Genzyme and Alnylam Expand Collaboration on Rare Genetic Diseases
Jan 13, 2014
- Genzyme to Obtain Significant Global Rights to Alnylam's
Pipeline -
- Alnylam Retains Most Product Rights in North America and Western
Europe -
- Genzyme Becomes Major Alnylam Shareholder through $700 Million
Equity Investment -
PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Alnylam
Pharmaceuticals, Inc. (NASDAQ: ALNY) announced today that they have
significantly expanded their strategic agreement to develop and
commercialize treatments for rare genetic diseases. Genzyme will have
significant rights to Alnylam's portfolio of clinical and pre-clinical
stage drug candidates. Alnylam will retain most product rights in North
America and Western Europe, and will have significantly expanded
development and commercial opportunities for its genetic medicine
pipeline through Genzyme's established global infrastructure in rare
diseases.
"This collaboration is an important building block for our future. It
strengthens our pipeline and provides us with the opportunity to meet
the needs of patients with rare diseases around the world through our
well-established global organization," said David Meeker, MD,
Genzyme's President and CEO. "This transaction also powerfully
underscores Sanofi's commitment to investing in Genzyme as one of the
company's key growth drivers. Our partnership with Alnylam has been
highly collaborative, and their world-class RNAi technology holds the
promise to provide a platform for sustained drug development for rare
genetic diseases for years to come."
"This new relationship with Genzyme is transformational for Alnylam.
It is a game changer for both the advancement of RNAi therapeutics as
a new class of genetic medicines to patients around the world, and for
our commitment to build a leading, independent biopharmaceutical company
that delivers value to our shareholders," said John Maraganore,
Ph.D., Chief Executive Officer of Alnylam. "In this new alliance,
Alnylam benefits enormously from Genzyme's proven global capabilities,
enabling us to accelerate and expand market access for our ‘Alnylam
5x15' products."
In 2012, Alnylam and Genzyme formed an exclusive alliance to develop and
commercialize Alnylam's lead product, patisiran, which is in Phase 3
development for the treatment of transthyretin (TTR)-familial amyloid
polyneuropathy, a rare life-threatening disease that damages the nervous
system.
The expanded relationship between Genzyme and Alnylam includes the
following components:
First, Genzyme will obtain expanded rights to patisiran. Under the
original agreement from 2012, Genzyme had rights to commercialize
patisiran in Japan and the broader Asia-Pacific region. This disease has
a disproportionately high prevalence in these territories. Under the
expanded agreement, Genzyme will now commercialize patisiran in all
territories outside of North America and Western Europe, which are
retained by Alnylam for their commercialization.
Second, Genzyme will obtain rights to commercialize worldwide three
products in Alnylam's pipeline. Specifically, (1) Genzyme and Alnylam
will co-develop and co-commercialize ALN-TTRsc, a product currently in
Phase 2 development for the treatment of familial amyloid
cardiomyopathy, in North America and Western Europe, while Genzyme
commercializes the product in the rest of world; (2) Genzyme will have
the rights to two additional products after the completion of early
clinical trials and will be able to choose between full global rights or
co-commercialization rights, depending on the product.
Third, Genzyme will have the option up until 2020, with the possibility
of extension through the end of 2021,to develop and commercialize
outside of North America and Western Europe all products being developed
to treat rare genetic diseases from Alnylam's pipeline. Alnylam retains
its rights to co-develop and co-commercialize its genetic medicine
pipeline in North America and Western Europe.
Finally, Genzyme will become a major Alnylam shareholder with a stake of
approximately 12% percent through a $700 million investment at a price
of approximately $80/share, which represents a 27% premium as compared
to the average share price over the last 30 days. In addition, Alnylam
will receive R&D funding, starting on January 1, 2015, for programs
where Genzyme has elected to opt-in for development and
commercialization. Further, Alnylam is eligible to receive milestones
and royalties.
This transaction has been approved by the boards of both companies, and
is subject to customary closing conditions and clearances under the
Hart-Scott Rodino Antitrust Improvements Act.
Conference Call Information
Alnylam and Genzyme management will discuss this new alliance in a
conference call on January 13, 2014 at 9:00 am ET (6:00 am PT). A slide
presentation will also be available on the News & 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 31887205. A replay of
the call will be available beginning at 12 :00 pm ET (9 :00 am PT) on
January 13, 2014. To access the replay, please dial 855-859-2056
(domestic) or 404-537-3406 (international), and refer to conference ID
31887205.
About Alnylam
Alnylam is a biopharmaceutical company developing novel therapeutics
based on RNA interference, or RNAi. The company is leading the
translation of RNAi as a new class of innovative medicines with a core
focus on RNAi therapeutics for the treatment of genetically defined
diseases. As part of its "Alnylam 5x15" strategy, as updated in early
2014, the company expects to have six to seven genetic medicine product
candidates in clinical development - including at least two programs in
Phase 3 and five to six programs with human proof of concept - by the
end of 2015.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme's portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world's largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® is a registered trademark of Genzyme Corporation. All rights
reserved.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has
core strengths in the field of healthcare with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, consumer
healthcare, emerging markets, animal health and the new Genzyme. Sanofi
is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).
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, the Group's
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies 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, 2012. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Alnylam Forward-Looking Statements
Various statements in this press release concerning Alnylam's future
expectations, plans and prospects, including without limitation,
Alnylam's views with respect to the potential for RNAi therapeutics,
including the programs in its 5x15 pipeline, Genzyme's participation in
the development and commercialization of RNAi therapeutics, its
expectations regarding the receipt of potential R&D payments,
development and sales milestones and royalties from Genzyme, and its
expectations regarding available cash for its operations through
multiple product launches, constitute forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Actual results may differ materially from
those indicated by these forward-looking statements as a result of
various important 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 drug
candidates, the pre-clinical and clinical results for its product
candidates, which may not support further development of product
candidates, actions of regulatory agencies, which may affect the
initiation, timing and progress of clinical trials, Genzyme's ability to
successfully advance patisiran, ALN-TTRsc and other products in the
Genzyme territory, resulting in the potential payment of milestones and
royalties to Alnylam, as well as Alnylam's ability to develop and
commercialize such products in the rest of the world, the parties
ability to successfully co-develop and co-promote ALN-TTRsc and
potentially a second product in North America and Western Europe,
obtaining, maintaining and protecting intellectual property, Alnylam's
ability to enforce its patents against infringers and defend its patent
portfolio against challenges from third parties, obtaining regulatory
approval for products, competition from others using technology similar
to Alnylam's and others developing products for similar uses, Alnylam's
ability to 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, marketing, sales and distribution of products, the outcome
of litigation, 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 to update any forward-looking statements.
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Sanofi Media Relations
Jack Cox, +33 (0) 1 53 77 94 74
mr@sanofi.com
or
Genzyme
Media Relations
Lori Gorski, 617-768-9344
Lori.gorski@genzyme.com
or
Alnylam
Cynthia
Clayton, 617-551-8207
cclayton@alnylam.com
or
Sanofi
Investor Relations
Sébastien Martel, +33 (0) 1 53 77 45 45
ir@sanofi.com
or
Sanofi
Investor Relations
Kristen Galfetti, +1 908-981-5560
ir@sanofi.com
Source: Alnylam Pharmaceuticals, Inc.
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