D-Pharm Ltd. (TASE: DPRM) has obtained fast track status from the China's Food and Drug Administration (CFDA) for its epilepsy treatment, DP-VPA. D-Pharm is jointly developing the drug in China with its local partner, Jiangsu NHWA Pharmaceutical Co. Ltd., under a strategic agreement signed in 2011. D-Pharm has the right to use the Chinese data to support its development program for DP-VPA in North America and Europe.
The Fast Track notification follows a pre-IND meeting between NHWA and D-Pharm and the CFDA earlier this year. Fast track designation is intended to get important new drugs which treat a serious or life-threatening condition and fill an unmet medical need to the patient earlier. NHWA now is set to proceed with a Phase 1 bridging study and a large dose-ranging Phase IIb clinical trial in epilepsy patients.
D-Pharm discovered and is developing DP-VPA, a novel drug derived from the generic drug valproic acid, sales of which peaked at $1 billion for the treatment of epilepsy, migraine, and bipolar disorder. DP-VPA has already completed a first Phase II clinical trial.
“I’m delighted with the progress made by our partners NHWA. Advancement of DP-VPA in China is a great way to boost our own development program for DP-VPA in major pharmaceutical markets," said D-Pharm CEO Dr. Alex Kozak. "It enables the most efficient and effective introduction of our innovative product to the important and rapidly developing Chinese market, a feat clearly best accomplished by a competent local partner."
NHWA is developing and will manufacture, register and sell DP-VPA for epilepsy in China, Hong Kong and Macau, in compliance with US Food and Drug Administration (FDA) standards. D-Pharm will receive milestone payments upon achievements of the development and commercial goals, as well as royalty payments from sales of DP-VPA.
Published by Globes [online], Israel business news - www.globes-online.com - on June 8, 2014
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