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Astellas Files for Amendment of Isavuconazole Study Protocol

Astellas Pharma, Inc.’s (ALPMY) partner Basilea Pharmaceutica Ltd. announced that the former has submitted an amendment for its phase III study (:ACTIVE) protocol on isavuconazole to the relevant health authorities and ethics committees. The study is being conducted to evaluate the safety and efficacy of oral and intravenous (:IV) isavuconazole compared to Cancidas IV (caspofungin) followed by oral administration of Vfend (voriconazole) for the treatment of candidemia and other invasive Candida infections.

Under the proposed amendment, the targeted number of patients to be enrolled in the study will be reduced from 526 to 438 thereby facilitating an earlier finalization of the study.

A blinded assessment of the available study data indicated a higher evaluable patient rate than originally expected. Based on the estimated overall subject evaluability rate, the company has decided to reduce the number of patients to be enrolled in the study.

Basilea stated that this action should not adversely affect the statistical power of the primary objective of demonstrating non-inferiority in overall response rates at the end of intravenous treatment between isavuconazole and Cancidas IV.

Basilea said that if the amended protocol is approved, patient enrolment in the ACTIVE study should be completed by early 2015, earlier than previously expected. In such a scenario, top-line data should be out in the second half of 2015.

According to the press release issued by Basilea, fungal infections caused by Candida yeasts are associated with high morbidity with an estimated 15% – 49% mortality rate related to candidemia (Candida bloodstream infections).

Isavuconazole has Qualified Infectious Disease Product (:QIDP) status in the U.S. for the treatment of invasive candidiasis. It also has QIDP designation and orphan drug status in the U.S. for invasive mucormycosis and aspergillosis. Additionally, the candidate has orphan drug status in the EU for invasive mucormycosis and aspergillosis.

Isavuconazole is currently under review in the U.S. and the EU for the treatment of invasive aspergillosis and mucormycosis in adults. The FDA review is expected to be completed by Mar 8, 2015, while a response from the European Marketing Authorization (EMA.TO) should be out by the fourth quarter of 2015.

Astellas carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector are Lannett Company, Inc. (LCI), Pacira Pharmaceuticals, Inc. (PCRX) and Shire plc (SHPG). While Lannett and Pacira carry a Zacks Rank #1 (Strong Buy), Shire holds a Zacks Rank #2 (Buy).

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