PharmaMar has filed lurbinectedin for Temporary Marketing Authorisation with the Swiss Agency for Therapeutic Products

  • The Company has filed for lurbinectedin's "Temporary Authorisation", in monotherapy, for the treatment of relapsed
    Small Cell Lung Cancer (SCLC).
  • The filing is based on the phase II multicentre basket trial efficacy data.
  • The lurbinectedin monotherapy basket trial for SCLC achieved its primary endpoint of Overall Response Rate (ORR).

Madrid, 20th July, 2020.- PharmaMar (MSE:PHM) has announced that it has submitted lurbinectedin for "Temporary Authorisation" for marketing to the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with SCLC who have progressed after prior platinum-containing therapy.

This filing is based on data from the phase II monotherapy basket trial with lurbinectedin for the treatment of SCLC. The data, which appeared in The Lancet Oncology1, in the May 2020 issue, showed that in relapsed SCLC, lurbinectedin demonstrated an Overall Response Rate (ORR) of 35 percent and a median Duration of Response (DoR) of 5.3 months, as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC).

Temporary authorisation is granted by Swissmedic under certain conditions to make medicinal products for the treatment of life-threatening diseases available to patients as quickly as possible. It is a streamlined procedure with shorter overall timelines than that of a standard registration procedure. There must be no alternative medicinal product authorised or available in Switzerland. Major therapeutic benefit is expected from use of the product for which authorisation is being requested.

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About PharmaMar

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Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

About lurbinectedin

Lurbinectedin (ZepzelcaTM), 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.

Media Contact:

Alfonso Ortín - Communications Director aortin@pharmamar.comMobile: +34 609493127

Miguel Martínez-Cava - Communication Manager mmartinez-cava@pharmamar.comMobile: +34 606597464

Phone: +34 918466000

Capital Markets & Investor Relations:

José Luis Moreno- Capital Markets & Investor Relations Director María Marín de la Plaza - Capital Markets & Investor Relations investorrelations@pharmamar.com

Phone: +34 914444500

Or please visit our website at www.pharmamar.com

1 Trigo J. et al, Lancet Oncology, 2020, Vol 21 (5), P645-654

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Pharma Mar SA published this content on 20 July 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 July 2020 10:35:04 UTC