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The Female Health Company / Veru Healthcare Initiates Bioequivalence Clinical Trial Comparing Tamsulosin DRS with FLOMAX®

Stage 1 of Clinical Trial Designed to Select Formulation; NDA Filing Under the 505(b)(2) Regulatory Pathway Late 2017 / Early 2018 And Approval Expected by Mid to Late 2018

MIAMI, March 09, 2017 (GLOBE NEWSWIRE) -- The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced that it has initiated Stage 1 of a bioequivalence (BE) clinical trial designed to select the optimal formulation of its proprietary Tamsulosin Delayed Release Sachet (DRS) product. Tamsulosin DRS is a new, slow release oral powder formulation that addresses the large patient population of men with benign prostatic hyperplasia (BPH) that have difficulty swallowing tablets or capsules.

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/EIN News/ -- Stage 1 of the trial compares two formulations of Tamsulosin DRS to determine the optimal formulation in terms of bioequivalence to FLOMAX® and to determine whether the formulation has a food effect. The goal is to have Stage 1 clinical trial results completed by April 2017.

Assuming successful Stage 1 data, Stage 2 of the clinical trial will test the selected formulation from Stage 1 in a larger number of subjects versus FLOMAX®. The goal is to have Stage 2 of the clinical trial completed by late May 2017. Stability data is also being collected for the commercial manufactured drug batches to allow an anticipated NDA filing late 2017 / early 2018. The expected NDA approval would be sometime in mid to late 2018.

“The initiation of the bioequivalence clinical study represents a very important milestone in the advancement of Tamsulosin DRS, as well as in the progression of our pipeline,” said Mitchell Steiner, M.D., President and Chief Executive Officer of The Female Health Company / Veru Healthcare. “We believe the unique attributes of Tamsulosin DRS may have substantial advantages over FLOMAX®, especially in the long-term care setting, and could improve patient compliance. Based on our pre-IND meeting in August 2016, FDA indicated that this bioequivalence trial would be acceptable means of proceeding under the 505(b)(2) regulatory pathway.”

About Tamsulosin DRS for the Treatment of BPH
Overview- Tamsulosin DRS is a new powder-like formulation containing the active pharmaceutical ingredient in FLOMAX® (tamsulosin HCI) capsules which is a commonly used medicine for the treatment of BPH, also known as enlargement of the prostate. FLOMAX® is indicated for the treatment of BPH. Tamsulosin is a selective alpha1 blocker specific to receptors located in prostate and bladder smooth muscle. Symptoms associated with BPH occur because of increased prostate and bladder smooth muscle leading to constricted urinary flow, urinary retention, urinary infection, kidney damage and a life threatening blood infection called urosepsis. Blocking these receptors relaxes smooth muscle resulting in improved urinary flow and reduction of BPH symptoms. As stated in the FDA package insert, FLOMAX® capsules should not be crushed, chewed or opened, because they cannot be reliably absorbed into the bloodstream. Men with high FLOMAX® drug levels in their bloodstream are placed at risk for postural hypotension (sudden drop in blood pressure upon standing that can lead to fainting). Tablets and capsules are problematic for 15% of men over the age of 60 who have difficulty swallowing tablets and capsules and the up to 60% of men in long term facilities who have difficulty swallowing tablets and capsules because of certain medical conditions, including degenerative neurological diseases like Parkinson’s or having suffered a stroke. Not being able to take alpha1 blockers for BPH because of difficulty swallowing tablets and capsules, may lead to increased risk of acute urinary retention, urinary catheterization, urosepsis and death. Because Tamsulosin DRS is a new proprietary powder-like formulation containing the active pharmaceutical ingredient in FLOMAX®, it would provide a more convenient and reliable way to deliver therapeutic levels of tamsulosin to men who have difficulty swallowing tablets and capsules.

Market- 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 $3.48 billion in the U.S. The U.S. 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.

About The Female Health Company / Veru Healthcare
The Female Health Company / Veru Healthcare is a pharmaceutical and medical device company, with a focus on the development and commercialization of pharmaceuticals that qualify for the FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway.  The Company does business both as "Veru Healthcare" and as "The Female Health Company" and is organized as follows:

  • Veru Healthcare manages the Pharmaceuticals Division, which develops and commercializes pharmaceutical products for men's and women's health and oncology.
     
  • Veru Healthcare manages the Consumer Health / Medical Devices Division, which is focused on commercializing sexual healthcare products and devices for the consumer market, including the Company's FC2 Female Condom® in the consumer health products sector and PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product that helps in the prevention of premature ejaculation.
     
  • The Female Health Company manages the Global Public Health Division, which is focused on the global public health sector FC2 business.  This division markets the Company’s Female Condom (FC2) to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.

More information about the Female Health Company and its products can be found at www.femalehealth.com, www.veruhealthcare.com and www.femalecondom.org.  For corporate and investor-related information about the Company, please visit www.FHCinvestor.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release which are not historical fact are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995.  Forward-looking statements in this release include statements relating to the expected timing for BE trails and an NDA filing for Tamsulosin DRS and the potential competitive advantages of Tamsulosin DRS.  These statements are based upon the Company's current plans and strategies, and reflect the Company's current assessment of the risks and uncertainties related to its business, and are made as of the date of this release.  The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company's actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements.  Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following:  product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; many of the Company's products are at an early stage of development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; the Company's reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints; risks related to the costs and other effects of litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2016.  These documents are available on the "SEC Filings" section of our website at www.veruhealthcare.com/investors.

 

Contact:
                    Kevin Gilbert     312-366-2633

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