Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the commercialization of Yondelis for the treatment of soft tissue sarcoma. The regulatory process required the presentation of a registration dossier adapted to Swissmedic requirements.
PharmaMar has the distribution license of the product in Switzerland, which guarantees the product launch. Switzerland joins now the list of 30 countries of the EEA (European Economic Area) where Yondelis is already authorized for commercialization.
PharmaMar is also conducting clinical trials to expand the use of Yondelis in sarcoma, such as a phase III multi-centre study of Yondelis as first-line therapy in patients with tumour traslocation, and a phase II study in children diagnosed with Ewing Sarcoma, Rhabdomyosarcoma, and other types of STS. Yondelis is being studied in solid tumours with high incidence and prevalence in the population, such as prostate, breast and lung cancer.
Yondelis has been designated orphan drug for the treatment of soft tissue sarcomas and ovarian cancer in the European Union, United States and Switzerland, and for soft tissue sarcomas in Korea.
According to the agreement between PharmaMar - a subsidiary of Zeltia, S.A- and Ortho Biotech Products, L.P. -a subsidiary of Johnson & Johnson- , under which Yondelis is developed, PharmaMar will market Yondelis in Europe (including Eastern Europe) and Japan, and Ortho Biotech Products, L.P. will market Yondelis in the rest of the world. Both companies filed a registration dossier to the EMEA and the FDA for Yondelis for the treatment of refractory ovarian cancer at the end of 2008. At the end of 2008 both companies submitted a Registration Dossier of Yondelis in relapsed ovarian cancer (ROC) to the EMEA and the FDA. A decision on the approval for this indication is expected to take place during 2009.
STS are a diverse group of more than 50 types of tumours that appear in fatty tissue, muscle, nerve tissue, tendons and blood and lymph vessels. Nearly half of them affect the extremities. According to data from GEIS (Spanish research group in sarcomas) soft tissue sarcomas (STS) have an incidence of around 3/100,000 new cases per year, which represents 2% of the overall mortality from cancer. The highest incidence is situated in patients around 50 years of age.
PharmaMar is the world-leading biopharmaceutical company of the Zeltia Group, committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines. Yondelis is the first Spanish anti-tumoural compound, currently marketed in several countries of the European Union for the treatment of soft tissue sarcomas in adults after the failure of standard therapy.