Astellas Pharma, Inc. (ALPMY) announced the presentation of new data on Cresemba (isavuconazole) from an open-label, multi-center phase III study (VITAL) for invasive mucormycosis (also known as zygomycosis) in immunocompromised patients.
According to an analysis by an independent data review committee, 31.4% of the patients enrolled in the study showed successful overall response at the end of the treatment with Cresemba. Moreover, 54.5% (more than half) of the patients who were refractory to prior antifungal therapy were alive after undergoing treatment for 84 days. There were no new safety issues related to Cresemba in the patients.
We remind investors that Cresemba is under review in the U.S. for the treatment of invasive mucormycosis and aspergillosis. With fast track status in the U.S., the FDA review is expected to be completed by Mar 8, 2015. Cresemba has orphan drug status and Qualified Infectious Disease Product (QIDP) designation in the U.S. for both indications.
Cresemba also has orphan drug status in the EU for the same indications. It is under the European Marketing Authorization’s review with a response expected by the fourth quarter of 2015.
Astellas is developing Cresemba in collaboration with Basilea Pharmaceutica Ltd. While Astellas has exclusive rights to develop, manufacture and commercialize Cresemba in the U.S. and Canada, Basilea holds complete rights to Cresemba in other markets.
Given the rising number of immunocompromised patients who are at a risk of developing invasive mucormycosis, we believe Cresemba stands to gain a large share of the market, if approved.
Astellas carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector are Lannett Company, Inc. (LCI), Shire plc (SHPG) and Pacira Pharmaceuticals, Inc. (PCRX). All these stocks carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment