Apr 08, 2019 Press Release for Alnylam
Alnylam and Regeneron Announce Broad Collaboration to Discover, Develop and Commercialize RNAi Therapeutics Focused on Ocular and Central Nervous System (CNS) Diseases
Apr 08, 2019
− 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
− Alnylam to Host Conference Call Today,
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
“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
Regeneron has agreed to make a
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
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.
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
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-
Regeneron Forward-Looking Statements and Use of
This press release includes forward-looking statements that involve
risks and uncertainties relating to future events and the future
performance of
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/
Source:
Alnylam Pharmaceuticals, Inc.
Christine Regan Lindenboom
(Investors
and Media)
617-682-4340
Josh Brodsky
(Investors)
617-551-8276
Regeneron Investor Relations
Mark Hudson
Tel: +1 (914)
847-3482
Mark.hudson@regeneron.com
Regeneron Media Relations
Hala Mirza
Tel: +1 (914)
847-3422
Hala.mirza@regeneron.com
For Media Inquiries, please contact:
Christine Lindenboom
SVP, Investor Relations & Corporate Communications media@alnylam.com 617-682-4340
For Investor Inquiries, please contact:
Josh Brodsky
VP, Investor Relations & Corporate Communications investors@alnylam.com 617-551-8276
MEDIA KIT
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