UROVANT-SCIENCES
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
BitGo sikrer OCC-godkendelse til konvertering til føderalt chartret National Trust Bank13.12.2025 02:12:00 CET | Pressemeddelelse
Sætter ny standard for institutionel digital aktivinfrastruktur med samlet føderal tilsyn BitGo Holdings, Inc. (“BitGo”), virksomheden inden for digital aktivinfrastruktur, annoncerede i dag, at Office of the Comptroller of the Currency (“OCC”) godkendte virksomhedens ansøgning om at konvertere BitGo Trust Company, Inc., et trustselskab registreret i South Dakota, til en nationalbank ved navn BitGo Bank & Trust, National Association (N.A.). Med dagens OCC-godkendelse af konverteringen fungerer BitGos datterselskab af Trust Company nu som BitGo Bank & Trust, National Association (N.A.). BitGo Bank & Trust, N.A. vil operere under et enkelt, ensartet føderalt tilsynssystem, der gør det muligt at levere den klarhed, styring og reguleringssikkerhed, som institutioner forventer af et føderalt reguleret fiduciært selskab. Denne godkendelse styrker BitGos position som et institutionelt fundament for det moderne finansielle system, der kombinerer tilsyn på bankniveau med den sikkerhed, complian
FIA, Formula 1 Group and All 11 Race Teams Officially Sign the Ninth Concorde Agreement, Securing Strength and Stability for the Sport in Pivotal Five-Year Agreement12.12.2025 17:10:00 CET | Press release
Multi-year Concorde Governance Agreement signed by the FIA, Formula 1 Group and all 11 teams, securing the World Championship through 2030 Paves the way for a more professionalised sport and represents a new era of collaboration between the FIA and Formula 1 Group Long-term commitment enhances sporting reliability, global reach and stability for teams, fans and broadcasters The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, and Formula 1 Group, the Commercial Rights Holder, have today announced the signing of the Concorde Governance Agreement, a crucial contract defining the regulatory framework and governance terms of the FIA Formula One World Championship until 2030. This follows the announcement in March that the 2026 Commercial Concorde Agreement had been signed by all the teams and Formula 1 Group. Together, these agreements constitute the ninth Concorde Agreement, representing a m
Anabranch Capital Management, LP supports relisting of SmartCraft ASA to Nasdaq Stockholm12.12.2025 16:26:00 CET | Press release
Reference is made to the stock exchange announcement by SmartCraft ASA ("SmartCraft" or the "Company") on 1 December 2025 regarding the contemplated relisting of SmartCraft from Euronext Oslo Børs to Nasdaq Stockholm (the "Relisting") and the announcement of a cross-border merger to effect the Relisting. Funds managed by Anabranch Capital Management, LP (“Anabranch”) intend to vote in favour of the merger plan resolved by the boards of SmartCraft and its Swedish wholly owned subsidiary, SmartCraft Group AB (publ), to effect the Relisting at the Company's extraordinary general meeting planned for January 2025 (the "EGM"). Anabranch intends to vote with all Anabranch shares held at the Record Date for the EGM in favour of the relisting effected by the merger plan. Funds managed by Anabranch currently hold approximately 15.9 million shares in SmartCraft. Disclaimer: The views expressed are those of the authors and Anabranch Capital Management, LP as of the date referenced and are subject
Mohammed Ben Sulayem Re-Elected as President of the FIA12.12.2025 15:49:00 CET | Press release
The Fédération Internationale de l’Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, today confirms that Mohammed Ben Sulayem has been re-elected as President of the FIA, following the election of his Presidential List by the General Assembly in Tashkent, Republic of Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212213181/en/ President Mohammed Ben Sulayem now begins his second four-year term, having overseen a period of significant renewal and stabilisation for the organisation since his initial election in 2021. Over the past four years, the FIA has undergone a wide-ranging transformation, improving governance, operations and restoring the financial health of the federation. These changes have strengthened the FIA’s position as the world’s governing body for motorsport and the leading authority on safe, sustainable, and affordable mobility.
Perma-Pipe International Holdings, Inc. Announces Third Quarter 2025 Financial Results12.12.2025 15:00:00 CET | Press release
Net sales of $61.1 million for the quarter and $155.8 million year-to-date.Income before income taxes of $10.9 million for the quarter and $21.1 million year-to-date.Diluted earnings per share of $0.77 for the quarter and $1.49 year-to-date.Backlog of $148.9 million at October 31, 2025, up from $138.1 million at January 31, 2025. Perma-Pipe International Holdings, Inc. (NASDAQ: PPIH) announced today financial results for the third quarter ended October 31, 2025. “For the three months ended October 31, 2025, net sales were $61.1 million, an increase of $19.5 million, or 46.9%, compared to $41.6 million in the same quarter of the prior year. Growth was driven by higher sales volumes in both the Middle East and North America. Gross profit was $21.0 million, up $6.9 million from $14.1 million last year, reflecting higher activity levels. Selling, general and administrative expenses increased to $8.3 million from $7.3 million, primarily due to higher payroll and professional fees, including
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