D-Pharm Ltd. Receives First Payment for Epilepsy Drug, DP-VPA From Its Chinese Partner
Published: May 03, 2012
DP-VPA is a novel drug discovered and developed by D-Pharm; a derivative of the generic drug valproic acid which has sales over $1B for treatment of patients with epilepsy, migraine and bipolar disorder. DP-VPA has already completed a first Phase II study in epilepsy patients.
D-Pharm and NHWA entered into a strategic agreement in May 2011. According to the agreement, NHWA assumed the responsibility for development, manufacturing, registration and marketing of DP-VPA for epilepsy in China, Hong Kong and Macau. NHWA is committed to develop DP-VPA in China in compliance with US FDA standards. D-Pharm has the right to use data produced in China towards the global development effort outside China.
D-Pharm is entitled to receive cumulatively $2.4M, including the current $1M, as R&D funding and a development milestones. In addition to milestone payments and fulfillment of the research and development objectives, D-Pharm may receive royalty payments (5%), subject to certain conditions stipulated in the agreement and D-Pharm will pay NHWA royalty payments (0.1%) from worldwide sales outside China. At present, D-Pharm is progressing with the development and testing in healthy volunteers of novel a tablet formulation of DP-VPA. Completion of this task will pave the way for Phase II clinical studies both in epilepsy (China) and migraine (ROW) patients.
Approximately 50 million people worldwide suffer from epilepsy, with around 30% not responding to existing marketed therapies. In addition, for many patients, current therapies induce severe side effects including tremor, somnolence, weight gain and liver damage.
D-Pharm believes that DP-VPA has the potential to be beneficial for patients with epilepsy, migraine and bipolar disorder.
D-Pharm (www.dpharm.com) is a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders. D-Pharm’s pipeline includes clinical stage II products, as well as a rich preclinical development pipeline for Alzheimer's disease, dementia and ALS.
D-Pharm was established in 1993 by Dr. Alex Kozak, President and CEO.In August 2009 the Company completed the first offering of its shares on the Tel Aviv stock exchange.
NHWA is a leading Chinese pharmaceutical company, engaged in developing cures for central nervous system disorders. The company develops anesthetics, anti-epilepsy drugs and drugs to treat pain.
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Statements in this press release that are not historical facts are forward-looking information, as defined in the Securities Law, based on information available to D-Pharm at the time of this press release. The estimations could, some or all, be unrealized, or could be realized in significantly different ways than expected.