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Cosmo & Ferring Pharmaceuticals enter into licensing agreement for CORTIMENT®MMX® (budesonide) in Japan

Luxembourg, 14 December 2015 – Cosmo Pharmaceuticals S.A. (SIX: COPN) announced today that it has signed a licensing agreement with Ferring Pharmaceuticals, granting Ferring the rights to CORTIMENT®MMX® for Japan.

In Japan, it is believed that as many as 160’000 people suffer from ulcerative colitis, a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life.

If approved, CORTIMENT®MMX® will offer a treatment with a novel formulation for active, mild-to-moderate ulcerative colitis. Its oral tablet formulation, which utilizes MMX® multi-matrix technology, is designed to result in a prolonged release and distribution of budesonide throughout the length of the colon.

Ferring already had the rights of CORTIMENT®MMX® ex-US, ex-Japan and is currently launching in Europe and many territories.

“We are very pleased to have acquired rights to CORTIMENT®MMX® for Japan. Ferring Pharmaceuticals is committed to building its gastroenterology franchise in Japan and to improving the quality of life and outcomes for Japanese patients suffering from Intestinal Bowel Disease. CORTIMENT®MMX® is Ferring Japan’s second entry in the gastroenterology field1”, said Michel Pettigrew, President of the Ferring Executive Board and COO.

Alessandro Della Cha, CEO of Cosmo Pharmaceuticals SA said: “We firmly believe that CORTIMENT®MMX® will play an increasingly important role in treating ulcerative colitis patients in Japan. Ferring is one of the most experienced companies in inflammatory bowel disease world-wide and we are pleased to extend our collaboration to Japan.”

Under the terms of the agreement, Ferring will conduct, at its expense, the necessary clinical trials which are required for the submission of the registration in Japan. Ferring will commit to a payment of EUR 8 million and double digit royalties upon first sale of the product.


1 First entry is the submission of PICOPREP® (sodium picosulphate, magnesium oxide, citric acid), an oral solution indicated for cleansing of the colon as a preparation for colonoscopy in adults.


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About CORTIMENT®MMX®
CORTIMENT is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes MMX® multi-matrix technology and is designed to result in the prolonged release and distribution of budesonide throughout the length of the colon. Budesonide has mainly topical anti-inflammatory activity and due to its high first pass metabolism, it has low system bioavailability. Budesonide using MMX® technology may be marketed under another name in some countries.

About Ulcerative Colitis
Ulcerative Colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis do not respond to aminosalicylate (5-ASA) drugs and require a different or add on therapy. Patients refractive to treatment with 5-ASA drugs typically receive a course of a systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

About Cosmo Pharmaceuticals S.A.
Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal and topically treated Skin Disorders. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company is developing a diagnostic for the detection of colon cancer and a medical device for polyp excision as well as new chemical entities that are being developed by the associate company Cassiopea SpA for the topical treatment of skin diseases.
Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Salix and in the Rest of the World except for Japan to Ferring as Cortiment®. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com
Financial agenda
Results 2015: 7 March, 2016
AGM: 23 March, 2016

About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.


FERRING, CORTIMENT and PICOPREP are trademarks of Ferring B.V. MMX is a trademark of Cosmo Pharmaceuticals SA. UCERIS in the USA is a trademark of Santarus Inc/Salix Pharmaceuticals Inc.

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.


For further information:

Cosmo Pharmaceuticals S.A.
Dr. Chris Tanner, CFO and Head of Investor Relations
Tel: +352 2784 87 49
ctanner@cosmopharma.com

Ferring Pharmaceuticals
Helen Gallagher
Corporate Communications
Tel. +41 58 301 00 51
helen.gallagher@ferring.com

Nicole Barraud-Estoppey
Corporate Communications
Tel. +41 58 301 00 53
nicole.barraud-estoppey@ferring.com

 

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