1 serious adverse effect in the placebo group and 2 in the vibegron treatment group which were not considered treatment related by the investigator. The adverse events reported for vibegron were in the placebo range (33.3 percent in both groups). In particular, the adverse events of worsening of IBS were 2.7 percent for both vibegron and placebo and the adverse event of diarrhea was 0 percent for vibegron 75 mg and 1.8 percent for placebo respectively.

“While we are disappointed by the topline results from this Phase 2a trial, we want to sincerely thank the patients, investigators and their site staff who participated,” said Cornelia Haag-Molkenteller, M.D., Ph.D., chief medical officer of Urovant Sciences. “We look forward to advancing our Phase 3 program for vibegron in men with overactive bladder and benign prostatic hyperplasia (BPH), as well as our Phase 2a program for URO-902 in OAB and look forward to the U.S. Food and Drug Administration’s (FDA) upcoming assigned Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020 for the New Drug Application (NDA) for vibegron to treat overactive bladder (OAB).”

About Irritable Bowel Syndrome Related Pain
Irritable bowel syndrome (IBS) is characterized by recurrent abdominal pain associated with two or more of the following symptoms: defecation, change in stool frequency, and/or change in stool form or appearance. In the United States, approximately 30 million to 40 million have IBS symptoms, 30 percent of whom consult with a physician.1 Approximately 80 percent of these patients identify pain as a symptom contributing to the severity of their IBS2 and it is estimated 7.2 million to 9.6 million IBS patients suffer from IBS-associated pain.1 While there are approved therapies for IBS with constipation and IBS with diarrhea, these therapies do not adequately address IBS-associated pain. Moreover, there are no currently marketed drugs indicated specifically for IBS-associated pain.3

About Vibegron 
Vibegron is an oral, once-daily small molecule beta-3 agonist that is being evaluated for overactive bladder (OAB), OAB in men with benign prostatic hyperplasia (OAB+BPH) and for abdominal pain associated with irritable bowel syndrome (IBS).

Urovant has submitted a New Drug Application (NDA) for vibegron in OAB to the U.S. Food and Drug Administration’s (FDA), which has an assigned Prescription Drug User Fee Act (PDUFA) goal date of December 26th. Data available to date on vibegron, which includes an international Phase 3 safety and efficacy study for OAB, indicate vibegron is well tolerated. If approved, vibegron would be the first new branded prescription drug for the treatment of OAB in nearly a decade and would offer these suffering patients another potential treatment option.

About Urovant Sciences
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The Company’s lead product candidate, vibegron is being evaluated for overactive bladder (OAB), OAB in men with benign prostatic hyperplasia (OAB+BPH), and for abdominal pain associated with irritable bowel syndrome (IBS). Urovant’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 subsidiary of Sumitovant Biopharma Ltd., which is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., 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 a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising 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 the European Union. 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 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

  1. Canavan C., et al., Clinical Epidemiology 2014
  2. Lovell RM, Ford AC, et al., Clin Gastroenterol Hepatol. 2012; Drossman DA, et al., J Clin Gastroenterol 2009
  3. International Foundation for Gastrointestinal Disorders, accessed December 14, 2018; https://www.aboutibs.org/treating-ibs-pain.html

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief, or expectations, and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions; including expectations regarding the clinical development of vibegron in patients with overactive bladder (OAB), the clinical development of URO-902 in patients with OAB, the clinical development of vibegron in patients with OAB+BPH and IBS-pain, and the related status of FDA approval. The Company’s forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted, or expected. Although the Company believes that the assumptions underlying these forward-looking statements are reasonable, they are not guarantees and the Company can give no assurance that its expectations will be attained. Factors that could materially affect the Company’s operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to: the Company’s limited operating history and the fact that it has never generated any product revenue; the Company’s ability to achieve or maintain profitability in the future; the Company’s dependence on the success of its lead product candidate, vibegron; the impact on the Company’s business, financial results, results of operations and ongoing clinical trials from the effects of the COVID-19 pandemic; the Company’s ability to satisfy future funding needs on commercially reasonable terms and conditions if at all; the Company’s dependence on Sumitomo Dainippon Pharma and its affiliates to provide loan funding under the Company’s loan agreement and commercial and operational support for the Company’s product candidates and the significant control Sumitomo Dainippon Pharma Co., Ltd., through its wholly owned subsidiary, Sumitovant Biopharma Ltd., can assert over the Company through its ownership of the Company’s common shares and control of the Company’s board of directors; the Company’s reliance on its key scientific, medical or management personnel, and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Company’s clinical trials for vibegron and URO-902 and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; the Company’s dependence on Merck Sharp & Dohme Corp. and Ion Channel Innovations, LLC to have accurately reported results and collected and interpreted data related to vibegron and URO-902 prior to the Company’s acquisition of the rights related to these product candidates; reliance on third parties to conduct, supervise, and monitor the Company’s clinical trials; reliance on a single supplier for the enzyme used to manufacture vibegron; the ability to obtain, maintain, and enforce intellectual property protection for the Company’s technology and products; risks related to significant competition from other biotechnology and pharmaceutical companies; the failure to achieve the market acceptance necessary for commercial success for a product candidate; and other risks and uncertainties listed in the Company’s filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented, or superseded from time to time by other filings with the SEC. 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, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Investor and Media Inquiries: 
Ryan Kubota
949.769.2706 
ryan.kubota@urovant.com

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