Centocor Ortho Biotech Products, L.P.:
Taiho
Pharmaceutical Co., Ltd.:
PharmaMar
SA:
Yondelis(R) Receives Five New Approvals Outside the European
Economic Area
Yondelis(R) has been approved for soft
tissue sarcoma (STS) in Israel, Panama and Ukraine. Additionally, the
authorities in Paraguay and Azerbaijan have approved the drug for
platinum-sensitive recurrent ovarian cancer (ROC).
Yondelis(R) is
currently approved in 56 countries.
currently approved in 56 countries.
MADRID, March 15
/PRNewswire/ — Centocor Ortho Biotech Products has informed PharmaMar
SA (Grupo Zeltia, ZEL.MC) that the regulatory authorities in Israel, Panama
and Ukraine have approved Yondelis(R)
for advanced soft tissue sarcoma (STS) in adults. Furthermore, the
authorities in Paraguay and Azerbaijan have approved the drug for
platinum-sensitive recurrent ovarian cancer (ROC). Yondelis is already
approved for STS in Paraguay and Azerbaijan.
The
European Commission approved Yondelis(R) for platinum-sensitive ROC in September 2009. Outside the European Economic
Area (EEA), Yondelis(R) has now been approved for platinum-sensitive ROC
in Azerbaijan and Paraguay; it had already been approved in Kazakhstan and the
Philippines.
In view of
the three new approvals for STS, Yondelis(R) now has authorization for
this indication in 25 countries outside the EEA: Argentina, Azerbaijan,
Bolivia, Chile,
Colombia, Curacao,
Hong Kong, India,
Israel, Kazakhstan,
Macao, Malaysia,
Mexico, Panama,
Paraguay, The
Philippines, Russia, Singapore, South
Korea, Switzerland, Thailand, Ukraine,
Uruguay, Venezuela
and Vietnam. PharmaMar has already
begun collecting royalties from sales in the aforementioned countries.
Clinical
trials are under way to expand the use of Yondelis(R) in sarcoma,
including a trial as first-line treatment in patients with
translocation-associated tumors, in children with Ewing sarcoma,
rhabdomyosarcoma and other forms of STS. Yondelis(R) is also undergoing
trials in solid tumors, such as prostate, breast and lung cancer.
Yondelis(R)
has orphan drug status for soft tissue sarcoma and ovarian cancer in
the European Union, the United States, Switzerland, and for soft tissue sarcoma in South Korea.
According
to the licensing agreement between PharmaMar (Zeltia, S.A. subsidiary)
and Centocor Ortho Biotech Products, L.P., PharmaMar has the rights to
sell Yondelis(R) in Europe (including Eastern Europe), while Centocor Ortho
Biotech Products, L.P. has the rights to sell the drug everywhere else,
except in Japan, where Taiho
Pharmaceutical Co., Ltd. has a licensing agreement for the development
and sale of Yondelis(R).
About
PharmaMar
PharmaMar
is Zeltia Group's biotechnology subsidiary; it is a world leader in
discovering, developing and selling marine-based drugs to treat cancer.
Yondelis(R) is Spain's first
anti-cancer drug. It is currently approved for STS in 25 countries
outside the EEA, and in five of those countries for platinum-sensitive
ROC as well. Yondelis(R) is approved for STS and platinum-sensitive ROC
in all 30 countries of the EEA; in Switzerland
it is approved for STS. Phase II clinical trials with Yondelis(R) are
also under way on prostate, breast, lung and pediatric cancers.
PharmaMar has four other compounds in clinical development: Aplidin(R),
Irvalec(R), Zalypsis(R) and PM01183. PharmaMar also has a rich pipeline
of pre-clinical candidates and a major R&D programs.
Important
note
PharmaMar,
which is headquartered in Madrid (Spain), is a subsidiary of the Zeltia Group
(Spanish stock exchange: ZEL), which has been listed on the Spanish
Stock Exchange since 1963 and on Spain's
Electronic Market since 1998. This document is a press release, not a
prospectus. This document does not constitute or form part of an
offering or invitation to sell or a solicitation to purchase, offer or
subscribe shares of the company. Moreover, no reliance should be placed
upon this document for any investment decision or contract and it does
not constitute a recommendation of any type with regard to the shares of
the company.
SOURCE Group Zeltia