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YONDELIS(R) Granted Orphan Drug Designation by the U.S. FDA For The Treatment of Ovarian Cancer
Madrid, Spain (ots/PRNewswire) - PharmaMar announced today that its marine-derived anti-cancer drug, YONDELIS(R) (trabectedin), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ovarian cancer. The U.S. application sponsor, is Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), co-developing the compound with PharmaMar. The European Commission granted orphan drug status to YONDELIS for this indication in Europe in 2003.
In the western world, 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). The death rate for this disease has not changed significantly in the last 50 years. The median age of women with ovarian cancer is 60, although it may occur in younger women with a family history of the disease. Nearly 70% of women with epithelial ovarian cancer, the most common type of ovarian cancer, are not diagnosed until the disease is advanced. The 5-year survival rate for these women with advanced disease is only 15 to 20%, whereas the 5-year survival rate for Stage I disease patients approaches 90% and for Stage II disease patients 70%.
In 2004, there were an estimated 25,580 new cases of ovarian cancer in United States, and more than 16,000 women died from the disease. Incidence in the European Union was about 48,000 new cases in 2004 and caused approximately 31,000 deaths (Globocan 2002, IARC, WHO). According to the World Health Organisation, the highest incidence rates occur in the United States, Canada, Scandinavia and Eastern Europe.
Orphan Drug designation in the United States is awarded to compounds that offer potential therapeutic value in the treatment of rare diseases, defined as those affecting fewer than 200,000 Americans. If the company complies with certain FDA specifications and should the drug receive marketing approval, orphan drug designation qualifies the sponsor for seven years of marketing exclusivity, exemption of the New Drug Application user fee and tax credits related to clinical research. The designation does not shorten the duration of the regulatory review and approval process. Orphan Drug designation in Europe offers similar incentives including, upon marketing approval, 10 years marketing exclusivity for the indication in question.
Isabel Lozano, CEO of PharmaMar, said: "We are pleased that YONDELIS has received Orphan Drug Designation from the FDA and we look forward to further development in ovarian cancer together with our partner Johnson & Johnson."
This press release is also available in the News section on PharmaMar's web site: www.pharmamar.com.
YONDELIS(R) (trabectedin), is PharmaMar's most advanced compound in development, and originally was isolated from the marine tunicate Ecteinascidia turbinate, but now is manufactured by chemical synthesis. YONDELIS currently is being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar will market YONDELIS in Europe (including Eastern Europe) while Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will market it in the U.S., Ortho Biotech, a division of Janssen-Cilag, will market it in the rest of the world.
Johnson &Johnson Pharmaceutical Research and Development, L.L.C., Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based manufacturer of health care products.
YONDELIS(R) currently is also in Phase II studies in soft tissue sarcoma (comparative pivotal trial) and for prostate cancer.
In clinical studies to date, YONDELIS has shown a good safety and tolerability profile. The most frequent side effect is neutropenia, which is reversible and controllable. A transient increase in transaminases also has been observed.
PharmaMar is the world leader biopharmaceutical company, advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar's clinical portfolio currently includes YONDELIS(R) in Phase III clinical trials (co-developed with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.), designated Orphan Drug for STS by the European Commission (E.C.) in 2001 and by the FDA in 2004, and Orphan Drug for ovarian cancer by the E.C. in 2003. It also features Aplidin(R), in Phase II, designated Orphan Drug for acute lymphoblastic leukaemia by the E.C. in 2003 and by the FDA in 2004, and for multiple myeloma by the FDA and the E.C. in 2004; as well as Kahalalide F in Phase II and ES-285 and Zalypsis(R) in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL)
ots Originaltext: PharmaMar and Zeltia Group
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For more information, please contact: Media: Lola Casals, PharmaMar
Communication (tel.: +34-91-846-6000) Coro Egaña, Zeltia Corporate
Communication (tel.: +34-91-444-4500) Investors: Catherine
Moukheibir, Zeltia Capital Markets Operations (tel.: +34-91-444-4500)