Hadasit Bio-Holdings

Press Releases

Approval of 2015 Work Plan of D Pharm Ltd.

Feb. 15, 2015

HBL – Hadasit Bio-Holdings Ltd.

(the “Company”)

February 15, 2015

 

 

To                                            To

Securities Authority                Tel Aviv Stock Exchange Ltd.

www.isa.gov.il                        www.tase.co.il

 

Re: Approval of 2015 Work Plan of D Pharm Ltd.

 

The Company is pleased to announce that D Pharm Ltd., a company traded on the Tel Aviv Stock Exchange (hereinafter: “D Pharm”), of which about 5.57% is held by the Company, published today through an immediate report that further to the issuance of the rights completed by D Pharm on January 20, 2015, in a scope of consideration of about NIS 12.8 million (gross), D Pharm held a discussion regarding the approval of its 2015 work plan, considering the funding at its disposal. The Company has decided to update the aforesaid work plan as follows:

1.      Continued development of D-Pharm's flagship product, THR-18, for which Phase IIa clinical trials have been successfully completed and have achieved the main objective of the trial for the safety of the product in combination with tPA and the identification of the maximum dosage of the drug (for additional details regarding the results of the trial, see the Company’s immediate report dated December 18, 2014, reference no.: 2014-01-225231). D-Pharm intends to invest resources in the production of the drug for further clinical trials, with the intent of performing an additional Phase IIa trial in order to prepare for the Pre-IND meeting with the FDA in the framework of the preparations for Phase IIb trials in Western Europe and the United States.

2.      Further to the Company’s report regarding the receipt of “fast track” status for the drug in China, D-Pharm announces the continuation of the cooperation with NHWA for the development of the D-Pharm's DP-VPA product in an indication of epilepsy in China. In D-Pharm’s estimation, during 2015, NHWA will progress in the development and begin Phase IIb clinical trials, following which D-Pharm is expected to receive payment for compliance with a milestone in accordance with the NHWA agreement.

3.      Subject to the receipt of financing required, D-Pharm intends to act to expand the Phase II clinical trial with the Company’s DP-b99 product for the treatment of acute pancreatitis, both in the quantity of the centers and with their geographic distribution, which will require material financial and managerial resources that D-Pharm does not have as of the date of this report. As of the date of this report, eight patients have been recruited of the 30 planned for this trial. Therefore, D-Pharm intends to achieve a strategic cooperation with an international drug company. Until such cooperation is achieved, D-Pharm will freeze the current trial of the DP-b99 product. 

It should be emphasized that the D-pharm's board of directors and its management will examine, during 2015, the need to perform additional adjustments to the budget of D-Pharm, to the extent required, in accordance with the funding at its disposal and in light of D-Pharm's focus on the continued development of its products.

 

 

 

Sincerely,

 

HBL – Hadasit Bio-Holdings Ltd.

By: Ms. Tamar Kfir, CEO

 
 

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