2006-07-27

PharmaMar Submits Marketing Authorization Application in Europe for Yondelis(R) In Soft Tissue Sarcoma


Madrid (ots/PRNewswire) - PharmaMar today announces the submissionof a Marketing Authorization Application to the European MedicinesAgency (EMEA) for Yondelis(R) (trabectedin) as a treatment for softtissue sarcomas (STS). The application is based on the results of arandomised, Phase II pivotal study of Yondelis, known as STS-201.

José María Fernández, Chairman of PharmaMar, commented:

"The Marketing Authorization Application submission is asignificant milestone for PharmaMar and demonstrates our commitmentto providing an effective therapy for soft tissue sarcoma patientswith limited treatment options. We look forward to working closelywith the regulatory authorities as we progress through theregistration process."

About Yondelis(R)

Yondelis was originally isolated from the marine tunicateEcteinascidia turbinata. Yondelis has a distinct mechanism of action.It is a unique anti cancer agent that binds into the minor groove ofthe DNA and interacts with DNA repair enzymes and transcriptionfactors, interferring with different cell cycle processes.

In addition to STS, Yondelis is being studied in a pivotal PhaseIII trial in ovarian cancer and in Phase II in prostate and breastcancers. It was designated Orphan Drug status for STS and ovariancancer by the European Commission (E.C.) and the United States Foodand Drug Administration (US FDA).

Yondelis is being developed by PharmaMar together with Johnson &Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD). If keystudies are successful and support marketing approval, the agreementbetween the parties provides that PharmaMar will market Yondelis(R)in Europe while Ortho Biotech Products, L.P. and Janssen-Cilag willmarket 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 thatconnects, supports, or surrounds other structures and organs of thebody. Soft tissue includes muscles, tendons, fibrous tissues, fat,blood vessels, nerves, and synovial tissues. More than 30 sub-typesof STS have been identified.

Soft tissue sarcomas are very rare making up only about onepercent of all adult cancers and 7% (NCI Soft Tissue Sarcoma PDQ) ofall pediatric cancers. In the European Union, about 11,000 people arediagnosed 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. Advancedsarcomas are highly treatment resistant tumors; medicationsconsidered active in this disease produce response rates of between10 and 20 percent.

More than 50 percent of newly diagnosed patients will ultimatelydie of the disease. The 5-year survival rate for soft-tissue sarcomapatients is approximately 50 to 60 percent if the cancer is foundearly, while it is small and before it has metastasised. In contrast,the 5-year survival rate for sarcomas that have spread to other partsof the body is between 10 percent and 15 percent.

About PharmaMar

PharmaMar is the world's leading biopharmaceutical company inadvancing cancer care through the discovery and development ofinnovative, marine-derived medicines. PharmaMar's clinical portfoliocurrently includes 6 compounds: Yondelis(R) (co-developed withJ&JPRD), in Phase III clinical trials, was designated Orphan Drugstatus for soft tissue sarcomas and ovarian cancer by the EuropeanCommission (E.C.) and by the United States Food and DrugAdministration (US FDA); Aplidin(R), in Phase II, was designatedOrphan Drug status for acute lymphoblastic leukaemia and multiplemyeloma by the E.C. and the US FDA; Kahalalide F, in Phase II; andES-285, Zalypsis(R) and PM02734, in Phase I clinical trials.

PharmaMar, based in Madrid, Spain, is a subsidiary of the ZeltiaGroup (Spanish stock exchange, ZEL).

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 Tel: +34-91-444-4500

This press release is also available in the News section onPharmaMar's web site: http://www.pharmamar.com/en/press/

ots Originaltext: PharmaMarIm Internet recherchierbar: http://www.presseportal.de

Contact: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, Tel: +34-91-444-4500

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PharmaMar Submits Marketing Authorization Application in Europe for Yondelis(R) In Soft Tissue Sarcoma

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