Santarus, Inc. recently enrolled the last patient for the CONTRIBUTE study (n=509) on its ulcerative colitis drug, Uceris (budesonide). Santarus is developing Uceris as an add-on therapy. The company is evaluating the incremental benefit of a dosage of Uceris extended release 9 mg tablets plus oral aminosalicylate (5-ASA) therapy for disease remission in adults.
The primary objective of the multicenter, randomized, double-blind, placebo controlled 8-week study is clinical remission, which is defined as a score of 0 for both rectal bleeding and stool frequency on the Ulcerative Colitis Disease Activity Index (UCDAI) scale.
We note that Uceris was approved by the US Food and Drug Administration (FDA) in Jan 2013, for the induction of remission in patients suffering from mild-to-moderate ulcerative colitis. The product was launched in Feb 2013, earlier than the company’s initial launch date of Mar 2013. Santarus’ shares were up significantly on the FDA approval of Uceris. Uceris is off to a strong start and should continue performing well. Santarus reported Uceris sales of $6.6 million in the first quarter of 2013.
We note that Santarus has an impressive pipeline with phase III candidates such as Ruconest and rifamycin SV MMX.
Ruconest is currently under FDA review for the treatment of hereditary angioedema (HAE) patients suffering from acute angioedema attacks. A response from the US regulatory body is expected by Apr 16, 2014 (target date).
Ruconest is already approved in Europe for the same indication. We note that it enjoys orphan drug status in the US for treating acute attacks of HAE as well as for the prophylactic treatment of HAE. Once approved, Ruconest could have 12 years of data exclusivity.
We are also encouraged by the company’s effort to stem the decline in prescription trends for the branded Zegerid (heartburn). Santarus resumed promotion of Zegerid in Feb 2013.
We expect investor focus to remain on the Uceris launch, the Zegerid re-launch and the outcome of the FDA advisory panel meeting for Ruconest.
Santarus, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Stocks in the biopharma space, which appear to be more attractive, include Jazz Pharmaceuticals (JAZZ - Free Report) , Medivation, Inc. and Sarepta Therapeutics, Inc. (SRPT - Free Report) with a Zacks Rank #1 (Strong Buy).