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Home > Press > Alnylam Grants New InterfeRx™ Intellectual Property License to Calando for Development and Commercialization of RNAi Therapeutics

Abstract:
- New Target-Specific License Provides Non-Exclusive Access to Alnylam Intellectual Property for an RNAi Therapeutic Product -

Alnylam Grants New InterfeRx™ Intellectual Property License to Calando for Development and Commercialization of RNAi Therapeutics

CAMBRIDGE, MA and PASADENA, CA | Posted on July 21st, 2008

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that it has granted Calando Pharmaceuticals Inc., a majority-owned subsidiary of Arrowhead Research Corporation (NASDAQ: ARWR), a new target-specific InterfeRx™ license to discover, develop, and commercialize a synthetic siRNA directed toward an undisclosed cancer gene target. The new non-exclusive, gene-specific license agreement includes an Alnylam right of first negotiation to opt-in for co-development and co-commercialization of the RNAi therapeutic product in the U.S. market. Detailed financial terms were not disclosed, but include upfront, and milestone payments, and royalties on sales of any products covered by the licensing agreement.

"We are pleased to be granting Calando a new InterfeRx license, providing them access to Alnylam intellectual property, which we believe is critical for the development and commercialization of all RNAi therapeutic products," said Jason Rhodes, Vice President, Business Development of Alnylam Pharmaceuticals. "Calando has demonstrated exciting progress with the only clinical stage RNAi therapeutic oncology program, currently in Phase I trials, and we are encouraged by the potential for similar success with this new target. Calando exemplifies the progress in our InterfeRx program, an important part of our overall strategy to create value today by leveraging our intellectual property portfolio for the development of RNAi therapeutics."

"This license from Alnylam represents an important step in our continued efforts to develop and commercialize novel oncology therapeutics requiring systemic delivery," said James Hamilton, M.D., Chief Executive Officer, Calando Pharmaceuticals. "We are excited by the success we have seen to date with our RNAi therapeutic programs targeting cancer, and are looking forward to continuing our work with Alnylam in this area."

Alnylam created the InterfeRx licensing program to grant licenses under its intellectual property to biotechnology and pharmaceutical companies wishing to pursue RNAi therapeutics against specific targets outside Alnylam's core strategic interests. To date, a total of five companies are InterfeRx licensees; the license grants cover nine active target programs including three in clinical development. In 2006, Alnylam granted Calando an InterfeRx license to develop and commercialize an RNAi therapeutic targeting the M2 subunit of ribonucleotide reductase ("RRM2") formulated with Calando's proprietary RONDEL™ (RNAi/Oligonucleotide Nanoparticle Delivery) polymer delivery system.

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.

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About Alnylam Pharmaceuticals, Inc.
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.

Alnylam Forward-Looking Statements

Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including its views with respect to the expected importance and scope of its intellectual property rights, 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.

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Contacts:
Alnylam Pharmaceuticals, Inc.
Investors:
Cynthia Clayton
617-551-8207
or
Media:
Yates Public Relations
Kathryn Morris
845-635-9828

Copyright © Business Wire 2008

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