OVERVIEW

 
About SermonixAbout Lasofoxifene

Sermonix Pharmaceuticals is an Ohio LLC privately held biotechnology company with a targeted focus towards bringing female-specific oncology products through proof of concept, preclinical, and clinical development with a clear regulatory pathway in place. Sermonix was founded in late 2014 by David Portman, MD, a leading clinical researcher and expert in women’s health, menopause and selective estrogen receptor modulators, or SERM therapy. Sermonix has as its lead product oral lasofoxifene with exclusive licensing rights for the U.S. and Japan obtained from Ligand Pharmaceuticals, Inc (NASDAQ; LGND). Lasofoxifene is a highly potent third-generation Selective Estrogen Receptor Modulator (SERM) (also known as an estrogen agonist/antagonist) with demonstrated benefits to breast, bone, and vaginal tissue. Sermonix is currently focused on breast and ovarian cancer treatment, particularly an indication in advanced Estrogen Receptor positive (ER+) hormone-resistant breast cancer.

Sermonix has assembled an experienced internal management team that includes Drs. Portman, Symons, Attias, and Plourde. Dr. Portman has extensive experience in all stages of the drug development and 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 vulvar and vaginal atrophy as well as for multiple successful women's health submissions to the FDA during his tenure at Pfizer. Paul Plourde, MD, Sermonix Oncology Team Leader, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, anastrozole, and fulvestrant. 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. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women’s Health Research and has extensive experience in clinical research, with a focus on FDA regulatory issues, clinical trial conduct, budgets and contracts. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division.

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Lasofoxifene, originally developed by Pfizer and Ligand, has been studied in over 15,000 women in a comprehensive world-wide phase I-III clinical development program and has established efficacy for treating both vulvovaginal atrophy (VVA)and postmenopausal osteoporosis, reducing the risk of vertebral fractures by 42% and non-vertebral fractures by 26%— no other SERM has shown such robust efficacy on bone at all skeletal sites.

There was no increase in endometrial cancer (a concern with other SERMs like tamoxifen) with lasofoxifene in the 5-year Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene –(PEARL) study in which over 8,500 women were followed for up to 5years.

In addition to reducing osteoporotic fracture rates in the PEARL trial, lasofoxifene demonstrated a significant 80% reduction in estrogen receptor-positive breast cancers in women with osteoporosis. Duke University and Sermonix have recently identified in vitro activity signals in resistant breast and ovarian cancer models.

Although never approved by the FDA for osteoporosis or VVA, lasofoxifene was approved in the EU by the EMEA for the treatment of postmenopausal osteoporosis in 2009. That same year Pfizer acquired Wyeth along with its competing SERM bazedoxifene and subsequently returned all lasofoxifene rights to Ligand in 2011.

Chiva, a Chinese pharmaceutical company had rights for a brief period of time to lasofoxifene, but failed to actively pursue approval and marketing and rights were once again returned to Ligand in 2013. Sermonix entered into an exclusive licensing agreement for oral lasofoxifene with Ligand in February 2015.