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news.Avigen has come to an agreement to license North American rights for the neuroactive drug, tolperisone, from SDI Diagnostics International, a division of Austrian based Sanochemia Pharmazeutika.
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Avigen will pay an upfront $3 million to SDI, as well as payments based on successful clinical and regulatory product development milestones, assumption of certain liabilities and royalty payments on sales.
The compound, renamed AV650 by Avigen, is approved in Europe for painful muscle spasm, but the drug has never been submitted for approval in the US. As such, Avigen intends to file an investigational new drug application with the FDA in early 2006 and develop the drug for the treatment of disabling neuromuscular spasm.
The companies have also entered into a long-term supply agreement in which SDI will manufacture the product for Avigen.
“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,” commented Dr Dawn McGuire, Avigen’s chief medical officer.