Ligand Pharmaceuticals Incorporated announced that its partner Pfizer has received approval from the US 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.

Estrogens have been used as hormonal treatments for over 60 years to help manage menopausal symptoms. Using estrogen alone can increase the chance of developing cancer of the uterine lining. When treating postmenopausal women with a uterus, estrogens have traditionally been combined with a progestin. This can decrease the risk of hyperplasia (the thickening of the endometrium), which may be a precursor to cancer of the uterine lining.

Duavee is the first and only therapy to pair conjugated estrogens (CE) with an estrogen agonist/antagonist also known as a selective estrogen receptor modulator (SERM). Duavee uses bazedoxifene - instead of a progestin - to help protect the uterine lining against hyperplasia that may result from estrogen alone treatment.

Bazedoxifene was specifically selected to be studied as the SERM in Duavee because of its unique pharmacologic profile and mechanism of action, as demonstrated by pre-clinical studies that looked at a number of different SERMs. The pairing of CE with bazedoxifene enables Duavee to work selectively in different tissues to activate estrogen receptors in some while inhibiting estrogen activity in others (the uterus). This pairing allows Duavee to offer estrogen efficacy in treating moderate-to-severe hot flashes and preventing postmenopausal osteoporosis while providing an alternative way to help protect the uterine lining from hyperplasia.

Ligand is a biopharmaceutical company focused on assembling a large portfolio of revenue generating assets through licensing and acquisition with the goal to generate sustainable cash-flow and profitability.