Madrid, February 3rd, 2010: Centocor Ortho Biotech Products, L.P. has informed PharmaMar SA (Grupo Zeltia, ZEL.MC) of the regulatory approval of Yondelis® (trabectedin) by the authorities of Bolivia, Paraguay, Thailand, Curaçao, Malaysia, Azerbaijan and Kazakhstan for the treatment of Advanced Soft Tissue Sarcoma (STS) in adults.
Yondelis® received the marketing approval for the treatment of Relapsed Ovarian Cancer (ROC) by the European Commision in October 2009. Outside the EEA, Yondelis® is also approved for ROC in the Philippines and has now received Marketing Authorization in Kazakhstan.
With these eight new approvals, Yondelis® is approved for treatment of STS in 21 countries outside the European Economic Area (EEA), ie,Argentina, Colombia, South Korea, Hong Kong, Macau, India, the Philippines, Russia, Mexico, Chile, Uruguay, Singapore Vietnam, Switzerland, Bolivia, Paraguay, Thailand, Curacao, Malaysia, Azerbaijan and Kazakhstan. PharmaMar has already started to receive royalties from sales in these countries.
PharmaMar is also conducting clinical trials to expand the use of Yondelis® in sarcoma as first-line therapy in patients with tumor translocation, and in children diagnosed with Ewing sarcoma, rhabdomyosarcoma, and other types of STS. Yondelis® is being studied in solid tumors including prostate, breast and lung cancer. Yondelis® has been granted orphan drug status for the treatment of soft tissue sarcomas and ovarian cancer in the European Union, United States and Switzerland, and for soft tissue sarcoma (STS) in South Korea.
According to the licensing agreement between PharmaMar – a subsidiary of Zeltia, S.A – and Centocor Ortho Biotech Products, L.P., PharmaMar will market Yondelis® in Europe (including Eastern Europe), and Centocor Ortho Biotech Products, L.P. has rights to market Yondelis® in the rest of the world, except Japan, a market where PharmaMar SA and Taiho Pharmaceutical CO., LTD. have a licensing agreement to develop and commercialize Yondelis®.
Soft Tissue Sarcoma
Soft tissue sarcomas are a heterogeneous group of more than 50 types of tumours that arise in adipose, muscle or nerve tissue, tendons, blood and the lymph vessels. Almost half of these tumours affect the limbs. Sarcomas account for about 1% of all cancers diagnosed – about 3,000 cases a year in the UK. Soft tissue sarcomas affect around 4 out of every 100,000 people per year and account for 2% of the overall cancer mortality rate. STS is most common among people in their 50s. The 5-year survival rate of patients with STS is around 90% when it is detected early (Phase I), i.e. when the tumour is small and has not metastasised, but only 10-20% if the disease has metastasised. The life expectancy in patients with metastasis is 8-12 months after having received first-line therapy.
Ovarian cancer
In the West, epithelial ovarian cancer represents 4% of all cancers among women and ranks fifth as a cause of female deaths from cancer (American Cancer Society [ACS], Cancer Reference Information, 2005). According to 2009 clinical data from the European Society for Medical Oncology (ESMO), ovarian cancer in the European Union affects 18 out of every 100,000 women per year, and the mortality rate is 12 per 100,000 women per year. The average age of diagnosis is 63, and the incidence increases with age, particularly above the age of 70; however, it may also occur in younger women, especially in those with a family history of the disease. 70% of women with ovarian cancer are diagnosed late, when the disease is already advanced (Stages III and IV).The 5-year survival rate for these women is only 15%-20%, whereas the 5-year survival rate is nearly 90% for patients in Stage I of the disease (i.e. the earliest stage) and 70% for Stage II (intermediate).
PharmaMar
PharmaMar is a biopharmaceutical company Zeltia Group and global leader in the discovery, development and commercialization of anticancer drugs of marine origin. Yondelis ® is the first Spanish anti-cancer drug. Yondelis® is already approved in the 30 countries of the EEA and Switzerland and in 21 countries outside the EEA (European Economic Area). Yondelis ® is also in Phase II development in prostate, breast and pediatric cancers. PharmaMar has four novel compounds in clinical development: Aplidin ®, Irvalec ®, Zalypsis ® and PM01183. PharmaMar also has a rich pipeline of preclinical candidates, and a strong research and development program.
Important note
PharmaMar, based in Madrid, Spain, is a subsidiary of Grupo Zeltia (Spanish Stock Exchange, ZEL) that has been quoted on the Spanish Stock Exchange since 1963 and on Spain's Electronic Market since 1998. This document is a press release, not a brochure. This document does not constitute nor is part of any offer or invitation to sell or issue any application of purchase, offer, or shares subscription of the Company. Likewise, neither this document nor its distribution is part or can be of base for any contract or investment decision and does not constitute any kind of recommendation in relation with the shares of the Company.
For more information:
Media Relations (tel. +34 91 846 60 00)
Fernando Mugarza
Carlos Martínez de la Serna
Carolina Lanzas Otazu
Capital Markets (Ph: +34 91 444 45 00)
José Luis Moreno
Florencia Radizza
This press release is also availabe at Pharmamar web site: www.pharmamar.com