Basilea reports U.S. FDA approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis

Basilea Pharmaceutica AG / Basilea reports U.S. FDA approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, March 6, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) approved Astellas' New Drug Application (NDA) for the use of isavuconazole for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). These are life-threatening fungal infections predominantly occurring in immunocompromised patients. Basilea's partner Astellas will market the drug as CRESEMBA^® (isavuconazonium sulfate) in the United States.

"We are very pleased with the FDA's approval of isavuconazole, which offers an important new broad-spectrum treatment for patients suffering from life-threatening invasive fungal infections in the United States," said Ronald Scott, Basilea's Chief Executive Officer.

Prof. Andrew J. Ullmann, Head of Infectious Diseases, Julius-Maximilian-University Wurzburg, Germany, said: "We are desperately seeking new antifungal agents that provide broad coverage against fungi including those causing aspergillosis and mucormycosis. Those drugs need to have a good safety profile to be utilized in our severely ill patient populations. The new antifungal agent isavuconazole clearly has the potential to improve patient care by fulfilling these unmet medical needs."

Prof. Achim Kaufhold, Basilea's Chief Medical Officer, added: "We anticipate completion of the review of Basilea's European Marketing Authorization Application for isavuconazole for the treatment of invasive aspergillosis and mucormycosis in adults in the fourth quarter of 2015. In addition, in the second half of 2015 we expect topline results from the isavuconazole ACTIVE phase 3 study in invasive candidiasis, a potential further indication."

Isavuconazole is being co-developed with Astellas Pharma Inc. Basilea holds full global rights to isavuconazole outside the U.S. and Canada where Astellas is the exclusive license holder.
A CHF 30 million milestone payment from Astellas is associated with the approval of isavuconazole for the treatment of invasive aspergillosis in the United States.

The safety and efficacy profile of isavuconazole in patients with invasive aspergillosis was demonstrated based on the data from two phase 3 clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of patients with invasive aspergillosis; and VITAL, an open-label non-comparative study of isavuconazole in patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other fungi, including those causing mucormycosis.