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
Does Muscle Composition Identify High-Risk Individuals in Chronic Kidney Disease? New AMRA Medical Study Says Yes, Reveals Strong Link to Mortality23.4.2026 17:10:00 CEST | Press release
AMRA Medical researchers recently set out to answer the question: what is the relationship between adverse muscle composition (AMC) and mortality in kidney disease? Recent findings demonstrate that AMC, characterized by low muscle volume z-score and high muscle fat infiltration, is an independent and strong predictor of all-cause mortality in individuals with chronic kidney disease (CKD). The findings, published in Clinical Journal of the American Society of Nephrology, were based on data from the UK Biobank imaging study and further reinforce the clinical relevance of MRI-derived muscle biomarkers in identifying high-risk populations across chronic diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423198497/en/ AMRA's MRI-based muscle biomarkers in clinical trials Researchers from AMRA, alongside our collaborators at Linköping University (LiU), analyzed 894 participants with CKD using AMRA’s MRI-based body composi
Diligent Unveils AI Board Member and Agentic GRC Workforce at Elevate 202623.4.2026 15:00:00 CEST | Press release
Diligent’s agentic AI strengthens board oversight and transforms how GRC teams work — reducing manual effort and outside-advisor dependency, tightening control over sensitive workflows and enabling leaders to make faster, more defensible decisions Diligent, the AI leader in governance, risk and compliance (GRC) SaaS solutions, today unveiled a new generation of autonomous AI agents, including AI Board Member — a secure AI assistant for directors — and a coordinated network of agents embedded across the Diligent One Platform. Accessible through a single command center, agents automate multi-step workflows across governance, risk, compliance and third-party management, giving organizations the impact of a “GRC manager” without adding headcount. “AI supercharges teams that embrace it, and boards are no exception,” said Brian Stafford, President and CEO of Diligent. “With AI Board Member and a network of autonomous agents woven through the Diligent One Platform, we’re giving the C-suite an
Safe Software Bolsters Leadership Team with CFO and CPO Appointments to Drive Next Phase of Growth23.4.2026 15:00:00 CEST | Press release
CFO and CPO executive hires to enhance operational and financial performance on the company’s path to $250M by 2028 Safe Software (Safe), creator of FME, the only All-Data, Any-AI enterprise integration platform, today welcomes two executives to its leadership team as it moves into the next phase of growth. Judd Lee has been appointed as the company’s Chief Financial Officer (CFO), and Vanessa Ribreau has been appointed as Chief People Officer (CPO). Having recently crossed $100M in revenue, the expanded leadership team will further enable the company to scale as it accelerates toward its goal of reaching $250M in revenue by 2028. Judd Lee is a seasoned CFO with over 15 years of experience partnering closely with CEOs to align financial strategy and accelerate sustainable growth. He is known for his strong commitment to mentorship and for building high-performing global teams rooted in trust, morale and a shared sense of purpose. With more than two decades of financial leadership acros
Corpay Cross-Border Named the Official FX Supplier of Toulouse Football Club23.4.2026 14:30:00 CEST | Press release
Providing access to currency risk management and cross-border payments solutions Corpay, Inc.*, (NYSE: CPAY) a global leader in corporate payments, is pleased to announce that Corpay’s Cross-Border business has entered into an agreement with Toulouse Football Club to become their Official Foreign Exchange (FX) Supplier. A partnership brought together by SPORTFIVE, an international sports marketing agency. Through this partnership, Corpay Cross-Border will deliver comprehensive FX risk management solutions to support Toulouse Football Club’s operations. In addition, its award-winning platform will enable the club to manage global payments seamlessly through a single point of access. “Corpay Cross-Border is proud to be named the Official FX Supplier of Toulouse Football Club,” said Brad Loder, Chief Marketing Officer, Corpay Cross-Border Solutions. “This partnership reinforces Corpay’s position as a leading provider of corporate payments and currency risk management solutions within prof
Philip Morris International Expands its Partnership with Ducati Corse as Decades-Long Partnership Races Forward with Purpose23.4.2026 14:00:00 CEST | Press release
ZYN branding to be present at select MotoGP races in the 2026 season and beyond Philip Morris International1 (NYSE: PM) today announced an expanded partnership with Ducati Corse for the 2026 season and beyond. This next chapter introduces a major development: the ZYN brand of nicotine pouches—the number one nicotine pouch brand globally2—will feature on Ducati Corse MotoGP liveries at select races throughout the seasons. Just as Ducati pushes the limits of performance, ZYN represents PMI’s commitment to delivering innovation, offering a product that delivers exceptional quality while being thoughtfully designed. This partnership allows ZYN to connect with adult consumers in a space they’re passionate about—and to do so in a way that’s authentic, respectful, and dynamic. Philip Morris International’s relationship with Ducati Corse began in 2003—the year Ducati arrived in MotoGP—ushering in a bold new era of ambition. Since then, the collaboration has evolved alongside both organizations
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