Date:2/28/2013

provide us with significant value.  We established three collaborations with Biogen Idec focused on neurologic severe and rare diseases.  Biogen Idec's extensive expertise and experience in neurological diseases makes Biogen Idec an ideal partner to work with us to build a neurologic disease franchise.  In addition, we established a collaboration with AstraZeneca that allows us to broaden and expand our antisense drug discovery and development efforts and apply our antisense technology to novel oncology targets with a global leader in cancer drug development and commercialization," concluded Ms. Parshall. 

Drug Development Highlights for 2012/ Early 2013

Isis and Genzyme were successful in bringing KYNAMRO to the market for patients with HoFH.  These patients are at high cardiovascular risk and may not be able to reduce their LDL-C sufficiently with currently available lipid-lowering therapies. 

KYNAMRO was approved for marketing in the United States by the US FDA for the treatment of patients with HoFH.

Isis received a total of $50 million in milestone payments from Genzyme related to the NDA acceptance in 2012 and marketing approval of KYNAMRO by the FDA in 2013.

Genzyme continues to enroll the FOCUS FH study, which is designed to provide 60-week safety and efficacy data in FH patients to support an additional regulatory filing.  Genzyme reached an agreement with the FDA on the design of the FOCUS FH study via a Special Protocol Assessment, or SPA.

Genzyme submitted a request for re-examination of the EMA's negative opinion on the marketing authorization application for KYNAMRO and expects to report the outcome of the re-examination in the first half of 2013.

Isis received European GMP certification of its manufacturing facility for production of drug substance to support KYNAMRO commercial launch.

Clinical investigators presented KYNAMRO data at important car
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SOURCE Isis Pharmaceuticals, Inc. Copyright©2012 PR Newswire. All rights reserved

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