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.
Celgene sees year-to-year revenue increase of more than 50 percent
WARREN, N.J. Celgene’s revenue increased by more than 50 percent in 2007 as compared to 2006. The growth was due to sales of its cancer drug Revlimid.
Revlimid is used in combination with the corticosteroid dexamethasone to treat multiple myeloma patients who have received at least one prior therapy. Net sales of the drug increased more than 140 percent in 2007 to nearly $775 million.
The company also reported good sales results for its skin disease treatment drug Thalomid, the chemotherapy drug Alkeran and the attention deficit hyperactivity disorder drugs Focalin XR and Ritalin and the Ritalin family of products.
The company expects revenue to increase more than 30 percent this year to approximately $1.8 billion and adjusted diluted earnings per share to increase approximately 45 percent up to $1.55.
Valeant divests Infergen rights to Three Rivers
ALISO VIEJO, Calif. Valeant Pharmaceuticals International has completed its divestment of the rights to its hepatitis C drug Infergen in the U.S. and Canada to Three Rivers Pharmaceuticals.
Under the terms of the agreement, Valeant received from Three Rivers an initial payment of about $70.8 million in cash and will receive up to $20.5 million in two noncontingent payments over the next 18 months.
The company had been looking to sell the drug since the third quarter of 2007 due to poor sales.