Santarus, Inc recently announced the US launch of Uceris (budesonide) extended release tablets for the induction of remission in patients suffering from mild-to-moderate ulcerative colitis. Earlier, Santarus had planned to launch the product in Mar 2013. Uceris received FDA approval in Jan 2013.
Clinical trials effectively proved the efficacy of Uceris against placebo with three times the number of patients achieving remission and mucosal healing compared to placebo. No significant side effects were noticed with Uceris.
Uceris was jointly developed by Santarus and Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. As per the agreement, Santarus will pay Cosmo $7 million on the first commercial sale of Uceris in the form of cash or common stock.
The commercial launch of Uceris ahead of time is a positive for Santarus. The company expects Uceris to contribute significantly to sales growth. At the time of approval, the company had said that it expects total revenues in the range of $320-$325 million, representing double-digit growth from the 2012 guidance. The company will jointly promote both Uceris and Zegerid to gastroenterologists.The company increased its sales force for this joint promotion.
Currently, companies like Salix Pharmaceuticals Ltd and AstraZeneca PLC have a presence in the ulcerative colitis market.
We are positive on the early launch of Uceris and expect the product to strengthen the company’s portfolio. However, we prefer to remain on the sidelines until we gain more visibility on sales.
Santarus currently carries a Zacks Rank #4 (Sell). Comparatively Valeant Pharmaceuticals International, Inc. looks better. Valeant Pharma carries a Zacks Rank #1 (Strong Buy). Meanwhile, Salix Pharma carries a Zacks Rank #2 (Buy).