Alnylam Responds to Tekmira Complaint
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, is reporting the filing of a complaint by Tekmira Pharmaceuticals Corporation in the Business Litigation Session (BLS) of the Massachusetts Superior Court. The complaint alleges misappropriation and misuse of information, amongst other allegations. Alnylam has had a longstanding relationship and business partnership with Tekmira dating back to at least 2006, which includes significant past and ongoing funding of Tekmira as well as a significant equity position held by Alnylam in Tekmira. Alnylam received no prior notification of this complaint or dispute.
"We firmly believe that the complaint filed by Tekmira is without merit or foundation, and we intend to fully defend ourselves in this matter," said Barry Greene, President and Chief Operating Officer of Alnylam. "Given the longstanding supportive and fully collaborative relationship we have had with Tekmira, it is surprising and extremely unfortunate that they have chosen to voice concerns through unexpected litigation rather than constructive business dialog, and to shift resources away from the scientific and clinical advancement of RNAi therapeutics, which should be the sole focus at this time."
As part of the communication to Alnylam regarding the filed complaint, Tekmira has stated that it will meet its contractual obligations related to the manufacturing of certain Alnylam development-stage and clinical pipeline products. Alnylam is maintaining its guidance regarding the company's pipeline, partnership, and cash goals.
Since 2007, Alnylam has provided over $45 million in funding, including equity purchases, to Tekmira and provided approximately $6 million in manufacturing-related funding in 2010 with similar levels expected in 2011. In exchange, Alnylam has obtained broad license rights to Tekmira intellectual property in addition to exclusive rights, with the sole right to sublicense, to many patents and patent applications including the so-called "Semple" and "Wheeler" patent families (Semple U.S. Patent No. 6,858,225, and Wheeler U.S. Patent Nos. 5,976,567 and 6,815,432). In addition, Alnylam maintains exclusive research and discovery collaborations on novel lipid nanoparticle (LNP) formulations through agreements with AlCana Technologies, Inc., The University of British Columbia, and the Massachusetts Institute of Technology.
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, and ALN-HPN for the treatment of refractory anemia. As part of its "Alnylam 5x15TM" strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in advanced stages of clinical development 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-aventis. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for application in biologics manufacturing, including recombinant proteins and monoclonal antibodies. 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 allegations included in Tekmira's complaint and its intentions to provide a vigorous defense against such allegations, and Alnylam's expectations with respect to its "Alnylam 5x15" product strategy and its guidance regarding its pipeline, partnership, and cash goals, 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, risks and uncertainties related to the successful defense of litigation, Tekmira's continued compliance with its contractual obligations, Alnylam's ability to discover and develop novel drug candidates, successfully demonstrate the efficacy and safety of its drug candidates in human clinical trials and 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 annual report on Form 10-K 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.
Alnylam Pharmaceuticals, Inc.
Cynthia Clayton, 617-551-8207
Senior Director, Investor Relations and
Amanda Sellers, 202-955-6222 x2597