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Catalyst Pharmaceutical Partners Files U.S. Provisional Patent Application for GABA Aminotransferase Inhibitor Use in Treatment of Tourette Syndrome
Thursday, February 09, 2012
Coral Gables, FL -- Catalyst Pharmaceutical Partners, Inc. announced today that it has filed a provisional patent application with the United States Patent and Trademark Office for the use of GABA aminotransferase inhibitors, including CPP-109 and CPP-115, in the treatment of Tourette Syndrome. Catalyst, one of the inventors, through a license agreement with the co-inventors' respective institutions, has exclusive worldwide rights to GABA aminotransferase inhibitors for this use.
Catalyst's intellectual property is a method of treating Tourette Syndrome using GABA aminotransferase inhibitor drugs, including CPP-109 and CPP-115, which significantly increase presynaptically stored GABA, and enhance GABA signaling in the striatal-thalamo-cortical tracts involved in habit formation and motor control.
Catalyst has agreed to provide drug product and financial support for a proof-of-concept study at a prestigious academic institution in the United States. This study will evaluate the use of CPP-109 in treating Tourette Syndrome, and is expected to take approximately one year to complete.
"The filing of this provisional patent application represents another important step forward in advancing and maximizing the value of Catalyst's GABA aminotransferase inhibitor platform for the benefit of our patients and shareholders," said Patrick J. McEnany, Chief Executive Officer of Catalyst. "Our goal is to build a leading central nervous system (CNS) specialty pharmaceutical company focused on developing drugs to address unmet medical needs and orphan diseases. The use of CPP-109 and CPP-115 in the treatment of Tourette Syndrome may provide us with significant CNS expansion opportunities while addressing an important medical need."
About Tourette Syndrome
Tourette Syndrome is a neurobiological disorder characterized by multiple motor and vocal tics that are associated with considerable disability and reduction in quality of life. The tics are often involuntary, rapid, sudden movements and/or vocal outbursts that occur repeatedly. No definite cause has been established for Tourette Syndrome, although considerable evidence points to abnormal metabolism of dopamine in the brain. The majority of clinically referred youth with Tourette Syndrome meet the criteria for comorbid obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder (ADHD), while young adults meet the criteria for additional anxiety, mood and substance abuse disorders. It is estimated that approximately 200,000 people are affected by the most severe form of Tourette Syndrome in the United States, often leading the FDA to grant orphan drug designation for such product candidates to treat this disorder. There is no cure for Tourette Syndrome and the only approved products for treatment are haloperidol and pimozide, with both having limited efficacy and significant side effects.
About Catalyst Pharmaceutical Partners, Inc.
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system. Catalyst has two products in development, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109 (vigabatrin), for the treatment of cocaine dependency. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine dependency. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions and OCDs. Catalyst is also developing CPP-115, a next-generation GABA aminotransferase inhibitor, which is more potent than vigabatrin and potentially has reduced side effects (e.g., visual field defects, or VFDs) from those associated with vigabatrin. Catalyst is planning to develop CPP-115 for several indications, including drug addiction, epilepsy (initially infantile spasms) and for other selected CNS indications. CPP-115 has been designated as a "Fast Track" development program for the treatment of cocaine dependency and has been granted orphan drug designation for the treatment of infantile spasms, both by the FDA. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to the inhibition of GABA aminotransferase. For more information about Catalyst, go to www.catalystpharma.com.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from forecasted results. A number of factors, including whether CPP-109 will be determined to be effective in the treatment of Tourette Syndrome, whether CPP-109 or CPP-115 will ever be approved for commercialization, and those other factors described in the Company's filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect the Company. Copies of the Company's filings with the SEC are available from the SEC, may be found on the Company's website or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.
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