Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics
company, announced today that the U.S. District Court of the District of
Massachusetts has ruled in favor of Alnylam and has denied Tekmira
Pharmaceuticals Corporation’s motion to dismiss
certain claims and motion to disqualify
Alnylam’s counsel in an infringement suit filed in January 2012. The
infringement suit against Tekmira is based upon Alnylam’s allegations
that Tekmira has improperly provided lipid nanoparticle (LNP)-formulated
small interfering RNA (siRNA) molecules to pharmaceutical collaborators.
As announced today, the Court has ruled that Alnylam has standing in
suing Tekmira for infringement of several patents that Tekmira has
exclusively licensed to Alnylam. In addition, Alnylam announced today
that it has expanded the infringement action with a suit in Canada.
“Alnylam has contracts with Tekmira granting us exclusive rights to
deploy LNP technologies in the RNAi field, and we are resolute in
enforcing our intellectual property against infringement,” said Laurence
Reid, Ph.D., Senior Vice President, Chief Business Officer of Alnylam.
“In this regard, we are pleased with the ruling of the Federal Court
that has confirmed Alnylam’s rights to enforce certain in-licensed
patents against infringing activities. In addition, Alnylam has multiple
other patents that protect our innovative discoveries, including the
patent used in our expanded infringement action against Tekmira in
Canada.”
As alleged in the complaint filed in January 2012, Tekmira’s activities
are not protected under the exemption from patent infringement for drug
development. As described in the complaint, Tekmira has allegedly
infringed a number of issued patents related to siRNA and LNP
technologies, including: U.S.
Patent No. 7,695,902; U.S.
Patent No. 6,858,225; U.S.
Patent No. 6,815,432; U.S.
Patent No. 6,534,484; U.S.
Patent No. 6,586,410; and, U.S.
Patent No. 6,858,224. Under Alnylam’s contractual right to enforce
Isis’ patent U.S. Patent No. 7,695,902, Alnylam joined Isis to the suit
as a co-plaintiff.
In addition, Alnylam today has expanded its infringement action against
Tekmira to include CA
Patent No. 2,359,180. In a complaint filed today in the Federal
Court of Canada, Alnylam alleges Tekmira is infringing this patent in
its collaboration activities and in its own research and development
efforts.
About RNA Interference (RNAi)
RNAi (RNA interference) is a revolution in biology, representing a
breakthrough in understanding how genes are turned on and off in cells,
and a completely new approach to drug discovery and development. Its
discovery has been heralded as “a major scientific breakthrough that
happens once every decade or so,” and represents one of the most
promising and rapidly advancing frontiers in biology and drug discovery
today which was awarded the 2006 Nobel Prize for Physiology or Medicine.
RNAi is a natural process of gene silencing that occurs in organisms
ranging from plants to mammals. By harnessing the natural biological
process of RNAi occurring in our cells, the creation of a major new
class of medicines, known as RNAi therapeutics, is on the horizon. Small
interfering RNA (siRNA), the molecules that mediate RNAi and comprise
Alnylam’s RNAi therapeutic platform, target the cause of diseases by
potently silencing specific mRNAs, thereby preventing disease-causing
proteins from being made. RNAi therapeutics have the potential to treat
disease and help patients in a fundamentally new way.
About Alnylam Pharmaceuticals
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 with a core
focus on RNAi therapeutics for the treatment of genetically defined
diseases, including ALN-TTR for the treatment of transthyretin-mediated
amyloidosis (ATTR), ALN-AT3 for the treatment of hemophilia, ALN-PCS for
the treatment of severe hypercholesterolemia, ALN-HPN for the treatment
of refractory anemia, and ALN-TMP for the treatment of
hemoglobinopathies. As part of its “Alnylam 5x15TM” strategy,
the company expects to have five RNAi therapeutic products for
genetically defined diseases in clinical development, including programs
in advanced stages, on its own or with a partner by the end of 2015.
Alnylam has additional partnered programs in clinical or development
stages, including ALN-RSV01 for the treatment of respiratory syncytial
virus (RSV) infection, ALN-VSP for the treatment of liver cancers, and
ALN-HTT for the treatment of Huntington’s disease. The company’s
leadership position on RNAi therapeutics and intellectual property have
enabled it to form major alliances with leading companies including
Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko
Kirin, Cubist, Ascletis, and Monsanto. In addition, Alnylam and Isis
co-founded Regulus Therapeutics Inc., a company focused on discovery,
development, and commercialization of microRNA therapeutics; Regulus has
formed partnerships with GlaxoSmithKline, Sanofi, Biogen and
AstraZeneca. Alnylam has also formed Alnylam Biotherapeutics, a division
of the company focused on the development of RNAi technologies for
applications in biologics manufacturing, including recombinant proteins
and monoclonal antibodies. Alnylam’s VaxiRNA™ platform applies RNAi
technology to improve the manufacturing processes for vaccines;
GlaxoSmithKline is a collaborator in this effort. Alnylam scientists and
collaborators have published their research on RNAi therapeutics in over
100 peer-reviewed papers, including many in the world’s top scientific
journals such as Nature, Nature Medicine, Nature
Biotechnology, and Cell. Founded in 2002, Alnylam maintains
headquarters in Cambridge, Massachusetts. For more information, please
visit www.alnylam.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam’s future
expectations, plans and prospects, including, without limitation,
statements regarding the allegations included in the complaint filed
against Tekmira, Alnylam’s intentions regarding the enforcement of its
intellectual property against infringement and statements regarding
Alnylam’s expectations with respect to its “Alnylam 5x15” product
strategy, 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, risks and uncertainties related
to the successful pursuit of litigation, 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 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
Alnylam’s short operating history, as well as those risks more fully
discussed in the “Risk Factors” section of its most recent quarterly
report on Form 10-Q on file with the Securities and Exchange Commission.
In addition, any forward-looking statements represent Alnylam’s views
only as of today and should not be relied upon as representing its views
as of any subsequent date. Alnylam does not assume any obligation to
update any forward-looking statements.
