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.
Copyright Business Wire 2014