REHOVOT, Israel, November 9 /PRNewswire/ -- D-Pharm Ltd. (TASE: DPRM) announced today that it has enteredinto a licensing, co-development and supply agreement with WanbangBiopharmaceuticals Ltd. for commercialization of DP-b99 in the People'sRepublic of China. DP-b99 is a novel drug discovered and developed by D-Pharmfor treatment of patients with acute ischemic stroke. DP-b99, designated asan Investigational New Drug (IND) in the US, is currently in a Phase IIImultinational clinical study (study acronym: MACSI).
Under the terms of the agreement D-Pharm will receivesignificant royalties from the sales of DP-b99 in China in exchange for theexclusive supply of DP-b99 to Wanbang. In addition, D-Pharm will receive upto $25.5M USD upon reaching certain development, regulatory and salesmilestones, up to $7M out of this sum may be replaced by additional royaltiesto D-Pharm from the sales of DP-b99.
D-Pharm and Wanbang will co-develop DP-b99 in China. The jointclinical program includes a Phase III clinical study of DP-b99 in acutestroke patients similar to MACSI. Wanbang will finance the first 450 patientsrecruited into the study and D-Pharm may elect to fund recruitment ofadditional patients. The Phase III trial in China will be performed incompliance with the Food and Drug Administration (FDA) Good Clinical Practice(GCP) and applicable ICH guidelines. D-Pharm will be entitled to use theresults of the trial towards the receipt of regulatory approvals outsideChina. This new trial will be entirely independent of MACSI, the Phase IIItrial D-Pharm is initiating in North America, Europe, South Africa andIsrael.
Dr.
The agreement is the first of its kind, wherein a late-stagedrug candidate developed by Israeli biotech is licensed to a domestic Chinesecompany for co-development in accordance with the standards acceptable to theFDA and EMEA. The transaction is support by the bi-national Jiangsu (China) -Israel Industrial R&D Cooperation Program.
Mr.
About DP-b99
DP-b99 is a unique neuroprotective drug that addresses anarray of brain damaging processes occurring in stroke patients. Bothpreclinical and clinical Phase I and II studies indicate a favorable efficacyand safety profile for DP-b99. In the recently completed Phase IIb trial in150 ischemic stroke patients, DP-b99 increased by two-fold the percentage ofpatients that completely recovered from ischemic stroke. DP-b99 may beadministered within a nine hour therapeutic window. D-Pharm's Phase IIItrial, MACSI, will enroll 770 moderate to severely affected ischemic strokepatients worldwide.
About Wanbang Biopharmaceuticals
Wanbang Biopharmaceuticals is a leading pharmaceutical companyin China that specializes in research, production and marketing of medicinesfor diabetes, cardiovascular disease and endocrinology. Among domesticpharmaceutical companies, Wanbang is the largest manufacturer and marketer ofa comprehensive portfolio of drugs for diabetes. Wanbang is a subsidiary ofFosun 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, thelargest non-state owned enterprise group in China which is listed on the HongKong stock exchange (HKG:0656).
About D-Pharm
D-Pharm (http://www.dpharm.com) is a clinical stage,biopharmaceutical company pioneering the development of lipid-liketherapeutics, and has generated a rich pipeline of patent protectedproprietary products. D-Pharm's pipeline includes advanced clinical stageproducts, DP-b99 for treatment of acute ischemic stroke patients and DP-VPA,a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis ofmigraine. DP-VPA, a prodrug of valproic acid, is in Phase II clinicaldevelopment. DP-460 is in preclinical development intended as an oral,disease-modifying therapy for Alzheimer's disease. Other mimics of bioactivelipids, LipidoMimetix, are at an earlier developmental stage for cancer.
Disclaimer
Statements in this press release that are not historical factsare forward-looking information, as defined in the Securities Law, based oninformation available to D-Pharm at the time of this press release. Theestimations could, some or all, be unrealized, or could be realized insignificantly different ways than expected.
For further information please contact: Tami Horovitz Tel: +972-8-9385100 Fax: +972-8-9300795 Email: thorovitz@dpharm.comPR Newswire
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