SAN DIEGO, March 9, 2016 /PRNewswire/ -- Katama Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of products focused on the unmet therapeutic needs of the central nervous system, today announced receipt of a Notice of Allowance of a Composition of Matter patent for a novel form of tolperisone, an approved product outside the United States that has demonstrated improvement in the treatment of skeletal muscle disorders without sedation. Tolperisone is subject to a composition of matter patent that has been issued in Canada.
Katama is the exclusive licensee of tolperisone in North America and other territories from Sanochemia Pharmazeutika AG (ISIN: AT0000776307). The licensing agreement provides Katama the right to develop and market Sanochemia's proprietary and patent protected tolperisone formulation in the United States and other licensed territories. Katama plans to initially develop tolperisone for the treatment of acute, painful muscle spasms as well as for spasticity.
Tolperisone holds a market-leading position in Eastern Europe, Germany and parts of Asia as an approved treatment for muscular pain and neuromuscular spasms. The product 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 improves 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 differentiates it from other products in the category," 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 an effective muscle relaxant that has the profile of tolperisone: a rapid onset of action, no risk of abuse, and is non-sedating. In addition, the broad clinical experience and patient usage with this compound outside of the United States suggests low clinical development and regulatory risk."
Katama's experienced team has successfully developed, gained regulatory approval for, and commercialized numerous CNS drugs. The team will initially develop tolperisone for the treatment of acute, painful muscular spasms and spasticity for the North American markets (United States, Canada and Mexico). In the United States, treatment for these indications accounts for more than 60 million prescriptions per year and represents a branded market potential of approximately $8 billion.
"We are excited to receive this composition of matter patent protection which builds on the already issued patent relating to the novel formulation of tolperisone and it will be eligible for listing in the Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Evaluation Equivalence List (Orange Book) which provides long-term protection for this significantly differentiated product in a large skeletal-muscle relaxant market," said David F. Hale, Katama's executive chairman.
New Chemical Entity for the U.S. 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. Tolperisone will represent 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 patents is expected to extend protection to at least 2032. 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 FDA. The product is ready for Phase 2 clinical studies and Katama believes that, subject to successful Phase 2 and Phase 3 trials, a New Drug Application (NDA) can be filed within three years.
Licensing Agreement Details
Under the agreement with Sanochemia, Katama has licensed the exclusive rights to all tolperisone products and intellectual property currently or in the future developed or secured by Sanochemia, in addition to exclusive commercialization rights in North America. The license agreement includes 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 agreementt.
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 private company founded by an experienced and successful drug development and commercial team. The company is focused on the development of drugs to treat neuromuscular disorders.
For Katama Pharmaceuticals
SOURCE Katama Pharmaceuticals