Successful Planned Independent Analysis of Pivotal Phase III Trial of YONDELIS(R) in Ovarian Cancer

Madrid (ots/PRNewswire) - PharmaMar today announced the successful
planned review by the Independent Data Monitoring Committee (IDMC) of
the YONDELIS(R) (trabectedin) Phase III pivotal clinical trial in
ovarian cancer, known as OVA-301. The IDMC recommended that the
present study should continue without modification.

The IDMC can recommend that the study protocol be stopped,
temporarily suspended or amended if it determines that a trial is not
meeting the necessary safety and efficacy requirements. In the case
of OVA-301, this recommendation means that the trial is progressing
positively as expected.

The OVA-301 pivotal Phase III multi-national study will enrol a
total of 650 patients. The accrual halfway point in the study (325
patients) has occurred and recruitment is on target for completion in
the first half of 2007. Currently there are 130 active clinical trial
sites in 21 countries in the US, Europe, Asia and South America.

The pivotal trial OVA-301 compares monotherapy CAEYLX(R)
(doxorubicin HCl liposome injection), marketed as DOXIL(R) in the
United States, to a combination of YONDELIS(R) and CAELYX(R)
(DOXIL(R)) in ovarian cancer patients who have relapsed after
receiving standard first-line chemotherapy. The primary objective is
to test the hypothesis that this combination therapy improves
progression-free and overall survival in women with relapsed ovarian
cancer.

Dr Miguel A. Izquierdo, PharmaMar's Director of Clinical
Development, said:

"The data presented in various congresses over the last two years
indicate that YONDELIS(R) is amongst the most active agents in the
treatment of patients with relapsed ovarian cancer. We are pleased
that the recommendation from the IDMC has now confirmed the positive
progress of this pivotal trial. Recruitment for the study is on track
and we look forward to generating the data that will enable us to
present an application for marketing approval for YONDELIS(R) in
ovarian cancer."

About the IDMC

The IDMC is an independent advisory group of experts with a
mandate to periodically review and evaluate safety and / or efficacy
data during a clinical trial or product development program.
Membership includes individuals with clinical, scientific, and
statistical expertise in the relevant therapeutic area.

About Ovarian Cancer

Ovarian cancer is the most common gynaecological cancer in women,
representing the seventh most common cancer and the fourth most
deadly. Incidence of ovarian cancer in the European Union is about
43,000 new cases each year and approximately 31,000 deaths occur per
year. According to the World Health Organisation, the highest
incidence rates occur in the United States, Canada, Scandinavia and
Eastern Europe and the lowest rates in Africa and Asia.

The death rate for this disease has not changed significantly in
the last 50 years. Ovarian cancer is predominantly a disease of
older, post-menopausal women with the majority of cases being
diagnosed in women over 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. The vast majority of patients are
diagnosed once the cancer has already spread from the ovary and the
disease is advanced. Long term survival remains unfavourable: the
5-year survival rate for these women is only 15%-20%, whereas the
5-year survival rate for Stage I disease patients is nearly 90% and
for Stage II disease patients is 70%.

About YONDELIS(R)

YONDELIS(R) was originally isolated from the marine tunicate
Ecteinascidia turbinata. YONDELIS(R) 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, interfering with different cell cycle
processes.

In addition to ovarian cancer, YONDELIS(R) is being studied in
soft tissue sarcomas (STS) and in Phase II in prostate and breast
cancers. It was designated Orphan Drug status for STS and ovarian
cancer by the European Commission (EC) and the United States Food and
Drug Administration (US FDA).

YONDELIS(R) 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 PharmaMar

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:
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 on
PharmaMar's web site: http://www.pharmamar.com/en/press/

ots Originaltext: PharmaMar
Im 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