ZELTIA SA PharmaMar maintains its status as manufacturer of active ingredient trabectedin for the U.S.
Madrid, July 31, 2015: PharmaMar announced that the U.S. FDA has inspected the quality system and the manufacturing process for the YONDELIS® active ingredient, trabectedin, and that PharmaMar maintains the status as manufacturer of active ingredient for the U.S. that wasgranted in September 2009. The recent inspection has taken place during the second quarter at the facilities of PharmaMar in Colmenar Viejo (Madrid).
About YONDELIS® (trabectedin)
YONDELIS® (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery. It is approved in 78 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection). Under a licensing agreement
with PharmaMar, Janssen Products has the rights to develop and sell YONDELIS® globally except in
Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to
Taiho Pharmaceuticals.
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. YONDELIS® is the first anticancer drug of marine origin and is commercially available in 78 countries for the treatment of advanced soft tissue sarcomas as a single-agent, and for relapsed platinum-sensitive ovarian cancer in combination with DOXIL®/CAELYX®. PharmaMar develops and commercializes YONDELIS® in Europe and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States. To learn more about
PharmaMar, please visit us at www.pharmamar.com.
This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.
Media Inquiries:1
Carolina Pola - Communications Director
Phone: +34 918466000
Mobile: +34 608933677
Phone: +34 914444500
Or please visit our website at www.pharmamar.com and www.zeltia.com
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