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WPD Pharmaceuticals Holds Pre-Submission Meeting with the European Medicines Agency and Receives Second Prepayment of C$954,248 From a Total C$7.4 Million Grant for Development of Berubicin

Nachrichtenquelle: globenewswire
06.04.2021, 13:30  |  113   |   |   

VANCOUVER, British Columbia, April 06, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical-stage pharmaceutical company, is pleased to announce that it has received prepayment of approximately C$954,248 (3,000,000 PLN) from the Polish National Center for Research and Development (“NCRD”) for the further development of Berubicin, the Company’s drug candidate targeting glioblastoma multiforme (“GBM”). The funds received are from a total C$7.4 million grant awarded to WPD, and will be used for two clinical studies, planned to be implemented under the project: “New approach to glioblastoma treatment addressing the critical unmet medical need”. The grant was made by the European Union, under the Smart Growth Operational Program 2014-2020. The approved prepayment for WPD’s continued advancements of the Berubicin drug candidate further validates WPD’s scientific development strategy and government support in doing so and helps WPD fulfill requirements under its sublicense agreement with CNS Pharmaceuticals, Inc.

As a part of the Berubicin development strategy, WPD has requested scientific advice on pre-clinical and clinical development from the European Medicines Agency (“EMA”). On March 24, 2021, WPD attended a Pre-Submission Meeting with EMA experts during which useful information was provided on the preparation of documentation for the upcoming meeting with the Scientific Advice Working Party (“SAWP”) of EMA.

EMA allows medicinal drug developers to request scientific advice during initial drug development, before submission of a marketing authorization application. EMA established SWAP for the purpose of providing scientific advice to applicants by providing advice on quality aspects, methodology and pre-clinical and clinical development of drugs being developed, based on documentation provided by the developer.

Mariusz Olejniczak, CEO of WPD commented, “We are very excited with the results of our Pre-Submission Meeting with the EMA Experts as this helps us plan our Berubicin development program. As a result of our discussion with the EMA experts, we have decided to apply for orphan designation for Berubicin. The EU offers a range of incentives to encourage the development of designated orphan medicines, to facilitate the development and authorization of medicines for rare diseases. Drugs in development that obtain orphan designation benefit from protocol assistance, scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market. Fee reductions may also available.”

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WPD Pharmaceuticals Holds Pre-Submission Meeting with the European Medicines Agency and Receives Second Prepayment of C$954,248 From a Total C$7.4 Million Grant for Development of Berubicin VANCOUVER, British Columbia, April 06, 2021 (GLOBE NEWSWIRE) - WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical-stage pharmaceutical company, is pleased to announce that it has received prepayment of …

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