Female Health Company & Aspen Park Pharmaceuticals Announce FDA Clears Pathway

The Female Health Company (FHC) and Aspen Park Pharmaceuticals, Inc. (APP) recently announced that the US FDA has agreed to an expedited regulatory pathway for APP’s BPH drug Tamsulosin DRS (Delayed Release Sachet). As previously announced, FHC and APP have entered into a definitive merger agreement. A special meeting of FHC shareholders is scheduled for September 20, 2016, to approve matters relating to the proposed merger.

“FDA’s decision to allow us to utilize its 505(b)(2) regulatory pathway is a significant milestone for the accelerated development of our BPH product,” said Mitchell Steiner, MD, CEO, and President of APP and the combined company, Veru Healthcare, after completion of the proposed merger. “Our product is a novel powder which utilizes a proprietary extended release formulation of the existing active ingredient in Flomax. Many men have difficulty swallowing tablets or capsules, which represents an unmet medical need. We believe the novel Tamsulosin DRS formulation will be a preferred dosage form for these patients. The US market for Flomax and its generic equivalents, which are currently only available in tablet or capsule form, is about a $3.5-billion market. The 505(b)(2) pathway allows us to reference previous findings of safety and efficacy for an already approved product (Flomax), which substantially reduces our time and cost to further develop the product.”

“More specifically, the FDA also agreed with our plans to conduct a single bioequivalence study to support the filing of a NDA. We intend to initiate a three week bioequivalence study in the fourth quarter of this year and submit a NDA in 2017. In addition to Tamsulosin DRS, APP has a deep portfolio of high profile drug product candidates in late and early stages of development, focused in the areas of oncology and men’s and women’s health,” he added

“Today’s announcement provides strong additional momentum for the merger of our two companies,” said O.B. Parrish, Chairman and CEO of FHC. “We now have a potentially faster and less costly path to bring APP’s innovative BPH product to market. This jumpstarts the combined company’s exciting future and entry into the proprietary pharmaceutical space.”

In April 2016, FHC entered into a definitive merger agreement with APP. FHC believes that the proposed transaction with APP provides an extraordinary opportunity to establish a new company with the potential to enhance both short-term and long-term stockholder value. The new company will have multiple products that provide opportunities for growth, while mitigating the risk associated with FHC being a single product company. The new company will include a women’s health division that will focus on expanding FHC’s existing, profitable business, while beginning development of newly acquired oncology assets for breast and ovarian cancer, and a men’s health division, focused on the areas of benign prostatic hyperplasia, male infertility, hot flashes in men on prostate cancer therapy, gout and advanced prostate cancer, together with consumer health products for premature ejaculation and sexual health vitamin supplements. Following the business combination, the Company will be renamed Veru Healthcare Inc.

Tamsulosin DRS is a novel powder which utilizes a proprietary extended release formulation of the existing active ingredient in Flomax, which is a commonly used medicine for the treatment of BPH, also known as enlargement of the prostate. Tablets or capsules are problematic for 15% of men over the age of 60 who have difficulty swallowing and the up to 60% of men in long term facilities who have difficulty swallowing because of certain medical conditions. Because Tamsulosin DRS is a novel powder formulation containing the active pharmaceutical ingredient in Flomax, it would provide a convenient and reliable way to deliver therapeutic levels of tamsulosin to men who have difficulty swallowing tablets or capsules.

The initial marketing plan will target men in long term care facilities and men in the community that have difficulty swallowing tablets and capsules. Initially a sales force is not required for this product as pharmacists and physicians have the ability to identify and to provide the appropriate formulation of tamsulosin for a patient who has BPH and difficulty swallowing tablets and capsules. Based on IMS data Flomax and generic tamsulosin sales from March 2014 to March 2015 were about $3.5 billion in the US. The US market for all alpha blockers for BPH is estimated to be $4.5 billion annually per IMS. Men in long-term care or nursing homes have up to a 60% prevalence of swallowing difficulties and account for about 13% of total tamsulosin sales, whereas over 15% of men over 60 years of age in the general population have difficulty swallowing tablets and capsules.

Aspen Park Pharmaceuticals, Inc. is a privately held therapeutics company focused on the development and commercialization of pharmaceutical and consumer health products for men’s and women’s health and oncology. For men, product and product candidates are in the areas of benign prostatic hyperplasia, male infertility, amelioration of side effects of hormonal prostate cancer therapies, gout, sexual dysfunction, and prostate cancer. For women, product candidates are for advanced breast and ovarian cancers and for female sexual health. Aspen Park Pharmaceuticals is planning to launch in the US the PREBOOST OTC product for treating premature ejaculation in Q4 of fiscal 2016. Aspen Park Pharmaceuticals has offices in New York City, New York. For more information on PREBOOST™ OTC product visit www.preboost.com or for more information on APP visit www.aspenparkpharma.com.

The Female Health Company, based in Chicago, IL, manufactures and markets the FC2 Female Condom (FC2). Since the Company began distributing FC2 in 2007, the product has been shipped to 144 countries. The company owns certain worldwide rights to the FC2 Female Condom, including patents that have been issued in a number of countries around the world. The patents cover the key aspects of the FC2 manufacturing process and design. The FC2 Female Condom is the only currently available female-controlled product approved by the FDA that offers dual protection against sexually transmitted infections, including HIV/AIDS, the Zika virus and unintended pregnancy. The World Health Organization has cleared FC2 for purchase by UN agencies.