Basilea reports that U.S. FDA sets date of Advisory Committee meeting on isavuconazole NDA for the treatment of invasive aspergillosis and mucormycosis
Basel, Switzerland, November 21, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) announced a public meeting of the Anti-Infective Drugs Advisory Committee to discuss the New Drug Application (NDA) for the investigational antifungal isavuconazole, which was submitted by a subsidiary of Basilea's licensing partner Astellas Pharma Inc. The meeting is scheduled for Thursday, January 22, 2015.
The meeting notification was published in the U.S. Federal Register today and can be accessed via http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.htm.
Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its Swiss subsidiary Basilea Pharmaceutica International Ltd. to develop and commercialize innovative pharmaceutical products to meet the significant medical needs of patients with serious and potentially life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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Peer Nils Schröder, PhD
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Barbara Zink, PhD, MBA
Head Corporate Development
+41 61 606 1233
This press release can be downloaded from www.basilea.com.