Japan, January 31, 2006 - Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) today announced that it has recently achieved the following progress in its efforts to develop new drugs:
-Marketing authorization application (MAA) for the immunosuppressant FK506 Modified Release Formulation in Europe
The European subsidiary of Astellas has submitted an MAA for the immunosuppressant FK506 Modified Release Formulation (generic name: tacrolimus) to the European Medicines Agency (EMEA) with the proposed indication of the inhibition of rejection in organ transplantation.
FK506 Modified Release Formulation is a once-daily version of Prograf. Because this formulation is more convenient than the existing twice-daily formulation, it is expected to improve compliance and thereby improve the long-term efficacy in the protection of transplanted organs. Its safety is also expected to be comparable to or even superior to that of the existing formulation since peak blood concentrations can be controlled at lower levels. It also makes it possible to titrate the dosage based on blood concentrations.
-Application of YM060 for the Irritable Bowel Syndrome Treatment in Japan
Astellas filed an application of YM060 (generic name: ramosetron hydrochloride) for the irritable bowel syndrome (IBS) treatment in Japan with a proposed indication of diarrhea-predominant IBS.
IBS is a functional gastrointestinal disorder consisting of two major complaints of abdominal pain and abnormal bowel habit. It is generally classified into three types: diarrhea-predominant-type, constipation-predominant-type and alternate-predominant-type. YM060 improves colonic functions via its 5-HT3 (serotonin) receptor antagonism with the proposed indication of IBS associated with diarrhea. If approved, it will be Japanfs first 5-HT3 receptor antagonist for this indication.
The clinical development of YM060 (Phase II) is also under way in Europe.
The development status of other compounds is announced today as a supplement to the financial result release package for 3Q of FY2005.