Veru Healthcare Announces Key Advancements in the Development of Tamsulosin DRS for Benign Prostatic Hyperplasia
July 20 2017 - 8:30AM
Veru Healthcare (NASDAQ:FHCO), a biopharmaceutical company focused
on urology and oncology, today announced that the company has
initiated the subject screening process for Stage 2 of its
bioequivalence study of Tamsulosin DRS (Delayed Release Sachet),
the company’s novel, proprietary, slow release granular formulation
of tamsulosin designed for the treatment of benign prostatic
hyperplasia (enlarged prostate or BPH). In addition, the
company has initiated manufacturing of the NDA required
registration batch through its contract manufacturer, which will be
used for FDA submission.
“Having reached the next and final stage of the required
bioequivalence clinical study of Tamsulosin DRS in such a
rapid timeframe positions us to make preparations for NDA
submission,” said Mitchell Steiner, MD, president and CEO of Veru.
“Utilizing the 505 (b)(2) pathway for this, and many of our other
prescription products, allows us to more rapidly get to the market,
and bring treatments to those who need them sooner. Tamsulosin DRS
is needed for the treatment of BPH for the 60% of men who are
currently in long-term care facilities and the 15% of men the
community who have difficulty swallowing pills.”
The second stage of the bioequivalence trial is a 21-day single
dose comparison of Tamsulosin DRS slow release granules with
FLOMAX® capsules in 36 patients who have either
fasted or eaten prior to dosing. In addition, the company’s
manufacturing partner has started the production of the commercial
registration batch of Tamsulosin DRS required for FDA registration
and product launch supply.
“Tamsulosin is the most widely prescribed medicine to treat
symptoms of BPH, but is only currently available as a slow release
capsule,” said Ridwan Shabsigh, MD, professor of clinical urology,
Weill-Cornell School of Medicine of Cornell University, New York,
and a recognized expert in the treatment of BPH. “Many men who
cannot swallow this capsule, whether because of stroke, Parkinson’s
disease or other limitations may be subjected to surgery, wear
diapers, or have indwelling urinary catheters. As a slow
release granules formulation, Tamsulosin DRS has the potential to
change these men’s lives. It may also be taken on an empty stomach,
which may aid in avoiding dizziness and hypotension potentially
seen when the current formulation of the drug is taken on an empty
stomach.”
About Tamsulosin DRSTamsulosin 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.
About Veru Healthcare Veru Healthcare (Veru) is
a biopharmaceutical company focused on urology and oncology.
Veru specifically focuses on the development and commercialization
of pharmaceutical products that qualify for FDA's 505(b)(2)
regulatory approval pathway, which is designed to allow for
potentially expedited regulatory approval based on a previously
established safety and efficacy profile of the product. Veru
is developing products under the 505(b)(1) pathway as well, which
is the traditional new drug application (NDA) pathway. The
company is currently developing prescription products for benign
prostatic hyperplasia (BPH or enlarged prostate), hot flashes
associated with cancer treatment, male infertility and novel
chemotherapies for a variety of cancers, including prostate,
metastatic breast and ovarian. In addition, the company sells
the FC2 Female Condom® (now available by prescription in the US)
and PREBOOST® medicated individual wipe, which is a male genital
desensitizing drug product that helps in the prevention of
premature ejaculation.
The company’s division, 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 Veru and its products can be found at
www.veruhealthcare.com, www.PREBOOST.com and
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 that are not historical fact are "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements
in this 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
Veru Healthcare
312-366-2633
KGilbert@veruhealthcare.com
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
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