"This is the expected breakthrough in the tolperisone project, which we persistently worked for. Our partner Neurana has established a first-class development team and a top portfolio of financial investors." said Dr. Klaus Gerdes, CMO of Sanochemia Pharmazeutika AG.
Neurana plans to commence a Phase II clinical trial later this year to demonstrate safety and efficacy of tolperisone in patients with acute, painful neuromuscular spasms.
"Due to the non-sedating side effect and the unique mechanism of action, tolperisone represents a novel approach for treatment of acute, painful muscle spasms and spasticity. With the successful funding of the studies, another important step towards a NDA submission has been achieved." said Dr. Christina Abrahamsberg, CSO of Sanochemia Pharmazeutika AG.
SANOCHEMIA will receive Up front payments, Milestone payments as well as sales-related royalties if the clinical study program and market penetration are successful. As part of the license agreement, Sanochemia will manufacture the patented drug substance for Neurana.
Tolperisone is a muscle relaxant used for the symptomatic treatment of spasticity. Tolperisone holds a market-leading position in Eastern Europe, Germany and parts of Asia for the treatment of muscle pain and neuromuscular spasms. Tolperisone shows a unique, double action mechanism that acts on the peripheral neural system as well as on the spinal cord and brain stem to alleviate severe muscle cramps and significantly improve patient mobility. Tolperisone, unlike other marketed muscle relaxant products, has no sedative side effects.
According to FDA requirements only highly pure tolperisone can be used in the U.S. Sanochemia Pharmazeutika AG developed a highly purified form of tolperisone that provides the basis for a patent portfolio, including a Composition of Matter patent, which extends to 2032 in the U.S.
About Neurana Pharmaceuticals Inc.
Neurana Pharmaceuticals Inc. is a private company founded by an experienced and successful drug development and commercial team, based in San Diego, California. The company is focused on the development of drugs to treat neuromuscular disorders.