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Female Health Company completes Aspen Park merger, rebrands as Veru Healthcare


CHICAGO - The Female Health Company on Monday announced that it has successfully completed a transformational merger with Aspen Park Pharmaceuticals under modified terms. The combined company brings together FHC’s existing FC2 Female Condom product with APP’s extensive drug development portfolio of products.

The combined company will be organized as follows: Veru Healthcare will manage the Pharmaceuticals and Medical Devices and Consumer Health divisions and The Female Health Company will manage the global Public Health sector FC2 business.

“We are extremely pleased to consummate this opportunity for our company and our shareholders,” stated O.B. Parrish, co-founder of FHC. “Our shareholders have shown substantial support for the merger with APP and it is in that spirit that the boards of both companies approved and agreed to the modified terms of the transaction."

“As The Female Health Company’s new president and CEO, I am ready to lead our company’s efforts to expand our business and generate significant shareholder value,” commented Mitchell Steiner, formerly CEO of APP. “This merger creates a pharmaceutical company and medical device company with multiple opportunities for substantial near-term revenues. Our product portfolio includes a number of drug candidates that utilize a special development process, which allows for a potentially faster and less expensive and less risky path to secure approval," he said. "We are eager to bring to the marketplace these exciting products that fulfill unmet needs and expand the market for FC2 [Female Health's Company's female condom].”

The combined company’s board of directors is comprised of the following nine members: Elgar Peerschke, who will serve as chairman, O.B. Parrish, who will serve as vice chairman,  David Bethune, Mario Eisenberger, Harry Fisch, Mary Margaret Frank, Lucy Lu, Georges Makhoul and Mitchell Steiner.  Andy Love will serve as Board Observer.

Consumer Health will include the FC2 Female Condom (FC2) for consumer markets and PREBOOST, OTC medicated individual wipes for reducing the incidence of premature ejaculation. The U.S. premature ejaculation market is estimated to be $500 million annually per IMS.

Pharmaceuticals and Medical Devices will include:

  • Tamsulosin DRS, a novel oral formulation for men with benign prostatic hyperplasia and swallowing difficulties. U.S. market for alpha blockers to treat BPH is estimated to be $4.5 billion annually per IMS. 505(b)(2) product candidate. Plan to file FDA new drug application (NDA) in 2017;

  • 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. 505(b)(2) product candidate;

  • 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. 505(b)(2) product candidate;

  • 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. Also a novel NCE being developed as a first-in-class oral anti-tubulin targeting chemotherapy for women with advanced breast or ovarian cancer. (Will initiate NCE drug development for advanced breast or ovarian cancer after lead indication for advanced prostate cancer in men.);

  • 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; and

  • Disposable Contraceptive Device, FC2 Female Condom, currently the only available female condom that is approved by the FDA for marketing in the U.S. and cleared by the World Health Organization. FC2 provides dual protection against unintended pregnancy and sexually transmitted infections, including HIV/AIDS and the Zika virus.

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