C-FDA Approves IND for D-Pharm's Anti-Epileptic Drug, DP-VPA in China
The approval letter allows clinical development of DP-VPA through Phase 3 for epilepsy
14 Apr, 2015, 08:00 ET
REHOVOT, Israel, April 14, 2015 /PRNewswire/ --
D-Pharm Ltd., (TASE: DPRM) has been notified by its co-development partner, Jiangsu Nhwa Pharmaceutical Co., Ltd. (Nhwa), that they received an approval letter from the Chinese Food and Drug Administration (C-FDA) that allows clinical development of DP-VPA, through Phase 3, for epilepsy. The specific clinical protocols will be communicated to the C-FDA before the start of each new study. NHWA will begin with a bridging safety study and then proceed with a large dose-ranging Phase 2b clinical study in epilepsy patients.
Prior to the IND approval, DP-VPA was granted Fast Track status, a designation designed to bring important new drugs which treat a serious or life-threatening condition and fill an unmet medical need to patients earlier.
Dr. Alex Kozak, D-Pharm's CEO commented, "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 is a novel drug discovered and developed by D-Pharm, a derivative of the valproic acid (VPA). VPA is the active ingredient in one of the best antiepileptic drugs, with combined peak sales over $1B in epilepsy, migraine and bipolar disorder. In Phase 1 and 2 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.
D-Pharm (http://www.dpharm.com ) is a clinical stage, biopharmaceutical company developing proprietary products for treatment of CNS disorders. D-Pharm's pipeline includes three Phase 2 clinical stage products, as well as preclinical products for misfolding protein diseases. D-Pharm recently successfully completed a Phase 2 study with THR-18, a first-in-class drug to protect the blood brain barrier (BBB) under pathological conditions.
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.
For further information please contact: Tami Horovitz Tel: +972-8-9385100 Fax: +972-8-9300795 Email: [email protected]
SOURCE D-Pharm Ltd
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