30.05.2017

Corporate News

Sanochemia - 'Notice of Allowance' for Tolperisone in the US

Vienna, May 30, 2017 - Sanochemia Pharmazeutika AG, Vienna (ISIN AT0000776307 ISIN DE000A1G7JQ9), announces receipt of a Notice of Allowance from the US Patent and Trade Office (USPTO)for two new Tolperisone patents including a second Composition of Matter patent for a novel form of Tolperisone.

The company also received a Notice of Allowance for a Method of Making patent. Tolperisone, an approved product that has regulatory approval and is commercialized in many countries outside the United States, has demonstrated improvement in the treatment of skeletal muscle disorders without sedation. A requirement by the US Food and Drug Administration (FDA) for a highly purified form of Tolperisone provided the basis for the four patents that are either issued or subject to issuance. The Tolperisone patent family term extends to 2032. Tolperisone also was granted a composition of matter patent that has been issued in Canada.

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'The positive response is an important milestone for the further development of Tolperisone in the US, together with our partner Neurana Pharmaceuticals, who is moving forward the clinical program. It is hereby confirmed that the 'Notice of Allowance' grants the long-term value of Tolpersione in the US ', says Dr. Klaus Gerdes, CMO.

'Based on market research and actual patient use data, physicians and patients have expressed a strong preference for an effective muscle relaxant that has the profile of Tolperisone: a rapid onset of action, no risk of abuse, and non-sedating. In order to confirm the non-sedating properties of Tolperisone, Neurana will commence a Driving Simulation study in the second quarter of 2017. Results are expected by the fourth quarter of this year. In addition, the broad clinical experience and patient usage with this compound outside of the United States suggests low clinical development and regulatory risk,' said Judy Caron, PhD., Neurana's Chief Operating Officer and Head of Clinical Development.


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About Tolperisone
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. Another important advantage is that clinical studies have shown that Tolperisone - unlike other marketed muscle relaxant products - has no sedative side effects.

About Neurana Pharmaceuticals Inc.
Neurana Pharmaceutical Inc. is the exclusive licensee for Tolperisone in North America and other territories from Sanochemia Pharmazeutika AG. The licensing agreement provides Neurana the right to develop and market Sanochemia's proprietary and patent protected Tolperisone formulation in the United States and other licensed territories. Neurana plans to initially develop Tolperisone for the treatment of acute, painful muscle spasms as well as for spasticity.

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Contact information:
Bettina Zuccato
Corporate Communications & Investor Relations
Tel .: +43 1/319 14 56-336
b.zuccato(at)sanochemia.at

Sanochemia Pharmazeutika AG published this content on 30 May 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 06 June 2017 10:48:21 UTC.

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