The Dutch Regulatory Agency (MEB) reverses decision
and approves Cosmo's Cortiment(TM) MMX
Lainate, Italy - February 1, 2013 - Cosmo Pharmaceuticals, (SIX:COPN)
announces that it was informed by the Dutch Regulatory Agency (MEB) that the
Appeals Committee put in place to review the MEBs decision of August 8, 2012
has now approved Cortiment(TM) (budesonide with Cosmo's MMX(TM) technology),
indicated for the induction of remission in patients with active, mild to
moderate ulcerative colitis for marketing in the Netherlands.
Mauro Ajani, Chairman and Chief Executive Officer of Cosmo Pharmaceuticals,
said: "I am very glad that MEB has come back on its decision. This will pave
the way for making available a low risk steroid which fills a critical need of
the around 900'000 patients suffering from ulcerative colitis in the EU. Given
the complex framework of EU regulations we will now assess the best means to
pursue approval for the marketing of Cortiment(TM) MMX in the other EU member
states so that Ferring, our licensee partner can start marketing Cortiment(TM)
MMX as quickly as possible."
About Ulcerative Colitis
Ulcerative colitis is 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, diarrhea, bleeding, fatigue, weight loss and frequent bowel
movements, which may also strongly affect quality of life. It is believed that
as many as 0.7 million people in the U.S. and as many as 0.9 million people in
the EU have 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
Cosmo is a speciality 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 new chemical entity for the topical skin treatment. Cosmo's first
MMX® product that has reached the market is Lialda®/Mezavant®/Mesavancol®, a
treatment for IBD that is licensed globally to Giuliani and Shire Limited and
on January 14, 2013 the FDA approved Uceris(TM), licensed to Santarus, for the
induction of remission in patients with mild to moderate ulcerative colitis.
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 intestines.
For further information on Cosmo, please visit the Company's website:
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 and endocrinology. Ferring has
its own operating subsidiaries in more than 50 countries and markets its
products in more than 90 countries. To learn more about Ferring or our
products please visit www.ferring.com.
Contact: Cosmo Pharmaceuticals S.p.A.
Dr. Chris Tanner, CFO and Head of Investor Relations
Tel: +39 02 9333 7614
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
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