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

  • Sumitomo Dainippon Pharma and Sumitovant announced the launch of a phase 1 study of a new drug candidate for carbapenem-resistant bacterial infections.
  • Two publications on Urovant’s FDA-approved OAB therapy, GEMTESA® (vibegron), showed clinical effectiveness and safety in patients with overactive bladder (OAB).
  • Spirovant presented data on an investigational novel recombinant adeno-associated virus gene therapy at the 2021 North American Cystic Fibrosis Conference.

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

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


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

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

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

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

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

In November, Spirovant presented SP-101, an investigational novel recombinant adeno associated virus (AAV) gene therapy selected for its tropism to human airway epithelia, at the 2021 North American Cystic Fibrosis Conference. In oral and poster presentations, Spirovant summarized recent pre-clinical data suggesting SP-101 functionally corrects human CF airway epithelia. In addition, the presentations showed that CFTR expression and CF correction exhibited by SP-101 are dose responsive and durable, demonstrating that SP-101 is a promising drug development candidate.

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

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

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

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

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


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.


Maya Frutiger
Sumitovant Biopharma
Head of Corporate Communications

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

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