On August 18, 2022 Immedica Pharma AB reported that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency), presented earlier by our valued partner PharmaMar (see full press release below) (Press release, Immedica Pharma, AUG 18, 2022, View Source [SID1234618471]).
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Anders Edvell, CEO says: "To be awarded an Innovation Passport under the new Innovative Licensing and Access Pathway means a lot to us. We are excited about engaging with UK healthcare system stakeholders through this new pathway to explore the opportunities for bringing Lurbinectedin to patients as quickly as possible".
The pressrelease from PharmaMar, follows below.
AUGUST 5, 2022
PharmaMar has announced today that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency).
The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. The ILAP comprises as the first step an "Innovation Passport" designation which supports innovative approaches to the safe, timely and efficient development of medicines to improve patient access. The criteria for the innovation passport include where the condition is life-threatening or seriously debilitating, or where there is a significant patient or public health need and where the medicinal product has the potential to offer benefits to patients (improved efficacy or safety, improved patient care or quality of life as compared to alternative therapeutic options).
Ali Zeaiter, M.D., VP Clinical Development & Regulatory Affairs of PharmaMar, said:
"Lurbinectedin is an innovative medicine that showed clinical benefit for patients with relapsed Small Cell Lung Cancer (SCLC) and obtained provisional approvals in a number of countries (including USA, Canada and Australia) and is being developed in other clinically significant indications. SCLC represents an unmet medical need in the UK and worldwide, and our objectives are aligned with those of the UK public health authorities to facilitate and improve patients access to medicines such as lurbinectedin," and added: "We believe that the innovation passport designation is an important step towards facilitating SCLC patients’ access to a new treatment option."
On May 4th 2022, PharmaMar announced it had submitted a conditional marketing authorization application to the UK’s MHRA for the treatment with lurbinectedin in adult patients with metastatic Small Cell Lung Cancer who have progressed following prior platinum-based chemotherapy based on data from the Phase II basket trial with lurbinectedin in monotherapy. PharmaMar expects a response to such application by the end of this year or first quarter of 2023. In addition, the LAGOON Phase III trial could be used as a confirmatory trial.
On 2020 PharmaMar and Immedica Pharma AB signed an agreement for the exclusive distribution and marketing of lurbinectedin for the UK and other territories.
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