PharmaMar has obtained a trademark for its commercial formulation of PM 1183 (lurbinectedin) — developed for the treatment of ovarian and lung cancers — from European and U.S. authorities, the company announced recently from its Madrid, Spain headquarters.
The biopharmaceutical company with worldwide subsidiaries is currently developing Zepsyre with clinical studies in order to treat solid tumors in platinum-resistant ovarian cancer as well as small cell lung cancer. The medication acts as an inhibitor of RNA polymerase II, a protein complex-based enzyme.
Assessment and approval from two regulatory agencies — the European Medicines Agency (EMA) and the U.S. Food and Drug Administration — is necessary prior to marketing the product; in addition, establishing a unique trade name is integral to the process.
“We trust in the potential of Zepsyre as a therapeutic alternative due to its novel mechanism of action and the antitumoral activity observed in all clinical trials for different type of tumors,” PharmaMar’s oncology business unit managing director Luis Mora said.
Zepsyre is one of the three products chosen for an upcoming presentation by the pediatric oncology subcommittee of the FDA’s Oncologic Drugs Advisory Committee. PharmaMar maintains a pipeline of marine-derived anticancer drug candidates as well as an R&D oncology program.