Alnylam Amends Agreements with Max Planck Society and Reinforces Exclusive License to Key Fundamental Patent for RNAi; Amended Agreement Increases Operating Flexibility at Alnylam Europe AG
CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 16, 2005--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has signed an amendment to its agreements with Garching Innovation GmbH (Garching Innovation), the licensing agent for the Max Planck Gesellschaft (Max Planck Society). This amendment reinforces Alnylam's continued exclusivity for the so-called "Tuschl II" patent application, a critical fundamental patent for RNAi, and improves the operating flexibility for its wholly owned subsidiary, Alnylam Europe AG (Alnylam Europe).
"With this new amendment to our Garching Innovation agreements, we have reinforced our exclusivity to the Tuschl II patent application, a patent that we believe will be required for development and commercialization of RNAi therapeutics," said Barry Greene, Chief Operating Officer of Alnylam Pharmaceuticals. "This amendment also provides greater flexibility for how we design and grow our Alnylam Europe AG organization consistent with our broader business objectives."
"We are pleased that with this amendment Alnylam continues to be our exclusive partner for developing RNAi therapeutics based on the Tuschl II technology," said Jorn Erselius, Senior Patent and Licensing Manager of Garching Innovation. "The amendment affirms Alnylam's commitment to further strengthen this very successful transatlantic partnership in a flexible and fruitful manner."
The Tuschl II patent application is based on the discoveries of Alnylam founder, Dr. Thomas Tuschl, that were published in the landmark 2001 Nature paper by Elbashir et al. The Tuschl II patent application is licensed exclusively to Alnylam for therapeutic products, and is distinct from the so-called "Tuschl I" patent application, for which Alnylam has a non-exclusive license. The Tuschl II patent application covers key structural features of short interfering RNAs (siRNAs), the molecules that mediate RNAi, namely the presence of "overhangs" at the 3' end of each of the two siRNA strands, and also covers the activity of such molecules in mammalian cells and their use as therapeutics. Tuschl II was the first patent application in the Tuschl series to show data from mammalian cells and to demonstrate that 3' overhangs are required for optimal siRNA function.
In addition to reinforcing its exclusive access to Tuschl II, the new amendment also increases Alnylam's flexibility in operating Alnylam Europe. Under the terms of Alnylam's license agreements with Garching Innovation prior to the amendment, Alnylam was required to build certain development and commercial capabilities in Germany at Alnylam Europe (formerly Ribopharma AG) comparable to those in the United States. The new amendment modifies staffing requirements at Alnylam Europe and removes obligations to add functions in Germany that would unnecessarily duplicate those in the U.S. In connection with this amendment, Alnylam will be issuing a total of 270,000 shares to the Max Planck Society and other co-owners of the intellectual property licensed to Alnylam under its agreements with Garching Innovation.
About RNA Interference (RNAi)
RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing and regulating specific genes. Since many diseases are caused by the inappropriate activity of specific genes, the ability to silence and regulate such genes selectively through RNAi could provide a means to treat a wide range of human diseases. The discovery of RNAi has been heralded by many as a major breakthrough, and the journal Science named RNAi the top scientific achievement of 2002, as well as one of the top 10 scientific advances of 2003.
Alnylam is a biopharmaceutical company seeking to develop and commercialize novel therapeutics based on RNA interference, or RNAi. Growing from its foundation as the world's first company focused on RNAi therapeutics, the company's leadership in the field of RNAi is supported by its preeminent founders and advisors and its strengths in fundamental patents, technology, and know-how that underlie the commercialization of RNAi therapeutics. Alnylam is developing a pipeline of RNAi products using Direct RNAi to treat ocular, central nervous system, and respiratory diseases and Systemic RNAi to treat a broad range of diseases, including oncology, metabolic, and autoimmune diseases. The company's global headquarters are in Cambridge, Massachusetts. For additional information, please visit www.alnylam.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning our future expectations, plans, prospects and future operating results 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: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales and distribution of our products; the successful development of products, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; obtaining, maintaining and protecting intellectual property utilized by our products; and our short operating history; as well as those risks more fully discussed in the "Certain Factors That May Affect Future Results" section of our most recent Form 10-Q filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.
SOURCE: Alnylam Pharmaceuticals, Inc.
Lilian Stern, Stern Investor Relations, Inc.