On February 3, 2015 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the signing of a license agreement with Sermonix Pharmaceuticals LLC for the development and commercialization of oral lasofoxifene in the United States and additional territories (Press release, Ligand, FEB 3, 2015, View Source [SID1234532265]). Under the terms of the agreement, Ligand has received an undisclosed initial payment, and is entitled to receive up to $45 million in potential regulatory and commercial milestone payments and tiered royalties of 6% to 10% on future net sales. Lasofoxifene is an estrogen partial agonist for the treatment of osteoporosis and other diseases.
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"Lasofoxifene has a promising profile and a large clinical dataset, and we are excited to see development of the oral form move forward in additional territories," commented John Higgins, Chief Executive Officer of Ligand. "Sermonix is highly familiar with lasofoxifene and is well-positioned to advance its development, and we look forward to their progress with this important program. This transaction represents yet another partnership for lasofoxifene as we continue to build on our portfolio of more than 100 shots-on-goal."
Based on the lasofoxifene safety and efficacy data from clinical trials in more than 15,000 women, Sermonix plans to seek regulatory approvals in several women’s health indications.
"Sermonix is excited to partner with Ligand on lasofoxifene, a best-in-class selective estrogen receptor modulator, or SERM, and to seek regulatory approval of this remarkable drug," stated David Portman, M.D., Chief Executive Officer of Sermonix. "The robust clinical development program to date has demonstrated efficacy for many common conditions greatly impacting women’s health in mid-life, with targeted beneficial effects on the vagina, bone and breast. With several SERMs approved in the last two years, lasofoxifene is well-positioned to offer women a tremendous and much-needed alternative to hormone therapy to improve their overall menopausal health."
About Lasofoxifene and Ligand’s Lasofoxifene Partnerships
Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its Conbriza (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In July 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women’s health. Also in July 2013 Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent.