Alnylam and Kyowa Hakko Form Alliance for the Development and Commercialization of...

Alnylam and Kyowa Hakko Form Alliance for the Development and Commercialization of ALN-RSV01 in Asia

- ALN-RSV01, Alnylam's Lead RNAi Therapeutic, is in Phase II
Clinical Development for Treatment of Respiratory Syncytial Virus
(RSV) Infection -
CAMBRIDGE, Mass. & TOKYO--(Business Wire)--
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Kyowa Hakko Kogyo
Co., Ltd. (TSE: 4151) today announced that they have formed an
exclusive alliance to develop and commercialize ALN-RSV01, an RNAi
therapeutic in Phase II clinical development by Alnylam for the
treatment of respiratory syncytial virus (RSV) infection, in Japan and
other major markets in Asia.

Under the terms of the collaboration, Kyowa Hakko will pay Alnylam
$15 million in an upfront cash payment and up to an additional $78
million in development and sales milestone payments. Upon
commercialization, Alnylam will receive double-digit royalties from
Kyowa Hakko based on the sales of ALN-RSV01 in this territory. The
partnership also includes additional RSV-specific RNAi therapeutic
compounds that comprise the ALN-RSV program. Alnylam retains all
development and commercialization rights worldwide excluding Asia.

"We are excited to have formed this new alliance with Kyowa Hakko,
a Japanese biotechnology company with a strong commitment to bringing
innovative new drugs to the marketplace," said John Maraganore, Ph.D.,
Chief Executive Officer at Alnylam. "This new collaboration is yet
another example of Alnylam's commitment to work with leading
biotechnology and pharmaceutical companies to advance RNAi
therapeutics to patients on a global basis. This is an important
partnership on our company's lead clinical program in an important
pharmaceutical market, and also our third significant alliance formed
this year. We will provide an update on our near-term partnership
goals and revised financial guidance at our upcoming second quarter
conference call."

"We have been watching the progress Alnylam has made with their
ALN-RSV01 program since last year and are very excited to partner with
this program at this time. We are looking forward to working with
Alnylam, the most scientifically advanced company in the field of
RNAi, in the development and commercialization of ALN-RSV01 in Japan
and other major markets in Asia," said Yuzuru Matsuda, Ph.D., Chief
Executive Officer at Kyowa Hakko. "There is a significant need for
novel medicines to effectively treat patients with RSV, a leading
cause of serious infections in both pediatric and adult patients. We
are excited to have the opportunity in delivering the benefit of this
novel medicine to patients in Asia through the partnership with
Alnylam."

Earlier this year, Alnylam achieved human proof of concept for
ALN-RSV01 in the Phase II GEMINI study, where intranasally
administered ALN-RSV01 demonstrated statistically significant
anti-viral efficacy with a 38 percent relative reduction in RSV
infection rate and a 95 percent increase in the number of
infection-free subjects as compared with placebo. In addition, Alnylam
has initiated a Phase II clinical trial to assess the safety and
tolerability of aerosolized ALN-RSV01 versus placebo in adult lung
transplant patients naturally infected with RSV. As a secondary
objective, this trial will also aim to evaluate the anti-viral
activity of ALN-RSV01. The data from this study, in combination with
the previous Phase II GEMINI trial and multiple Phase I trials, will
comprise a comprehensive safety and efficacy data set with which
Alnylam expects to further advance its overall ALN-RSV development
program.

About RNA Interference (RNAi)

RNAi (RNA interference) is a revolution in biology, representing a
breakthrough in understanding how genes are turned on and off in
cells, and a completely new approach to drug discovery and
development. Its discovery has been heralded as "a major scientific
breakthrough that happens once every decade or so," and represents one
of the most promising and rapidly advancing frontiers in biology and
drug discovery today which was awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi is a natural process of gene silencing
that occurs in organisms ranging from plants to mammals. By harnessing
the natural biological process of RNAi occurring in our cells, the
creation of a major new class of medicines, known as RNAi
therapeutics, is on the horizon. RNAi therapeutics target the cause of
diseases by potently silencing specific messenger RNAs (mRNAs),
thereby preventing disease-causing proteins from being made. RNAi
therapeutics have the potential to treat disease and help patients in
a fundamentally new way.

About Alnylam Pharmaceuticals

Alnylam is a biopharmaceutical company developing novel
therapeutics based on RNA interference, or RNAi. The company is
applying its therapeutic expertise in RNAi to address significant
medical needs, many of which cannot effectively be addressed with
small molecules or antibodies, the current major classes of drugs.
Alnylam is leading the translation of RNAi as a new class of
innovative medicines with peer-reviewed research efforts published in
the world's top scientific journals including Nature, Nature Medicine,
and Cell. The company is leveraging these capabilities to build a
broad pipeline of RNAi therapeutics; its most advanced program is in
Phase II human clinical trials for the treatment of respiratory
syncytial virus (RSV) infection. In addition, the company is
developing RNAi therapeutics for the treatment of a wide range of
disease areas, including hypercholesterolemia, liver cancers, and
Huntington's disease. The company's leadership position in fundamental
patents, technology, and know-how relating to RNAi has enabled it to
form major alliances with leading companies including Medtronic,
Novartis, Biogen Idec, Roche, Takeda, and Kyowa Hakko Kogyo. To
reflect its outlook for key scientific, clinical, and business
initiatives, Alnylam has established "RNAi 2010" which includes the
company's plan to significantly expand the scope of delivery solutions
for RNAi therapeutics, have four or more programs in clinical
development, and to form four or more new major business
collaborations, all by the end of 2010. Alnylam is a joint owner of
Regulus Therapeutics LLC, a joint venture focused on the discovery,
development, and commercialization of microRNA therapeutics. Founded
in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts.
For more information, visit www.alnylam.com.

About Kyowa Hakko

Kyowa Hakko (TSE:4151) is a biotechnology-based company focused on
pharmaceutical operations engaged in the research and development,
manufacturing, and marketing of prescription drugs. Kyowa Hakko is
marketing medications for a wide range of diseases, including allergy,
hypertension, angina pectoris, and cancer. With the aim of penetrating
the global market, Kyowa Hakko has overseas development bases in the
U.S. (Kyowa Pharmaceutical, Inc. and BioWa, Inc.) and in the U.K.
(Kyowa Hakko U.K. Ltd.). In the U.S., the U.K., and China, Kyowa Hakko
is pushing ahead with the clinical development of new drug candidates
as well as the therapeutic antibody business based on Kyowa Hakko's
proprietary technology that enhances the activity of antibodies.

Last October, Kyowa Hakko announced that the Kyowa Hakko group and
the Kirin group entered into an agreement to form a strategic
alliance. Through this strategic alliance, the two groups will
endeavor to build a global leader in the research and
development-driven life sciences business based in Japan, which is
centered on pharmaceutical operations with strengths in biotechnology.
The new company "Kyowa Hakko Kirin Co., Ltd." will start operating on
October 1, 2008.

For more information on Kyowa Hakko, visit
http://www.kyowa.co.jp/eng/index.htm.

Alnylam Forward-Looking Statements

Various statements in this release concerning Alnylam's future
expectations, plans and prospects, 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 risks
related to: Alnylam's approach to discover and develop novel drugs,
which is unproven and may never lead to marketable products;
obtaining, maintaining and protecting intellectual property; Alnylam's
ability to enforce its patents against infringers and to defend its
patent portfolio against challenges from third parties; Alnylam's
ability to obtain additional funding to support its business
activities; Alnylam's ability to realize future milestones and
royalties; Alnylam's dependence on third parties for development,
manufacture, marketing, sales and distribution of products; obtaining
regulatory approval for products; competition from others using
technology similar to Alnylam's and others developing products for
similar uses; Alnylam's dependence on collaborators; and Alnylam's
short operating history; as well as those risks more fully discussed
in the "Risk Factors" section of its most recent quarterly report on
Form 10-Q on file with the Securities and Exchange Commission. 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 does not assume any
obligation to update any forward-looking statements.

Alnylam Pharmaceuticals, Inc.
Cynthia Clayton, 617-551-8207 (Investors)
or
Yates Public Relations
Adriana Jenkins, 617-551-8252 (Media)
or
Kyowa Hakko Kogyo Co., Ltd.
Tetsuro Kuga, +81-3-3282-1903
Corporate Communications Dept.
Fax: +81-3-3282-0990

Copyright Business Wire 2008