Isis Provides Update on CHMP Opinion on KYNAMRO™ (mipomersen)

        Isis Provides Update on CHMP Opinion on KYNAMRO™ (mipomersen)

PR Newswire

CARLSBAD, Calif., March 22, 2013

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 KYNAMRO^TM (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.

Website: http://www.isispharm.com
Contact: Media, Amy Blackley, Ph.D., 760-603-2772 (Media), E-mail:
ABlackley@isisph.com, or, Investor Relations, D. Wade Walke, Ph.D.,
760-603-2741(Investors), WWalke@isisph.com
 
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