) 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
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
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
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
Sarepta Therapeutics, Inc.
) with a Zacks Rank #1 (Strong Buy).
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