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Alnylam and PBL Sign License Agreement for Baulcombe & Hamilton RNAi Patent

CAMBRIDGE, Mass. & NORWICH, United Kingdom--(BUSINESS WIRE)--May. 23, 2012-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and Plant Bioscience Limited (PBL), a technology development and intellectual property (IP) management company, announced today that they have entered into a licensing agreement. PBL has granted Alnylam a world-wide, non-exclusive license to the Baulcombe patent (U.S. Patent No. 8,097,710) for use in the field of human therapeutics. Financial terms were not disclosed.

“We are pleased to expand our leading IP estate with a license to the Baulcombe patent,” said Laurence Reid, Ph.D., Senior Vice President and Chief Business Officer of Alnylam. “Alnylam continues to leverage its patent estate for the advancement of innovative medicines to patients and to enable the entire RNAi therapeutics field, with over 30 license agreements formed to date.”

Alnylam’s IP estate includes issued, allowed, or granted fundamental patents in many of the world’s major pharmaceutical markets that claim the broad structural and functional properties of RNAi therapeutic products.

PBL’s Managing Director, Dr Jan Chojecki, stated, “We are very pleased to enter into this agreement with Alnylam, a global leader in the development of novel human therapeutics based on RNA interference. We are excited to have Alnylam as a partner, which has an impressive pipeline of RNAi drug candidates in clinical development. This agreement further endorses the strength of our patent estate in the RNAi field and we look forward to working with other partners through our non-exclusive licensing strategy in agricultural, research, diagnostic and therapeutic commercial applications. This is an excellent example of how UK scientific research contributes inventions that have many beneficial applications across the life sciences. We are pleased to be able to make non-exclusive licences available on reasonable commercial terms to assist our partners in delivering benefits to patients in areas of unmet medical need.”

U.S. Patent No. 8,097,710 issued in January 2012, and is the most recently issued patent in PBL’s IP estate in short RNAs derived from the seminal work of Prof David Baulcombe and Dr Andrew Hamilton, at The Sainsbury Laboratory (Norwich, UK).

About PBL

Plant Bioscience Limited (PBL) www.pbltechnology.com is a technology development and intellectual property management company owned in equal parts by The Sainsbury Laboratory www.tsl.ac.uk, the John Innes Centre www.jic.ac.uk and the Biotechnology and Biological Sciences Research Council www.bbsrc.ac.uk. PBL promotes the development and commercial uptake of academic research results for public use and benefit and is specialised in life sciences, and in particular plants, agriculture, food and microbial science. PBL is the owner of the patent rights created at The Sainsbury Laboratory by the pioneering contributions of Professor Sir David Baulcombe and Dr Andrew Hamilton to the field of RNA interference. PBL’s issued patents in this IP estate include: US 6,753,139 (Detection of Gene Silencing in Plants); US 7,704,688 (Detection of Gene Silencing in Mammals); and US 8,097,710, issued on 17th January 2012, with claims covering methods of inducing gene silencing in organisms, using short RNA molecules.

About The Sainsbury Laboratory

The Sainsbury Laboratory (TSL) www.tsl.ac.uk is a world-leading research centre located in Norwich, UK, focusing on making fundamental discoveries about plants and how they interact with microbes. Professor Sir David Baulcombe is now Regius Professor of Botany and Royal Society Research Professor at The University of Cambridge. Dr Andrew Hamilton is now at The University of Glasgow, in the Division of Cancer Sciences and Molecular Pathology.

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. Small interfering RNAs (siRNAs), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific 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 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, including ALN-TTR for the treatment of transthyretin-mediated amyloidosis (ATTR), ALN-PCS for the treatment of severe hypercholesterolemia, ALN-HPN for the treatment of refractory anemia, ALN-APC for the treatment of hemophilia, and ALN-TMP for the treatment of hemoglobinopathies. As part of its “Alnylam 5x15TM” strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in clinical development, including programs in advanced stages, on its own or with a partner by the end of 2015. Alnylam has additional partner-based programs in clinical or development stages, including ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection, ALN-VSP for the treatment of liver cancers, and ALN-HTT for the treatment of Huntington’s disease. The company’s leadership position on RNAi therapeutics and intellectual property have enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, and Cubist. In addition, Alnylam and Isis co-founded Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics; Regulus has formed partnerships with GlaxoSmithKline and Sanofi. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for applications in biologics manufacturing, including recombinant proteins and monoclonal antibodies. Alnylam’s VaxiRNA™ platform applies RNAi technology to improve the manufacturing processes for vaccines; GlaxoSmithKline is a collaborator in this effort. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 100 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, and Cell. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit www.alnylam.com.

Alnylam Forward-Looking Statements

Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including without limitation, statements regarding Alnylam’s views with respect to the potential for RNAi therapeutics, and its expectations regarding its “Alnylam 5x15” product strategy, 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, 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, obtaining, maintaining and protecting intellectual property, obtaining regulatory approval for products, competition from others using technology similar to Alnylam’s and others developing products for similar uses, and Alnylam’s ability to establish and maintain strategic business alliances and new business initiatives, 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.

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Source: Alnylam Pharmaceuticals, Inc.

Alnylam Pharmaceuticals, Inc.
Cynthia Clayton, 617-551-8207
Vice President, Investor Relations and
Corporate Communications
Amanda Sellers (Media), 202-955-6222 x2597
Plant Bioscience Limited
Dr Jan Chojecki, +44 1603 456500
Managing Director
Rebecca McIntosh (Media & Inquiries), +44 1603 456500

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Alnylam Pharmaceuticals's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.