Alnylam and Takeda Form Strategic Worldwide Platform Alliance in RNAi Therapeutics



    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.