The Female Health Company / Veru Healthcare Announces Successful Stage 1 of the Clinical Trial to Evaluate Bioequivalence Bet...
April 12 2017 - 8:30AM
--Stage 1 of Clinical Trial Completed; A
Tamsulosin DRS Formulation is Selected That Demonstrates Profile
Similar to FLOMAX® and May Provide Other Potential
Advantages, Including Ease-of-Use and Safety Benefits; New
Tamsulosin DRS Formulation Advances to Stage 2; Planned NDA Filing
Under the 505(b)(2) Regulatory Pathway On Track; Approval Expected
in Second Half of 2018--
The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today
announced the successful Stage 1 of a bioequivalence (BE) clinical
trial which was 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) who have difficulty swallowing tablets or
capsules.
“Today’s announcement further validates our product
diversification strategy and recently completed merger
transaction,” said Mitchell Steiner, M.D., President and Chief
Executive Officer of The Female Health Company / Veru
Healthcare. “Tamsulosin DRS should allow us to participate in
the multi-billion dollar benign prostatic hyperplasia market and is
just one of multiple drug candidates in our pharmaceutical pipeline
that not only addresses large patient populations but also utilizes
a potentially lower cost, lower risk and expedited approval
pathway. We are making excellent progress with our entire
drug portfolio and believe this is an important step in delivering
significant value to our shareholders.
“With Stage 1 successfully completed on schedule, we will now
advance the selected Tamsulosin DRS formulation into the second and
final stage of the BE clinical trial. Our results from Stage
1 of the BE trial demonstrated that Tamsulosin DRS may have an
improved safety profile. Unlike FLOMAX®, Tamsulosin DRS is a
slow release powder that does not have to be administered after a
meal and may be taken on an empty stomach. These benefits are
especially important in the long-term care setting for men who have
difficulty swallowing capsules or tablets and could also improve
patient compliance. We remain on track under the 505(b)(2)
regulatory pathway.”
In Stage 2 of the BE clinical trial, Tamsulosin DRS will be
tested in a larger number of subjects versus FLOMAX®.
Stability data is also being collected for the commercial
manufactured drug batches to allow an anticipated late 2017/ early
2018 NDA submission. The expected NDA approval would be
sometime in the second half of 2018.
About Tamsulosin DRS for the Treatment of
BPHOverview- Tamsulosin DRS is a new powder-like
formulation containing the active pharmaceutical ingredient in
FLOMAX® (tamsulosin HCI) capsules. FLOMAX® is
indicated for the treatment of BPH also known as enlargement of the
prostate. 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 approved 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) and consequently such men may not
continue to treat their BPH with FLOMAX®. Tablets and capsules are
problematic for approximately 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 an 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
HealthcareThe 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.fc2femalecondom.com. For
corporate and investor-related information about the Company,
please visit https://veruhealthcare.com/investors.
"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 trials, an NDA filing and FDA approval 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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