Astellas Pharma, Inc. (ALPMY) and partner Basilea Pharmaceutica announced that the FDA has accepted their new drug application (NDA) for isavuconazole. The companies are looking to get isavuconazole approved for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis) in immunocompromised patients.
With fast-track status in the U.S., the FDA review is expected to be completed by Mar 8, 2015.
The acceptance of the NDA has entitled Basilea to a CHF 12 million milestone payment from Astellas. We note that isavuconazole is also under review in the EU for the same indication with an action expected from the European Medicines Agency (EMA) by the fourth quarter of 2015.
Isavuconazole has orphan drug status and Qualified Infectious Disease Product (QIDP) designation in the U.S. for the treatment of invasive aspergillosis and mucormycosis. If approved, isavuconazole will gain a five-year extension of market exclusivity in the U.S. based on the QIDP status, apart from the seven-year exclusivity based on the orphan drug designation. Additionally, isavuconazole has orphan drug status in Europe for these indications.
Astellas has exclusive rights to develop, manufacture and commercialize isavuconazole in the U.S. and Canada, whereas Basilea holds complete rights to isavuconazole in other markets.
According to the press release issued by Basilea, invasive aspergillosis occurs in approximately 5%−13% of bone marrow transplant recipients, 5%−25% of heart or lung transplant recipients and 10%−20% of intensive chemotherapy patients for leukemia. Moreover, mucormycosis causes high morbidity and mortality in immunocompromised patients including those undergoing chemotherapy or bone marrow transplantation.
Given the rising number of immunocompromised patients who are at the risk of developing invasive fungal infections, we believe isavuconazole stands to gain a large share of the market, if approved.
Astellas carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Endo International plc (ENDP), Lannett Company, Inc. (LCI) and Anacor Pharmaceuticals, Inc. (ANAC). While Endo and Lannett carry a Zacks Rank #1 (Strong Buy), Anacor holds a Zacks Rank #2 (Buy).
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