REHOVOT, Israel, November 9 /PRNewswire/ -- 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 Israel.
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 RD 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.
DP-b99 is a unique neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients. Both preclinical and clinical Phase I and II studies indicate a favorable efficacy and safety profile for DP-b99. In the recently completed Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window. D-Pharm's Phase III trial, MACSI, will enroll 770 moderate to severely affected ischemic stroke patients worldwide.
About Wanbang Biopharmaceuticals
Wanbang Biopharmaceuticals is a leading pharmaceutical company in China that specializes in research, production and marketing of medicines for diabetes, cardiovascular disease and endocrinology. Among domestic pharmaceutical companies, Wanbang is the largest manufacturer and marketer of a comprehensive portfolio of drugs for diabetes. Wanbang is a subsidiary of Fosun Pharmaceutical Group which is listed on the Shanghai stock exchange (SHA:600196). Fosun Pharma, a major shareholder of Sino Pharma (HKG:1099), the largest drug distributor in China, is part of the Fosun Group, the largest non-state owned enterprise group in China which is listed on the Hong Kong stock exchange (HKG:0656).
D-Pharm (http://www.dpharm.com) is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products. D-Pharm's pipeline includes advanced clinical stage products, DP-b99 for treatment of acute ischemic stroke patients and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. DP-VPA, a prodrug of valproic acid, is in Phase II clinical development. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease. Other mimics of bioactive lipids, LipidoMimetix, are at an earlier developmental stage for cancer.
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.
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SOURCE: D-Pharm Ltd
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