Astellas Pharma, Inc.
) 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
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
Astellas carries a Zacks Rank #3 (Hold). Some better-ranked stocks
in the health care sector are Endo International plc (
) and United Therapeutics Corp. (
). Both carry a Zacks Rank #1 (Strong Buy).
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