-- Intellectual Property Position
Strengthened; U.S. Patent Issued for VERU-944, Expiring 2035
--
Veru Inc. (NASDAQ:VERU), a urology and oncology biopharmaceutical
company, today announced the submission of an Investigational New
Drug (IND) application with the U.S. Food and Drug Administration
(FDA) for VERU-944 (cis-clomiphene citrate). Based on
previous input by the FDA, filing the IND will allow the company to
advance its proprietary drug candidate, VERU-944, directly to a
Phase 2 clinical study. The Phase 2 clinical study will evaluate
the efficacy and safety of VERU-944 for the treatment of hot
flashes caused by androgen deprivation hormone therapy (ADT) in men
with advanced prostate cancer.
“Hot flashes are the most common and debilitating side effect of
ADT for men with advanced prostate cancer,” said Mitchell Steiner,
M.D., Chairman, President and Chief Executive Officer of
Veru. “According to the scientific literature, up to 80% of
men treated with ADT experience hot flashes. VERU-944 has an
estimated U.S. addressable market size of approximately $600
million for hot flashes alone.”
Dr. Steiner added, “We expect this summer to commence enrolling
approximately 120 patients into a Phase 2 multi-center,
double-blind, placebo-controlled dose-finding clinical study.
The primary endpoint for the VERU-944 trial will be the change in
frequency of ADT-induced moderate and severe hot flashes. We
are able to proceed directly to a Phase 2 clinical trial on an
expedited basis because of the significant amount of existing
preclinical and clinical information on clomiphene citrate.”
The company also announced today that the U.S. Patent and
Trademark Office has issued Patent No. 9,913,815. The patent,
which expires in 2035, provides intellectual property protection
for the use of VERU-944 in men with prostate cancer as a method of
treating and preventing side effects caused by ADT including hot
flashes, bone loss and bone fractures.
“The issuance of this patent reinforces and strengthens our
intellectual property position for VERU-944,” said Dr.
Steiner. “The expansion of our IP portfolio is an integral
aspect of our clinical development and commercialization strategy,
which is aimed at positioning VERU-944 as a first-in-class
therapy.”
About Hot Flashes and Bone Loss 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, which includes Lupron®, Eligard®
and Firmagon®. 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. Up to 40% of men continue to
suffer from moderate to severe hot flashes by 8 years of ADT.
It is widely accepted by the scientific/medical community that
an important side effect in men suffering from prostate cancer
undergoing ADT is the development of bone loss leading to
osteoporosis and bone fractures. Men on ADT are four times
more likely to develop a significant bone deficiency (Shahinian VB
et al., NEJM 2005) and a loss of BMD occurs in the majority of
patients being treated by ADT by six months. Men on ADT have
an approximately 20% risk for developing a bone fracture which is
significantly higher than men not receiving ADT (Bienz and Saad,
BoneKEy Reports 2015).
About Veru Inc.Veru Inc. (Veru) is a urology
and oncology biopharmaceutical company. The company is currently
developing drug product candidates: Tamsulosin DRS, slow release
granules, and Tamsulosin XR capsules for lower urinary tract
symptoms of benign prostatic hyperplasia (BPH) (NDA planned 2018),
Solifenacin DRG, slow release granules, for overactive bladder
(urge incontinence, urgency and frequency of urination) (NDA
planned 2019), Tadalafil/finasteride combination capsule for
restricted urination because of an enlarged prostate (NDA planned
2019), VERU-944 (cis-clomiphene citrate) for hot flashes in men
associated with prostate cancer hormone treatment (planned Phase 2
in 2018), and VERU-111 a novel oral anti-tubulin cancer therapy
targeting alpha & beta tubulin for a variety of malignancies,
including metastatic prostate, breast, endometrial and ovarian
cancers (planned Phase 1/2 in 2018).
To help support these clinical development programs, the company
markets and sells the PREBOOST® medicated individual wipe, which is
a male genital desensitizing drug product for the prevention of
premature ejaculation which is being co-promoted with Timm Medical
Technologies, Inc. and the FC2 Female Condom® (now available by
prescription in the US including through the virtual doctor
smartphone app “HeyDoctor” at www.fc2.us.com) in the United States
and through The Female Health Company Division in the Global Public
Health Sector. The Female Health Company Division markets 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.verupharma.com,
www.PREBOOST.com, www.fc2.us.com and www.fc2femalecondom.com. For
corporate and investor-related information about the Company,
please visit https://verupharma.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. Forward-looking statements in this
release include statements relating to the regulatory pathway to
secure FDA approval of the Company's drug candidates and the
anticipated timeframe for clinical studies and FDA
submissions. Any forward-looking statements in this release
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 because of new
information or future events, developments or circumstances. Such
forward-looking statements are subject to known and unknown risks,
uncertainties and assumptions, and if any such risks or
uncertainties materialize or if any of the assumptions prove
incorrect, our actual results could differ materially from those
expressed or implied by such 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: risks related to the development of the Company's
product portfolio, including clinical trials, regulatory approvals
and time and cost to bring to market; potential delays in the
timing of and results from clinical trials and studies and the risk
that such results will not support marketing approval and
commercialization; potential delays in the timing of any submission
to the FDA and regulatory approval of products under development;
risks relating to the ability of the Company to obtain sufficient
financing on acceptable terms when needed to fund development and
operations; product demand and market acceptance; competition in
the Company's markets and the risk of new or existing competitors
with greater resources and capabilities and new competitive product
introductions; price erosion, both from competing products and
increased government pricing pressures; manufacturing and quality
control problems; compliance and regulatory matters, including
costs and delays resulting from the extensive governmental
regulation, and effects of healthcare insurance and regulation,
including reductions in reimbursement and coverage or
reclassification of the products; some of the Company's products
are in development and the Company may fail to successfully
commercialize such products; risks related to intellectual
property, including the uncertainty of obtaining patents, the
effectiveness of the patents or other intellectual property
protections and ability to enforce them against third parties, the
uncertainty regarding patent coverages, the possibility of
infringing a third party’s patents or other intellectual property
rights, and 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,
restructuring or substantial delayed payments; 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; penalties and/or debarment for failure to satisfy
tender awards; the Company's reliance on its international partners
and on the level of spending by country governments, global donors
and other public health organizations in the global public sector;
risks related to concentration of accounts receivable with our
largest customers and the collection of those receivables; 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 and
interruptions, including due to labor unrest or strikes; risks
related to the costs and other effects of litigation, including
product liability claims; 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,
2017. These documents are available on the "SEC Filings" section of
our website at www.verupharma.com/investors.
Contact: Kevin Gilbert
786-322-2213
Veru (NASDAQ:VERU)
Historical Stock Chart
From Apr 2024 to May 2024
Veru (NASDAQ:VERU)
Historical Stock Chart
From May 2023 to May 2024