D-Pharm has entered into a licensing, co-development and supply agreement with Wanbang Biopharmaceuticals, for commercialisation of DP-b99 in the People’s Republic of China. DP-b99 is a novel drug discovered and developed by D-Pharm for treatment of patients with acute ischemic stroke.
DP-b99, designated as an Investigational New Drug (IND) in the US, is currently in a Phase III multinational clinical study (MACSI).
Under the terms of the agreement D-Pharm will receive royalties from the sales of DP-b99 in China in exchange for supply of DP-b99 to Wanbang. In addition, D-Pharm will receive up to $25.5m upon reaching certain development, regulatory and sales milestones, up to $7m out of this sum may be replaced by additional royalties to D-Pharm from the sales of DP-b99.
D-Pharm and Wanbang will co-develop DP-b99 in China. The joint clinical program includes a Phase III clinical study of DP-b99 in acute stroke patients similar to MACSI. Wanbang will finance the first 450 patients recruited into the study and D-Pharm may elect to fund recruitment of additional patients.
The Phase III trial in China will be performed in compliance with the FDA good clinical practice (GCP) and applicable ICH guidelines. D-Pharm will be entitled to use the results of the trial towards the receipt of regulatory approvals outside China. This new trial will be entirely independent of MACSI, the Phase III trial D-Pharm is initiating in North America, Europe, South Africa and Israel.
Alex Kozak, CEO of D-Pharm, said : “The agreement provides us with an opportunity to access the growing chinese market. In addition, the FDA GCP compliant Phase III study in china will complement D-Pharm’s own global development program and may accelerate the registration process of DP-b99 in the major pharmaceutical markets.”