Astellas Pharma, Inc. (ALPMY) and partner Basilea Pharmaceutica’s isavuconazole has been accepted for review in the EU. The companies are looking to get isavuconazole approved in the EU for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
The Marketing Authorization Application (MAA) for isavuconazole will be reviewed by the European Medicines Agency (EMA) under the centralized marketing authorization procedure. This ensures that isavuconazole, on approval, can be commercialized in the 28 member states of the EU, as well as in Iceland, Liechtenstein and Norway.
Astellas and Basilea are jointly developing isavuconazole for the treatment of life-threatening invasive fungal infections, primarily those affecting immunocompromised patients. Isavuconazole has orphan drug status and Qualified Infectious Disease Product (QIDP) designation in the U.S. for the treatment of invasive aspergillosis and mucormycosis. Additionally, isavuconazole has orphan drug status in Europe for these indications.
We note that 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.
We remind investors that in Jul 2014, Astellas filed a new drug application (NDA) with the FDA for isavuconazole for the treatment of invasive aspergillosis and mucormycosis. Basilea is eligible to receive a milestone payment from Astellas once the FDA accepts the NDA. With fast track status in the U.S., we expect isavuconazole’s FDA review process to expedite. Additionally, isavuconazole is in the phase III ACTIVE study for the treatment of invasive Candida infections.
We are pleased to see Astellas’ progress with its pipeline. 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. Given the rising number of immunocompromised patients who are at the risk of developing invasive fungal infections, we believe that isavuconazole stands to gain a large share of the market in this field, if approved.
A drug approved for the treatment of invasive fungal infections is Pfizer’s (PFE) Vfend.
Astellas carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Endo International plc (ENDP) and United Therapeutics Corp. (UTHR). Both carry a Zacks Rank #1 (Strong Buy).
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