Investment and New Board Leadership Will Support the Path to Commercialization for Investigational Drug, Lasofoxifene
COLUMBUS, OH (May 3, 2016) – Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, today announced Anthony H. Wild, Ph.D., as Chairman of the Board and also a Series Seed Preferred Round investor. Wild’s leadership and investment will further advance the path to commercialization for Sermonix’s lead investigational drug, lasofoxifene. Sermonix is seeking FDA approval, as well as approval in other territories, for oral lasofoxifene for several women’s health indications including treatment of postmenopausal osteoporosis, improved symptoms of vulvovaginal atrophy (VVA) and prevention of breast cancer in women at risk for bone loss.
“I am so pleased to welcome the expertise of Dr. Anthony Wild to Sermonix in the critical role of Chairman of the Board,” said David Portman, M.D., Founder and Chief Executive Officer of Sermonix. “He brings with him years of worldwide strategic pharmaceutical executive experience that will serve our company well as we bring lasofoxifene through development, regulatory approval and commercialization. His significant investment, personal commitment and leadership role in Sermonix is a testament to the unmet need for this oral SERM, and to the strength of our program and our exceptional management team.”
Lasofoxifene, a third-generation selective estrogen receptor modulator (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, GARNET and other trials. In addition to its positive impact on VVA, clinical studies have shown that oral lasofoxifene reduces the risk of vertebral fractures by 42% and non-vertebral fractures by 26% compared to placebo. Lasofoxifene 0.5 mg oral daily demonstrated a 79% reduction in the incidence of total breast cancer and an 83% reduction in ER+ breast cancer compared to placebo.
“I have been impressed with the robust data set and profile of lasofoxifene and am excited about the potential I see for it in treating women,” said Wild. “I am thrilled to invest in Sermonix and support David and his amazing team in my role as board chairman.”
Wild is a General Partner and Co-founder of BOWS Pharmaceuticals AG. He was recently the Chairman of the Board at Sprout Pharmaceuticals and was the Founding Partner, President and CEO at MedPointe Capital Partners, LLC and Chairman and CEO at MedPointe, Inc. He was previously the Executive Vice President at Warner Lambert and President of the Global Pharmaceutical Sector of Parke-Davis.
More on lasofoxifene
Lasofoxifene – a SERM, also known as an estrogen agonist/antagonist – was originally developed through collaboration between Ligand Pharmaceuticals and Pfizer. Pfizer developed the oral form of lasofoxifene tartrate for osteoporosis under the proposed trade name Fablyn®. While lasofoxifene was never approved in the U.S., in 2009, it was approved in Europe for osteoporosis treatment by the EMEA. Sermonix obtained licensing rights to oral lasofoxifene from Ligand in February 2015 and is currently seeking regulatory approval.
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 2 and Phase 3 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. Paul Plourde, MD, Oncology Clinical Development Team Leader, has 25 years of experience developing new oncology drugs, including arimidex and tamoxifen. He was previously the VP of Oncology at AstraZeneca. Elizabeth Attias, MMSc, ScD, Vice President of Business Development, has over 20 years of pharmaceutical experience in all stages of women’s health product assessment, market development, launch and commercialization strategy. She was the founder and serves as the President and CEO of Atom Strategic Consulting. Miriam Portman, MD, 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.