Press Releases
Alnylam and Isis Form New Agreement, Extending Decade-Long Partnership for Leadership in RNA Therapeutics
New Agreement Includes Cross-License on Four Disease Targets, Providing Each Company Exclusive RNA Therapeutic License Rights for Two Programs
“Isis and Alnylam lead the RNA-targeted therapeutics space and are
innovators in understanding the science and developing the technologies
to support RNA-targeted drug discovery. At Isis, we have dedicated
ourselves to advancing the core understanding of RNA-based drugs,
continually evolving and optimizing our technology and creating an
extensive IP position. We believe that providing access to our IP
supports our business strategy of generating revenue from our partners
while focusing our efforts on our internal programs and promising
pipeline of maturing products,” said
“We and Isis have each benefited enormously from our long-standing
collaborative efforts over the last decade. We believe that our
collaboration has enabled both companies to succeed as leaders in the
development and commercialization of RNA therapeutics,” said
Per the terms of the new agreement, Alnylam and Isis are forming an IP cross-license with reciprocal economic terms on four therapeutic targets, where each company obtains exclusive license rights to two therapeutic programs. Alnylam is granting Isis an exclusive, royalty-bearing license to its chemistry, RNA-targeting mechanism and target-specific IP for oligonucleotide therapeutics against two targets: Factor XI and apolipoprotein (a) – or Apo(a). Isis is currently developing an investigational antisense drug toward Factor XI for the prevention of thrombosis. ISIS-FXIRx is currently in Phase 2 clinical development. Isis is also currently developing an investigational antisense drug targeting Apo(a) to treat cardiovascular disease. ISIS-APO(a)Rx is currently in a Phase 2 clinical trial. In exchange, Isis is granting Alnylam an exclusive, royalty-bearing license to its chemistry, RNA-targeting mechanism and target-specific IP for oligonucleotide therapeutics against two targets: antithrombin (AT) and aminolevulinic acid synthase-1 (ALAS-1). Alnylam is currently developing an investigational RNAi therapeutic targeting AT for the treatment of hemophilia and rare bleeding disorders. ALN-AT3 is currently in a Phase 1 clinical trial enrolling hemophilia subjects. Alnylam is also currently developing an investigational RNAi therapeutic targeting ALAS-1 for the treatment of hepatic porphyrias, including acute intermittent porphyria (AIP); Alnylam has just filed a clinical trial application (CTA) to begin a Phase 1 clinical trial with ALN-AS1.
The new agreement also includes an extended technology IP cross-license.
Specifically, Alnylam is granting Isis a royalty-bearing, non-exclusive
license to new platform technology arising from
About
Isis is exploiting its leadership position in RNA-targeted technology to
discover and develop novel drugs for its product pipeline and for its
partners. Isis’ broad pipeline consists of 33 drugs to treat a wide
variety of diseases with an emphasis on cardiovascular, metabolic,
severe and rare diseases, including neurological disorders, and cancer.
Isis’ partner, Genzyme, is commercializing Isis’ lead product, KYNAMRO®,
in
About
Alnylam is a biopharmaceutical company developing novel therapeutics
based on RNA interference, or RNAi. The company is leading the
translation of RNAi as a new class of innovative medicines. Alnylam’s
pipeline of investigational RNAi therapeutics is focused in 3 Strategic
Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of
RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic
Disease, with a pipeline of RNAi therapeutics toward genetically
validated, liver-expressed disease targets for unmet needs in
cardiovascular and metabolic diseases; and Hepatic Infectious Disease,
with a pipeline of RNAi therapeutics that address the major global
health challenges of hepatic infectious diseases. In early 2015, Alnylam
launched its “Alnylam 2020” guidance for the advancement and
commercialization of RNAi therapeutics as a whole new class of
innovative medicines. Specifically, by the end of 2020, Alnylam expects
to achieve a company profile with 3 marketed products, 10 RNAi
therapeutic clinical programs – including 4 in late stages of
development – across its 3 STArs. The company’s demonstrated commitment
to RNAi therapeutics has enabled it to form major alliances with leading
companies including Merck,
Isis Pharmaceuticals’ Forward-looking Statement
This press release includes forward-looking statements regarding
Isis Pharmaceuticals® is a registered trademark of
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam’s future
expectations, plans and prospects, including without limitation,
potential further RNA therapeutic advances enabled by the extended
agreement with Isis, its expectations regarding the benefit that RNA
therapeutics have the potential to provide to patients across a broad
range of diseases, its STAr pipeline growth strategy, and its plans
regarding commercialization of RNA therapeutics, constitute
forward-looking statements for the purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important factors,
including, without limitation, Alnylam’s ability to discover and develop
novel drug candidates and delivery approaches, successfully demonstrate
the efficacy and safety of its drug candidates, the pre-clinical and
clinical results for its product candidates, which may not support
further development of product candidates, actions of regulatory
agencies, which may affect the initiation, timing and progress of
clinical trials, obtaining, maintaining and protecting intellectual
property, Alnylam’s ability to enforce its patents against infringers
and defend its patent portfolio against challenges from third parties,
obtaining regulatory approval for products, competition from others
using technology similar to Alnylam’s and others developing products for
similar uses, Alnylam’s ability to manage operating expenses, Alnylam’s
ability to obtain additional funding to support its business activities
and establish and maintain strategic business alliances and new business
initiatives, Alnylam’s dependence on third parties for development,
manufacture, marketing, sales and distribution of products, the outcome
of litigation, and unexpected expenditures, as well as those risks more
fully discussed in the “Risk Factors” filed with Alnylam’s most recent
Quarterly Report on Form 10-Q filed with the
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Source:
Alnylam Pharmaceuticals, Inc.
Cynthia Clayton, 617-551-8207
Vice
President, Investor Relations and Corporate Communications
or
Media
Spectrum
Liz
Bryan, 202-955-6222 x2526
or
Isis Pharmaceuticals, Inc.
D.
Wade Walke, Ph.D., 760-603-2741
Vice President, Corporate
Communications and Investor Relations
or
Amy Blackley, Ph.D.,
760-603-2772
Associate Director, Corporate Communications