Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY) and Takeda Pharmaceutical
Company Limited (TOKYO:4502) today announced that they have formed a
strategic platform alliance in RNAi therapeutics in the fields of
oncology and metabolic disease with the option to expand to additional
therapeutic areas. This landmark alliance is the first major RNAi
therapeutics partnership between a Japanese pharmaceutical company and a
U.S. biotechnology company, representing a new frontier in the
advancement of RNAi therapeutics to patients on a global basis. RNAi is an entirely new approach for the discovery of breakthrough
medicines that utilizes a natural mechanism found within the body to
inhibit expression of certain genes. Harnessing the activity of RNAi
creates a direct opportunity to develop specific and potent new
medicines for the treatment of a broad range of diseases, including
those that are difficult to treat with today´s
drug approaches. The discovery of RNAi was awarded the 2006 Nobel Prize
and the advancement of RNAi is recognized as one of the most important
advances in biomedical sciences in decades. "We are very pleased and honored to have a
strategic platform partnership with Takeda, one of the world´s
leading pharmaceutical companies. As the first RNAi technology
partnership with a pharmaceutical company located in Asia, this new
alliance expands the advancement of RNAi therapeutics to patients on a
global basis," said John Maraganore, Ph.D.
Chief Executive Officer of Alnylam. "Across
multiple dimensions, this new partnership is a major event in Alnylam´s
efforts to build a leading biopharmaceutical company. A particularly
important element in this new platform alliance is Alnylam´s
opportunity to co-develop and co-commercialize Takeda RNAi therapeutic
products with Takeda in the U.S. market." "We are excited to work with Alnylam, as the
leading worldwide company in the field of RNAi therapeutics with a
strong commitment to scientific excellence and an unparalleled
intellectual property position," said
Yasuchika Hasegawa, President of Takeda. "We
believe this alliance will accelerate our initiatives to establish the
foundation for RNAi drug discovery supported by Alnylam´s
platform technologies and know-how. We expect that our product portfolio
will be enhanced by the addition of RNAi therapeutics to our current
small molecule and anti-body research platforms." This collaboration provides Takeda with broad, worldwide, non-exclusive
access to and enablement with Alnylam´s RNAi
therapeutics platform technology and intellectual property in the fields
of oncology and metabolic disease, with the right to expand the number
of therapeutic fields in the future. The agreement also includes the
transfer of platform technology from Alnylam to Takeda, a collaboration
and cross-license of delivery technologies between the two companies
and a drug discovery collaboration on certain RNAi therapeutic targets
subject to certain Alnylam third party obligations. Takeda becomes Alnylam´s strategic partner
for RNAi therapeutics over a five-year period and the only Asian company
to obtain a right of first negotiation to develop and commercialize
Alnylam RNAi therapeutic development programs for the Asian market
excluding Alnylam´s ALN-RSV01 program. In
addition, Alnylam obtains opt-in options to co-develop and
co-commercialize Takeda RNAi therapeutic programs in the U.S. market on
a 50-50 basis. The partnership includes $100 million in upfront payments and $50
million in near-term technology transfer payments for a non-exclusive
license in two therapeutic fields and is valued at potentially over $1
billion in future research and development and commercial milestones
upon successful commercialization of multiple products. At Takeda´s
option, the scope of the partnership can be expanded to include
additional fields with a $50 million per field expansion payment.
Alnylam is also eligible to receive research and development funding
related to the drug discovery collaboration. In addition, Alnylam is
eligible to receive up to $171 million in development and commercial
milestone payments and significant royalties per product. Alnylam plans
to update financial guidance when it announces its second quarter 2008
financial results. 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, and Takeda. 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 Takeda Founded in 1781 and located in Osaka, Japan, Takeda is a research-based
global company with its main focus on pharmaceuticals. As the largest
pharmaceutical company in Japan and one of the global leaders of the
industry, Takeda is committed to striving toward better health for
individuals and progress in medicine by developing superior
pharmaceutical products. Additional information about Takeda is available through its corporate
website, www.takeda.com. 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 as well as
co-development and co-commercialization opportunities; 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. Takeda Forward-Looking Statements This press release contains forward-looking statements regarding the
Company´s plans, outlook, strategies and results for the future. All
forward-looking statements are based on judgments derived from the
information available to the Company at this time. Certain risks and uncertainties could cause the Company´s actual results
to differ materially from any projections presented in this press
release. These risks and uncertainties include, but are not limited to
the economic circumstances surrounding the Company´s business;
competitive pressure; relative laws and regulations; product development
programs; and changes in exchange rates. We assume no obligation to update or reverse any forward-looking
statements or other information contained in this press release, whether
as a result of new information, future events, or otherwise.
