Sumitomo Pharma Subsidiary Companies in the U.S., Including Sunovion, to Combine and Form Sumitomo Pharma America

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc., an indirect, wholly owned subsidiary of Sumitomo Pharma Co. Ltd, announced today that it will combine with affiliate companies Sumitomo Pharma America Holdings, Inc., Sumitovant Biopharma Ltd., Myovant Sciences, Inc., Urovant Sciences, Inc., Enzyvant Therapeutics, Inc., and Sumitomo Pharma Oncology, Inc. to form Sumitomo Pharma America, Inc. effective July 1, 2023. Spirovant Sciences, Inc., Sumitovant’s remaining wholly owned subsidiary, will operate as a standalone company under Sumitomo Pharma America. Sumitovant’s current CEO Myrtle Potter will serve as President and CEO of Sumitomo Pharma America upon completion of the combination.

Sumitomo Pharma America will establish a science-based, technology-driven biopharmaceutical company focused on addressing unmet patient needs in the critical areas of central nervous system, oncology, urology, women’s health, and cell and gene therapies. Sumitomo Pharma America will house a diverse portfolio of commercialized products and robust pipeline of early- to late-stage assets leveraging proprietary technology platforms and advanced computational analytics capabilities to accelerate research, development, and potential commercialization of new therapies. Each subsidiary will continue to operate independently until the combination is complete but are collaborating on key integration efforts in the interim to allow for a smooth transition for all stakeholders in preparation for Day 1 of Sumitomo Pharma America.

Hiroshi Nomura, President and CEO of Sumitomo Pharma, said, “We remain deeply committed to addressing pressing health challenges and believe Sumitomo Pharma America will serve as a valuable growth engine. Sumitomo Pharma America will have increased scale and a combined network of resources and talent to accelerate a diverse portfolio of commercial and investigational programs for critical indications while creating a sustainable platform for growth.”

“Sumitomo Pharma America represents an exciting opportunity to leverage each subsidiary’s competitive strengths to create an innovative biopharma company with the scale, agility and efficiency needed for accelerated impact and patient-focused outcomes,” said Myrtle Potter, current CEO of Sumitovant and future President and CEO of Sumitomo Pharma America. “We will combine our deep R&D and life sciences expertise with unparalleled advance technology platforms, DrugOME and Digital Innovation, to underpin growth of existing product lines and pipeline efforts. Sumitomo Pharma America will build on the group’s mission and bring needed therapies to patients sooner in key areas where treatment options remain limited or non-existent.”

“Sunovion is proud to have brought forward important therapies over the last decade, which have improved the lives of people worldwide. In addition, Sunovion’s R&D pipeline includes promising new compounds being developed for the treatment of patients suffering from serious neuropsychiatric conditions,” said Antony Loebel, M.D., President and CEO, Sunovion. “We look forward to bringing together our strengths with other Sumitomo Pharma Group companies to create new synergies that will contribute to the betterment of healthcare for all.”

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About Sunovion Pharmaceuticals Inc.

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion has charted new paths to life-transforming treatments that reflect an ongoing commitment to research and development for people living with serious psychiatric and neurological conditions. Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Pharma Co. Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s websites: www.sunovion.com and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Pharma America Holdings, Inc.

Sumitomo Pharma America Holdings, Inc. supports certain affiliates of the Sumitomo Pharma Group by providing professional shared services expertise to achieve greater efficiencies and enable discovery, development and commercialization of innovative treatments to help patients. Headquartered in Marlborough, MA, U.S., Sumitomo Pharma America Holdings, Inc. is a wholly-owned subsidiary of Sumitomo Pharma Co., Ltd., a global pharmaceutical company based in Japan.

About Sumitovant Biopharma Ltd.

Sumitovant is a technology-driven biopharmaceutical company accelerating development and commercialization of new potential therapies for patients with rare conditions and other diseases. Through its proprietary computing and data platforms, scientific expertise and diverse company portfolio, Sumitovant has supported development of multiple FDA-approved products and a robust pipeline of early- through late-stage investigational assets addressing unmet patient needs in pediatrics, urology, oncology, women’s health, specialty respiratory and infectious diseases. Sumitovant Biopharma is a wholly owned subsidiary of Sumitomo Pharma. Please visit our website www.sumitovant.com for more information on Sumitovant and our portfolio.

About Myovant Sciences

Myovant Sciences aspires to redefine care for women and men through purpose-driven science, empowering medicines, and transformative advocacy worldwide. Since its formation in 2016, Myovant has secured five regulatory approvals in the United States and Europe for its products ORGOVYX® and MYFEMBREE® in hormone-sensitive oncology and women's health, respectively. Myovant and its partners continue to file for additional indications of its products, as well as advance development of its pipeline. Myovant is a wholly owned subsidiary of Sumitovant Biopharma Ltd., as of March 10, 2023. For more information, please visit www.myovant.com.

About Urovant Sciences

Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in urology. The Company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Named one of the Fortune® Best Workplaces in BioPharma™ (2022), twice as one of the “Best Places to Work” in Orange County by the Orange County Business Journal (2021, 2022) and winner of the PM360 Trailblazer Award for Best Product Launch of the Year, Urovant’s people-focused culture leads the way for innovation and impact. Learn more at www.Urovant.com

About GEMTESA

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

• urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
• urgency: the need to urinate right away
• frequency: urinating often

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

IMPORTANT SAFETY INFORMATION

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

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

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

What are the possible side effects of GEMTESA?

GEMTESA may cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

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

Please click here for full Product Information for GEMTESA.

About Enzyvant Therapeutics

Enzyvant is a biopharmaceutical company making life-altering impact for people affected by rare disease, where the communities are small, and the human need is immense. Driven by purpose, we engage with rare disease communities with compassion and commitment, partnering to accelerate the development of transformative medicines they so urgently need. We prioritize collaborative connections with academia, industry, associations, advocacy groups and government, because strong relationships make bold science possible. A nimble and unique organization, Enzyvant has a full range of capabilities spanning non-clinical and clinical development and commercialization and is developing in-house manufacturing. Enzyvant has delivered a first-of-its-kind FDA approval in regenerative medicine and promising advances against some of the greatest challenges in immunology and cardiopulmonology. Enzyvant is part of Sumitovant, wholly owned by Sumitomo Pharma. For more information about Enzyvant and our programs, visit www.Enzyvant.com.

About Spirovant Sciences

Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company’s current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant’s lead programs are in development for cystic fibrosis. Spirovant, a wholly owned subsidiary of Sumitovant Biopharma, is located in Philadelphia, PA. For more information, please visit our website at spirovant.com.

About Sumitomo Pharma Oncology, Inc.

Sumitomo Pharma Oncology, Inc. is a wholly owned subsidiary of Sumitomo Pharma Co., Ltd. As a global oncology organization with teams in the U.S. and Japan, SMP Oncology is committed to the goal of advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. SMP Oncology's robust and diverse pipeline of preclinical and clinical-stage assets spans multiple areas, including oncogenic pathways, survival mechanisms and novel protein interactions, which aim to address unmet clinical needs in oncology. For more information, visit www.oncology.sumitomo-pharma.com.

Forward Looking Statements

This press release contains forward-looking statements that may be deemed to be “forward-looking statements” within the meaning of applicable securities laws and Sumitomo Pharma may make related oral, forward-looking statements on or following the date hereof. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein.

Media / IR Contacts
Amy Ryan
Sunovion Pharmaceuticals Inc.
amy.ryan@sunovion.com
1-617-821-8389