ZELTIA NEWS

Yondelis® approved for sale in 10 new countries

The regulatory authorities in 10 countries have granted 14 sales authorisations for

Yondelis®.

Ten of those authorisations are for Yondelis® in combination with Caelyx® (pegylated liposomal doxorubicin) for treating relapsed platinum-sensitive ovarian cancer: Bahrain, Costa Rica, the Dominican Republic, Jamaica, Jordan, Nepal, Oman, Panama, Vietnam and Qatar.

The other four authorisations are for Yondelis® for soft tissue sarcoma: Bahrain, the

Dominican Republic, Jordan and Nepal. Yondelis® is currently approved in 73 countries.

Madrid, 3rd December 2012: Janssen Products, LP (previously Centocor Ortho Biotech Products, LP) has informed Pharma Mar SA (Grupo Zeltia, ZEL.MC) that regulatory authorities in 10 countries have granted 14 new authorisations to sell Yondelis®: 10 for treating relapsed platinum-sensitive ovarian cancer (ROC), in combination with Caelyx® (pegylated liposomal doxorubicin), and 4 as monotherapy for treating soft tissue sarcoma (STS).

The ten countries that have authorised Yondelis® for ROC are, Bahrain, Costa Rica, the Dominican Republic, Jamaica, Jordan, Nepal, Oman, Panama, Vietnam and Qatar. The four countries that authorised the drug for STS are Bahrain, the Dominican Republic, Jordan and Nepal.

As a result, Yondelis® is now approved in 73 countries, 30 of which are in the European Economic Area (EEA). The European Commission approved the sale of Yondelis® in combination with pegylated liposomal doxorubicin for relapsed platinum-sensitive ovarian cancer at the end of 2009. Since then, the drug has been approved and commenced sale in other territories. The European Commission approved Yondelis® for soft tissue sarcoma in

2007.

Yondelis® has orphan drug status for soft tissue sarcoma and ovarian cancer in the European Union, the United States, and Switzerland, and for soft tissue sarcoma in Japan and South Korea.

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According to the licensing agreement between PharmaMar (Zeltia, S.A. subsidiary) and Janssen Products, LP, PharmaMar has the rights to sell Yondelis® in Europe (including Eastern Europe), while Janssen Products, LP has the rights to sell the drug everywhere else except Japan, where Pharma Mar SA (Grupo Zeltia, ZEL.MC) has granted a license to Taiho Pharmaceutical Co., Ltd. for the development and sale of Yondelis®.

About 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; however, it may also occur in younger women, especially in those with a family history of the disease. Seventy per cent 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%, compared with nearly 90% for patients in Stage I of the disease (i.e. the earliest stage) and 70% for Stage II (intermediate).
About PharmaMar
PharmaMar is a biopharmaceutical subsidiary of Grupo Zeltia; it is a world leader in discovering, developing and marketing marine-based drugs to treat cancer. Yondelis® is Spain's first antitumour drug. It is currently approved for soft tissue sarcoma (STS) in 42 countries outside the EEA, and for platinum-sensitive ROC in 31 of those countries plus Brazil. Yondelis® is approved for STS and platinum-sensitive ROC in all 30 countries of the EEA. Yondelis® is also undergoing Phase II trials on breast and paediatric cancers. PharmaMar has four other compounds in clinical development: Aplidin®, Zalypsis®, PM01183 and PM060184. PharmaMar also has a rich pipeline of pre-clinical candidates and a major R&D programme.
About Zeltia
Zeltia S.A. is a world-leading biopharmaceutical company specialised in the development of marine-based drugs for use in oncology and central nervous system illnesses. Grupo Zeltia consists mainly of the following companies: PharmaMar, the world-leading biotechnology company in advancing cancer care through the discovery and development of innovative marine-derived medicines; Noscira, a biotech firm focused on discovering and developing new drugs against Alzheimer's disease and other neurodegenerative diseases of the central nervous system; Genomica, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical division comprising Zelnova and Xylazel, two highly profitable companies that are leaders in their respective market segments.
Important note
PharmaMar, which is headquartered in Madrid (Spain), is a subsidiary of Zeltia, S.A. (Spanish stock exchange: ZEL), which has been listed on the Spanish Stock Exchange since 1963 and on Spain's Electronic Market since

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1998. 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.
For more information +34 91 444 4500

This note is also available on the PharmaMar web site: www.pharmamar.comand at Zeltia's website:
www.zeltia.com

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