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GEN News Highlights : Nov 9, 2009

Wanbang to Advance D-Pharm’s Late-Stage Stroke Therapy in China

Deal could be worth up to $25.5 million in milestones.

Wanbang Biopharmaceuticals and D-Pharm signed a licensing, co-development, and supply agreement for commercialization of the latter’s late-stage ischemic stroke therapy, DP-b99, in China. D-Pharm could earn up to $25.5 million in development, regulatory, and sales milestones.

It will also receive royalties from sales of DP-b99 in China in exchange for exclusive supply of the drug to Wanbang. Up to $7 million of the milestone payments may be exchanged for royalties.

D-Pharm is already carrying out a multinational Phase III trial with DP-b99 in acute stroke patients.  As part of the co-development arrangement in China, D-Pharm and Wanbang will jointly undertake a Phase III study in acute stroke patients, separate from D-Pharm’s Phase III study in North America, Europe, South Africa, and Israel. D-Pharm will have the right to use results from this trial to expedite regulatory clearance in other territories.

DP-b99 is a membrane active chelator (MAC) derivative of the known calcium chelator BAPTA. D-Pharm claims the drug acts as a lipophilic chelator of calcium, zinc, and copper ions but sequesters metal ions only within and in the proximity of cell membranes.

DP-b99 is also in early clinical development as a potential therapy for traumatic brain injury and for the prophylactic treatment of neurological damage associated with coronary artery bypass grafting.

D-Pharm specializes in the development of drugs for brain disorders. The company’s lipid-based MAC technology is used to design small molecules that specifically function only within the lipid environment of cell membranes.

D-Pharm is also exploiting another technology, D-RAP™ (regulated activation of prodrugs), for the rational design of new chemical entities that represent phospholipid derivatives of marketed drugs. Lead D-RAP candidate, DP-VPA, is a lipid-conjugated prodrug comprising valproic acid. DP-VPA has completed a Phase II trial in the treatment of epilepsy. Earlier-stage clinical studies are ongoing in bipolar disorder and migraine prophylaxis.