PharmaMar’s shares have risen by more than 3% in the early stages of trading, although as the morning progressed the increases stood at 1.83% to 62.28 euros within an Ibex 35 that the same hour falls 0.29%. It is the third consecutive session in green for the value, which in the accumulated of the year rises 11% with the market capitalization at 1,160 million euros.
PharmaMar today announced that Zepzelca (lurbinectedin) has been awarded the “Innovation Passport” by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to speed up time to market, facilitating patient access to medicines, the company explains in a relevant fact submitted to the National Commission of the Stock Market (CNMV).
ILAP comprises, as a first step, the designation of an “Innovation Passport” that supports innovative approaches for safe, timely and efficient drug development to improve patient access.
Criteria for this designation include where the disease is life-threatening or seriously debilitating, or where there is a significant patient or public health need and where the drug has the potential to offer benefits to patients (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 provisional approvals in several countries (such as the US, Canada or Australia) and is being developed in other clinically significant indications,” he explains. In a statement Dr. Ali Zeaiter, VP of Clinical Development and Regulatory Affairs of PharmaMar. “Small cell lung cancer represents an unmet medical need in the UK and around the world, and our goals are aligned with those of UK public health authorities to facilitate and improve patient access to medicines such as lurbinectedin”.
“We believe this designation is an important step in facilitating access for patients with small cell lung cancer to 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 with lurbinectedin in adult patients with metastatic small cell lung cancer who have 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 at the end of this year or during 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 United Kingdom and other territories.