The Company reaffirms that it will file for the lurbinectedin NDA to the FDA under accelerated approval regulations for the treatment of relapsed Small Cell Lung Cancer (SCLC) during the fourth quarter (Q4) of 2019.
- The meeting is aimed at analysts and investors and will feature experts in various fields
- The Company reaffirms that it will file for the lurbinectedin NDA to the FDA under accelerated approval regulations for the treatment of relapsed Small Cell Lung Cancer (SCLC) during the fourth quarter (Q4) of 2019.
Madrid, November 7th, 2019. – PharmaMar (MSE:PHM) announced today that it will participate in Solebury Trout KOL Day for analysts and investors on November 15th, 2019, with its presentation at 12:30 ET (18:30 CET) at the White & Case Event Space, in New York.
Pascal Besman, PharmaMar COO in the USA, will present the development of lurbinectedin in SCLC. This will be followed by a presentation by Jacob Sands, MD, of the Dana-Farber Cancer Institute, entitled “SCLC: Recent approvals in first and third line could be joined with Lurbinectedin in 2nd line”.
As agreed with the FDA, PharmaMar will file for accelerated approval its New Drug Application (NDA) for lurbinectedin monotherapy for the treatment of relapsed SCLC during Q4, 2019. If approved, this could allow the product to be launched in the US market in 2020.
The lurbinectedin trial in monotherapy in SCLC was presented at the last ASCO congress and achieved the primary endpoint of the Overall Response Rate (ORR).
Interested parties can access a live video webcast of the PharmaMar presentation on the Events Calendar section of our website or directly at https://services.choruscall.
For more information or to RSVP, institutional investors and sell-side analysts may contact access@troutgroup.com.
KOL BIOGRAPHY
Dr Sands is a thoracic medical oncologist at Dana-Farber Cancer Institute and an instructor of medicine at Harvard Medical School. In addition, he is a National Spokesperson for the American Lung Association and is a current member of the NCCN Small Cell Lung Cancer panel.
Dr. Sands received his MD from the University of Cincinnati in 2005. He completed his residency in internal medicine at the University of California, Davis and fellowship training in hematology/oncology also at the University of California, Davis. He joined the faculty in the Lowe Center for Thoracic Oncology at Dana-Farber in 2017. His research focuses on improved diagnostics and treatments for small cell lung cancer as well as improving lung screening and assisting in the development of lung screening programs throughout the country.
His research focuses on the diagnostics and treatment of small cell lung cancer with ongoing development of new treatment protocols for clinical trials. Dr. Sands is also active in advancing lung screening as a way of diagnosing lung cancer early enough to significantly increase the chances of cure. He is the treasurer of the Rescue Lung Rescue Life Society, an organization focused on assisting hospitals with building robust lung screening programs.
Legal warning
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.
About PharmaMar
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 (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.
Media Contact:
Alfonso Ortín – Communications Director aortin@pharmamar.com Mobile: +34 609493127
Miguel Martínez-Cava – Communication Manager mmartinez-cava@pharmamar.com Mobile: +34 606597464
Phone: +34 918466000
Investor Relations:
José Luis Moreno Martínez-Losa – Capital Markets & Investor Relations Director
investorrelations@pharmamar.
Phone: +34 914444500