– Agreement Includes Investigational RNAi
Therapeutic Program for Hepatitis B Virus Infection and Discovery
Collaboration on Additional Development Candidates for Treatment of
Infectious Diseases –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today announced an exclusive licensing
agreement with Vir Biotechnology, a company dedicated to
transforming the care of people with serious infectious diseases,
for the development and commercialization of RNAi therapeutics for
infectious diseases, including chronic hepatitis B virus (HBV)
infection. As part of this agreement, the companies will advance
Alnylam’s HBV program and also initiate a research collaboration
for the development and advancement of up to four additional RNAi
therapeutic programs for the treatment of other infectious diseases
with high unmet needs.
“This agreement represents another step toward bringing RNAi
therapeutics to patients with limited or inadequate therapeutic
options. Partnering with the exceptional, experienced team at Vir
to advance investigational RNAi therapeutics in infectious diseases
will expedite the development path for these medicines, while
enabling Alnylam to maintain operational focus on our robust
pipeline of later-stage programs,” said John Maraganore, Ph.D.,
Chief Executive Officer of Alnylam. "We believe the innovative
structure of this deal, including the right for Alnylam to opt into
a profit-sharing arrangement prior to the start of Phase 3 for HBV,
gives us both strategic flexibility in our committed spend and
retention of significant product value.”
“We are excited to partner with Alnylam to bring scientific
innovation to infectious diseases, such as hepatitis B, that impact
global health and currently have significant unmet needs,” said
George Scangos, Ph.D., Chief Executive Officer of Vir. “This
collaboration is a key step forward toward our goal of leveraging
discovery and development to better control, or even cure,
infectious diseases, thereby benefitting those patients most in
need around the world.”
Alnylam is developing ALN-HBV for the treatment of chronic HBV
infection. A Phase 1/2 clinical trial of ALN-HBV was initiated in
July 2016. Alnylam plans to discontinue further development of this
investigational compound and to advance a new Development
Candidate, ALN-HBV02, utilizing the Company’s Enhanced
Stabilization Chemistry-Plus (ESC+) GalNAc conjugate technology. As
recently reported, ESC+ conjugates have the potential to improve
target specificity with an expanded therapeutic index.
As part of the agreement, Alnylam will lead ALN-HBV02 to IND
filing, with Vir then progressing ALN-HBV02 through human proof of
concept (POC); the companies will co-fund the program through this
point. Subsequently, Vir will fund and conduct all development
through completion of Phase 2 studies. Thereafter, Alnylam retains
the right to opt into a profit-sharing arrangement prior to the
start of Phase 3. In connection with the companies’ research
collaboration for up to four additional infectious disease
programs, Vir will fund all research and development costs, while
Alnylam retains a product-by-product option on each program to opt
into a profit-sharing arrangement following human POC.
Under the terms of the agreement, Alnylam will receive an
upfront payment, comprised of cash and shares of Vir common stock.
Alnylam is also eligible to receive more than $1 billion in
potential milestone payments related to the successful advancement
of ALN-HBV02 and other infectious disease programs, as well as
tiered royalties on products ultimately commercialized by Vir under
the collaboration, should Alnylam elect to decline its
co-development and profit share option on a per-product basis.
About HBV Infection
Worldwide, 2 billion people – or one out of three – are infected
with HBV, and more than 250 million people are chronically
infected, including 1 to 2 million people in the U.S. An estimated
1 million people die each year from HBV and its complications
worldwide, of whom about 5,000 are in the U.S. Worldwide, chronic
infection with hepatitis causes 80 percent of all cases of
hepatocellular carcinoma (HCC), which kills more than 500,000
people each year. About 5 percent of the population is a chronic
carrier of HBV, and nearly 25 percent of all carriers develop
serious liver diseases such as chronic hepatitis, cirrhosis or HCC.
Current treatment options include long-term antiviral therapies,
which permit low levels of virus cells to replicate, leading to HBV
viral persistence and affecting therapeutic outcomes. There is a
significant need for safe and convenient novel therapeutics that
restore the host immune response through targeted hepatitis B
surface antigen (HBsAg) knockdown, thereby offering HBV patients
the potential for functional cures by eliminating virus-producing
cells.
About Alnylam Pharmaceuticals, Inc.
Alnylam (Nasdaq: ALNY) is leading the translation of RNA
interference (RNAi) into a whole new class of innovative medicines
with the potential to transform the lives of people afflicted with
rare genetic, cardio-metabolic, and hepatic infectious diseases.
Based on Nobel Prize-winning science, RNAi therapeutics represent a
powerful, clinically validated approach for the treatment of a wide
range of severe and debilitating diseases. Founded in 2002, Alnylam
is delivering on a bold vision to turn scientific possibility into
reality, with a robust discovery platform and deep pipeline of
investigational medicines, including four product candidates that
are in late-stage development. Looking forward, Alnylam will
continue to execute on its "Alnylam 2020" strategy of building a
multi-product, commercial-stage biopharmaceutical company with a
sustainable pipeline of RNAi-based medicines to address the needs
of patients who have limited or inadequate treatment options.
Alnylam employs over 600 people in the U.S. and Europe and is
headquartered in Cambridge, MA. For more information about our
people, science and pipeline, please visit www.alnylam.com and
engage with us on Twitter at @Alnylam or on LinkedIn.
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 development of ALN-HBV02 and
the potential development of investigational RNAi therapeutics for
up to four additional infectious disease programs, the potential of
ESC+ conjugates to improve target specificity with an expanded
therapeutic index, the potential for Alnylam to earn milestones and
royalties under its collaboration with Vir, Alnylam’s right to opt
into a profit sharing arrangement under the Vir collaboration, and
expectations regarding its "Alnylam 2020" guidance for the
advancement and 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 and future plans may differ materially from
those indicated by these forward-looking statements as a result of
various important risks, uncertainties and other 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 product 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 for a specified indication or at all, actions or
advice of regulatory agencies, which may affect the design,
initiation, timing, continuation and/or progress of clinical trials
or result in the need for additional pre-clinical and/or clinical
testing, delays, interruptions or failures in the manufacture and
supply of its product candidates, obtaining, maintaining and
protecting intellectual property, Alnylam's ability to enforce its
intellectual property rights against third parties and defend its
patent portfolio against challenges from third parties, obtaining
and maintaining regulatory approval, pricing and reimbursement for
products, progress in establishing a commercial and ex-United
States infrastructure, competition from others using technology
similar to Alnylam's and others developing products for similar
uses, Alnylam's ability to manage its growth and operating
expenses, 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 and distribution of products, the
outcome of litigation, the risk of government investigations, 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, except to the extent required
by law, to update any forward-looking statements.
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