REHOVOT, Israel, November 9 /PRNewswire-FirstCall/ -- 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 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
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.
For further information please contact: Tami Horovitz, Tel:
+972-8-9385100, Fax: +972-8-9300795, Email: firstname.lastname@example.org
SOURCE D-Pharm Ltd