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PharmaMar Submits Marketing Authorization Application in Europe for Yondelis(R) In Soft Tissue Sarcoma
Madrid (ots/PRNewswire) - PharmaMar today announces the submission of a Marketing Authorization Application to the European Medicines Agency (EMEA) for Yondelis(R) (trabectedin) as a treatment for soft tissue sarcomas (STS). The application is based on the results of a randomised, Phase II pivotal study of Yondelis, known as STS-201.
José María Fernández, Chairman of PharmaMar, commented:
"The Marketing Authorization Application submission is a significant milestone for PharmaMar and demonstrates our commitment to providing an effective therapy for soft tissue sarcoma patients with limited treatment options. We look forward to working closely with the regulatory authorities as we progress through the registration process."
Yondelis was originally isolated from the marine tunicate Ecteinascidia turbinata. Yondelis has a distinct mechanism of action. It is a unique anti cancer agent that binds into the minor groove of the DNA and interacts with DNA repair enzymes and transcription factors, interferring with different cell cycle processes.
In addition to STS, Yondelis is being studied in a pivotal Phase III trial in ovarian cancer and in Phase II in prostate and breast cancers. It was designated Orphan Drug status for STS and ovarian cancer by the European Commission (E.C.) and the United States Food and Drug Administration (US FDA).
Yondelis is being developed by PharmaMar together with Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD). If key studies are successful and support marketing approval, the agreement between the parties provides that PharmaMar will market Yondelis(R) in Europe while Ortho Biotech Products, L.P. and Janssen-Cilag will market the product in the US and the rest of the world respectively.
About Soft Tissue Sarcomas
Soft tissue sarcoma (STS) is a type of cancer in tissues that connects, supports, or surrounds other structures and organs of the body. Soft tissue includes muscles, tendons, fibrous tissues, fat, blood vessels, nerves, and synovial tissues. More than 30 sub-types of STS have been identified.
Soft tissue sarcomas are very rare making up only about one percent of all adult cancers and 7% (NCI Soft Tissue Sarcoma PDQ) of all pediatric cancers. In the European Union, about 11,000 people are diagnosed with STS and more than 3,300 die of the disease every year (ESMO guidelines STS Task Force 2005).
Primary treatment for most sarcoma patients is surgery. Advanced sarcomas are highly treatment resistant tumors; medications considered active in this disease produce response rates of between 10 and 20 percent.
More than 50 percent of newly diagnosed patients will ultimately die of the disease. The 5-year survival rate for soft-tissue sarcoma patients is approximately 50 to 60 percent if the cancer is found early, while it is small and before it has metastasised. In contrast, the 5-year survival rate for sarcomas that have spread to other parts of the body is between 10 percent and 15 percent.
PharmaMar is the world's leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative, marine-derived medicines. PharmaMar's clinical portfolio currently includes 6 compounds: Yondelis(R) (co-developed with J&JPRD), in Phase III clinical trials, was designated Orphan Drug status for soft tissue sarcomas and ovarian cancer by the European Commission (E.C.) and by the United States Food and Drug Administration (US FDA); Aplidin(R), in Phase II, was designated Orphan Drug status for acute lymphoblastic leukaemia and multiple myeloma by the E.C. and the US FDA; Kahalalide F, in Phase II; and ES-285, Zalypsis(R) and PM02734, in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL).
For more information, contact:
PharmaMar Communications Tel: +34-91-846-6000
David Yates / Sarah MacLeod
Financial Dynamics Tel: +44-20-7831-3113
Catherine Moukheibir / Carlos Ruiz-Garma
Zeltia Capital Markets Operations Tel: +34-91-444-4500
This press release is also available in the News section on PharmaMar's web site: http://www.pharmamar.com/en/press/
ots Originaltext: PharmaMar
Im Internet recherchierbar: http://www.presseportal.de
For more information, contact: Media: Lola Casals, PharmaMar
Communications Tel: +34-91-846-6000, David Yates / Sarah MacLeod,
Financial Dynamics Tel: +44-20-7831-3113; Investors: Catherine
Moukheibir / Carlos Ruiz-Garma, Zeltia Capital Markets Operations,