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The FDA has Granted Orphan Drug Status to Yondelis for the Treatment of STS
Madrid (ots/PRNewswire) - The United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to Yondelis in the indication of Soft Tissue Sarcoma (STS). The sponsor of this application in the US is our partner Johnson & Johnson Pharmaceutical Research & Development. The European Commission (E.C.) already granted Orphan Drug status for this indication to Yondelis in 2001 in Europe, where PharmaMar is the applicant.
Orphan drug designation in the US is awarded to drugs that offer potential therapeutic value in the treatment of rare diseases and conditions and therefore may benefit directly from the provisions of the Orphan Act which includes: regulatory assistance and numerous financial incentives for the development and approval of the orphan product, including seven years of marketing exclusivity; New Drug Application fee waivers; tax credits for clinical research and grant funding for the investigation of the rare disease treatment.
The orphan drug designation in Europe offers the applicant several incentives, such as centralised procedure review of the Marketing Authorisation Application and, upon approval, 10-years marketing exclusivity throughout Europe for the therapeutic indication for which it was granted.
In the US as in Europe, about 9,000 people are diagnosed with STS every year and more than 4,000 die of the disease. More than half of the patients with grade 3 tumours die within 5 years of diagnosis and those with inoperable metastatic disease live on average only 8 to 12 months following diagnosis. The survival rate after 5 years of chemotherapy treatment in metastatic disease is 8%.
Isabel Lozano, Chief Executive Officer of PharmaMar said: "STS is an aggressive type of cancer with unfavourable prognosis and limited treatment options. The FDA's ODD to Yondelis in this indication is good news for all of us and we look forward to continuing with the clinical development of Yondelis, together with our partner J&J."
YONDELIS(TM) is a novel marine-derived anti-tumour agent isolated from the colonial tunicate Ecteinascidia turbinata. It is being co- developed by PharmaMar and Johnson & Johnson Pharmaceutical Research & Development, and is in Phase II clinical trials for soft tissue sarcoma (STS), ovarian, breast, endometrial, prostate and non-small cell lung cancers.
PharmaMar is a biopharmaceutical company, advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar's clinical portfolio currently includes Yondelis(TM) in phase II clinical trials (co-developed with Johnson & Johnson Pharmaceutical Research & Development), designated Orphan Drug for STS by the European Commission (E.C.) in 2001 and Orphan Drug for ovarian cancer in 2003; Aplidin(R), in phase II, designated Orphan Drug for acute lymphoblastic leukaemia by the E.C. in 2003 and by the FDA in 2004; also designated Orphan Drug for multiple myeloma by the FDA in 2004; Kahalalide F in phase II and ES-285 in phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange: ZEL.MC; Bloomberg: ZEL SM; Reuters: ZEL.MC). PharmaMar can be found on the Web at http://www.pharmamar.com
ots Originaltext: Zeltia Group
Im Internet recherchierbar: http://www.newsaktuell.ch
Lola Casals David Yates & James Strong, PharmaMar Financial Dynamics,
Tel: +34-91-846-6000 Tel: +44-207-831-3113