Cosmo's licensee Santarus receives FDA approval of UCERIS(TM)

Cosmo's licensee in the US Santarus receives FDA approval of UCERIS(TM) for
the induction of remission in patients with active, mild to moderate
ulcerative colitis

Lainate, Italy - January 15, 2013 - Cosmo Pharmaceuticals, (SIX:COPN) today
announced that its licensee in the USA, Santarus (NASDAQ:SNTS) announced that
the U.S. Food and Drug Administration (FDA) has approved the New Drug
Application (NDA) for UCERIS(TM) (budesonide) extended release tablets for the
induction of remission in patients with active, mild to moderate ulcerative
colitis. Santarus expects the commercial launch of UCERIS to begin in March

UCERIS(TM) contains budesonide, a corticosteroid, in a novel oral tablet
formulation that utilizes proprietary MMX® multi-matrix system colonic
delivery technology. The approved dosing regimen for adult patients is one 9
mg tablet taken orally once daily in the morning for up to 8 weeks. UCERIS(TM)
was developed in collaboration with Cosmo Technologies Limited, a subsidiary
of Cosmo Pharmaceuticals S.p.A.

"The FDA approval of UCERIS(TM) provides an important new therapeutic option
to patients and physicians for the treatment of active, mild to moderate
ulcerative colitis," said William J. Sandborn, M.D., chief, division of
Gastroenterology, director, University of California San Diego (UCSD) IBD
Center and professor of clinical medicine, UCSD Health System. "Specifically,
UCERIS(TM) is indicated for use in the induction of remission of active
disease, an acute phase of the disease often characterized by cramping,
bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel

Mauro Ajani, Chairman and CEO of Cosmo Pharmaceuticals SpA, the parent of
Cosmo Technologies Ltd said: "This approval documents the versatility of the
MMX technology for colonic applications. Uceris(TM) is the only corticosteroid
approved for treatment of patients with active mild to moderate ulcerative
colitis in the USA. We are very pleased to have contributed to US patients'
now having an important treatment option".

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.
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:

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
forward-looking statements.

Press release (PDF)

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