* Says U.S. study evaluates drug in ulcerative colitis
* Expects top-line results from European study in Nov
* Shares up 14 percent after-hours
Sept 29 Santarus Inc SNTS.O and its Italian
partner Cosmo Pharmaceuticals (COPN.S) said their experimental
anti-inflammatory drug met the main goal of a U.S. late-stage
study in treating patients with inflammatory bowel disease.
The company said the study evaluating the once daily drug
Budesonide MMX met the primary goal of superiority to a dummy
drug in achieving clinical remission after eight weeks of
The drug, in its 9 milligram and 6 milligram dosage, was
also well tolerated, the companies said in a joint statement.
The drug is being evaluated in two late stage trials for
the treatment of mild or moderate active ulcerative colitis --
a form of inflammatory bowel disease that produces inflammation
and ulcers along the inside of the colon.
Results from an European late-stage study is expected in
"Assuming positive results in the European clinical study
we plan to submit the new drug application in the second half
of 2011," Santarus Chief Executive Gerald Proehl said.
Santarus shares, which have lost almost 12 percent since
the company cut about 37 percent of its workforce in June, were
trading up 14 percent at $3.20 in Wednesday after-hours trade.
They closed at $2.80 on Nasdaq.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by