Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, announced today an expansion of its previous collaboration with Mitsubishi Tanabe Pharma Corporation (Head Office; Osaka, Japan, “MTPC”) to develop a second protein therapeutic for an undisclosed orphan disease using Synageva’s product development capabilities and proprietary protein expression platform. “The expansion of our relationship with Mitsubishi Tanabe is an exciting one for the company. It validates our experience in product development and manufacturing for rare diseases and allows the team to continue its focus on our lead development programs,” said Sanj K. Patel, Synageva’s President and Chief Executive Officer. "We are pleased to expand our collaborative alliance with Synageva for orphan diseases. The synergy of Synageva’s innovative technologies and MTPC’s expertise in R&D of biologics will seek to create protein therapeutics that contribute to healthy life around the world," said Dr. Masayuki Mitsuka, Board Director, Executive Officer, Global Product Strategy of MTPC. Terms of the expanded collaboration Under the terms of the agreement, Mitsubishi Tanabe Pharma will make an upfront payment of $9 million. Synageva will receive reimbursement for development costs, potential future development and commercial milestone payments, as well as royalties from potential product revenue. Today’s announced agreement does not impact Synageva’s previously stated net operating loss guidance of between $40 and $45 million for 2012. About Synageva BioPharma Corp. Synageva is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of therapeutic products for patients with life-threatening rare diseases and unmet medical need. Synageva has several protein therapeutics in its pipeline. The company has assembled a team with a proven record of bringing orphan therapies to patients. Synageva’s lead program, SBC-102 is being developed as an enzyme replacement therapy for Lysosomal Acid Lipase (LAL) Deficiency, a lysosomal storage disorder (LSD), and is a recombinant form of the human LAL enzyme. SBC-102 is currently being evaluated in global clinical trials and has been granted orphan designations by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency. Additionally, SBC-102 received fast track designation by the FDA. Further information regarding Synageva BioPharma Corp. is available at www.synageva.com. About Mitsubishi Tanabe Pharma Corp. Mitsubishi Tanabe Pharma Corporation is a research-driven pharmaceutical company based in Osaka. Our philosophy states that “We contribute to the healthier lives of people around the world through the creation of pharmaceuticals”. In accordance with this philosophy, we strive to continually discover drugs with new value and to provide those drugs to patients around the world. Mitsubishi Tanabe Pharma is taking on the challenge of drug discovery in the fields of autoimmune disorders, diabetes, and renal diseases, as well as in other fields with high levels of unmet medical needs. To those ends, the Company is strengthening its R&D pipeline.
Further information regarding Mitsubishi Tanabe Pharma Corp. is available at www.mt-pharma.co.jp/e.Forward-Looking Statements This news release and oral statements made from time to time by Synageva representatives in respect of the same subject matter may contain “forward-looking statements” under the provisions of the Private Securities Litigation Reform Act of 1995. Such statements can be identified by introductory words such as “expects,” “plans,” “intends,” “believes,” “will,” “estimates,” “forecasts,” “projects,” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Many factors may cause actual results to differ materially from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known, including those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 22, 2012 and other filings the Company periodically makes with the SEC, and others of which are not. Synageva cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials or how quickly patient enrollment in clinical trials will occur. In addition, early clinical results are not necessary predictive of results that may be achieved from subsequent clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Synageva will obtain regulatory approval for any phase of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Our future financial results may differ from those currently anticipated due to a number of factors, including unanticipated costs in our research and development programs, fluctuations in royalty revenues and unplanned costs associated with maintaining and enforcing patents and other patent-related costs. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Synageva undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.