Veru Healthcare to Advance Proprietary Drug for the Treatment of Hot Flashes in Men Receiving Prostate Cancer Hormonal Therap...
May 24 2017 - 8:30AM
Veru Healthcare (NASDAQ:FHCO), a pharmaceuticals company focused on
developing pharmaceuticals for men’s and women’s health and
oncology, today announced that following a Pre-Investigational New
Drug Application meeting with the U.S. Food and Drug Administration
(FDA), it plans to advance into Phase 2 clinical trial its
proprietary drug candidate, VERU-944, for the treatment of hot
flashes in men receiving hormone therapy for prostate cancer.
“VERU-944 addresses a $600 million US market,” said Mitchell S.
Steiner, M.D., Chief Executive Officer of Veru Healthcare.
“As a 505(b)(2) drug candidate, VERU-944 may be developed on an
accelerated basis and at lower cost and lower risk.
Importantly, VERU-944 has the potential to be the first FDA
approved medication for this indication. Our plan is to
commence the Phase 2 trial as soon as possible, and if successful,
we expect to begin our Phase 3 trial in the second half of
2018.”
“We had a very positive meeting with FDA during which we
received clarification on a path forward for the clinical
development of VERU-944,” said Robert H. Getzenberg, Ph.D.,
Executive Vice President for Clinical Development at Veru
Healthcare. “The FDA expressed enthusiasm for the development of
this product, acknowledging the importance of treating the unmet
medical need of hot flashes in the large number of men that are
undergoing androgen deprivation therapy.”
Initially VERU-944 will be developed as a once weekly oral agent
for the treatment of hot flashes that are often associated with the
use of androgen deprivation therapy (ADT) in men with advanced
prostate cancer. Approximately 80% of men receiving one of
the common forms of ADT, including Lupron®, Eligard® and Firmagon®,
experience hot flashes.
About Hot Flashes in Men with Prostate Cancer Undergoing
Hormonal TherapyADT is widely used to treat men with
advanced prostate cancer. Approximately, 600,000 men in the US are
currently on ADT. The symptom of hot flashes is the most common
side effect of ADT. These hot flashes can range from
bothersome to debilitating. Associated symptoms may include
anxiety and palpitations. Hot flashes usually last from a few
seconds to several minutes but can persist for up to 20 minutes.
Unlike postmenopausal hot flashes, ADT induced hot flashes do not
get better or resolve over time. There are no FDA approved
treatments available.
About Veru HealthcareVeru Healthcare is a
pharmaceutical company, with a focus on the development and
commercialization of pharmaceuticals that qualify for FDA's
505(b)(2) accelerated regulatory approval pathway as well as the
505(b)(1) pathway. The Company does business 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® (now available by prescription) 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 division of Veru Healthcare 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 Company and its products can be found
at 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 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 timing, cost and
risk of the regulatory pathway to secure FDA approval of the
Company's Veru-944 drug candidate. 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
Veru Healthcare
312-366-2633
KGilbert@veruhealthcare.com
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