Three New Key Studies at ASCO Highlight Antitumoral Activity of Yondelis(R)

Atlanta, Georgia (ots/PRNewswire) -

- 86% Rate of Tumour Control in myxoid liposarcomas

- Correlation Between DNA Repair Gene Expression and Response Rate
in Sarcomas

- 78% Rate of Tumour Control in Platinum Pretreated Ovarian Cancer
Patients

PharmaMar highlights the results of three important studies out of
10 presented on Yondelis(R) at the Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Atlanta, Georgia (USA) on 3-4
June 2006. Yondelis(R) is being developed by PharmaMar in partnership
with Johnson & Johnson Pharmaceutical Research & Development, L.C.C.
(J&JPRD). The key points from each of the presentations are set out
below.

Yondelis - Soft Tissue Sarcomas

Two pharmacogenomic studies were presented which demonstrate
the activity of Yondelis in specific types of advanced sarcomas.

Oral Presentation: Patterns of tumour response to Yondelis in
myxoid liposarcomas - Dr F. Grosso et al

Data was obtained from a compassionate use study of 44 patients
with advanced myxoid liposarcomas, and was carried out by six
investigators in referral centres specialising in the treatment of
patients with soft tissue sarcoma (STS). The results indicate
significant evidence of Yondelis' anti-tumoural activity in this
specific patient population with long-lasting objective remissions
and tumour control in 86% of patients. The median progression free
survival (duration of tumour control) is 18 months and the median
survival time is 28 months.

The study also identified a clear correlation between the level of
response and changes in the density of the patients' tumour tissue.
This "tissue response" preceded dimensional regression (tumour
shrinkage) in 62% of responders.

Commenting on the study, Dr F Grosso, Investigator at Istituto
Nazionale dei Tumori in Milan, Italy, said: "These remarkable results
demonstrate that Yondelis, a drug known to provide benefit to
patients with STS, may bring increased benefits to patients that
suffer from this specific type of sarcoma. Myxoid liposarcomas are
known to be linked to chromosomal abnormalities and ongoing studies
are underway to identify the correlation between a given molecular
signature and successful treatment outcome."

Dr Jose Jimeno, Vice President of Scientific Development at
PharmaMar, added: "Beyond the known clinically relevant impact of
Yondelis in advanced pre-treated STS patients, the data presented in
this population with dismal prognosis reinforces the value of
Yondelis as an active anticancer agent. Yondelis has a clear role in
myxoid liposarcomas and probably in other malignancies such as Ewing
sarcomas that bear similar genetic abnormalities. The results
generated warrant further studies in this tumour type as a first line
treatment for metastatic disease as well as preoperative therapy."

Poster: DNA repair functionality modulates the clinical outcome of
patients with advanced sarcoma treated with Yondelis - Dr P.
Schöffski et al

Based upon the significant accumulated evidence that demonstrates
the ability of Yondelis to induce long-lasting rates of prolonged
responses (up to a number of years in several cases) and its
correlation with DNA repair processes, this exploratory retrospective
pharmacogenomic study was implemented to investigate whether there is
a molecular signature that correlates with sensitivity or resistance
to Yondelis.

Data collected from analysis of tumour samples of sarcoma patients
treated with Yondelis indicate the impact of the DNA repair mechanism
on progression free survival and overall survival. This data shows
that patients with an efficient TC-NER machinery (as demonstrated per
high levels of ERCC1) have a better outcome to treatment with
Yondelis, and that patients with a deficient homologous recombination
repair machinery (demonstrated by low levels of expression of BRCA1)
experience better progression-free survival and overall survival.

Prof. Dr. P. Schöffski, Lead Investigator at the Universitaire
Ziekenhuizen Leuven, Belgium, said: "This study provides powerful
evidence of Yondelis' role in soft tissue sarcoma and also, more
generally, of the future importance of pharmacogenomics in the
treatment of cancer. The impact of deficient or mutant BRCA1 is well
established in other tumour types such as breast and prostate cancers
and development strategies for Yondelis for these highly prevalent
cancers should be considered by the company."

Dr José Jimeno, Vice President of Scientific Development at
PharmaMar, said: "The data reinforces the notion of a targeted
trans-tumoural oriented strategy and thus customised trials in other
tumours, as breast, ovarian and prostate, known to be sensitive to
Yondelis, should be implemented. Selective approach might be a good
option for the clinical development of the compound in these
important indications."

Yondelis - Ovarian Cancer

Poster: Phase II randomized open-label study of Yondelis given as
two different dosing schedules in women with platinum-sensitive
recurrent ovarian carcinoma - Dr JM del Campo et al

This Phase II trial was designed to test the activity of two
dosing schedules of Yondelis administered over 3-hour or 24-hour
infusion every 3 weeks in patients with relapsed ovarian carcinoma.
107 patients were enrolled in the trial at 34 centres across Europe.

The results demonstrate that both schedules are active, with 28.3%
and 29.6% of objective response rates in the 3-hour 1.3 mg/m2 and the
24-hour 1.5 mg/m2 regimen respectively, with a median duration of
response of 5.4 months. The activity of Yondelis appears to be
independent of the number of previous platinum lines of therapy.
Moreover, the rate of tumour control (Complete Responses + Partial
Responses + Stable Disease) is 78% in the overall population. The
safety results confirm the lack of cumulative toxicity, thus allowing
multi-cycle therapies.

A worldwide Phase III study in ovarian cancer (650 patients in 135
centres and 21 countries) is ongoing to compare the combination of
Yondelis plus Doxil(r)(1)/Caelyx(r) (doxorubicin HCI liposome
injection) to Doxil(r)/Caelyx(r) alone, in the second line treatment
of ovarian cancer patients.

(1) DOXIL(r) (doxorubicin HCI liposome injection) is marketed in
the United States by Tibotec Therapeutics, a Division of Ortho
Biotech Products, L.P., and in Israel by Janssen-Cilag.
Schering-Plough Corporation, under a licensing agreement, has
exclusive rights to market this medication as CAELYX(R) throughout
the rest of the world, excluding Japan.

Dr Miguel Angel Izquierdo, Director of Clinical Development at
PharmaMar, commented: "Yondelis is amongst the most active agents in
the treatment of patients with relapsed ovarian cancer and this
randomized study adds further evidence of its activity. The response
rates corroborate those of earlier studies and confirm the
suitability of the 3-hour outpatient infusion regime being used in
the Phase III pivotal trial that is now well underway."

About Yondelis(R)

Yondelis(r) (trabectedin) is PharmaMar's most advanced compound in
development. It was originally isolated from the marine tunicate,
Ecteinascidia turbinata, but now is manufactured by chemical
synthesis. Yondelis is being developed by PharmaMar in partnership
with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD) If key studies are successful and support marketing
approval, PharmaMar will market Yondelis in Europe (including Eastern
Europe), while Tibotec Therapeutics, a division of Ortho Biotech
Products, L.P., and Janssen-Cilag will market it in the rest of the
world.

In addition to a pivotal Phase II trial in soft tissue sarcoma,
Yondelis also is being studied in a Phase III trial in ovarian
cancer, and in Phase II in breast and prostate cancers. More than
3,400 patients have been treated to date with Yondelis.

In clinical studies to date, Yondelis has shown a good safety and
tolerability profile. The most frequent side effect is neutropenia,
which is reversible and manageable. A transient increase in
transaminases has been observed.

Yondelis is a new chemical entity with a unique multicomponent
mechanism of action. It is believed to be the only chemotherapy agent
that binds to the DNA's minor groove and bends toward the major
groove, producing its therapeutic effect by interfering with various
cell division processes.

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: Yondelis(R) (co-developed with J&JPRD) in Phase
III clinical trials; it was designated Orphan Drug status for soft
tissue sarcomas and ovarian cancer by the European Commission (E.C.)
and by the United States Food & Drug Administration (US FDA).
Aplidin(R), in Phase II, designated Orphan Drug for acute
lymphoblastic leukaemia and for multiple myeloma by the E.C. and by
the 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 Communication (tel.: +34-91-846-6000)
Investors: Catherine Moukheibir, 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: Zeltia Group
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information, contact: Media: Lola Casals, PharmaMar
Communication (tel.: +34-91-846-6000). Investors: Catherine
Moukheibir, Zeltia Capital Markets Operations, (tel.:
+34-91-444-4500)