Actelion Gains on QIDP and Fast Track Status
Shares of Actelion Ltd. (ALIOF) 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, cadazolid.
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 the drug.
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 10 days.
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 mid 2014.
The successful development and commercialization of cadazolid will enable Actelion to build an additional specialty franchise beyond PAH.
Actelion carries a Zacks Rank #2 (Buy). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Gilead Sciences Inc. (GILD), Shire plc (SHPG) and Alkermes plc (ALKS), all of which carry a Zacks Rank #1 (Strong Buy).
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