Pfizer, Ligand submit application to FDA for Fablyn

SAN DIEGO Ligand Pharmaceuticals announced that its partner in the development of a new drug, Pfizer, has submitted an application to the Food and Drug Administration for their joint venture, Fablyn, according to published reports.

Fablyn is used for the treatment of osteoporosis in postmenopausal women. In August 2004, Pfizer filed an application with the FDA for the use of Fablyn in the prevention of osteoporosis, Ligand said. An additional application was filed in December 2004 for the treatment of vaginal atrophy. Pfizer received ‘not-approvable’ letters from the FDA for Fablyn for the prevention of post-menopausal osteoporosis in September 2005 and for the treatment of vaginal atrophy in January 2006.

Pfizer is responsible for the registration and worldwide marketing for Fablyn. Ligand is entitled to a milestone payment upon FDA approval, and would also receive royalty payments equal to 3 percent of net sales.