Isis Pharmaceuticals, Inc. Provides Update on CHMP Opinion on KYNAMRO™ (Mipomersen)
CARLSBAD, Calif., March 22, 2013 /PRNewswire/ -- Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that following Genzyme's request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMROTM (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH).
The FDA approved KYNAMRO in the United States in January 2013 for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
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 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare diseases, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO, in the United States for the treatment of patients with HoFH. Genzyme is also pursuing marketing approval of KYNAMRO in other markets. Isis' patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
Isis Forward Looking Statement
This press release includes forward-looking statements regarding Isis' collaboration with Genzyme, a Sanofi company, and the development, activity, therapeutic benefit 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, 2012, which is on file with the SEC. Copies of these and other documents are available from the Company.
Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.
Genzyme® is the registered trademark of Genzyme Corporation. All rights reserved.
KYNAMRO is the registered trademark of Genzyme Corporation submitted to health authorities for investigational agent mipomersen. All rights reserved.
SOURCE Isis Pharmaceuticals Inc.