Ligand Pharmaceuticals says that it has earned a milestone payment of an undisclosed amount as a result of Wyeth's confirmation of submission on June 23 of a New Drug Application to the US Food and Drug Administration for bazedoxifene, which is being investigated as a postmenopausal osteoporosis therapy. Bazedoxifene is a selective estrogen receptor modulator. According to the National Osteoporosis Foundation, as of 2002 eight million American women have osteoporosis and almost 27 million women are estimated to have osteopenia (low bone mass), placing them at increased risk for osteoporosis.
"If approved, bazedoxifene could provide an important new therapeutic option to postmenopausal women who are at risk for osteoporosis and, as a second generation SERM, is designed to prevent osteoporosis in postmenopausal women," said Andres Negro-Vilar, Ligand's executive vice president of R&D and chief scientific officer.
Under the terms of the deal, Ligand is entitled to receive additional milestones upon submission of an NDA equivalent in a major market country ex-USA; approval of bazedoxifene in the USA and in a major market elsewhere, if obtained, and, if thereafter marketed, royalty payments up to mid-single digits on net sales of bazedoxifene worldwide for any indication, of which 3.0125% of net sales for a period of 10 years have been purchased from Ligand by Royalty Pharma.
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