D-Pharm Ltd. (TASE: DPRM) has been notified by its co-development partner, Jiangsu Nhwa Pharmaceutical Co., Ltd., that they received approval from the Chinese Food and Drug Administration (C-FDA) for clinical development of epilepsy treatment DP-VPA, through Phase III. The specific clinical protocols will be handed to the C-FDA before the start of each new study. Nhwa will begin with a bridging safety study, followed by a large dose-ranging Phase IIb clinical study in epilepsy patients.
Prior to the IND approval, DP-VPA was granted fast track status for new drugs that treat a serious or life-threatening condition and fill an unmet medical need to patients.
D-Pharm CEO Dr. Alex Kozak said, “Development of DP-VPA in China creates value and paves the way for our own development of this exciting product in major pharmaceutical markets. I’m delighted by our vibrant collaboration with Nhwa and with the forthcoming approach of the C-FDA.”
DP-VPA, a novel drug discovered and developed by D-Pharm, is a derivative of valproic acid (VPA). VPA is the active ingredient in one of the best antiepileptic drugs, with combined peak sales over $1 billion in epilepsy, migraine and bipolar disorder. In Phase II and III clinical studies DP-VPA showed superb safety and efficacy in epilepsy patients.
D-Pharm and Nhwa are developing DP-VPA following a strategic agreement signed in 2011. Nhwa has responsibility for development, manufacturing, registration and marketing of DP-VPA for epilepsy in China, Hong Kong and Macau. D-Pharm has the rights for DP-VPA in the rest of the world. D-Pharm also has the right to use data produced in China to support its global development program, primarily in North American and European markets. The financial terms of the collaboration agreement include milestone payments upon achieving 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 April 15, 2015
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