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
58% of Consumers Say They Don't Care Whether a Product is a National Brand or Private Label. They Just Buy What They Need21.8.2026 12:00:00 CEST | Press release
New NIQ & World Data Lab report reveals how consumer polarization is redefining value, accelerating private label adoption, and reshaping competition on the shelf As fast-moving consumer goods (FMCG) prices rose 26% globally between 2021 and 2025, consumers have become more deliberate about where they save and where they spend. NielsenIQ (NYSE: NIQ) has released new findings showing that private label is no longer viewed simply as a lower-cost substitute, but as a credible competitor across value, mainstream, and premium segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819950224/en/ Private label is no longer just a value play. The findings, published in NIQ’s latest report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, created in collaboration with World Data Lab, show how consumer polarization is redefining value and reshaping competition on the shelf. The report also draws on ins
Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 21:10:00 CEST | Press release
Company to focus on deepening its Autonomous IT capabilities, further expanding AI offerings across its portfolio, and strengthening customer and partner engagement Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build
PCI Energy Solutions to Join Mitsubishi Electric, Reinforcing Long-Term Commitment to Customers, Employees, and the Energy Industry20.8.2026 19:46:00 CEST | Press release
Mitsubishi Electric to retain PCI’s core management team and support continuity of operations, customer service, and product innovation PCI Energy Solutions ("PCI"), a leading U.S.-based provider of enterprise software for energy management and optimization, announced today that it has entered into a definitive agreement to be acquired by Mitsubishi Electric Corporation. The agreement was executed on August 20, 2026 (Japan Standard Time). The Transaction represents a strong endorsement of PCI's business, technology, employees, customer relationships and position in the energy industry. Mitsubishi Electric intends to retain PCI's core management team following completion of the Transaction, enabling PCI to preserve leadership continuity, industry expertise and its customer-focused operating model while benefiting from Mitsubishi Electric's global scale, complementary capabilities and long-term investment capacity. The agreement has been signed, but the Transaction has not yet closed. PC
Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 19:02:00 CEST | Press release
Awards include significant Oil & Gas projects in MENA and Canada, as well as the Company's largest single leak detection project to date and continued growth at its new Ohio facility. Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizabl
Impartner Launches the First CPQ Built for Partners20.8.2026 15:00:00 CEST | Press release
New quote management capability brings configure, price, and quote (CPQ) into Impartner’s PRM platform, connecting product configuration, pricing, segmentation, and approvals. Impartner, the leading partner revenue orchestration platform, today announced the launch ofImpartner CPQ, giving partners a direct path to create and advance quotes within the Impartner PRM platform. The new capability enables faster movement from opportunity to submission while giving vendors control over the rules, products, pricing, and approvals that govern each transaction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260820479441/en/ Give partners a faster path from opportunity to quote with Impartner's CPQ. For many partnership programs, quoting remains a largely manual process. Partners often depend on vendor sales teams to prepare quotes because traditional CPQ systems are designed primarily for direct sellers or require additional licensin
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