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COLUMBUS, OH -- (Marketwired) -- 07/23/15 -- Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women's health products, recently convened the inaugural meeting of its Scientific Advisory Board. The board, which includes leading multidisciplinary experts in selective estrogen receptor modulators (SERMs), osteoporosis, vulvovaginal atrophy (VVA) and breast cancer, discussed unmet medical needs in menopausal women's health and the path to commercialization for Sermonix's lead investigational drug, lasofoxifene.
Lasofoxifene, a third-generation SERM, is one of the most well-studied drugs in its category. It has been evaluated in over 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL and other trials. In addition to its positive impact on VVA, clinical studies have shown that lasofoxifene reduces the risk of vertebral fractures by 42% and non-vertebral fractures by 26% compared to placebo.
"We talked about the SERM concept and the attempt to produce all the right effects in all the right tissues," said Felicia Cosman, M.D., Medical Director, Clinical Research Center, Helen Hayes Hospital; Professor of Medicine, Columbia University, who participated in the meeting. "We're diagnosing women with osteoporosis in their fifties and then they could live thirty plus more years and continue to lose bone. We need more novel agents that can be used to treat patients at different stages across the menopause."
Sermonix plans to seek FDA approval, as well as approval in other territories, for lasofoxifene for several women's health indications, including postmenopausal osteoporosis and symptoms of vulvovaginal atrophy.
"I was drawn to the idea of developing a drug that would advance menopausal women's health by addressing issues on several levels at once -- the bone, the vagina, as well as provide informative data on breast effects," said David Portman, M.D., Founder and Chief Executive Officer of Sermonix. "The advisory board discussed the great demand for both hormonal and non-hormonal options for the variety of patients seeking treatment in menopause."
"Lasofoxifene is the SERM that has the potential to address multiple conditions affecting menopausal women with a single agent," said James A. Simon, M.D., Clinical Professor of Obstetrics and Gynecology at George Washington University and Sermonix Advisory Board member. "Not only does lasofoxifene have the potential to treat the symptoms of vulvovaginal atrophy, but it also has the potential to protect against bone loss and fractures. It would be a welcomed addition to my therapeutic armamentarium."
The Sermonix Scientific Advisory Board includes:
More on lasofoxifene
Lasofoxifene -- a SERM, also known as an estrogen agonist/antagonist -- was discovered through a collaboration between Ligand Pharmaceuticals and Pfizer in 1991. Pfizer developed the oral 0.5 mg form of lasofoxifene tartrate for osteoporosis under the proposed trade name Fablyn®. In 2009, it was not approved by the FDA, however in Europe that year lasofoxifene was approved for osteoporosis treatment by the EMEA. While pursuing FDA approval, Pfizer acquired Wyeth and its Conbriza® (bazedoxifene), a similar SERM product. Pfizer never marketed lasofoxifene in Europe and subsequently all rights to lasofoxifene reverted back to Ligand in 2011. Sermonix obtained global licensing rights to oral lasofoxifene from Ligand in February 2015.
Sermonix Pharmaceuticals LLC is a specialty pharmaceutical company focused on bringing new and emerging late-stage women's health products through clinical development and regulatory approval. Founded in 2014 Sermonix has assembled considerable talent within women's healthcare clinical development and product commercialization. Dr. David Portman, Sermonix's founder and CEO, was principal investigator for the Phase II and Phase III lasofoxifene clinical trials and was actively involved during the drug's clinical development. Dr. Portman has experience in all stages of the regulatory approval process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix and was the global clinical lead for the lasofoxifene development program for vulvovaginal atrophy as well as for multiple women's health submissions to the FDA during his tenure at Pfizer. Elizabeth Attias, MMSc, ScD, Vice President of Business Development has experience in all stages of women's health product assessment, market development, launch and commercialization.
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