REHOVOT, Israel, May 31, 2011 /PRNewswire/ --
D-Pharm Ltd. (TASE: DPRM) announced today that it has entered into a licensing and co-development agreement with Jiangsu NHWA Pharmaceutical Co., Ltd.(NHWA) to commercialize DP-VPA for epilepsy in the People's Republic of China. DP-VPA is a novel drug discovered and developed by D-Pharm for treatment of patients with epilepsy, migraine and bipolar disorder. DP-VPA has completed a first Phase II study in epilepsy patients.
Under the terms of the agreement D-Pharm will receive up-front and development milestone payments. In addition, upon reaching defined annual sales NHWA will pay to D-Pharm annual sales bonuses and royalties on DP-VPA sales over a certain threshold in China.
NHWA will be responsible for development, manufacturing and commercialization of DP-VPA in China. The development of DP-VPA in China will be performed in compliance with applicable US FDA standards and will be a part of the global development effort. D-Pharm and NHWA will also cooperate on development and optimization of the manufacturing process for DP-VPA.
Dr. Alex Kozak, D-Pharm's CEO, commented: "I am delighted to have a partnership with NHWA, a prominent pharmaceutical company with an established presence in the Chinese CNS market. We recognize how important it is to promote our products in rapidly growing markets. This is D-Pharm's third licensing agreement with an Asian company. Importantly, the data generated by NHWA gives us the opportunity to accelerate global development of DP-VPA."
This partnership was facilitated by Xintech, a company that specializes in developing technological cooperation between China and Israel in the life sciences.
DP-VPA is a new chemical entity (NCE), rationally designed utilizing D-Pharm's proprietary technology, Regulated Activation of Prodrugs (RAP), which enables precise control over drug action at the site of pathology. In preclinical and clinical studies, DP-VPA demonstrated a superior safety and pharmacokinetic profile compared to valproic acid. Valproic acid formulations are first-line drugs for the treatment of epilepsy in China. Despite excellent efficacy, however, a variety of adverse effects limit valproic acid's maximum dose and extended use. DP-VPA will provide a safer, more efficacious alternative to valproic acid.
About Jiangsu NHWA Pharmaceutical Co., Ltd.
Jiangsu NHWA Pharmaceutical Co., Ltd is a pharmaceutical company that combines science manufacture and trade. NHWA focuses on the CNS market and is a leader in CNS drug sales in China. NHWA has two large GMP manufacturing bases for API and Final Product with ISO14001 and EU GMP certification by the European Union.
D-Pharm (http://www.dpharm.com) is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products. D-Pharm's pipeline includes advanced clinical stage products, DP-b99, in Phase III for treatment of acute ischemic stroke patients and DP-VPA for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease. Other mimics of bioactive lipids, LipidoMimetix, are at an earlier developmental stage for cancer.
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.
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SOURCE D-Pharm Ltd