PharmaMar leads the rise of the ibexes

Stock market up for PharmaMar: UK green light for its lung cancer drug

The gestures of PharmaMar they rose by more than 3% at the start of trading, even if over the morning the increases stood at 1.83% at 62.28 euros within an Ibex 35 which fell at the same time from 0 .29%. This is the third consecutive session in the green for the value, which over the year has increased by 11% with a market capitalization of 1,160 million euros.

PharmaMar announced today that Zepzelca (lurbinectedin) has been awarded the “Innovation Passport” (Designation of Innovative Medicine) by the MHRA (Medicines and Health Products Regulatory Agency of the United Kingdom). The MHRA Innovative Licensing and Access Pathway (ILAP) aims to accelerate time to market, by facilitating patient access to medicinesexplains the company in a relevant fact submitted to the National Securities Market Commission (CNMV).

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 when the disease is life-threatening or severely debilitating, or there is a significant patient or public health need and the drug has the potential to provide patient benefit. (improved efficacy or safety, improved patient care or quality of life compared to other treatment options).

“Lurbinectedin is an innovative drug that has shown clinical benefit for patients with recurrent small cell lung cancer and has obtained tentative approvals in several countries (such as the United States, Canada or the Australia) and is being developed in other clinically significant indications.” In a statement, Dr. Ali Zeaiter, vice president of clinical development and regulatory affairs at PharmaMar. “Small cell lung cancer is an unmet medical need in the UK and around the world, and our aims are aligned with those of the UK public health authorities to facilitate and improve patient access to medicines such as lurbinectedin”.

“We believe this designation is an important step in making it easier for patients with small cell lung cancer to access a new treatment option.”

On May 4, 2022, PharmaMar announced that it had submitted a conditional Marketing Authorization Application to the UK MHRA for the treatment of lurbinectedin in adult patients with metastatic small cell lung cancer having 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 said request by the end of this year or in the first quarter of 2023..

In addition, the phase III LAGOON trial could be used as a confirmatory trial. In 2020, PharmaMar and Immedica Pharma AB signed an agreement for the exclusive distribution and marketing of lurbinectedin in the UK and other territories.

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