- Open IND in the US, ready for Phase 2 clinical studies
- U.S. NCE status, pending patent applications would provide exclusivity to 2028
- Novel mechanism of action provides muscle tone and pain relief without sedation
SAN DIEGO, Oct. 5, 2012 /PRNewswire/ -- Katama Pharmaceuticals, a newly formed specialty pharmaceutical company, today announced the signing of an exclusive license agreement with Sanochemia Pharmazeutika AG (ISIN: AT0000776307). The agreement provides Katama the exclusive right to develop and market Sanochemia's proprietary tolperisone formulation in North America. Katama will initially develop tolperisone for the treatment of acute, painful muscle spasms.
Tolperisone has held a market-leading position in Eastern Europe, Germany and parts of Asia for many years as an approved treatment for muscular pain and neuromuscular spasms. The drug has a novel, dual mechanism of action that acts on the peripheral neural system as well as in the spinal cord and brainstem to relieve severe muscular cramps and significantly improve patient mobility. The product delivers benefit without the sedating side effects common to other products in the category.
"There are significant clinical advantages to tolperisone that differentiate it from its competitors," said Jeff Raser, Katama's president and CEO. "Based on market research and actual patient use data, physicians and patients have expressed a strong preference for a muscle relaxant that has the profile of tolperisone: a rapid onset of action, no risk of abuse, and non-sedating. In addition, the broad clinical experience with this compound outside of the United States suggests low clinical development and regulatory risk."
"We are excited to launch Katama with this lead product and an experienced team who have successfully developed, gained regulatory approval for and commercialized numerous CNS drugs," he said.
Katama will develop tolperisone for the treatment of acute, painful muscular spasms and spasticity for the North American markets (US, Canada and Mexico). In the United States, treatment for these indications accounts for more than 50 million prescriptions per year and represents a branded market volume of approximately $8 billion.
New chemical entity for the US market
While tolperisone has demonstrated efficacy and safety in years of clinical practice in Germany, Eastern Europe and Asia, it has never been fully clinically tested or approved in the United States. The drug therefore represents a novel approach for the treatment of acute, painful muscle spasms and spasticity among U.S. patients. Accordingly, tolperisone will be classified as a new chemical entity (NCE) for the U.S. market, which confers regulatory exclusivity. In addition, Sanochemia has filed for related patent protection for the product candidate in the United States and other territories. Issuance of the pending patents will extend protection to 2028.
There is an open investigational new drug application (IND), and data from recent tolperisone pre-clinical and clinical trials have already been submitted to the U.S. Food and Drug Administration (FDA). The product is ready for Phase 2 clinical testing, and Katama believes that a New Drug Application (NDA) can be filed within three years.
Licensing Agreement Details
Under the new agreement, Katama has acquired the rights to all tolperisone products and intellectual property currently or in the future developed or secured by Sanochemia, in addition to exclusive marketing and sales rights in North America. The license agreement defines milestone payments, which are linked to intellectual property, development and marketing milestones, as well as sales-related royalty payments. Sanochemia will also manufacture the product for Katama for the duration of the contract.
Sanochemia and Katama have established a joint development board to facilitate rapid clinical development.
About Katama Pharmaceuticals
San Diego, California-based Katama Pharmaceuticals is a newly formed, closely-held private company founded by an experienced and successful drug development and commercial team. The company is focused on the development of drugs to treat pain-related disorders.
For Katama Pharmaceuticals