Zepzelca® (lurbinectedin) approved by the Ministry of Health in Oman for the treatment of metastatic Small Cell Lung Cancer
Stockholm, July 21, 2023 – Immedica’s product Zepzelca® (lurbinectedin) has received approval by the Ministry of Health in Oman for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Anders Edvell, CEO of Immedica commented: “SCLC is a type of lung cancer that tends to grow and spread fast. The medical need for these patients is huge and lurbinectedin has the potential to benefit the SCLC patients in Oman. We will work with our partner PharmaMar to support access of Zepzelca to these patients”.
This approval of lurbinectedin is based on the data from the open-label, multi-centre, single-arm monotherapy clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.
In 2020, Immedica signed a strategic alliance agreement with PharmaMar for the exclusive distribution and commercialization of lurbinectedin in several territories, including the United Kingdom, Ireland, the Nordic countries, some Eastern European countries, the Middle East and North Africa.
About Small Cell Lung Cancer
About 15% of all lung cancers are Small Cell Lung Cancer (SCLC). This type of lung cancer tends to grow and spread faster than Non-Small Cell Lung Cancer. In most people with SCLC, the cancer has already spread beyond the lungs at the time it is diagnosed.
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 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.
Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and The United States. PharmaMar also wholly owns Sylentis, a company dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
About Zepzelca®
Zepzelca® (lurbinectedin), 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.. Zepzelca is approved for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy in 13 countries.
About Immedica Pharma
Immedica is pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory and medical affairs as well as market access. Immedica has a network of Contract Manufacturing Organizations (CMOs) for manufacturing of both drug substances and drug products. With a global distribution network, we serve patients in more than 50 countries and are fully dedicated to helping those living with diseases which have a large unmet medical need.
Immedica’s therapeutic areas are within genetic & metabolic diseases, hematology & oncology and specialty care.
Immedica was founded in 2018 by the investment company Impilo and Buy-in-Management. Today Immedica employs more than 90 people across Europe and the Middle East.
For more information visit www.immedica.com
Immedica contact:
Linda Holmström
Head of Communication
linda.holmstrom@immedica.com
+ 46 708 73 40 95
Immedica Pharma AB
Solnavägen 3H
SE-113 63 Stockholm