Sermonix Pharmaceuticals Secures Worldwide Rights to Oral Lasofoxifene From Ligand Pharmaceuticals, Expanding From U.S., Japan

Accord allows Sermonix to globally develop and commercialize drug for treatment of advanced breast cancer

COLUMBUS, OH–(Marketwired – Feb 28, 2017) – Sermonix Pharmaceuticals LLC, a privately held biotechnology company focused on the development and commercialization of female-specific oncology products, today announced it licensed worldwide rights to develop and commercialize oral lasofoxifene, its lead investigational drug, from Ligand Pharmaceuticals Inc. (NASDAQ: LGND). Sermonix initially licensed oral lasofoxifene rights from Ligand in February 2015, covering the U.S., Japan and other select territories.

Lasofoxifene, a third-generation selective estrogen receptor modulator (SERM), is one of the most-studied drugs in its category. Sermonix is currently focused on developing lasofoxifene for breast and ovarian cancer treatment, particularly in advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer.

“We are pleased to now have the ability to bring the lasofoxifene oncology program forward on a global level,” said David Portman, MD, Sermonix Chief Executive Officer. “Data recently identified and licensed from Duke University on lasofoxifene’s activity signal in mutations of the estrogen receptor and the potential to treat endocrine-resistant breast cancer, will allow Sermonix to pursue indications in this area of significant and growing unmet medical need. A global strategy fits into our clinical development plans, and creates significant opportunity and value for Sermonix.”

Lasofoxifene has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program. An 80% reduction in ER+ breast cancer was seen in a five-year PEARL osteoporosis trial of over 8,500 women. Reductions in the risk of vertebral and non-vertebral fractures, and benefits on vulvovaginal atrophy (VVA) have been demonstrated (Cummings SR et al New England Journal of Medicine 2010).

Seventy percent of the more than 240,000 U.S. women annually diagnosed with breast cancer are ER+ and there are an estimated three million breast cancer survivors in the U.S. (Breast Cancer Facts & Figures 2015-2016 American Cancer Society). Many breast cancer patients suffer with significant osteoporosis and VVA, side effects of current therapies. Lasofoxifene’s potential benefits in this regard may confer additional treatment advantages.

“Sermonix has had productive and ongoing conversations with U.S. and European regulatory agencies,” said Paul Plourde, MD, Vice President of Oncology Clinical Development at Sermonix. “Lasofoxifene has an extensive non-clinical program and a large, supportive clinical safety dataset. In the near future, we hope to move oral lasofoxifene into the clinic in a Phase 2 trial for the treatment of locally advanced and metastatic breast cancer.”

About Sermonix

Sermonix Pharmaceuticals LLC is a biotechnology company with a targeted focus on bringing female-specific oncology products through proof of concept, clinical development, and regulatory approval. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women’s health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive worldwide licensing rights obtained from Ligand Pharmaceuticals, Inc. (NASDAQ: LGND). The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix, and led the global lasofoxifene VVA program while at Pfizer. Paul Plourde, MD, VP Sermonix Oncology Clinical Development, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, PhD, Sermonix Chief Scientific Officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. 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. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division.