Avigen Licenses Unique Neuroactive Compound for Disabling Neuromuscular Conditions from Sanochemia

18-Jan-2006

Avigen, Inc. announced it has signed an agreement with SDI Diagnostics International LTD ("SDI"), a division of Sanochemia Pharmazeutika AG. Under the terms of the agreement, Avigen receives an exclusive North American license to develop and commercialize proprietary formulations of the neuroactive compound tolperisone (AV650), a small molecule for the treatment of disabling neuromuscular conditions.

Avigen will provide SDI an upfront payment of $3 million; payments based on successful clinical and regulatory product development milestones; assumption of certain liabilities and royalty payments on sales. In return, Avigen receives the rights to all current and future proprietary formulations of tolperisone developed by SDI and exclusive marketing and sales rights in North America . The companies have also entered into a long-term supply agreement in which SDI, a leading API (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," said Kenneth G. Chahine, Ph.D., J.D., Avigen's President and CEO. The compound is a leading treatment in Europe for painful muscle spasm, but has never been submitted for approval in the United States. Avigen intends to file an investigational new drug application ( IND ) with the U.S. FDA 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. 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. Thus, it exerts its action at three levels: peripheral, spinal and brainstem levels of the nervous system. Like conventional muscle relaxants, 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.

https://www.bionity.com/en/news/51669/avigen-licenses-unique-neuroactive-compound-for-disabling-neuromuscular-conditions-from-sanochemia.html