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:10/13/2017)... CT (PRWEB) , ... October 13, 2017 , ... ... long-term care services, staged a mock evacuation of the facility as part of a ... Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... , ... October 13, 2017 , ... “The Journey: From ... every danger possible to save lost souls in the Philippines. “The Journey: From the ... is a dedicated teacher of the Bible. She has taught all ages and currently ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest ... its plans to open a flagship location in Covington, LA at 401 N. U.S. ... Go store next to Office Depot in the Holiday Square shopping center. Its location ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., a ... design, and immune-engineering today announced the launch of ... development of personalized therapeutic cancer vaccines. EpiVax has ... exclusive access to enabling technologies to the new ... will lead EpiVax Oncology as Chief Executive Officer. ...
(Date:9/22/2017)... 2017 AVACEN Medical (AVACEN) announced that its ... helping those with the widespread pain associated with fibromyalgia ... in Essex, England commented, "I ... experiencing no sleep at all, tremendous pain, with every ... recommend [the AVACEN 100] enough, how this has and ...
Breaking Medicine Technology: