Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi
therapeutics company, announced today the appointment of Pushkal
Garg, M.D., to the position of Senior Vice President, Clinical
Development. Dr. Garg has extensive experience in clinical
development across a broad range of therapeutic areas. At Alnylam,
he will join the existing development team and be responsible for
managing the company’s clinical research, clinical operations, and
biometrics functions.
“We are entering a particularly exciting time in the evolution
of our company where clinical data from our pipeline of novel RNAi
therapeutics highlight what we believe to be significant potential
for RNAi therapeutics as a new class of genetic medicines.
Accordingly, we are delighted to welcome Pushkal to the Alnylam
team. His experience and expertise in early and late-stage drug
development will be tremendously valuable as we continue to advance
our pipeline of RNAi therapeutics through the clinic,” said Akshay
Vaishnaw, M.D., Ph.D., Executive Vice President and Chief Medical
Officer of Alnylam. “Indeed, Pushkal brings a deep understanding of
the biotechnology and pharmaceutical industries, extensive
experience, as well as a proven track record of success, and I am
excited to have him join our team as we expand our clinical
development capabilities.”
“The breakthrough field of RNAi therapeutics represents a unique
opportunity to develop and bring to market novel drugs that have
the potential to treat a broad array of human diseases with
significant unmet need. Alnylam has made tremendous progress in
advancing this innovative technology towards an entirely new class
of medicines,” said Pushkal Garg, M.D., Senior Vice President,
Clinical Development at Alnylam. “I am thrilled to be joining
Akshay and the broader Alnylam development team at this important
stage, as we advance our pipeline of novel therapies through the
clinic. I look forward to being part of a team that is so
passionate and committed to advancing RNAi therapeutics to
patients.”
Dr. Garg joins Alnylam with close to 15 years of experience in
clinical drug development. Most recently, he served as Vice
President, Global Clinical Research, Immunoscience at Bristol-Myers
Squibb (BMS). In this role he was responsible for strategic
leadership of the Immunoscience franchise and the successful
development of multiple clinical assets across immune-mediated
diseases in the areas of rheumatology, gastroenterology,
nephrology, and transplantation. During his eight-year tenure at
BMS, he was instrumental to the late-stage development and approval
of Nulojix® (belatacept) for kidney transplant recipients, and for
supplementary biologics license applications (BLA) for Orencia®
(abatacept) around the world. Previously, Dr. Garg was at
Millennium Pharmaceuticals, where he worked in various roles of
increasing responsibility, overseeing the clinical development of
multiple small molecule and biologic therapeutics for the treatment
of inflammatory disorders. Dr. Garg received a Bachelor of Arts
with high honors in Biochemistry from the University of California,
Berkeley, and an M.D. from the University of California, San
Francisco. He completed residency training in Internal Medicine at
UCSF, was a fellow in the Robert Wood Johnson Clinical Scholars
Program at Johns Hopkins University, and served on the faculty of
Harvard Medical School and the Brigham & Women’s Hospital in
Boston prior to joining industry.
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
5x15™” 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 aminolevulinic acid 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-associated liver disease; ALN-HBV, an RNAi therapeutic
targeting the hepatitis B virus (HBV) genome for the treatment of
HBV infection; 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; ALN-AC3, an RNAi
therapeutic targeting apolipoprotein C-III (apoCIII) for the
treatment of hypertriglyceridemia; ALN-AGT, an RNAi therapeutic
targeting angiotensinogen (AGT) for the treatment of hypertensive
disorders of pregnancy (HDP), including preeclampsia; ALN-GO1, an
RNAi therapeutic targeting glycolate oxidase (GO) for the treatment
of primary hyperoxaluria type 1 (PH1); 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, and The Medicines Company. In
early 2014, Alnylam and Genzyme, a Sanofi company, formed a
multi-product geographic alliance on Alnylam's genetic medicine
programs in the rare disease field. Specifically, Alnylam will lead
development and commercialization of programs in North America and
Europe, while Genzyme will develop and commercialize products in
the rest of world. In addition, Alnylam and Genzyme will co-develop
and co-commercialize ALN-TTRsc in North America and Europe. 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, 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 respect to the potential for RNAi
therapeutics, as well as its expectations regarding its “Alnylam
5x15” product strategy, and its plans regarding commercialization
of RNAi 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 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
CommunicationsorMedia:SpectrumLiz Bryan, 202-955-6222 x2526
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