− Companies to Also Jointly Advance Select
Number of Preclinical Disease Programs with Targets Expressed in
the Liver and Treatments for C5 Complement-Mediated Diseases –
− Regeneron to Invest $800 million Through
Upfront Cash and Equity Investment in Alnylam, with up to
Additional $200 Million in Potential Near-Term Milestones –
− Alnylam to Host Conference Call Today,
Monday, April 8th at 8:30 am ET –
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading
RNAi therapeutics company, and Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN), announced today a collaboration to discover,
develop and commercialize new RNA interference (RNAi) therapeutics
for a broad range of diseases by addressing disease targets
expressed in the eye and central nervous system (CNS), in addition
to a select number of targets expressed in the liver. The
collaboration will leverage both companies’ scientific and
technological expertise and will build on Alnylam’s recent
preclinical data showing potent and highly durable delivery of RNAi
therapeutics to achieve target gene silencing in the eye and CNS.
The collaboration will also benefit from Regeneron’s
industry-leading VelociSuite® technologies and capabilities from
the Regeneron Genetics Center (RGC).
Under the terms of the alliance, Alnylam will work exclusively
with Regeneron to discover RNAi therapeutics for eye and CNS
diseases. Regeneron will lead development and commercialization for
all programs targeting eye diseases, with Alnylam entitled to
potential milestone and royalty payments. The companies will
jointly advance and alternate leadership on CNS programs, with the
lead party retaining global development and commercial
responsibility. For CNS programs, both companies will have the
option at candidate selection to participate equally in potential
future profits of programs led by the other party.
The collaboration also includes a select number of RNAi
therapeutic programs designed to target genes expressed in the
liver, which can influence a wide variety of diseases throughout
the body. These programs include a planned joint effort evaluating
anti-C5 antibody-siRNA combinations for C5 complement-mediated
diseases including evaluating the combination of Regeneron’s
pozelimab (REGN3918), currently in Phase 1 development, with
Alnylam’s cemdisiran, currently in Phase 2 development. Alnylam
will retain control of cemdisiran monotherapy development, and
Regeneron will lead combination development. The parties will
equally share investment and potential future profits on the
monotherapy program, and Alnylam will receive royalties on any
potential combination product sales. For all other alliance liver
programs, the parties will alternate leadership and participate
equally in potential profits. The companies will continue their
previously-announced collaboration to identify RNAi therapeutics
for the chronic liver disease nonalcoholic steatohepatitis (NASH)
based on novel RGC findings. Alnylam retains broad global rights to
all of its other unpartnered liver-directed clinical and
preclinical pipeline programs.
“At Regeneron we believe the best use of our resources is to
invest in potentially game-changing science that will yield
innovative medicines for patients with serious diseases. This
collaboration couples proven and emerging RNAi technology, which
holds important promise in many diseases, with Regeneron’s
world-leading genetics research and target discovery engine,” said
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. “This collaboration enables us to reach
targets inside the cell complementing our expertise in antibodies,
which are ideal for extracellular targets and those on the cell
surface. Through the RGC and our other research groups, we are
already identifying additional targets that may be well-suited for
RNAi-based drug development, particularly in the eye and CNS.”
“This new industry-leading alliance is aimed at realizing what
we believe to be a significant opportunity for RNAi therapeutics as
potentially transformative medicines for ocular and CNS diseases.
We are thrilled to collaborate with Regeneron, a like-minded
science-based organization, to significantly accelerate our efforts
to bring RNAi therapeutics to patients,” said John Maraganore,
Ph.D., Chief Executive Officer of Alnylam. “Importantly, the
alliance structure enables Alnylam to continue to build its
industry-leading pipeline of RNAi therapeutics while retaining
significant product rights. In addition, the near-term payments
under this new agreement will strengthen Alnylam’s balance sheet
with over $2 billion in pro forma cash upon closing of the
transaction, supporting our global efforts to develop and
commercialize multiple products as potentially breakthrough
medicines and advance our profile toward sustainable
profitability.”
Regeneron has agreed to make a $400 million upfront payment to
Alnylam and to purchase $400 million of Alnylam equity at a price
per share of $90.00 (4.44 million common shares), based on the
volume-weighted average price over the last fifteen-trading-day
period. Alnylam is eligible to receive up to an additional $200
million in milestone payments upon achievement of certain criteria
during early clinical development for the eye and CNS programs. The
companies plan to advance programs directed to 30 targets and
introduce many into clinical development during the initial
five-year discovery period, which includes an option to extend. For
each program, Regeneron will provide Alnylam with $2.5 million in
funding at program initiation and an additional $2.5 million at
lead candidate identification, translating to the potential for
approximately $30 million in annual discovery funding to Alnylam as
the alliance reaches steady state. The alliance and equity-related
agreements are subject to customary closing conditions and
clearances, including clearance under the Hart-Scott Rodino
Antitrust Improvements Act.
Alnylam, alongside multiple other leading life sciences
companies, is also a member of Regeneron’s pre-competitive
consortium to sequence the DNA of 500,000 individuals in the UK
Biobank health resource and subsequently make the data publicly
available to the global research community.
Alnylam Conference Call Information
Alnylam Management will discuss this collaboration via
conference call on Monday, April 8, 2019 at 8:30 am ET. A webcast
presentation will also be available on the Investors page of the
Company’s website, www.alnylam.com. To access the call, please dial
800-289-0438 (domestic) or 323-794-2423 (international) five
minutes prior to the start time and refer to conference ID 2197882.
A replay of the call will be available beginning at 11:30 am ET on
the day of the call. To access the replay, please dial 888-203-1112
(domestic) or 719-457-0820 (international) and refer to conference
ID 2197882.
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, hepatic 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 discovery platform. Alnylam’s first U.S. FDA-approved
RNAi therapeutic is ONPATTRO® (patisiran) lipid complex injection
available in the U.S. for the treatment of the polyneuropathy of
hereditary transthyretin-mediated (hATTR) amyloidosis in adults. In
the EU, ONPATTRO is approved for the treatment of hATTR amyloidosis
in adults with stage 1 or stage 2 polyneuropathy. Alnylam has a
deep pipeline of investigational medicines, including five 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 1,000 people worldwide 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.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies, such
as VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
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 of RNAi therapeutics
to achieve target gene silencing in the CNS and eye, Regeneron’s
participation in the development and commercialization of RNAi
therapeutics directed to CNS, eye and a select number of liver
targets, as well as the planned joint effort evaluating an anti-C5
antibody-siRNA combination as well as a monotherapy approach, the
parties plans to advance 30 targets and file multiple
Investigational New Drug Applications during the discovery period,
Alnylam’s expectations regarding funding for each program under the
collaboration at various stages of development, its expectations
regarding the receipt of upfront cash and an equity investment, as
well as potential development, regulatory and sales milestones and
royalties from Regeneron, its expectations regarding available cash
for its operations through multiple product launches, 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; Regeneron’s ability to
successfully advance and develop programs targeting eye diseases,
resulting in the potential payment of milestones and royalties to
Alnylam; the parties ability to successfully develop and
commercialize CNS programs; 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, successfully launching, marketing and
selling its approved products globally; 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, 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 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, except to the
extent required by law, to update any forward-looking
statements.
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such
as "anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying
words. These statements concern, and these risks and
uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's or its
collaborators’ products, product candidates, and research and
clinical programs now underway or planned, such as the RNA
interference programs discussed in this press release (including
programs evaluating anti-C5 antibody-siRNA combinations for C5
complement-mediated diseases and RNAi therapeutics for the chronic
liver disease nonalcoholic steatohepatitis); the extent to which
the results from the research and development programs conducted by
Regeneron or its collaborators (including based on the
collaboration discussed in this press release) may be replicated in
other studies and lead to therapeutic applications; the potential
for any license or collaboration agreement, including Regeneron's
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), as
well as Regeneron’s collaborations with Alnylam Pharmaceuticals,
Inc. discussed in this news release, to be cancelled or terminated
without any product success; the likelihood, timing, and scope of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates and new indications for marketed
products; unforeseen safety issues resulting from the
administration of products and product candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron's or its collaborators’ product candidates in
clinical trials; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products, research and clinical
programs, and business, including those relating to patient
privacy; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's or
its collaborators’ ability to continue to develop or commercialize
products and product candidates; competing drugs and product
candidates that may be superior to Regeneron's or its
collaborators’ products and product candidates; uncertainty of
market acceptance and commercial success of Regeneron's or its
collaborators’ products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's or
its collaborators’ products and product candidates; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; the availability and extent of reimbursement of
the Company's products from third-party payers, including private
payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
guidance; and risks associated with intellectual property of other
parties and pending or future litigation relating thereto,
including without limitation the patent litigation and other
related proceedings relating to EYLEA® (aflibercept) Injection, and
Dupixent® (dupilumab) Injection, and Praluent® (alirocumab)
Injection, the ultimate outcome of any such proceedings, and the
impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31,
2018. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to
update publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190408005387/en/
Alnylam Pharmaceuticals, Inc.Christine Regan
Lindenboom(Investors and Media)617-682-4340
Josh Brodsky(Investors)617-551-8276
Regeneron Investor RelationsMark HudsonTel: +1 (914)
847-3482Mark.hudson@regeneron.com
Regeneron Media RelationsHala MirzaTel: +1 (914)
847-3422Hala.mirza@regeneron.com
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