Pharma Mar S A : PharmaMar receives positive opinion from EMA for Orphan Drug Designation of lurbinectedin for Mesothelioma
July 29, 2021 at 10:37 am EDT
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PharmaMar (PHM:MSE) announces that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has given its positive opinion for Orphan Drug Designation to Zepzelca (lurbinectedin) for the treatment of Mesothelioma.
PharmaMar plans to commence a Phase III trial with lurbinectedin and lurbinectedin in combination with immunotherapy in the second-line treatment of this type of tumor in 2021. Lurbinectedin is already marketed in the United States for the treatment of metastatic Small-Cell Lung Cancer and has Orphan Drug Designation for this indication in Europe, the United States, Switzerland and Australia.
Malignant Mesothelioma is a tumor that arises from the mesothelial cells of the pleural, peritoneal or pericardial lining, and is often associated with exposure to asbestos, usually with a very poor prognosis at the time of diagnosis, with pleural mesothelioma the most frequent location. There is currently no cure for most malignant mesotheliomas. Therefore, the goal of current cancer treatments (surgery, radiation therapy and chemotherapy) is to reduce or eliminate symptoms, as well as to prolong Progression-Free Survival (PFS) and/or Overall Survival (OS). It is estimated that the incidence of this type of cancer may increase in the coming years, after the exposure to asbestos as there is a long latency period before a Malignant Mesothelioma forms.
About PharmaMar PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases 2 with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation. PharmaMar has developed and now commercializes Yondelis in Europe by itself, as well as Zepzelca (lurbinectedin), in the US and Aplidin (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin and PM14. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar also wholly owns other companies: GENOMICA, a molecular diagnostics company and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi).
About lurbinectedin
Lurbinectedin (Zepzelca), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.
Pharma Mar SA is a Spain-based integrated biopharmaceutical company focused on oncology and committed to research and development (R&D) of antitumor drugs of marine origin. The Company, through its subsidiaries, operates three business segments: Oncology, Diagnostics and RNA interference. The Oncology segment encompasses research, develop and market anti-tumor drugs. The Diagnostics segment includes the development and marketing of diagnostic kits. The RNA interference segment consist of the development of drugs with therapeutic activity based on reducing or silencing gene expression. The Companyâs product portfolio includes Yondelis and ZEPZELCA. Yondelis (trabectedin) is indicated for the treatment of advanced soft tissue sarcoma, as well as for the treatment of relapsed platinum-sensitive ovarian cancer. ZEPZELCA (lurbinectedin) is indicated for the treatment of metastatic small cell lung cancer (SCLC) with disease progression. The Company is active globally.
PHARMA MAR, S.A. 
