Female Health Company and Aspen Park Pharmaceuticals announce merger
CHICAGO - The Female Health Company on Wednesday announced that it has entered into a definitive merger agreement with Aspen Park Pharmaceuticals, a privately held company focused on the development and commercialization of oncology and men’s and women’s health therapeutics and consumer health products.
“For FHC, this is a transformational merger, creating a powerful company with solid cash flows and a deep product development portfolio that serves multi-billion dollar industry segments,” stated O.B. Parrish, chairman and CEO of The Female Health Company. “More specifically, APP brings numerous late and early stage product candidates focused in the areas of oncology and men’s and women’s health, as well as a first-class experienced management team. Importantly, the strategic benefits of the transaction deliver on our objective to add a diversified and complementary mix of products that has the potential to substantially expand our revenue base and grow our business. We believe merging with APP is in the best interests of our shareholders, providing exciting new opportunities, while substantially mitigating the risks associated with being a single product company.”
“FHC has a long and dedicated history of improving the health and well-being of women around the world,” said Mitchell Steiner, CEO Aspen Park Pharmaceuticals and president and CEO of the combined company, upon closing. “The merger strategically joins a market-leading consumer health product that has been solidly profitable since 2006 with multiple high profile drug product candidates. I am excited by the prospect of advancing the combined company’s promising product development program, while at the same time expanding the market for FC2 and leveraging a state-of-the-art, modular manufacturing facility and global distribution network.”
The plan is to establish both a Men’s Health Division and a Women’s Health Division offering pharmaceuticals as well as consumer health products.
The Men’s Health Division will include:
APP-111, a novel, new chemical entity, being developed as a first-in-class oral chemotherapeutic agent that targets tubulin in men with advanced prostate cancer. U.S. market is estimated to be $5 billion annually;
Tamsulosin DRS, a novel oral formulation for men with benign prostatic hyperplasia and swallowing difficulties. U.S. market for alpha blockers for BPH is estimated to be $4.5 billion annually per IMS. Plan to file FDA new drug application in 2017;
APP-112, NCE, oral drug being developed for treatment of acute gout flares that has the potential to have a better safety profile than the currently used colchicine. U.S. market is estimated to be $725 million annually;
MSS-722, being developed as the first oral agent for the treatment of idiopathic male infertility. Orphan drug status pending. U.S. market is estimated to be $700 million annually;
APP-944, an oral drug being developed for the treatment of hot flashes caused by prostate cancer hormone therapies. U.S. market is estimated to be $600 million annually;
Preboost, OTC medicated individual wipes for reducing the incidence of premature ejaculation. U.S. premature ejaculation market is estimated to be $500 million annually per IMS. FDA OTC drug monograph compliant. Plan to launch product in fourth quarter of fiscal 2016; and
Sexual health vitamin and mineral supplement. Already formulated but not yet launched.
The Women’s Health Division will include:
APP-111, a novel, NCE, being developed also as a first-in-class oral anti-tubulin targeting chemotherapy for women with advanced breast or ovarian cancer;
FC2 Female Condom, the only currently available female condom that is FDA approved and cleared by the World Health Organization and under a women’s control. FC2 provides dual protection against unintended pregnancy and sexually transmitted infections, including HIV/AIDS and the Zika virus. The product generated approximately $33 million of net revenues in fiscal 2015;
Female sexual health lubricating and warming gel with niacin to enhance sexual activity. Already formulated but FDA 510(k) approval needed; and
Sexual health vitamin and mineral supplement. Already formulated but not yet launched.
The proposed merger, subject to certain closing conditions, including approval by a two-thirds vote of FHC stockholders, is expected to close in the third quarter of 2016 and has been approved by the boards of both companies.