PharmaMar announced Yondelis® has gained approval for price and reimbursement in Italy
Madrid, 26th January 2009:
PharmaMar announced today that Yondelis® has gained approval for price
and reimbursement in Italy. With this approval, PharmaMar has
successfully finalised negotiations for the price and reimbursement of
Yondelis® with the Italian authorities. Yondelis® will have same price
it has in the rest of European countries.
price and reimbursement approval for Yondelis® has been gained, the
next steps towards the commercialization of the drug in Italy will be
taken soon. This means Yondelis ® may be commercially available to
patients in Italy in the nest weeks.
is currently being marketed in the European Union for the treatment of
Soft tissue Sarcoma in adults after the failure of standard therapy.
PharmaMar has started a phase III multicenter study of Yondelis® as
first-line therapy in patients with tumor traslocation, Ewing's
sarcoma, or not rhabdomyosarcomatose soft tissue sarcomas and other
types of STS. Yondelis® is being studied in solid tumors with high
incidence and prevalence in the population, such as prostate, breast
and lung cancer.
Yondelis® has been designated
orphan drug for the treatment of soft tissue sarcomas and ovarian
cancer in the European Union, United States and Switzerland, and for
soft tissue sarcomas in Korea.
According to the
agreement between PharmaMar a subsidiary of Zeltia, S.A- and Ortho
Biotech Products, L.P. a subsidiary of Johnson & Johnson- , under
which Yondelis® is developed, PharmaMar will market Yondelis® in Europe
(including Eastern Europe) and Japan, and Ortho Biotech Products, L.P.
will market Yondelis® in the rest of the world. Both companies filed a
registration dossier to the EMEA and the FDA for Yondelis for the
treatment of refractory ovarian cancer at the end of 2008. At the end
of 2008 both companies submitted a Registration Dossier of Yondelis® in
relapsed ovarian cancer (ROC) to the EMEA and the FDA. A decision on
the approval for this indication is expected to take place during 2009.
Soft tissue sarcomas
are a diverse group of more than 50 types of tumours that appear in
fatty tissue, muscle, nerve tissue, tendons and blood and lymph
vessels. Nearly half of them affect the extremities.
data from GEIS (Spanish research group in sarcomas) soft tissue
sarcomas (STS) have an incidence of around 3/100,000 new cases per
year, which represents 2% of the overall mortality from cancer. The
highest incidence is situated in patients around 50 years of age.
five-year survival rate of patients with STS is around 90% when
detected early (stage I), that is, when the tumour is small and with no
metastasis. However, the five-year survival rate in patients with
metastatic disease is 10-20% . The estimated life expectancy in
metastatic patients is 8-12 months after receiving the first line of
is the world-leading biopharmaceutical company of the Zeltia Group,
committed to advancing the treatment of cancer through the discovery
and development of new marine-derived medicines. Yondelis® is the first
Spanish antitumoral compound, currently marketed in the European
for the treatment of soft tissue sarcomas in adults after the failure
of standard therapy. Last December 4th, 2008 PharmaMar submitted a
Registration Dossier of Yondelis® in relapsed ovarian cancer (ROC) to
the EMEA. A decision on the approval for this indication is expected to
take place by
mid-2009. PharmaMar has four novel compounds in
clinical development: Yondelis® is also in Phase II studies in
prostate, breast and pediatric cancers. Aplidin ®, Zalypsis ®, and
Irvalec ® are new marine-derived agents in clinical development.
PharmaMar also has an extensive portfolio of products in preclinical
research and a sound R&D program.
based in Madrid, Spain, is a company of the Zeltia Group (Spanish Stock
Exchange, ZEL) that has been listed on the Spanish Stock Exchange since
1963. This document is a press release, not a brochure. This document
does not constitute nor is it part of any offer or invitation to sell
or issue any application of purchase, offer, or shares subscription of
the Group. Likewise, this document nor its
distribution is part or
can be of base for any contract or investment decision and does not
constitute any kind of recommendation in relation with the shares of
For further information:
Media Relations (Ph: +34 91 846 60 00)
Carlos Martínez de la Serna
Carolina Lanzas Otazu
Capital Markets ( Ph: +34 91 444 45 00)
Alfonso Hurtado de Mendoza
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