D-Pharm’s anti-epileptic drug DP-VPA has been granted Fast Track status by the CFDA. NHWA has been 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 IIb 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.
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