Jan 07, 2018 Press Release for Alnylam
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Alnylam and Sanofi Enter into Strategic Restructuring of RNAi Therapeutics Rare Disease Alliance
Jan 07, 2018
–
– Alnylam Obtains Global Rights for Investigational ATTR Amyloidosis Programs: Patisiran and ALN-TTRsc02 –
– Sanofi Obtains Global Rights for Investigational Therapeutic Fitusiran in Hemophilia and Other Rare Bleeding Disorders –
– Alnylam to Host Conference Call Today,
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“This strategic restructuring enables streamlined development and an
optimized approach to bringing innovative medicines to patients with
ATTR amyloidosis and hemophilia around the world, maximizing the
commercial opportunities for these programs,” said
This restructuring provides Alnylam with the opportunity to consolidate its ATTR amyloidosis business to maximize its value, and the opportunity for near-term acceleration of product revenue growth based on newly obtained rights to commercialize patisiran around the world, once approved. In addition, it enables Alnylam to build a global presence and commercial infrastructure that can be leveraged for ALN-TTRsc02 and additional programs – including givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias, and cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases – where Alnylam has retained global ownership.
“The restructured alliance reflects Sanofi Genzyme’s sustained interest
in the strong potential of Alnylam’s portfolio of genetic medicines. The
new structure simplifies operations, providing both parties the agility
needed to make these medicines available to patients as quickly as
possible once approved,” said
Fitusiran complements Sanofi Genzyme’s rare hematology portfolio, and creates a focus on bringing an innovative product to market globally, upon approval, for people living with hemophilia, one of the most common rare diseases.
Terms of the Agreements
Patisiran and ALN-TTRsc02
Alnylam will fund all development and commercialization costs for
patisiran and ALN-TTRsc02 going forward. There will be no additional
milestones due to either company with respect to patisiran or
ALN-TTRsc02.
Fitusiran
The restructuring will enable
Product Royalties
Alnylam and Sanofi Genzyme will be eligible to receive tiered royalties
of 15 to 30 percent on global net sales of fitusiran and ALN-TTRsc02,
respectively, upon approval and commercialization. Previously, these
programs were subject to co-development and co-commercialization terms
in
The transaction is subject to customary closing conditions and clearances, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.
Conference Call Details
Alnylam management will discuss this restructured alliance in a
conference call on January 7, 2018 at 4:30 p.m. ET,
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 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, 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 (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 700 people in the
U.S. and
About Sanofi
With more than 100,000 people in 100 countries,
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.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 streamlined
development and an optimized approach to bringing innovative medicines
to patients with ATTR amyloidosis and hemophilia around the world,
maximizing the commercial opportunities for these programs under the
restructured alliance with Sanofi Genzyme, the development of patisiran
and ALN-TTRsc02 in a comprehensive manner, addressing the full spectrum
of transthyretin-mediated amyloidosis disease treatment and prevention,
expectations regarding a potential milestone payment and potential
royalty payments under the restructured alliance, 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 (
Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although
View source version on businesswire.com: http://www.businesswire.com/news/home/20180107005093/en/
Source:
Alnylam Pharmaceuticals, Inc.
(Investors and Media)
Christine
Regan Lindenboom, +1-617-682-4340
or
(Investors)
Josh
Brodsky, +1-617-551-8276
or
Sanofi
(Media
Relations)
Ashleigh Koss
Tel.: +1-908-981-8745
Mobile:
+1-908-205-2572
Ashleigh.Koss@sanofi.com
or
(Investor
Relations)
George Grofik, +33 (0)1 53 77 45 45
ir@sanofi.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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