FDA Advisory Committee to Review KYNAMRO™ New Drug Application
CARLSBAD, Calif., Oct. 18, 2012 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced NASDAQ has halted trading of the Company's common stock. The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meets today to review the new drug application (NDA) for KYNAMRO™ for the treatment of patients with homozygous familial hypercholesterolemia (FH). The NDA was filed in March 2012 with a standard review of 10 months. The PDUFA date is January 29, 2013.
At 7:30 p.m. Eastern Time today, October 18, Isis will conduct a live webcast conference call to discuss the outcome of the EMDAC meeting. Interested parties may listen to the call by dialing 866-700-0161 (international callers should dial 617-213-8832) and refer to passcode "ISIS 2012," or access the webcast at www.isispharm.com. A webcast replay will be available for a limited time at the same address.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 25 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis' partner, Genzyme, plans to commercialize Isis' lead product, KYNAMRO™, following regulatory approval. Isis' patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding Isis' collaboration with Genzyme, a Sanofi company, and the development, activity, therapeutic potential and safety of KYNAMRO™ in treating patients with high cholesterol. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of KYNAMRO, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2011 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries.
Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. KYNAMRO™ is a trademark of Genzyme Corporation.
SOURCE Isis Pharmaceuticals, Inc.