Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, today announced it received top honors for its research on investigational drug lasofoxifene at the 26th annual North American Menopause Society (NAMS) meeting in Las Vegas last week.
NAMS awarded the first prize for scientific posters to “Lasofoxifene, an estrogen agonist/antagonist improves symptoms of genitourinary syndrome of menopause (GSM) and physiologic markers associated with vulvovaginal atrophy (VVA) in two large Phase 3 studies.” David Portman, M.D., CEO and Chief Medical Officer of Sermonix, presented the poster, which showcased results from the Genitourinary Symptoms and Response to Treatment (GARNET) trial.
The poster illustrates that many women suffer from genitourinary symptoms in menopause as a consequence of falling sex steroid levels; however, a significant number remain untreated due to fears of estrogen-containing products. Results show that lasofoxifene – an estrogen agonist-antagonist, or SERM – was an effective and well-tolerated treatment of moderate to severe symptoms of VVA and may possibly offer women an alternative to vaginal and oral estrogens.
Additionally, the abstract “Endometrial effects of lasofoxifene: Results from two phase 3 osteoporosis prevention trials” presented by Steven Goldstein, M.D., Professor, Department of Obstetrics and Gynecology at New York University, was one of the four top-scoring abstracts at the conference.
“I have been involved with the lasofoxifene studies for many years, and was pleased to present this reassuring endometrial data at this 2015 NAMS Annual Meeting,” said Goldstein. “This is a treatment that could fulfill an unmet need in the menopausal landscape and it is unique with respect to the multitude of benefits that it offers menopausal women for both treatment and prevention of osteoporosis in addition to treatment for vulvovaginal atrophy. I look forward to this potential therapy entering the menopausal treatment armamentarium.”
Given each year at the close of the meeting, the NAMS awards are based on scientific content, presentation, and merit in the field of women’s health and menopause.
“We are honored to be recognized by such a highly-regarded organization for our efforts in the women’s health space,” said Portman.
Lasofoxifene has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL, GARNET 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 percent and non-vertebral fractures by 25 percent compared to placebo. Sermonix plans to seek FDA approval – and approval in other territories – for several women’s health indications, including postmenopausal osteoporosis and symptoms of vulvovaginal atrophy.
Lasofoxifene – a SERM, also known as an estrogen agonist/antagonist – was originally developed through a collaboration between Ligand Pharmaceuticals and Pfizer. 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 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.