• Pierre Fabre Médicament SAS (Pierre Fabre) to register and market vibegron for the treatment of overactive bladder (OAB) in the European Economic Area, United Kingdom and Switzerland.

• Urovant Sciences GmbH will receive compensation of up to US$75 million in upfront payments, regulatory and sales milestones, and sales-based royalties.

• Urovant Sciences retains all rights to commercialize vibegron (GEMTESA®) in the United States and certain other markets.

BASEL, Switzerland, & CASTRES, France, July 05, 2022–(BUSINESS WIRE)–Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament today announced that they have entered into an exclusive licensing agreement allowing Pierre Fabre to register and commercialize vibegron for the treatment of overactive bladder (OAB) in the European Economic Area, the United Kingdom and Switzerland, with some territories of option, which include in particular French-speaking countries of sub-Saharan Africa, Turkey and certain countries of Eastern Europe. Urovant will retain all rights in the United States and other selected markets.

“We are delighted to partner with Pierre Fabre, a leader in the international biopharmaceutical space,” said Jim Robinson, President and CEO of Urovant Sciences. “Their experience in the global overactive bladder and benign prostatic hyperplasia (BPH) market makes them well suited to deliver vibegron to more patients in need across Europe and surrounding areas.

Under the terms of the agreement, Urovant Sciences will receive payments of up to US$75 million, based on upfront, regulatory and sales milestone payments. In addition, Urovant will receive royalties based on sales performance.

Urovant Sciences and Pierre Fabre will share responsibility for clinical trials of vibegron in 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 with overactive bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s great expertise in urology and women’s health for five decades and the group’s ambitions to offer therapeutic solutions to very debilitating chronic diseases on a daily basis,” said Eric Ducournau, CEO of the Pierre Fabre group. .

The story continues

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), urge incontinence (involuntary loss of urine immediately after an urgent need to urinate), frequent urination (usually eight times or more in 24 hours) and nocturia (waking up more than twice in the night to urinate).¹

While 33 million American adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years of age are affected by OAB worldwide. ^1.2

About Urovant Sciences

Urovant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies for areas of unmet need, with a particular focus on urology. The company’s flagship product, GEMTESA^®(vibegron), is a small molecule beta-3 agonist taken orally once daily (75 mg) for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, d urgency and urinary frequency. GEMTESA was approved by the US FDA in December 2020 and launched in the US in April 2021. GEMTESA is also being evaluated for the treatment of overactive bladder in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy in development for patients with overactive bladder who have failed oral pharmacological 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. Discover us at www.urovant.com or follow us on Twitter or LinkedIn.

About Sumitovent Biopharma

Sumitovant is a technology-driven biopharmaceutical company accelerating the development of potential new therapies for patients with significant unmet medical needs. Through our portfolio of companies and the use of embedded computing technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-cleared products and advanced a promising pipeline of actives. early to late-stage experimental drugs for other serious conditions. Sumitovant’s portfolio of subsidiaries includes wholly-owned Enzyvant, Urovant, Spirovant and Altavant, and majority-owned Myovant (NYSE: MYOV). Sumitomo Pharma is the parent company of Sumitovant. For more information, please visit www.sumitovant.com.

About the Pierre Fabre Group

Pierre Fabre is the 2^n/a largest dermo-cosmetic laboratory in the world, the 2^n/a leading French private pharmaceutical group and leader in France of products sold without a prescription in pharmacies. Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.

In 2021, Pierre Fabre achieved 2.5 billion euros in sales, of which 66% internationally. Established in the South-West of France since its creation, the Group manufactures more than 95% of its products in France and employs some 9,500 people worldwide. Its products are distributed in approximately 115 countries. Pierre Fabre is 86% owned by the Pierre Fabre Foundation, a recognized public utility foundation, and secondarily by its own employees through an international employee shareholding plan.

To find out more, go to https://www.pierre-fabre.com/fr. 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 leaks or pee 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

Not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before taking GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have difficulty emptying your bladder or your urine stream is weak; taking medications containing digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; tell your doctor if you are pregnant or plan to become pregnant); you are breast-feeding or plan to breast-feed (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 are taking GEMTESA).

Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements. Know the medications you take. Keep a list to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA?

GEMTESA can cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your risk of not being able to empty your bladder, particularly if you have a bladder outlet obstruction or are taking other medicines for the treatment of overactive bladder. Tell your doctor immediately if you are unable to empty your bladder. The most common side effects of GEMTESA include headache, urinary tract infections, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infections. These are not all the possible side effects of GEMTESA. For more information, consult your doctor or pharmacist.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Please click here for complete GEMTESA product information.

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 International. 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: assessment 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 United States and other countries. All other trademarks are the property of their respective owners. © 2022 Urovant Science. All rights reserved.

PIERRE FABRE, the PIERRE FABRE logo are trademarks of Pierre Fabre Médicament SAS, registered in the United States and other countries. All other trademarks are the property of their respective owners. © 2022 Pierre Fabre Medicines. All rights reserved.

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contacts

Urovant Sciences
Alana Darden Powell
Vice President, Corporate Communications
949-436-3116
[email protected]

Sumitovent Biopharma
Maya Frutiger
Vice President, Head of Corporate Communications
[email protected]

Pierre Fabré
Anne Kerveillant
Media Relations PF Pharmaceuticals Management
Such. : +33 (0)6 20 88 54 57
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