FRANKFURT (AFX) - Fresenius AG said its unit Fresenius Biotech GmbH and US-based Enzon Pharmaceuticals Inc have received fast track status from the US Food and Drug Administration for their immunosuppressive agent ATG-Fresenius S in lung transplantation.
Fast track status allows accelerated development and approval of drugs to treat critically ill patients where adequate therapy is not available.
The joint venture said it has just recruited the first North American patient for a Phase II study for approval of ATG-Fresenius S antibody, and that a Phase III study using the immunosuppressive in renal transplant patients is currently being prepared.
ATG-Fresenius S suppresses immune reaction against transplanted organs to reduce the risk of rejection, Fresenius said.
The drug has been on the market for 27 years in over 60 countries and it accounts for some 10 pct of the global antibody market.
The peak sales potential for ATG-Fresenius S as mono- and polyclonal antibody in the immunosuppresive market in the US is 110 mln usd and 200 mln usd worldwide.
ragnhild.kjetland@afxnews.com
rkj/jlw
For more information and to contact AFX: www.afxnews.com and www.afxpress.com
Fast track status allows accelerated development and approval of drugs to treat critically ill patients where adequate therapy is not available.
The joint venture said it has just recruited the first North American patient for a Phase II study for approval of ATG-Fresenius S antibody, and that a Phase III study using the immunosuppressive in renal transplant patients is currently being prepared.
ATG-Fresenius S suppresses immune reaction against transplanted organs to reduce the risk of rejection, Fresenius said.
The drug has been on the market for 27 years in over 60 countries and it accounts for some 10 pct of the global antibody market.
The peak sales potential for ATG-Fresenius S as mono- and polyclonal antibody in the immunosuppresive market in the US is 110 mln usd and 200 mln usd worldwide.
ragnhild.kjetland@afxnews.com
rkj/jlw
For more information and to contact AFX: www.afxnews.com and www.afxpress.com
© 2005 AFX News
