PharmaMar moderates 0.75% rise after UK designation of lurbinectedin as Breakthrough Medicine

PharmaMar’s stock closed Friday’s session up 0.75% after the Galician company announced that its drug Zepzelca (lurbinectedin) had received Innovative Drug Designation (“Innovation Passport”) from the UK Medicines and Healthcare Products Regulatory Agency, as set out in a statement to the National Securities and Markets Commission (CNMV).

Concretely, the titles of the pharmaceutical laboratory close the trading day at 61.62 euros, against 61.16 euros at the close on Thursday. The action of the biopharmaceutical came to trade at a price of 63.3 euros in the middle of the session.

PharmaMar explained that the UK agency’s Innovative Licensing and Access Pathway (ILAP) aims to speed time to market, making it easier for patients to access medicines. ILAP initially includes the designation of an “Innovation Passport” that supports innovative approaches to the development of safe, rapid and effective medicines to improve patient access.

Criteria for this designation include if the disease is life-threatening or severely debilitating, or if there is a significant patient or public health need and the drug has the potential to provide benefit to patients. , whether in the form of improved efficacy or safety, patient care or quality of life compared to other treatment options.

PharmaMar’s Director of Clinical Development and Regulatory Affairs, Dr. Ali Zeaiter, emphasized that lurbinectedin “is an innovative drug that has demonstrated clinical benefit for patients with recurrent small lung cancer and has obtained provisional approvals in several countries”. United States, Canada or Australia.

“It is being developed in other clinically significant indications. Critical small lung cancer represents an unmet medical need in the UK and globally, and our goals are aligned with those of the UK public health authorities to facilitate and improve patient access to drugs like lurbinectedin,” added Zeaiter.

On May 4, the company announced that it had submitted a conditional marketing authorization application to the UK agency for the treatment of lurbinectedin in adult patients with metastatic small lung cancer. that progressed after prior platinum-based chemotherapy, based on data from the phase II basket trial with lurbinectedin monotherapy.

PharmaMar expects to receive a response to this request by the end of this year or in the first quarter of 2023. Additionally, the Phase III Lagoon trial could be used as a confirmatory trial. In 2020, the Spanish biopharmaceutical company and Inmedica Pharma AB signed an agreement for the exclusive distribution and commercialization of lurbinectedin in the UK and other territories.

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