Immedica Pharma AB announces that the United Arab Emirates Ministry of Health and Prevention has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC).
“Small cell lung cancer is a disease with limited treatment options. The approval of Zepzelca in United Arab Emirates represents an important treatment option for patients whose metastatic SCLC has progressed after traditional chemotherapy such as platinum-based therapy,” said Anders Edvell, CEO at Immedica Pharma.
Immedica has a strategic alliance/partnership with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.
Ashraf Attia, Regional Director in the Middle East at Immedica said: “Today’s announcement marks a significant milestone for Immedica’ s ambition to expand our presence in oncology in the Middle East region.”
The approval of Zepzelca by United Arab Emirates Ministry of Health and Prevention is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval is based on the same data.
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About Immedica AB
Immedica is a fast-growing private niche pharma group with headquarter in Stockholm, Sweden and commercial coverage across Europe and the Middle East. Immedica has significant know-how and experience in commercialization of niche/specialty care products across Europe and the Middle East, and the company’s management team has an outstanding track record of operating niche pharma products internationally. Immedica has capabilities to provide optimal access of specialty care medicines to patients with significant medical needs, including key areas such as regulatory affairs, pharmacovigilance, medical affairs, pricing & reimbursement, quality, and product distribution.
Immedica’ s main owner is Impilo AB, a private Nordic investment company established in 2017.
More information is available at www.immedica.com
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 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, PM184 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). To learn more about PharmaMar, please visit us at www.pharmamar.com.
Lurbinectedin (PM1183) is a synthetic compound currently under clinical investigation. 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.
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