Blackstone (NYSE: BX) and Alnylam Pharmaceuticals, Inc. (Nasdaq:
ALNY), the leading RNAi therapeutics company, today announced the
closing of the R&D funding component of the companies’
previously announced $2 billion strategic financing collaboration
to accelerate the advancement of RNAi therapeutics.
Under the terms of the agreement, Alnylam will receive up to
$150 million from Blackstone Life Sciences for the development of
Alnylam’s cardiometabolic disease programs vutrisiran and ALN-AGT.
The investment includes up to $70 million to support the ongoing
HELIOS-B Phase 3 study of vutrisiran in ATTR amyloidosis patients
with cardiomyopathy, and up to $80 million to support Phase 2 and
Phase 3 development of ALN-AGT, in development for the treatment of
hypertension.
In April 2020, Blackstone and Alnylam entered into a broad $2
billion strategic financing collaboration anchored by Blackstone’s
purchase of 50 percent of royalties owed to Alnylam on global sales
of inclisiran, an investigational RNAi therapeutic for the
treatment of hypercholesterolemia, currently under review by the
U.S. Food and Drug Administration and other regulatory authorities.
The strategic financing collaboration is expected to enable
Alnylam’s achievement of a self-sustainable financial profile
without need for future equity financing, accelerating the
commercial potential of Alnylam’s rapidly advancing product
portfolio.
About RNAi
RNAi (RNA interference) is a natural cellular process of gene
silencing that represents one of the most promising and rapidly
advancing frontiers in biology and drug development today. Its
discovery has been heralded as “a major scientific breakthrough
that happens once every decade or so,” and was recognized with the
award of the 2006 Nobel Prize for Physiology or Medicine. By
harnessing the natural biological process of RNAi occurring in our
cells, a new class of medicines, known as RNAi therapeutics, is now
a reality. Small interfering RNA (siRNA), the molecules that
mediate RNAi and comprise Alnylam's RNAi therapeutic platform,
function upstream of today’s medicines by potently silencing
messenger RNA (mRNA) – the genetic precursors – that encode for
disease-causing proteins, thus preventing them from being made.
This is a revolutionary approach with the potential to transform
the care of patients with genetic and other diseases.
About Alnylam Pharmaceuticals
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, infectious, and central nervous
system (CNS)/ocular 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 RNAi therapeutics platform. Alnylam’s commercial RNAi
therapeutic products are ONPATTRO® (patisiran), approved in the
U.S., EU, Canada, Japan, Switzerland and Brazil, and GIVLAARI®
(givosiran), approved in the U.S., EU and Brazil. Alnylam has a
deep pipeline of investigational medicines, including six product
candidates that are in late-stage development. Alnylam is executing
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 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.
About Blackstone Life Sciences
Blackstone Life Sciences is a private, global investment
platform with capabilities to invest across the life-cycle of
companies and products within the key life science sectors. By
combining scale investments and hands-on operational leadership,
Blackstone Life Sciences helps bring to market promising new
medicines and medical products that improve patients’ lives.
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam’s
expectations, plans and prospects, including, without limitation,
expectations regarding the direct or indirect effects on Alnylam’s
business, activities and prospects as a result of the COVID-19
pandemic, or delays or interruptions resulting therefrom and the
success of Alnylam’s mitigation efforts, Alnylam's views and plans
with respect to the potential for RNAi therapeutics, including
vutrisiran and ALN-AGT, expectations regarding its agreement with
Blackstone for funding of certain R&D activities for vutrisiran
and ALN-AGT, Alnylam’s belief that the funding provided by
Blackstone should enable Alnylam to achieve a self-sustainable
profile without the need for future equity financing, and
expectations regarding the achievement of its “Alnylam 2020”
strategic plan announced in 2015 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: the direct or indirect impact of the COVID-19 global
pandemic or any future pandemic, such as the scope and duration of
the outbreak, government actions and restrictive measures
implemented in response, material delays in diagnoses of rare
diseases, initiation or continuation of treatment for diseases
addressed by Alnylam products, or in patient enrollment in clinical
trials, potential supply chain disruptions, and other potential
impacts to Alnylam’s business, the effectiveness or timeliness of
steps taken by Alnylam to mitigate the impact of the pandemic, and
Alnylam’s ability to execute business continuity plans to address
disruptions caused by the COVID-19 or any future pandemic;
Alnylam's ability to discover and develop novel drug candidates and
delivery approaches and successfully demonstrate the efficacy and
safety of its product candidates, including vutrisiran and ALN-AGT;
the pre-clinical and clinical results for its product candidates,
including vutrisiran and ALN-AGT, 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 or its marketed products, including ONPATTRO,
GIVLAARI, inclisiran, lumasiran and vutrisiran; obtaining,
maintaining and protecting intellectual property; intellectual
property matters including potential patent litigation relating to
its platform, products or product candidates; obtaining regulatory
approval for its product candidates, including lumasiran and
inclisiran, and maintaining regulatory approval and obtaining
pricing and reimbursement for its products, including ONPATTRO and
GIVLAARI; progress in continuing to establish a commercial and
ex-United States infrastructure; successfully launching, marketing
and selling its approved products globally, including ONPATTRO and
GIVLAARI and achieving net product revenues for ONPATTRO within its
further revised expected range during 2020; Alnylam’s ability to
successfully expand the indication for ONPATTRO in the future;
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 within the reduced ranges
of guidance provided by Alnylam through the implementation of
further discipline in operations to moderate spend and its ability
to achieve a self-sustainable financial profile in the future
without the need for future equity financing; Alnylam’s ability to
establish and maintain strategic business alliances and new
business initiatives; Alnylam's dependence on third parties,
including Regeneron, for development, manufacture and distribution
of certain products, including eye and CNS products and ALN-APP,
Ironwood, for assistance with the education about and promotion of
GIVLAARI, and Vir for the development of ALN-COV and other
potential RNAi therapeutics targeting SARS-CoV-2 and host factors
for SARS-CoV-2; 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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version on businesswire.com: https://www.businesswire.com/news/home/20200817005158/en/
Blackstone Jennifer Friedman 212-583-5122
Jennifer.Friedman@blackstone.com
Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom
(Investors and Media) 617-682-4340 media@alnylam.com
Josh Brodsky (Investors) 617-551-8276 investors@alnylam.com
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