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ISIS > SEC Filings for ISIS > Form 8-K on 14-Dec-2012All Recent SEC Filings

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Form 8-K for ISIS PHARMACEUTICALS INC

14-Dec-2012

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

On December 14, 2012, Isis Pharmaceuticals, Inc. and Genzyme, a Sanofi company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for its marketing authorization application (MAA) for KYNAMROTM (mipomersen) for the treatment of patients with Homozygous Familial Hypercholesterolaemia (HoFH). Genzyme plans to request a re-examination of the CHMP Opinion. A copy of the Press Release related to this event is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

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.



Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99.1 Press Release dated December 14, 2012.

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