– Restructuring Enables Streamlined Development
and Optimization of Commercial Opportunities for ATTR Amyloidosis
and Hemophilia Programs –
– 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,
Sunday, January 7 at 4:30 pm ET, 1:30 pm PT to Discuss Restructured
Alliance –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, and Sanofi announced today a strategic
restructuring of their RNAi therapeutics alliance to streamline and
optimize development and commercialization of certain products for
the treatment of rare genetic diseases. Specifically, Alnylam will
obtain global development and commercialization rights to its
investigational RNAi therapeutics programs for the treatment of
ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will
receive royalties based on net sales of these ATTR amyloidosis
products. Sanofi will obtain global development and
commercialization rights to fitusiran, an investigational RNAi
therapeutic, currently in development for the treatment of people
with hemophilia A and B. Global commercialization of fitusiran,
upon approval, will be done by Sanofi Genzyme, the specialty care
global business unit of Sanofi. Alnylam will receive royalties
based on net sales of fitusiran products. With respect to other
products falling under the RNAi therapeutics alliance, the material
terms of the 2014 Alnylam-Sanofi Genzyme alliance remain
unchanged.
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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
John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “For
Alnylam, this provides strategic clarity and operational alignment
with regard to the development and commercialization of patisiran
and ALN-TTRsc02. This will allow us to develop both products in a
comprehensive manner, potentially addressing the full spectrum of
transthyretin-mediated amyloidosis disease treatment and
prevention. At the same time, we will continue to support and
benefit – via royalties – from the fitusiran opportunity through
Sanofi’s significant development and commercial leadership.”
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 Bill Sibold,
Executive Vice President and Head of Sanofi Genzyme. “This
restructuring will enable both parties to maximize the value of
each asset and allows us to maintain shared economics across the
alliance program.”
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. Sanofi intends to substantially complete
the transition of its patisiran activities in regions outside the
United States, Canada, and Western Europe, consistent with the
original scope of its license rights to patisiran, by mid-2018.
Fitusiran
The restructuring will enable Sanofi to assume full
responsibility for development and commercialization of fitusiran,
including costs. However, during the anticipated transition period
Alnylam will fund such costs. Alnylam intends to substantially
complete the transition of fitusiran to Sanofi by mid-2018. Sanofi
will pay Alnylam a milestone of $50 million following dosing of the
first patient in the ATLAS Phase 3 program for fitusiran.
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 United States, Canada, and
Western Europe. For patisiran, Sanofi Genzyme will be eligible to
receive royalties, increasing over time to up to 25 percent, on
sales in territories excluding the United States, Canada, and
Western Europe. Sanofi continues to have the right to opt into
other Alnylam rare genetic disease programs for development and
commercialization in territories outside of the United States,
Canada, and Western Europe, as well as one right to a global
license.
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,
1:30 p.m. PT. A slide presentation will also be available on the
Investors page of the Company's website, www.alnylam.com, to
accompany the conference call. To access the call, please dial
(877) 312-7507 (domestic) or (631) 813-4828 (international) five
minutes prior to the start time and refer to conference ID 3786228.
A replay of the call will be available beginning at 7:30 p.m.
ET, 4:30 p.m. PT on January 7, 2018. To access the
replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international), and refer to conference ID 3786228.
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 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, 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 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.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
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.
Sanofi, Empowering Life.
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 (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.
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 Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in exchange
rates and prevailing interest rates, volatile economic conditions,
the impact of cost containment initiatives and subsequent changes
thereto, the average number of shares outstanding as well as those
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31,
2016. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180107005093/en/
Alnylam Pharmaceuticals, Inc.(Investors and
Media)Christine Regan Lindenboom, +1-617-682-4340or(Investors)Josh
Brodsky, +1-617-551-8276orSanofi(Media Relations)Ashleigh
KossTel.: +1-908-981-8745Mobile:
+1-908-205-2572Ashleigh.Koss@sanofi.comor(Investor Relations)George
Grofik, +33 (0)1 53 77 45 45ir@sanofi.com
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