SAN DIEGO, California—Ligand Pharmaceuticals announced that its partner Pfizer, Inc has received approval from the European Commission (EC) for Fablyn^® (lasofoxifene) tablets. Lasofoxifene is a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. This is the first regulatory approval for lasofoxifene.

Lasofoxifene failed to win approval by the FDA because US regulators were concerned about deaths recorded among patients taking the drug in a clinical trial. However, the FDA's Advisory Committee for Reproductive Health Drugs had voted 9-3 (with one abstention) that the drug's benefits outweigh its risks for a subgroup of postmenopausal women with osteoporosis. The FDA has requested additional information from Pfizer about lasofoxifene.

The European marketing approval scores Ligand a $3 million milestone payment from Pfizer, which has worldwide commercialization rights.

"Today's announcement is an exciting development for Ligand, as the European approval of Fablyn marks the fourth drug associated with Ligand's research platform that has been approved and the second to be approved in just the past six months," said Ligand President and CEO John L. Higgins.

Ligand's new drug development focuses on critical unmet medical needs of patients with muscle wasting, frailty, hormone-related diseases, osteoporosis, inflammatory diseases, anemia, asthma, rheumatoid arthritis and psoriasis. The company's proprietary development programs are based on advanced cell-based assays, gene-expression tools, ultra-high throughput screening and one of the world's largest combinatorial chemical libraries.