Thursday August 27, 5:45 am Eastern Time
Company Press Release
SOURCE: Isis Pharmaceuticals, Inc.
Isis and CIBA Vision Receive FDA
Approval for CMV Retinitis Drug
CARLSBAD, Calif. and ATLANTA, Aug. 27 /PRNewswire/ -- Isis Pharmaceuticals, Inc.
(Nasdaq: ISIP - news) and CIBA Vision Corporation, the eye care unit of world life sciences
leader, Novartis AG, today announced the approval from the United States Food and Drug
Administration (FDA) of the New Drug Application (NDA) for Vitravene(TM) (fomivirsen sodium
injectable) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The NDA
for Vitravene(TM) was filed on April 9, 1998.
Vitravene(TM) is the first in a class of novel therapeutics based on antisense technology to be
approved for marketing in the United States. Vitravene(TM) is indicated for the local treatment of
CMV retinitis in patients with AIDS who are intolerant of or have a contraindication to other
treatments for CMV retinitis or who were insufficiently responsive to previous treatments for CMV
retinitis. The recommended labeled dosage consists of an induction dose on days 1 and 15
followed by a monthly intravitreal injection of 330 mg (micrograms).
''Vitravene(TM) is the first NDA for an antisense drug and it was reviewed and approved in only
5 months.'' said Daniel L. Kisner, M.D., President and Chief Operating Officer, Isis
Pharmaceuticals. ''We are confident that patients with CMV will benefit from the use of this novel
antisense drug.''
A Marketing Authorization Application (MAA) submitted by CIBA Vision in May, is currently
under review with the European Agency for the Evaluation of Medicinal Products (EMEA) for the
marketing of Vitravene(TM) in Europe.
''This is an important day for patients affected with CMV retinitis, for Isis and for antisense
technology,'' said Stanley Crooke, M.D., Ph.D., Chairman and Chief Executive Officer, Isis.
''Everyone at Isis shares a sense of pride in this accomplishment and we are hopeful that
Vitravene(TM) is the first of a many breakthrough drugs based on antisense technology to reach
the marketplace.''
Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and
development on novel human therapeutic compounds. Isis has six compounds in human clinical
trials: Vitravene(TM), to treat CMV-induced retinitis in AIDS patients, has been approved for
marketing by the FDA; ISIS 2302, an inhibitor of ICAM-1, is in pivotal quality trials for Crohn's
disease; Phase II clinical trials for renal transplant rejection, rheumatoid arthritis and ulcerative
colitis, and is being explored as a topical treatment for psoriasis and an aerosol administration for
asthma; ISIS 3521 is in Phase II trials as a treatment for cancer; ISIS 5132 is in Phase II clinical
trials as a treatment for cancer; ISIS 2503 is in Phase I trials as a treatment for cancer; and ISIS
13312 is in Phase I/II clinical trials for the treatment of CMV retinitis in AIDS patients. The
company also has several additional compounds in preclinical development. Isis' broad medicinal
chemistry and biology research programs support efforts in both antisense and small molecule drug
discovery.
This release contains forward-looking statements concerning the therapeutic and commercial
potential of Vitravene(TM), a drug for the treatment of CMV retinitis. Such statements are subject
to certain risk factors and uncertainties, particularly those inherent in the process of discovering,
developing and commercializing drugs that are safe and effective for use as human therapeutics.
Actual results could differ materially from those projected in this release. As a result, the reader is
cautioned not to rely on these forward-looking statements. These and other risks are described in
additional detail in Isis' Annual Report on Form 10-K for the year end December 31, 1997 and in
the Company's most recent quarterly report on Form 10-Q, which are available from the
company.
With worldwide headquarters in Atlanta, Georgia, USA, CIBA Vision is a global leader in
research, development and manufacturing of optical and ophthalmic products and services,
including contact lenses, lens care products and ophthalmic pharmaceuticals. CIBA Vision
products are available in more than 70 countries. For more information, you are invited to visit the
CIBA Vision websites at www.cibavision.com and www.fomivirsen.com.
CIBA Vision is the eye care unit of Novartis AG, a world leader in Life Sciences with its core
businesses in Healthcare, Agribusiness and Nutrition. In 1997, Novartis Group sales were 31.2
billion Swiss francs, of which 18.8 billion were in Healthcare, 8.3 billion in Agribusiness and 4.1
billion in Nutrition. Headquartered in Basel, Switzerland, Novartis employs 87,000 people in more
than 100 countries around the world. Vitravene(TM) is a trademark of Novartis AG.
SOURCE: Isis Pharmaceuticals, Inc.
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