SOURCE: Sermonix Pharmaceuticals LLC

Sermonix Pharmaceuticals LLC

September 30, 2015 11:00 ET

Sermonix Pharmaceuticals Shares Study Results at the North American Menopause Society

OPAL Results Revealed for the First Time

LAS VEGAS, NV--(Marketwired - Sep 30, 2015) - At the North American Menopause Society (NAMS) meeting kicking off today, Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women's health products, announced that experts will provide three presentations and a poster about its investigational drug, lasofoxifene during the show.

Sermonix is working to bring its investigational drug, lasofoxifene, to market. Lasofoxifene is a third-generation selective estrogen receptor modulator, or SERM, also known as an estrogen agonist/antagonist.

For the first time experts will be sharing the OPAL study results -- which confirm lasofoxifene's positive impact on bone density and cholesterol levels. The results from the clinical development program show lasofoxifene has the potential to treat the symptoms of vulvovaginal atrophy while also protecting against bone loss and fractures.

Data from the OPAL trial will debut at three podium presentations:

  • Steven Goldstein, M.D., Professor, Department of Obstetrics and Gynecology at New York University, will present "Endometrial effects of lasofoxifene: Results from two phase 3 osteoporosis prevention trials." This presentation will run from 10:30 am to 11:15 am on 10/2.
  • James Simon, M.D., Clinical Professor of Obstetrics and Gynecology, George Washington University, will deliver "Lasofoxifene, an estrogen agonist/antagonist favorably impacts lipid parameters: Results from the Osteoporosis and Lipid Lowering (OPAL) Study." This presentation will run from 4:15 pm to 5:30 pm on 10/2.
  • Risa Kagan, M.D., Clinical Professor, Department of Obstetrics and Gynecology at University of California, San Francisco, will present "Lasofoxifene prevents postmenopausal bone loss: Pooled data from two pivotal 24 month osteoporosis prevention trials." This presentation will also run from 4:15 pm to 5:30 pm on 10/2.

Additionally, a scientific poster from the Genitourinary Symptoms and Response to Treatment (GARNET) trial, "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," will be presented.

The North American Menopause Society runs from 9/30 to 10/3.

"There's great demand for options for the variety of patients seeking treatment in menopause -- especially for a drug that can address 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. "We're excited to present this data as it demonstrates the multiple benefits that lasofoxifene as a single treatment option may uniquely confer to menopausal women," he continued.

Lasofoxifene has been evaluated in over 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% and non-vertebral fractures by 25% compared to placebo. 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.

More on lasofoxifene
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 global licensing rights to oral lasofoxifene from Ligand in February 2015.

About Sermonix
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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