- PharmaMar will receive an upfront payment of €2 million and is eligible for additional remunerations of up to €6.5 million with the achievement of regulatory and sales milestones.
- PharmaMar will retain exclusive production rights and will supply the finished product for clinical and commercial use.
- The Parties agreed to submit regulatory filings in several Latin America countries based on the US (FDA) dossier and approval for metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Madrid (Spain), March 1st, 2021. – PharmaMar S.A. (MSE:PHM) has announced today a licensing agreement with Adium Pharma S.A. of Montevideo, Uruguay, to commercialize the anticancer drug Zepzelca® (lurbinectedin) in Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Trinidad and Tobago, Uruguay and Venezuela.
Under the terms of the agreement, PharmaMar will receive an upfront payment of €2 million upon signing and providing the US dossier of lurbinectedin to Adium. PharmaMar will also be eligible to receive additional remunerations of up to €6.5 million upon achieving regulatory and sales milestones. PharmaMar will retain exclusive production rights and will sell the finished product to Adium for its clinical and commercial use.
Lurbinectedin is commercialized by PharmaMar’s partner Jazz Pharmaceuticals in the United States since its approval by FDA (Food and Drug Administration) for the treatment of metastatic Small Cell Lung Cancer on June 15th, 2020. Additional marketing authorization applications have been submitted to health agencies in Australia, Canada, Switzerland, Israel, and others under accelerated approval pathways. Lurbinectedin regulatory review process in certain countries falls under the ‘Project Orbis’ initiative which allows collaboration between the FDA and selected international regulators.
PharmaMar and Adium agreed to submit regulatory filings in several Latin America countries in the coming months.
Outside of the US, lurbinectedin is available to patients in selected countries via named Patient Access Programs.
According to Luis Mora, General Manager of PharmaMar’s Oncology Business Unit, “This is our second commercial agreement with ADIUM, following the one signed a year ago with them for Yondelis®. With this new agreement, lurbinectedin could soon reach Latin American patients with metastatic Small Cell Lung Cancer.“
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.
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: Zepzelca® (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 ADIUM PHARMA S.A.
Adium is a private pharmaceutical company based in Montevideo, Uruguay. Adium distributes its products in 18 Latin American & Caribbean countries including Brazil, Mexico and Colombia. Adium has been distributing products from leading international companies, in the field of Oncology, Urology, Hematology and Rare Diseases, for more than 20 years. Adium provides its partners a full set of local capabilities including commercial, market access, regulatory and pharmacovigilance.
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.
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