Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
partner Pfizer received approval today from the U.S. Food and Drug Administration (FDA) for DUAVEE
(conjugated estrogens/bazedoxifene), for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause and the prevention of postmenopausal osteoporosis. Under the terms of a license agreement with Pfizer, Ligand has earned a $425,000 milestone payment for the approval.
“We believe this is an important achievement in the field of women’s medicine, a therapy area in which Ligand has had a rich history of research” commented John Higgins, President and Chief Executive Officer of Ligand. “There has been a significant therapeutic need for additional safe and effective medicines to improve health and well-being for women, and we commend the DUAVEE team at Pfizer for their commitment and leadership in driving this medicine to regulatory success. We are extremely pleased by the decision by the FDA, and we look forward to the launch of DUAVEE.”
DUAVEE was developed by Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, and is part of a broader research collaboration with Ligand Pharmaceuticals Incorporated.
Menopause is a normal, natural event - it marks the permanent end of fertility and is usually confirmed when a woman has missed her period for 12 consecutive months. Menopause is associated with reduced functioning of the ovaries due to aging, resulting in lower levels of estrogens and other hormones. Changes in these hormones cause symptoms of menopause, which may include hot flashes, night sweats and bone loss. While menopause is natural, many women have not discussed treatment options for their symptoms with their doctors.
Osteoporosis, the most common bone disease in humans, becomes a serious health threat in postmenopausal women by increasing their risk of fractures. Lower levels of estrogens at the time of menopause are associated with rapid bone loss, and an increased risk of osteoporosis. Approximately 50 percent of women in the U.S. 50 years of age or older have low bone mass, putting them at risk for osteoporosis.