Ligand Partner Pfizer Announces European Medicines Agency Accepts Regulatory
Submission for Bazedoxifene/Conjugated Estrogens for the Treatment of Symptoms
Associated with Menopause and Osteoporosis
SAN DIEGO & NEW YORK, Jul 19, 2012 (BUSINESS WIRE) -- Ligand Pharmaceuticals
Incorporated (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."
About Menopause
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.
About Osteoporosis
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.
About the Ligand/Pfizer Collaboration
BZA/CE was developed by Wyeth and was part of a broader research collaboration
with Ligand on SERMs. Pfizer acquired the rights to BZA/CE when it acquired
Wyeth. Under the terms of the agreement, Ligand receives certain payments and
royalties from Pfizer on predetermined development and sales milestones. |
