Yondelis Granted Orphan Drug Status By Swiss Agency For Therapeutic Products For Treatment Of Soft Tissue Sarcoma & Ovarian Cancer

Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 04 Apr 2008 - 1:00 PDT

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PharmaMar announces that Yondelis(R) has been granted orphan drug status by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with soft tissue sarcoma and ovarian cancer.

The European Commission and the FDA granted Orphan Drug Status to Yondelis in STS in 2001 and 2004 and in Ovarian Cancer in 2003 and in 2005, respectively.

An application for marketing authorization for Yondelis in the treatment of ovarian cancer is
expected to be submitted to the EMEA during 2008. Approval of Yondelis for patients with
advanced Soft Tissue Sarcoma is expected in Switzerland in the last quarter of 2008.

Switzerland will join other European countries where Yondelis is being currently commercialized, namely Germany, UK, Austria, Sweden, Norway, Finland, Denmark, Island, Greece, Ireland, Holland and Spain.

Luis Mora, PharmaMar General Manager stated: "We are very pleased to further advance in the development of Yondelis reaching those patients who may benefit from the efficacy of Yondelis, as shown in clinical trials. We therefore continue with our mission of delivering the best medicines of marine origin to cancer patients".

Yondelis® is currently being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development L.L.C.. According to the licensing agreement, PharmaMar will market Yondelis® in Europe (including Eastern Europe) while J&J´s Ortho Biotech Products, L.P., will market it in the U.S., and J&J´s Janssen-Cilag will market it in the rest of the world.

Ovarian cancer

Epithelial ovarian cancer accounts for 4% of all female cancers and is the fifth leading cause of death by cancer in the female population in developed countries (according to American Cancer Society [ACS], Cancer Reference Information, 2005). The mortality rate of this disease has not changed substantially over the past 50 years. The median age of women with ovarian cancer is 60, although it can occur in younger women, especially in cases with a family history of the disease. Some 70% of women with ovarian cancer are diagnosed when the disease is already in advanced stages (stages III and IV). Only 15% -20% of patients with advanced disease survive five or more years, this rate reaches nearly 90% in patients with stage I disease (earlier), and 70% for those in stage II (intermediate).

It is estimated that 205,000 new cases of ovarian cancer were diagnosed in 2006 in the world and that more than 125,000 women will die from this disease (Globocan 2005). According to the World Health Organization, the highest rates occur in the United States, Canada, Scandinavia and Eastern Europe.

The Orphan Drug designation in the United States is granted to compounds with potential therapeutic value in the treatment of uncommon or rare diseases, defined as those affecting fewer than 200000 Americans. If the company meets certain specifications of the FDA and if the drug receives marketing approval, the Orphan Drug designation entitles the company to seven years of marketing exclusivity, exemption from registration fees in the application of new drugs, and tax credits for clinical research. The designation does not shorten the duration of the regulatory process for review and approval. The Orphan Drug designation in Europe offers similar incentives, including ten years of marketing exclusivity for the treatment in question once commercialization is approved.

About PharmaMar

PharmaMar is the world leader biopharmaceutical company of the Zeltia Group, committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines. PharmaMar has five novel compounds in clinical development: Yondelis® has received Authorization for Commercialization from the European Commission for advanced soft tissue sarcoma. Yondelis® is also in phase III for ovarian cancer and phase II for prostate, breast and pediatric cancers. Aplidin®, Kahalalide F, Zalypsis® and PM02734 are in clinical trials.

PharmaMar also has a rich pipeline of preclinical candidates, and a strong R&D program.

PharmaMar