ALAMEDA, Calif., July 23, 2008 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company innovating therapeutics for neurological care, today announced an amendment to the company's contract with Sanochemia Pharmazeutika AG, Avigen's development partner for AV650 (tolperisone). Under the terms of the amendment, Avigen has agreed to pay up to $5 million in development-based milestone payments for the development of a proprietary, purer form of AV650. Avigen and Sanochemia have filed composition-of-matter and formulation patents in the United States for this purer form of AV650 that the company believes will provide exclusivity through 2027. Avigen is developing AV650 for commercialization in the North American market for the treatment of disabling neuromuscular spasticity and spasm under a license and supply agreement with Sanochemia. Avigen expects to announce the results of its Phase IIb clinical trial for AV650 in patients with spasticity associated with multiple sclerosis in the fourth quarter of 2008.
AV650 is a new chemical entity (NCE) in the United States and therefore must comply with all current U.S. Food and Drug Administration (FDA) regulatory requirements for clinical research and marketing. During the clinical development of AV650, Avigen and Sanochemia identified an impurity in tolperisone products commercialized in Europe that exceeds the FDA's standard for impurities in chronically used medicines in the United States. Over the last year, Avigen and Sanochemia reduced the levels of the impurity in the active pharmaceutical ingredient (API) of AV650 to levels below the FDA's limit. Avigen plans to initiate Phase III clinical trials with AV650 in 2009. Initiation of these trials is not dependent on the development of finished product using this purer API.
Kenneth G. Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer, commented, "There is a long-standing precedent in the pharmaceutical industry for the filing and granting of new composition-of-matter patents on purer versions of existing medicines. Our purer form of AV650 has allowed us to file multiple composition-of-matter patents that we believe will significantly enhance the value of this program by extending exclusivity of AV650 in the United States through 2027. The first of our filed patents is expected to be published later in 2008. The additional development costs were anticipated and are reflected in our previous cash burn forecasts."
Tolperisone is an orally administered, centrally acting small molecule marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia. Avigen's U.S. development program is designed to build on the extensive ex-U.S. safety and efficacy experience with this compound. Versions of tolperisone have been approved for marketing in Germany for over 10 years. Sanochemia and its European marketing partner, Orion Pharma, have recently launched a proprietary 150mg tablet formulation of tolperisone in Germany under the brand name Viveo(r).
About Avigen
Avigen is a biopharmaceutical company focused on developing and commercializing small molecule therapeutics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company that remains committed to its neurology products. Avigen is currently developing AV650 for spasticity and neuromuscular spasm and AV411 for neuropathic pain. Additionally, the company is advancing AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, toward clinical trials. For more information about Avigen, consult the company's website at www.avigen.com.
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Statement under the Private Securities Litigation Reform Act
The statements in this press release relating to Avigen's expectations regarding its expectations that the purer form of AV650 developed by Avigen and Sanochemia do not exceed the FDA's standard for impurities in chronically used medicines in the United States, its expectations regarding reporting AV650 Phase II data in the fourth quarter of 2008, its expectations regarding the timing of the publishing of the first of its filed patents later in 2008, Avigen's ability to obtain meaningful patent protection for AV650, including protection that would provide exclusivity for any length of time, its expectations that it will complete the development of a finished product using its purer API, that it will conduct a Phase III clinical trial using AV650 in 2009, and its goal of becoming a fully integrated commercial biopharmaceutical company remaining committed to its neurology products are forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the fact that development of small molecule therapeutics and other therapeutic discovery and development is a time- and resource-intensive process, which may result in the expenditure of a significant amount of time and resources with no progress towards clinical trials or marketable product resulting from the effort; the risk that Avigen will not be able to obtain regulatory approvals for its drug products, which is required prior to marketing drug products; and the risk that early positive preclinical and clinical results will not guarantee that the potential products will ultimately be effective in treating the indications for which they are developed, or exhibit the unique properties they appear to possess. In addition, there are many other risks and uncertainties inherent in the development of drug products. Other risks and uncertainties relating to Avigen are detailed in reports filed by Avigen with the Securities and Exchange Commission, including Avigen's Quarterly Report on Form 10-Q for the period ended March 31, 2008, under the caption "Risks Related to Our Business" in Item 2 of Part I of that report, which was filed with the SEC on May 12, 2008.