Astellas Pharma, Inc. ALPMY announced that its infectious disease drug, Cresemba has gained FDA approval for the treatment of adults, who are suffering from invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).
Cresemba will be available for oral or as well as intravenous administration. The drug is being developed by Astellas in partnership with Basilea Pharmaceutica Ltd. While Astellas holds the exclusive license to Cresemba in the U.S. and Canada, Basilea holds complete rights to the product in the rest of the world. The approval of Cresemba for the treatment of invasive aspergillosis in the U.S., has triggered a milestone payment of CHF30 million from Astellas to Basilea.
We remind investors that Cresemba is currently under review in the EU for the treatment of invasive aspergillosis and mucormycosis with a response expected by the fourth quarter of 2015.
Meanwhile, Astellas is working for the label expansion of Cresemba. The product is being evaluated in a phase III study (ACTIVE) for the treatment of patients suffering from invasive candidiasis. Top-line results from the ACTIVE study should be out in the second half of 2015.
We are encouraged by the approval of Cresemba and believe that the drug should strengthen Astellas’ infectious disease franchise (consisting of AmBisome and Mycamine). According to Astellas, there is a significant unmet medical need for the treatment of invasive aspergillosis and invasive mucormycosis. Hence, we believe that Cresemba has strong opportunity to gain a large market share.
Astellas carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector are Lannett Company, Inc. LCI, Salix Pharmaceuticals Ltd. SLXP and Endocyte, Inc. ECYT. While Lannett and Salix carry a Zacks Rank #1 (Strong Buy), Endocyte holds the same Zacks Rank as Astellas.
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