D-Pharm Ltd. (TASE: DPRM)announced today that it has entered
into a licensing, co-development and supply agreement with Wanbang
Biopharmaceuticals Ltd. for commercialization 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 (study acronym: MACSI).
Under the terms of the agreement D-Pharm will receive
significant royalties from the sales of DP-b99 in China in exchange for the
exclusive supply of DP-b99 to Wanbang. In addition, D-Pharm will receive up
to $25.5M USD 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 Food and Drug Administration (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
Dr. Alex Kozak, D-Pharm's CEO commented: "I am delighted to
have a partnership with Wanbang, a highly reputable Chinese pharmaceutical
company. The agreement provides us with an excellent opportunity to access
the increasingly important and rapidly 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."
The agreement is the first of its kind, wherein a late-stage
drug candidate developed by Israeli biotech is licensed to a domestic Chinese
company for co-development in accordance with the standards acceptable to the
FDA and EMEA. The transaction is support by the bi-national Jiangsu (China) -
Israel Industrial R&D Cooperation Program.
Mr. Ruben Krupik, The Chairman of D-Pharm's Board of
Directors, noted: "This agreement recognizes the quality and potential of
D-Pharm and its products. Licensing the rights for DP-b99 treatment of stroke
patients in such an important market is a great and significant achievement
for the company."
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