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Jul 22, 2013

Azure Nabs Rights to Ligand Lasofoxifene Formulation

  • Ligand Pharmaceuticals said today it licensed to Azure Biotech development rights for a new formulation of lasofoxifene targeting an undisclosed “underserved market in women's health.”

    In return, Azure has agreed to pay Ligand $2.7 million in payments tied to undisclosed development and regulatory milestones, and a 5% royalty on future net sales. Lasofoxifene is a selective estrogen receptor modulator (SERM) now indicated for osteoporosis treatment and other diseases.

    “Azure plans to rapidly build upon the extensive safety and efficacy data already available from trials completed in more than 15,000 women,” Azure president David Thompson, Ph.D., said in a statement.

    While the companies did not disclose the therapeutic focus, two recent trials evaluating lasofoxifene related to bone loss point to a potential target. According to ClinicalTrials.gov, a pair of Phase III trials for lasofoxifene were completed in 2011. One was intended to determine the safety and effectiveness of two doses of the drug compared to placebo in reducing new spinal fractures in women with osteoporosis; the other, to compare the effects of two years of lasofoxifene treatment with two years of raloxifene 60 mg/day use and two years of placebo use on bone mineral density of the lumbar spine.

    In addition, Ligand retains rights to lasofoxifene’s oral formulation that were reverted to it in 2011 from Pfizer following the pharma giant’s acquisition of Wyeth, whose assets included a similar SERM program called Conbriza® (bazedoxifene).

    Oral lasofoxifene was developed by Pfizer under the trade name Fablyn® and approved in the EU, though the two companies collaborated starting in 1991 on research leading to the drug. Dr. Thompson directed the Pfizer team in the discovery of lasofoxifene through Phase III development and regulatory filings.


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