Genzyme and Alnylam Expand Collaboration on Rare Genetic Diseases

  Genzyme and Alnylam Expand Collaboration on Rare Genetic Diseases

    - 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 -

Business Wire

PARIS & CAMBRIDGE, Mass. -- January 13, 2014

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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Contact:

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
 
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