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. With this new agreement, lurbinectedin could soon reach Latin American patients with metastatic Small Cell Lung Cancer.“ Outside of the US, lurbinectedin is available to patients in selected countries via named Patient Access Programs.Īccording 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 ®. PharmaMar and Adium agreed to submit regulatory filings in several Latin America countries in the coming months. Lurbinectedin regulatory review process in certain countries falls under the ‘Project Orbis’ initiative which allows collaboration between the FDA and selected international regulators. Additional marketing authorization applications have been submitted to health agencies in Australia, Canada, Switzerland, Israel, and others under accelerated approval pathways. 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. PharmaMar will retain exclusive production rights and will sell the finished product to Adium for its clinical and commercial use. PharmaMar will also be eligible to receive additional remunerations of up to €6.5 million upon achieving regulatory and sales milestones. 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. 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. (MSE:PHM) has announced today a licensing agreement with Adium Pharma S.A. 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.PharmaMar will retain exclusive production rights and will supply the finished product for clinical and commercial use.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.
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