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D-Pharm Ltd. Signs Deal with Jiangsu NHWA Pharmaceutical for Development and Commercialization of DP-VPA in China
5/31/2011 11:26:58 AM
(Rehovot, Israel) 31st May 2011: 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 (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.