D-Pharm Enters Into Collaboration With Wanbang Biopharmaceuticals.Summary: D-Pharm Ltd. (TASE TASE Tel Aviv Stock Exchange TASE The All Seeing Eye TASE Tactical Air Support Element TASE Thrust Assessment Support Environment TASE Telecontrol Application Service Elements (IEC communications protocol) : DPRM DPRM Digital Property Rights Management DPRM Directed Polymer in Random Media )announced today that it has entered 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 MACSI Mathematics and Computer Science MACSI Mathematics Applications Consortium for Science and Industry (Ireland) ). 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 USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 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 in·com·pli·ant adj. Not willing to comply; unyielding. in  com·pli with the Food and Drug Administration (FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Good Clinical Practice(GCP GCP Good Clinical Practice GCP Ground Control Point GCP Global Carbon Project GCP Gateway Control Protocol GCP Global Consciousness Project GCP Granulocyte Chemotactic Protein GCP Grand Central Parkway (New York) ) 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. Alex Kozak, D-Pharm's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. commented: "I am delighted tohave a partnership with Wanbang, a highly reputable Chinese pharmaceuticalcompany. The agreement provides us with an excellent opportunity to accessthe increasingly important and rapidly growing Chinese market. In addition,the FDA GCP compliant Phase III study in China will complement D-Pharm's ownglobal development program and may accelerate the registration process ofDP-b99 in the major pharmaceutical markets." 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 (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. . 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 ofDirectors, noted: "This agreement recognizes the quality and potential ofD-Pharm and its products. Licensing the rights for DP-b99 treatment of strokepatients in such an important market is a great and significant achievementfor the company." 2009 Al Bawaba (www.albawaba.com) 2009 Al Bawaba (Albawaba.com) Provided by Syndigate.info an Albawaba.com company |
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