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D-Pharm Ltd.'s Anti-Epileptic Drug DP-VPA Is Granted Fast Track Status By The Chinese Food And Drug Administration (CFDA)


6/9/2014 11:32:40 AM

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Rehovot, Israel June 8th, 2014 -- D-Pharm Ltd., (TASE: DPRM) has received notification from its partner, Jiangsu NHWA Pharmaceutical Co., Ltd. (NHWA), that DP-VPA was granted Fast Track status by the CFDA. NHWA is developing DP-VPA for epilepsy in China following a strategic agreement with D-Pharm, signed in 2011. D-Pharm has the right to use data produced in China to support its development program for DP-VPA, primarily in North American and European markets.

The Fast Track notification follows a pre-IND meeting between NHWA and the CFDA earlier this year, which was attended by D-Pharm’s VP for Clinical Development. The purpose of Fast Track designation is 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 2b clinical study in epilepsy patients.

Dr. Alex Kozak, D-Pharm’s CEO commented, “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. Moreover, 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. I look forward to continuing this excellent collaboration.”

DP-VPA is a novel drug discovered and developed by D-Pharm, a derivative of the generic drug valproic acid with combined peak sales over $1B in epilepsy, migraine and bipolar disorder. DP-VPA has already completed a first Phase II study in epilepsy patients.

NHWA has responsibility for development, manufacturing, registration and marketing of DP-VPA for epilepsy in China, Hong Kong and Macau. NHWA is committed to develop DP-VPA in China in compliance with US FDA standards and D-Pharm has the right to use data produced in China towards the global development effort outside China. The financial terms of the collaboration agreement include milestone payments upon achievements of the development and commercial goals, as well as royalty payments from sales of DP-VPA.

About D-Pharm

D-Pharm (www.dpharm.com) is a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders. D-Pharm’s pipeline includes clinical stage 2 products, as well as a rich preclinical development pipeline for Alzheimer's disease, and other types of dementia. D-Pharm is currently enrolling patients into two Phase 2 clinical studies, testing DP-b99 in acute pancreatitis patients, and THR-18 in stroke patients receiving thrombolytic therapy.

Disclaimer

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: thorovitz@dpharm.com

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