Navigation Links
Yondelis(R) Receives Five New Approvals Outside the European Economic Area
Date:3/15/2010

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

Back to top
'/>"/>
SOURCE Group Zeltia
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
2. DaVita Receives Civil Complaint
3. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
4. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
5. Edwards Lifesciences Receives CE Mark for Edwards SAPIEN Transcatheter Heart Valve
6. PainCare Receives $14.4 Million in Cash From Completed Sale of South Florida Ambulatory Surgery Centers
7. UT Southwesterns obesity research receives $22 million NIH Roadmap grant
8. Temple Emergency Medicine receives $1.8M to find best MRSA treatment
9. Prime Therapeutics Receives TIPPS Certification
10. Bioniche Receives $2 Million Government Grant For Market Development Related to its E. coli O157:H7 Cattle Vaccine
11. UCLA receives $22.5 million to explore the fundamental biology of mental disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2017)... (PRWEB) , ... July 25, 2017 , ... ... Winner for its Product Innovation in the prestigious CEO World Awards®. The coveted ... performance, new products and services, CEO case studies, corporate social responsibility, and milestones ...
(Date:7/25/2017)... ... July 25, 2017 , ... SignatureCare Emergency Center – South Austin is ... 24 Hours a day. , The Emergency Room opened early March, ... open four months now and things are running smoothly,” said Aaron Braun, SignatureCare Emergency ...
(Date:7/24/2017)... PARK (PRWEB) , ... July 24, 2017 , ... Engineers ... is bio-compatible, because it produces the same kind of electrical energy that the body ... the form of moving electrons. This flow of electrons out of the battery is ...
(Date:7/24/2017)... ... July 24, 2017 , ... ... kklaproth(at)robinsmorton(dot)com , Robins & Morton, Perkins Will, Newcomb & Boyd, Walter P ... of the new Destination Medical Building located at Mayo Clinic in Jacksonville, ...
(Date:7/24/2017)... ... July 24, 2017 , ... Cheerag D. Upadhyaya , ... Marion Bloch Neuroscience Institute (SLMBNI), part of Saint Luke’s Health System . ... , Cheerag D. Upadhyaya, MD. M.Sc., FAANS joins Stanley P. Fisher, M.D., ...
Breaking Medicine News(10 mins):
(Date:7/14/2017)... July 14, 2017 Endo International plc (NASDAQ: ... August 8, 2017.  Members of its senior management team will host ... at 8:30 a.m. ET. The dial-in number to ... International (678) 509-7598, and the passcode is 45397076. Please dial in ... A replay of the call will be ...
(Date:7/13/2017)... , July 13, 2017  New York City-based market research ... markets should be aware of.  From new products to new ... detailed in a recently completed study, Potential Pipeline Disruptors ... 1.  Age-Driven Growth - True ... been aware of the impact the growing population and, to ...
(Date:7/11/2017)... N.J. , July 11, 2017  Bayer has awarded ... eight countries as part of its prestigious Bayer Hemophilia Awards ... Hospital of Philadelphia and Uniformed Services ... are among the winners. Grant recipients were announced last ... and Hemostasis (ISTH) 2017 Congress, Berlin, Germany ...
Breaking Medicine Technology: