UROVANT-SCIENCES
5.7.2022 14:07:11 CEST | Business Wire | Press release
Urovant Sciences , a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament today announced they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries. Urovant will retain full rights in the United States and other select markets.
“We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space,” said Jim Robinson, Chief Executive Officer of Urovant Sciences. “Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas.”
Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.
Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.
“We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre's extensive expertise in urology and in women's health for five decades and the group's ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life,” said Eric Ducournau, group CEO at Pierre Fabre.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1
While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years are affected by OAB worldwide. 1,2
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for areas of unmet need, with a dedicated focus in Urology. The Company’s lead product, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. GEMTESA was approved by the U.S. FDA in December 2020 and launched in the U.S. in April 2021. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn about us at www.urovant.com or follow us on Twitter or LinkedIn .
About Sumitovant Biopharma
Sumitovant is a technology-driven biopharmaceutical company accelerating development of new potential therapies for patients with high unmet medical need. Through our company portfolio and use of embedded computational technology platforms to generate business and scientific insights, Sumitovant has supported development of FDA-approved products and advanced a promising pipeline of early-through late-stage investigational assets for other serious conditions. Sumitovant’s subsidiary portfolio includes wholly owned Enzyvant, Urovant, Spirovant and Altavant, and majority owned Myovant (NYSE: MYOV). Sumitomo Pharma is Sumitovant’s parent company. For more information, please visit www.sumitovant.com .
About Pierre Fabre Group
Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.
In 2021, Pierre Fabre generated €2.5 billion in revenues, 66% of which came from international sales. Established in the South-West of France since its creation, the Group manufactures over 95% of its products in France and employs some 9,500 people worldwide. Its products are distributed in about 115 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.
To learn more, please go to https://www.pierre-fabre.com/en . You can also join us on Twitter at @PierreFabre and Facebook at www.facebook.com/laboratoirespierrefabre .
About GEMTESA® tablets for oral use (US market)
GEMTESA® is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:
- urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
- urgency: the need to urinate right away
- frequency: urinating often
It is not known if GEMTESA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.
Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).
Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of GEMTESA?
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder. The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please click here for full Product Information for GEMTESA.
References:
1.
Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int
. 2011;108(7):1132-1138. doi:10.1111/j.1464-410X.2010.09993.x
2.
Leron E, Weintraub AY, Mastrolia SA, Schwarzman P. Overactive bladder syndrome: evaluation and management. Curr Urol
. 2017;11:117-125. doi:10.1159/000447205
UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Sciences. All rights reserved.
PIERRE FABRE, the PIERRE FABRE logo are trademarks of Pierre Fabre Medicament SAS, registered in the U.S and in other countries. All other trademarks are the property of their respective owners. © 2022 Pierre Fabre Medicament. All right reserved.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220705005255/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
TestMu AI Launches Kane CLI Exploration, an AI Agent That Maps an Entire Web App From a Single URL and Turns It Into Tests30.10.2026 15:00:00 CET | Press release
The exploration agent walks every page and flow of a web app on its own, flags UX, security and accessibility issues, and builds the map Kane CLI uses to write, run and ship tests to CI, even when no requirements exist TestMu AI, the Full Stack Agentic AI Quality Engineering platform, announced Kane CLI Exploration, an autonomous agent that learns a web application before anyone writes a test. Given a single URL, it walks the entire app on its own, flags problems along the way and gives Kane CLI the context it needs to generate and run tests, even when no requirements, user stories or acceptance criteria exist. Every test plan starts from something written down, and many apps never had it. Legacy products lose their specs when the people who wrote them move on, and apps a coding agent built in a week often have no record of intended behavior beyond the prompt history. With nothing to test against, a testing agent ends up grading the app against itself. Starting from the URL a developer
The Estée Lauder Companies and Microsoft Announce a New Strategic Partnership to Power Enterprise Efficiency and Consumer-Centric Growth30.10.2026 14:22:00 CET | Press release
The new collaboration will strengthen the company’s cloud, data, and AI capabilities to accelerate innovation and enhance productivity The Estée Lauder Companies Inc. (NYSE: EL) today announced a new strategic partnership with Microsoft Corp. to advance its cloud and data foundation and support the responsible adoption of AI-enabled capabilities across the enterprise. The collaboration will help connect data and intelligent tools to support faster innovation, more efficient operations, and more relevant consumer experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030616823/en/ This new partnership is a critical part of The Estée Lauder Companies’ One Operating Ecosystem, which brings together shared platforms, connected data, and best-in-class partners to enable consistent, scalable, and effective execution across the enterprise. A key initiative of this expanded partnership is harnessing the Microsoft platform to
Reply Named EMEA Winner at the 2026 GitHub Services and Channel Partner of the Year Awards30.10.2026 13:23:00 CET | Press release
Reply [EXM, STAR: REY] announced that it has been named the EMEA winner in the 2026 GitHub Services and Channel Partner of the Year Awards, recognising customer outcomes and GitHub ecosystem impact across Europe, the Middle East and Africa. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030597484/en/ Reply announced that it has been named the EMEA winner in the 2026 GitHub Services and Channel Partner of the Year Awards, recognising customer outcomes and GitHub ecosystem impact across Europe, the Middle East and Africa. Reply helps organisations adopt GitHub and modernise software development. Its capabilities combine large-scale migration, automation and embedded security to bring fragmented development environments into a shared platform, supporting consistent governance and collaboration across engineering teams. A key example is Reply’s collaboration with Nexi, one of Europe’s leading PayTech companies, to transform s
Centralized Supply Chain Services, LLC (CSCS®), Applebee’s®, and IHOP® Recognize 2026 Supplier Partners of the Year30.10.2026 13:00:00 CET | Press release
Pacific Prime Meats and Custom Foods of America recognized for exceptional collaboration, responsiveness and value Centralized Supply Chain Services, LLC (CSCS®), together with Applebee’s® and IHOP®, have named Pacific Prime Meats and Custom Foods of America their 2026 Supplier Partners of the Year, honoring the companies for their collaboration, innovation, and commitment to supporting restaurant success across the Applebee’s and IHOP systems. The awards were presented at the Applebee’s Franchise Conference and IHOP Supplier Summit in Austin, Texas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030647942/en/ Pacific Prime Meats was named 2026 Applebee’s Supplier Partner of the Year, recognizing the company’s exceptional responsiveness, agility, and support on behalf of the Applebee’s system. Pacific Prime Meats was named 2026 Applebee’s Supplier Partner of the Year, recognizing the company’s exceptional responsiveness,
Europerfusion 2026: Eurosets Introduces Trilly Baby, the New Oxygenator for Cardiopulmonary Bypass in the Smallest Patients30.10.2026 12:45:00 CET | Press release
Following the acquisition of the CE mark, the device will be introduced across 14 cardiac surgery centers in Europe in January 2027. The launch marks an expansion of the Italian biomedical company's portfolio, consolidating its presence in international markets Eurosets presents Trilly Baby at Europerfusion 2026 (Belgrade, October 30-31), a new oxygenator designed for cardiopulmonary bypass procedures in the smallest patients requiring open-heart cardiac surgery. Engineered to operate with flow rates from 0.1 to 1.8 liters per minute, Trilly Baby represents a further step in the evolution of the Italian biomedical company's cardiopulmonary portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030531073/en/ Trilly Baby at Europerfusion 2026. Antonio Petralia, CEO of Eurosets, and Gabriele Pastorelli, Sr. Global Marketing Manager Cardiopulmonary - LATAM Area Manager The device, which is expected to achieve the CE mark b
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom