Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
partner Pfizer announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for postmenopausal women with a uterus for the treatment of estrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture. Pfizer expects a decision from the European Commission in 2013.
BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens. BZA/CE has been studied in a Phase III clinical development program (Selective estrogens, Menopause And Response to Therapy [SMART] trials) which included approximately 7,500 postmenopausal women and assessed the safety and efficacy of BZA/CE for the treatment of estrogen deficiency symptoms, such as moderate-to-severe hot flashes and vulvar and vaginal atrophy, as well as postmenopausal osteoporosis. The most common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.
“We are encouraged by the progress Pfizer is making with bazedoxifene/conjugated estrogens as it potentially offers another option for the many women experiencing symptoms of menopause who are not currently being treated,” said John Higgins, President and Chief Executive Officer of Ligand. “Today’s announcement continues to demonstrate the commercial potential of Ligand’s product portfolio, which we believe is one of the strongest and deepest in the biotech industry.”
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 (in the absence of other obvious causes). Menopause is associated with reduced functioning of the ovaries due to aging, resulting in lower levels of estrogen and other hormones. In the European Union, an estimated 67 million women are of menopausal age. Of those, approximately 75% suffer from hot flashes.
Osteoporosis is a disease of the bones that leads to an increased risk of fracture. Decreased estrogen levels are associated with rapid bone loss, making women more susceptible to osteoporosis. Osteoporosis is estimated to affect up to a fifth of women in Europe between the ages of 50 and 79.