Alle Storys
Keine Story von PharmaMar and Zeltia Group mehr verpassen.

PharmaMar and Zeltia Group

YONDELIS(R) Granted Orphan Drug Designation by the U.S. FDA For The Treatment of Ovarian Cancer

Madrid, Spain (ots/PRNewswire)

PharmaMar announced today that
its marine-derived anti-cancer drug, YONDELIS(R) (trabectedin), has
been granted Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA) for the treatment of ovarian cancer. The U.S.
application sponsor, is Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), co-developing the compound with
PharmaMar. The European Commission granted orphan drug status to
YONDELIS for this indication in Europe in 2003.
Ovarian cancer
In the western world, ovarian cancer represents 4% of all cancers
among women and ranks fifth as a cause of female deaths from cancer
(American Cancer Society (ACS), Cancer Reference Information, 2005).
The death rate for this disease has not changed significantly in the
last 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. Nearly 70% of women with epithelial ovarian cancer, the most
common type of ovarian cancer, are not diagnosed until the disease is
advanced. The 5-year survival rate for these women with advanced
disease is only 15 to 20%, whereas the 5-year survival rate for Stage
I disease patients approaches 90% and for Stage II disease patients
In 2004, there were an estimated 25,580 new cases of ovarian
cancer in United States, and more than 16,000 women died from the
disease. Incidence in the European Union was about 48,000 new cases
in 2004 and caused approximately 31,000 deaths (Globocan 2002, IARC,
WHO). According to the World Health Organisation, the highest
incidence rates occur in the United States, Canada, Scandinavia and
Eastern Europe.
Orphan Drug designation in the United States is awarded to
compounds that offer potential therapeutic value in the treatment of
rare diseases, defined as those affecting fewer than 200,000
Americans. If the company complies with certain FDA specifications
and should the drug receive marketing approval, orphan drug
designation qualifies the sponsor for seven years of marketing
exclusivity, exemption of the New Drug Application user fee and tax
credits related to clinical research. The designation does not
shorten the duration of the regulatory review and approval process.
Orphan Drug designation in Europe offers similar incentives
including, upon marketing approval, 10 years marketing exclusivity
for the indication in question.
Isabel Lozano, CEO of PharmaMar, said: "We are pleased that
YONDELIS has received Orphan Drug Designation from the FDA and we
look forward to further development in ovarian cancer together with
our partner Johnson & Johnson."
This press release is also available in the News section on
PharmaMar's web site:
YONDELIS(R) (trabectedin), is PharmaMar's most advanced compound
in development, and originally was isolated from the marine tunicate
Ecteinascidia turbinate, but now is manufactured by chemical
synthesis. YONDELIS currently is being developed by PharmaMar in
partnership with Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. PharmaMar will market YONDELIS in Europe
(including Eastern Europe) while Tibotec Therapeutics, a division of
Ortho Biotech Products, L.P., will market it in the U.S., Ortho
Biotech, a division of Janssen-Cilag, will market it in the rest of
the world.
Johnson &Johnson Pharmaceutical Research and Development, L.L.C.,
Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of
the Johnson & Johnson Family of Companies, the world's most
comprehensive and broadly based manufacturer of health care products.
YONDELIS(R) currently is also in Phase II studies in soft tissue
sarcoma (comparative pivotal trial) and for prostate cancer.
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 controllable. A transient increase in
transaminases also has been observed.
About PharmaMar
PharmaMar is the world leader biopharmaceutical company, advancing
cancer care through the discovery and development of innovative
marine-derived medicines. PharmaMar's clinical portfolio currently
includes YONDELIS(R) in Phase III clinical trials (co-developed with
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.),
designated Orphan Drug for STS by the European Commission (E.C.) in
2001 and by the FDA in 2004, and Orphan Drug for ovarian cancer by
the E.C. in 2003. It also features Aplidin(R), in Phase II,
designated Orphan Drug for acute lymphoblastic leukaemia by the E.C.
in 2003 and by the FDA in 2004, and for multiple myeloma by the FDA
and the E.C. in 2004; as well as Kahalalide F in Phase II and ES-285
and Zalypsis(R) in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the
Zeltia Group (Spanish stock exchange, ZEL)


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