- 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
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.ch
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,