Alnylam Joins Max Planck in Legal Action toward Whitehead Institute

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has joined with the Max Planck Society in taking legal action toward the Whitehead Institute for Biomedical Research. Also named in the suit are the Massachusetts Institute of Technology (MIT) and the University of Massachusetts. The complaint, filed in Suffolk County Superior Court in Boston, Massachusetts, alleges that the Whitehead Institute has breached its contractual obligations to Max Planck and Alnylam in the manner in which it is prosecuting the Tuschl I patent applications and in its fiduciary duty to all of the co-owners of the Tuschl I patent series.

“Despite our exhaustive efforts, the Whitehead Institute, for whose scientific excellence we have the highest regard, has failed in their business obligations to Max Planck and Alnylam regarding the proper and successful prosecution of the Tuschl I applications. It is unfortunate that we needed to take this action, but we are convinced that it is necessary to correct improper and negligent prosecution of the Tuschl I patent applications. We have confidence that the court will recognize the merits of our case, and we will continue to take all appropriate actions needed to ensure the proper prosecution of our intellectual property rights,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “In the meanwhile, as the sole licensee of both the Tuschl I and Tuschl II patents in the RNAi therapeutics field, Alnylam’s rights to these patents remain unchanged and our broad intellectual property position remains unique and unparalleled. Moreover, our efforts remain focused on bringing our innovative medicines to patients.”

In the field of RNAi therapeutics, Alnylam is the exclusive licensee of the Tuschl I patent applications from Max Planck, MIT, and Whitehead and of the Tuschl II patent applications from Max Planck. To date, the Tuschl I family, whose prosecution is controlled by Whitehead, has resulted in just two patents, in New Zealand and Australia, and an intent to grant in Europe. In comparison, numerous patents in the Tuschl II family, whose prosecution is controlled by Max Planck, have been issued or granted in 33 countries worldwide, including the U.S., Europe, and Japan.

As this matter is now in active litigation, Alnylam and Max Planck will not provide specific details in response to inquiries on this topic. A copy of the filed complaint is available on Alnylam’s website at www.alnylam.com.

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 and is partnered with Cubist and Kyowa Hakko Kirin. In addition, the company is developing RNAi therapeutics for the treatment of a wide range of disease areas, including liver cancers, hypercholesterolemia, Huntington’s disease, and TTR amyloidosis. 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, Kyowa Hakko Kirin, and Cubist. To reflect its outlook for key scientific, clinical, and business initiatives, Alnylam established “RNAi 2010” in January 2008 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 and Isis are joint owners of Regulus Therapeutics Inc., a company focused on the discovery, development, and commercialization of microRNA-based therapeutics. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit www.alnylam.com.

Alnylam Forward-Looking Statement

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 whether we are successful in obtaining the remedies we seek in this litigation, whether our patents issue with valid and enforceable claims which are commercially useful, and whether we are able to successfully commercialize the technology underlying such claims 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.