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FDA Approval for Santarus' Uceris - Analyst Blog
1/18/2013 2:50:00 PM
) recently announced that the US Food and Drug Administration
(FDA) has granted approval to Uceris (budesonide) for the
induction of remission in patients suffering from
mild-to-moderate ulcerative colitis. The company plans to launch
the product in Mar 2013.
The approval of Uceris is a major positive for Santarus. The company expects peak sales of around $300 million. This is the second positive development for Santarus over the last few months. In Sep 2012, the US Court of Appeals for the Federal Circuit had reversed a part of an earlier decision issued by the US District Court for the District of Delaware regarding patent protection of Zegerid capsules and powder for oral suspension prescription products. As a result, the company will be re-launching Zegerid and is looking to stem the decline in prescription trends for the branded product.
Santarus shares were up significantly on the FDA approval of
Uceris and the 2013 guidance. We expect investor focus to remain
on the commercialization of Uceris and the Zegerid re-launch. We
currently have a Neutral recommendation on Santarus. The stock
carries a Zacks Rank #4 (Sell).
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