) gained 4.7% on the announcement of the receipt of Qualified
Infectious Disease Product (QIDP) and Fast Track designations for
its clostridium difficile-associated diarrhea (CDAD) candidate,
The QIDP designation allows the U.S. Food and Drug
Administration (FDA) to review the new drug application (NDA) for
cadazolid on a nine-month priority basis. The Fast Track
designation is intended to promote communication and
collaboration between the FDA and Actelion on the development of
Cadazolid is currently in a phase III program (IMPACT) for the
treatment of CDAD. The program is composed of two studies which
will evaluate the safety and efficacy of cadazolid (250 mg,
administered orally, twice daily) as compared to Vancocin (125
mg, administered orally, four times daily) in CDAD patients for
The studies will evaluate whether the clinical response of
cadazolid is non-inferior to Vancocin in CDAD patients and
whether administration of cadazolid is superior to Vancocin in
sustained clinical response. Enrollment began in the fourth
quarter of 2013. The program is expected to enroll 1280 patients
globally. Results are expected in early 2016.
Another interesting candidate in Actelion's pipeline is a
pulmonary arterial hypertension (PAH) candidate, selexipag. The
final results from a phase III study on selexipag are expected in
The successful development and commercialization of cadazolid
will enable Actelion to build an additional specialty franchise
Actelion carries a Zacks Rank #2 (Buy). Investors looking for
better-ranked stocks in the biopharma sector may consider
Gilead Sciences Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).
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