Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi
therapeutics company, announced today that the European Patent
Office (EPO) has upheld the McSwiggen EP 1423406 (’406) patent in
oral opposition proceedings in Munich, Germany. The McSwiggen
patent estate broadly describes chemical modifications of RNAi
therapeutics that the company believes are critical for achieving
“drug-like” properties in siRNA, the molecules that mediate RNAi.
The patent is owned by Alnylam, and was recently obtained through
the company’s acquisition of Sirna Therapeutics from Merck. The
McSwiggen patent family comprises a core component of Alnylam’s
overall intellectual property (IP) estate for the advancement of
RNAi therapeutics as a new class of medicines.
“We are pleased with the European Patent Office’s decision to
uphold the ’406 patent from our McSwiggen patent family, a key
component of the IP estate we recently obtained through our
acquisition of Sirna Therapeutics from Merck. This patent has broad
and significant claims describing chemical modifications of RNAi
therapeutics, which we believe are critical for the development and
commercialization of all RNAi therapeutics,” said Laurence Reid,
Ph.D., Senior Vice President and Chief Business Officer of Alnylam.
“Our IP estate remains a cornerstone in our efforts to advance RNAi
therapeutics to patients in need.”
The McSwiggen patent family includes 21 granted or issued
patents around the world, including patents in the U.S. (7,923,547;
7,956,176; 7,989,612; 8,202,979; 8,232,383; 8,236,944; 8,242,257;
8,268,986; 8,273,866) and the EU (1423406; 1458741; 1627061;
2278004; 2287306), and generally describes the chemical
modification of siRNA. The claims for the McSwiggen ’406 patent
cover compositions for siRNA, including, in general terms, a
chemically modified double-stranded RNA that down regulates
expression of a target gene by RNAi, wherein:
- each strand is independently 18 to 24
nucleotides in length and each duplex comprises 17 to 23 base
pairs; and
- 10 or more pyrimidine nucleotides of
the sense and/or antisense strand are chemically modified with
2'-deoxy, 2'-OMe, or 2'F with one or more phosphorothioate and/or a
terminal cap at the 5', 3' or both, present in the same or
different strand.
Granted claims of the ’406 patent as well as other granted
Alnylam owned or licensed patents are provided on the company’s
website, and in aggregate broadly cover siRNA and their use in a
wide range of lengths from 15 to 49 nucleotides, and chemical
modifications with naturally or non-naturally occurring
nucleotides, including, for example acyclic nucleotides such as
those termed “unlocked nucleobase analogs.” In addition, Alnylam’s
owned or licensed patents broadly cover delivery of RNAi
therapeutics, including those that employ GalNAc-siRNA conjugate
technology. Finally, Alnylam’s IP estate also includes patents that
broadly cover siRNA toward a wide range of disease targets.
About 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 as genetic
medicines, including programs as part of the company’s “Alnylam
5x15TM” product strategy. Alnylam’s genetic medicine programs are
RNAi therapeutics directed toward genetically defined targets for
the treatment of serious, life-threatening diseases with limited
treatment options for patients and their caregivers. These include:
patisiran (ALN-TTR02), an intravenously delivered RNAi therapeutic
targeting transthyretin (TTR) for the treatment of TTR-mediated
amyloidosis (ATTR) in patients with familial amyloidotic
polyneuropathy (FAP); ALN-TTRsc, a subcutaneously delivered RNAi
therapeutic targeting TTR for the treatment of ATTR in patients
with TTR cardiac amyloidosis, including familial amyloidotic
cardiomyopathy (FAC) and senile systemic amyloidosis (SSA);
ALN-AT3, an RNAi therapeutic targeting antithrombin (AT) for the
treatment of hemophilia and rare bleeding disorders (RBD); ALN-CC5,
an RNAi therapeutic targeting complement component C5 for the
treatment of complement-mediated diseases; ALN-AS1, an RNAi
therapeutic targeting aminolevulinate synthase-1 (ALAS-1) for the
treatment of hepatic porphyrias including acute intermittent
porphyria (AIP); ALN-PCS, an RNAi therapeutic targeting PCSK9 for
the treatment of hypercholesterolemia; ALN-AAT, an RNAi therapeutic
targeting alpha-1-antitrypsin (AAT) for the treatment of AAT
deficiency liver disease; ALN-TMP, an RNAi therapeutic targeting
TMPRSS6 for the treatment of beta-thalassemia and iron-overload
disorders; ALN-ANG, an RNAi therapeutic targeting angiopoietin-like
3 (ANGPTL3) for the treatment of genetic forms of mixed
hyperlipidemia and severe hypertriglyceridemia; and other programs
yet to be disclosed. As part of its “Alnylam 5x15” strategy, as
updated in early 2014, the company expects to have six to seven
genetic medicine product candidates in clinical development -
including at least two programs in Phase 3 and five to six programs
with human proof of concept - by the end of 2015. The company’s
demonstrated commitment to RNAi therapeutics has enabled it to form
major alliances with leading companies including Merck, Medtronic,
Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist,
GlaxoSmithKline, Ascletis, Monsanto, The Medicines Company, and
Genzyme, a Sanofi company. In March 2014, Alnylam acquired Sirna
Therapeutics, a wholly owned subsidiary of Merck. In addition,
Alnylam holds an equity position in Regulus Therapeutics Inc., a
company focused on discovery, development, and commercialization of
microRNA therapeutics. Alnylam scientists and collaborators have
published their research on RNAi therapeutics in over 200
peer-reviewed papers, including many in the world’s top scientific
journals such as Nature, Nature Medicine, Nature Biotechnology,
Cell, the New England Journal of Medicine, and The Lancet. 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,
Alnylam’s views with regard to the scope of its IP estate and
Alnylam’s expectations regarding 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, Alnylam’s
ability to manage operating expenses, 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 unexpected expenditures, as well as those risks
more fully discussed in the “Risk Factors” filed with Alnylam’s
most recent Annual Report on Form 10-K filed with the Securities
and Exchange Commission (SEC) and in other filings that Alnylam
makes with the SEC. 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
explicitly disclaims any obligation to update any forward-looking
statements.
Alnylam Pharmaceuticals, Inc.Cynthia Clayton,
617-551-8207Vice President, Investor Relations andCorporate
CommunicationsorSpectrumAmanda Sellers (Media), 202-955-6222
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