Isis Pharmaceuticals Earns $3 Million Milestone Payment from Eyetech for FDA Marketing Clearance of Macugen(TM)
20 December 2004 - 11:55PM
PR Newswire (US)
Isis Pharmaceuticals Earns $3 Million Milestone Payment from
Eyetech for FDA Marketing Clearance of Macugen(TM) Isis to Receive
Future Royalty Stream from Product Sales CARLSBAD, Calif., Dec. 20
/PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (NASDAQ:ISIS)
announced today that it has earned a $3 million milestone from
Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET) associated with the
marketing clearance of Macugen(TM) (pegaptanib sodium injection) by
the U.S. Food and Drug Administration (FDA). Macugen, a
non-antisense drug, is a treatment for patients with wet
age-related macular degeneration (AMD). The drug is also in
clinical trials for the treatment of diabetic macular edema. In
2002, Eyetech licensed from Isis specific patents necessary to
develop, manufacture and commercialize Macugen. In June 2004, Isis
earned a $1 million milestone payment from Eyetech associated with
its submission of a New Drug Application (NDA) for Macugen to the
FDA. Under the terms of the agreement, Isis may earn additional
milestone payments from Eyetech, and will earn royalties on
commercial sales of the drug. "The $6 million we have earned thus
far from our agreement with Eyetech, and our potential to earn
significant revenue from future product sales, validates the near
and long-term value of our large patent estate," said B. Lynne
Parshall, Isis' Executive Vice President and Chief Financial
Officer. "To date, we have earned more than $45 million from
licensing our intellectual property. By successfully
commercializing our inventions and innovation, we are generating
revenue for the continued advancement of our RNA-based drug
pipeline, while supporting other companies in bringing valuable new
products to market for the benefit of patients." Isis' chemistry
suite of patents represents a subset of Isis' overall intellectual
property estate of more than 1,400 issued patents that the company
owns or exclusively licenses covering RNA-based drug discovery and
development. More specifically, the estate covers fundamental
oligonucleotide chemistries; antisense-based gene functionalization
and identification of validated target regions of relevant genes;
multiple antisense mechanisms; antisense therapeutics;
manufacturing; formulations, and delivery of oligonucleotide
therapeutics. Additionally, Isis' patents cover Ibis' RNA
technology for the identification of infectious biological agents
(TIGER). Isis has taken advantage of its work in RNA-based drug
discovery and development to build the industry's leading
intellectual property position in this field. While Isis continues
to patent its inventions, the company actively leverages its
intellectual property rights and seeks licensing partners. About
Wet AMD and Macugen AMD is the leading cause of severe vision loss
in Americans age 65 years and over. The "wet" form of macular
degeneration accounts for about 10% of all AMD cases. Macugen is a
pegylated anti-vascular endothelial growth factor (VEGF) aptamer
(an oligonucleotide) which binds to and thus inhibits the activity
of VEGF. VEGF is a protein that plays a critical role in
angiogenesis (the formation of new blood vessels) and increased
permeability (leakage from blood vessels), two of the primary
pathological processes responsible for the vision loss associated
with wet AMD. About Isis Pharmaceuticals, Inc. Isis
Pharmaceuticals, Inc. is exploiting its expertise in RNA to
discover and develop novel human therapeutic drugs for its pipeline
and for its partners. The company has successfully commercialized
the world's first antisense drug and has 10 antisense products in
development to treat metabolic, cardiovascular, inflammatory and
viral diseases, and cancer. Through its Ibis Therapeutics(R)
program, Isis is developing a biosensor to identify infectious
organisms, and discovering small molecule drugs that bind to RNA.
As an innovator in RNA-based drug discovery and development, Isis
is the owner or exclusive licensee of more than 1,400 issued
patents worldwide. Additional information about Isis is available
at http://www.isispharm.com/ This press release contains
forward-looking statements concerning Isis Pharmaceuticals, its
business relationship with Eyetech Pharmaceuticals and the
potential of the company's intellectual property position and
potential for future payments to the company related to the success
of Macugen. Any statement describing our goals, expectations,
intentions or beliefs is a forward-looking statement and should be
considered an at-risk statement, including those statements that
are described as Isis' clinical goals. Such statements are subject
to certain risks and uncertainties, particularly those inherent in
the process of developing technology and in discovering and
commercializing drugs that are safe and effective for use as human
therapeutics and in the endeavor of building a business around such
products. Actual results could differ materially from those
discussed in this press release. As a result, you are cautioned not
to rely on these forward-looking statements. These and other risks
concerning Isis' research and development programs are described in
additional detail in Isis' Annual Report on Form 10- K for the year
ended December 31, 2003, and quarterly report on Form 10-Q for the
quarter ended September 30, 2004, which are on file with the U.S.
Securities and Exchange Commission. Copies of these and other
documents are available from the company. Macugen(R) is a trademark
of Eyetech Pharmaceuticals, Inc. Ibis Therapeutics(R) is a
registered trademark of Isis Pharmaceuticals, Inc. DATASOURCE: Isis
Pharmaceuticals, Inc. CONTACT: Kristina Peterson, Corporate
Communications of Isis Pharmaceuticals, Inc., +1-760-603-2331 Web
site: http://www.isispharm.com/
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