Avigen licenses tolperisone from SDI with aim of developing non-sedating muscle relaxer

By E. Janene Geiss

Philadelphia, Jan. 17 - Avigen, Inc. announced Monday that it has signed an agreement with SDI Diagnostics International Ltd. to license for development and commercialization proprietary formulations of the neuroactive compound tolperisone, AV650, a small molecule for the treatment of disabling neuromuscular conditions.

Avigen said it will pay SDI an upfront payment of $3 million with additional payments based on successful clinical and regulatory product development milestones and assumption of certain liabilities and royalty payments on sales, according to a company news release.

In return, Avigen said it receives rights to all current and future proprietary formulations of tolperisone developed by SDI and exclusive marketing and sales rights in North America.

The companies also have entered into a long-term supply agreement in which SDI, a leading active pharmaceutical ingredients manufacturer, will manufacture the product for Avigen.

"AV650, which is a unique neuroactive drug to treat disabling neuromuscular spasm and spasticity resulting from muscle injuries and serious neurological diseases, is synergistic with our AV411 program for neuropathic pain," Kenneth G. Chahine, Avigen's president and chief executive officer, said in the release.

"The transaction also delivers on our commitment to expanding our pipeline by in-licensing a compound with an established safety and efficacy record in Europe and establishes a collaboration with SDI that considerably strengthens Avigen's pipeline and positions both companies for solid long-term growth," Chahine added.

The compound is a leading treatment in Europe for painful muscle spasm but has never been submitted for approval in the United States, officials said.

Avigen said it intends to file an Investigational New Drug Application with the Food and Drug Administration in early 2006 and develop AV650 for the treatment of disabling neuromuscular spasm.

Based on existing clinical data, AV650 is not sedating and does not interact with alcohol. It is an oral centrally acting neuromuscular compound, officials said.

While the precise mechanism of action is not fully characterized, it possesses a high affinity for nervous system tissue, reaching highest concentrations in brain stem, spinal cord and peripheral nerves, officials said.

And like conventional muscle relaxants, officials said this compound does not act directly on the muscles, but acts centrally (in the brain) and is more of a total body relaxant, but without a sedating side effect.

"AV650's novel mechanism of action may allow it to be developed for a broader use in treating chronic and severe neuromuscular conditions, including spasticity, due to diseases like multiple sclerosis, Parkinson's disease, spinal cord injury and stroke," Dawn McGuire, Avigen's chief medical officer, said in the release.

Avigen is an Alameda, Calif., specialty biopharmaceutical company focused on unique small molecule therapeutics and biologics to treat serious neurological disorders, including neuropathic pain.

SDI is a subsidiary of Sanochemia Pharmazeutika AG, a research-based pharmaceutical corporation based in Vienna, Austria, and specializing in diseases affecting the central nervous system.

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