Ligand Pharmaceuticals Incorporated (LGND) partner Pfizer received approval today from the U.S. Food and Drug Administration (FDA) for DUAVEETM (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.
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.
DUAVEE should not be used in women who: have or had blood clots; are allergic to any of its ingredients; have unusual vaginal bleeding; have or had certain cancers (e.g. uterine or breast), liver problems, or bleeding disorders; or are pregnant, may become pregnant or are breastfeeding a baby.
About Ligand Pharmaceuticals
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. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand's Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline, Onyx Pharmaceuticals, Merck, Pfizer, Baxter International, Bristol-Myers Squibb, Lundbeck Inc., Eli Lilly & Co. and Spectrum Pharmaceuticals. Please visitwww.captisol.com for more information on Captisol and www.ligand.com for more information on Ligand.
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This news release contains certain forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These statements include those related to the importance of the approval of DUAVEE (conjugated estrogens/bazedoxifene) or any potential launch. Actual events or results may differ from Ligand's expectations. There can be no assurance that DUAVEE will be commercially successful, provide new options or be successfully marketed, that any future milestone or royalty payments will be received, or that if any future milestones or royalties are received that they will not be subject to sharing obligations with any third party. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases available via www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.