Basel, Switzerland, January 22, 2015 – Basilea Pharmaceutica Ltd. (SIX: BSLN) today announced that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral antifungal isavuconazole, the active moiety of the prodrug isavuconazonium sulfate, for the treatment of invasive aspergillosis, and eight to two with one abstention to recommend approval for the treatment of invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. Basilea’s partner Astellas presented the data to the FDA and, if approved, intends to market the drug as Cresemba® in the United States.
“The Advisory Committee’s positive vote is an important regulatory step in the ongoing FDA review of isavuconazole,” said Ronald Scott, Basilea’s Chief Executive Officer.
The Advisory Committee’s recommendation is based on data from the isavuconazole development program, which included analyses from two phase 3 clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of adult patients with invasive aspergillosis, and VITAL, an open-label non-comparative study of isavuconazole in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other fungi, including those causing mucormycosis.
The Advisory Committee provides the FDA with independent expert advice and recommendations. The FDA is not bound by the Advisory Committee’s recommendations, but its input will be considered by the FDA in its review of the isavuconazole New Drug Application (NDA), which was submitted by a subsidiary of Basilea’s licensing partner Astellas Pharma Inc. on July 8, 2014. The Prescription Drug User Fee Act (PDUFA) date for the isavuconazole NDA is March 8, 2015, which is the target date for the FDA to complete its review.
For additional information on the January 22, 2015 Advisory Committee meeting please visit http://www.fda.gov/AdvisoryCommittees/Calendar/ucm424436.htm.
Isavuconazole is also currently under regulatory review by the European Medicines Agency (EMA) for the treatment of invasive aspergillosis and mucormycosis in adults. The regulatory review of the Marketing Authorization Application (MAA), which was submitted by Basilea on July 16, 2014, is anticipated to be completed in the fourth quarter of 2015.
Enrollment of patients into a third phase 3 study, ACTIVE, which assesses isavuconazole in the treatment of candidemia and other invasive Candida infections, was completed in January 2015 and topline data are anticipated for the second half of this year, following completion of treatment and follow-up periods.
Isavuconazole is an investigational product and not approved for commercial use in any markets – it is currently under review by the FDA and the EMA.
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Friday, January 23, 2015, 4 p.m. (CET), during which the company will discuss today’s press release.
Dial-in numbers are:
+41 (0) 58 310 5000 (Europe and ROW)
+1 (1) 631 570 5613 (USA)
+44 (0) 203 059 5862 (UK)
A playback will be available 1 hour after the conference call until Monday, January 26, 2015, 6 p.m. (CET). Participants requesting a digital playback may dial:
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 11607 followed by the # sign.
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 subsidiary Basilea Pharmaceutica International Ltd. to develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and 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.
For further information, please contact:
|Media Relations||Investor Relations|
|Peer Nils Schröder, PhDHead Public Relations &Corporate Communications+41 61 606 1102||Barbara Zink, PhD, MBAHead Corporate Development+41 61 606 1233|
This press release can be downloaded from www.basilea.com.