– 200,000 Square Foot State-of-the-Art
Manufacturing Facility Supports Expanding Development Pipeline and
Transition Toward Commercial Stage –
– Facility Expected to be Operational in 2018
–
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today announced that it will break ground
today on a state-of-the-art biopharmaceutical manufacturing
facility in Norton, Massachusetts. The facility will supply RNAi
therapeutics for Alnylam’s clinical and commercial needs. The
location, selected in close collaboration with Commonwealth and
local officials, demonstrates Alnylam’s ongoing commitment to
Massachusetts. Construction on the 200,000 square foot
manufacturing facility is expected to complete in 2018 and it will
initially employ approximately 150 new full-time employees.
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Alnylam manufacturing facility to be
built in Norton, Massachusetts. (Photo: Business Wire)
“This flagship multi-product facility represents a key next step
in Alnylam’s transition toward a commercial stage company.
Increased manufacturing capability is vital to support our rapidly
growing pipeline of ten clinical stage programs, two of which are
in Phase 3 trials,” said John Maraganore, Ph.D., Chief Executive
Officer of Alnylam. “The Massachusetts talent pool, along with
strong support from state and local partners in the Baker
Administration, Massachusetts Life Sciences Center, and the Town of
Norton were critical to our ultimate decision to establish this
manufacturing facility in Norton, MA.”
Speaking at the groundbreaking ceremony are Charlie Baker, the
Governor of Massachusetts, Kimberly Haugstad, Executive Director of
the Hemophilia Federation of America, Travis McCready, President
and Chief Executive Officer of the Massachusetts Life Sciences
Center and Lisa Nelson, Senior District Representative to U.S.
Congressman Joseph Kennedy III.
“Alnylam’s decision to locate their biopharmaceutical
manufacturing facility in Massachusetts speaks to our
Commonwealth’s success in supporting an innovative economic
environment and talented workforce,” said Governor Charlie Baker.
“We are excited about Alnylam’s choice and congratulate them as
they continue to grow and advance investigational new medicines in
the Commonwealth’s life sciences sector, creating new jobs and
patient treatments.”
"The development of Alnylam’s manufacturing facility in Norton
is further evidence that the State of Massachusetts can support the
needs of integrated biotechnology companies such as Alnylam,
through the entire biopharmaceutical life cycle, from discovery to
development to manufacturing to sales and marketing,” said Travis
McCready, President and Chief Executive Officer, Massachusetts Life
Sciences Center.
“The Hemophilia Federation of America is dedicated to serving
the needs of patients and families affected by hemophilia and other
rare bleeding disorders,” said Kimberly Haugstad, Executive
Director of the Hemophilia Federation of America. “With the
development of this manufacturing facility, Alnylam demonstrates
its commitment and responsibility to the patient community as it
strives to provide innovative new treatment options.”
About RNAiRNAi (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 PharmaceuticalsAlnylam 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 Ionis, Novartis, Roche, Takeda, Merck,
Monsanto, The Medicines Company, and Sanofi Genzyme. 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, New England Journal of Medicine, and The Lancet. Founded in
2002, Alnylam maintains headquarters in Cambridge, Massachusetts.
For more information about Alnylam's pipeline of investigational
RNAi therapeutics, please visit www.alnylam.com.
Alnylam Forward Looking StatementsVarious statements in
this release concerning Alnylam's future expectations, plans and
prospects, including without limitation, Alnylam's views with
respect to the potential for RNAi therapeutics, its expectations
regarding its pipeline growth strategy, and its plans regarding
commercialization of RNAi therapeutics, construction of a
manufacturing facility and the hiring of employees to work in that
facility 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 be replicated or continue to
occur in other subjects or in additional studies or otherwise
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 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.
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Alnylam Pharmaceuticals, Inc.Investors and MediaChristine
Regan Lindenboom, 617-682-4340orInvestorsJosh Brodsky,
617-551-8276
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