Veru Announces Successful Bioavailability and Bioequivalence Clinical Trial for Tadalafil and Finasteride Combination Tablet ...
January 14 2019 - 8:00AM
Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical
company, today announced that the clinical trial of the Company’s
proprietary Tadalafil and Finasteride Combination tablet met the
U.S. Food and Drug Administration’s (FDA) requirements for
bioavailability and bioequivalence for the co-administration of
tadalafil 5mg and finasteride 5mg dosed daily for benign prostatic
hyperplasia (BPH) (Tad-Fin Combination Tablet).
Stability testing of commercially manufactured batches (GMP) of
the Tad-Fin Combination Tablet required for submission of a New
Drug Application (NDA) is in progress.
The Company has also requested a Pre-NDA meeting with FDA and
anticipates submitting an NDA under the 505(b)(2) regulatory
pathway in the second half of calendar year 2019.
Tad-Fin Combination Tablet combines two of the most popular
medicines, tadalafil and finasteride, that are currently prescribed
separately to treat lower urinary tract symptoms caused by an
enlarged prostate also known as BPH. The co-administration of
tadalafil and finasteride has been shown clinically to be more
efficacious in treating BPH symptoms than either tadalafil or
finasteride alone.* Our Tad-Fin Combination Tablet is proprietary
and is designed to improve patient compliance and safety.
According to current FDA approved labeling, Tadalafil (CIALIS®)
(PDE5 inhibitor) is approved to treat both BPH and erectile
dysfunction, and Finasteride (PROSCAR®) (5 alpha-reductase
inhibitor) is approved to treat symptoms of BPH, prevent the
progression of BPH, reduce the risk of acute urinary retention and
decrease the potential need for prostate surgery. Finasteride
(PROPECIA®) is also approved to treat male pattern hair loss.
“This successful clinical study for Tad-Fin Combination Tablet
will allow Veru to rely on the safety and efficacy of PROSCAR and
CIALIS for BPH in the FDA approval process without the requirement
of a large clinical trial. This is an exciting milestone for Veru
as the Tad-Fin Combination Tablet is our lead proprietary urology
pharmaceutical medicine and the first drug for which we plan to
submit an NDA to FDA later this year. We plan to use anticipated
cash flow from sales of our urology specialty pharmaceuticals, like
Tad-Fin Combination Tablet, to invest in our prostate cancer
programs and to execute on our strategy to become the leading
pharmaceutical company in providing products for the continuum of
care for prostate cancer, said Mitchell Steiner, M.D., Chairman,
President and Chief Executive Officer of Veru. “We believe our
Tad-Fin Combination Tablet will be an attractive product for the
multi-billion-dollar global market for BPH and substantially
increase compliance and safety in men who suffer from BPH or BPH
and erectile dysfunction.”
About Veru Inc.Veru Inc. is an oncology
and urology biopharmaceutical company developing novel urology
specialty pharmaceuticals and medicines for the prostate cancer
continuum of care. The Veru prostate cancer
pipeline includes zuclomiphene citrate (also known
as VERU-944, cis-clomiphene)
and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen
receptor agonist being evaluated in a Phase 2 trial to treat hot
flashes, a common side effect caused by hormone treatment for men
with advanced prostate cancer. VERU-111 is an oral,
next-generation, first-in-class selective small molecule that
targets and disrupts alpha and beta subunits of microtubules in
cells to treat metastatic prostate cancer patients whose disease is
resistant to both castration and novel androgen blocking agent
(abiraterone or enzalutamide) therapies. Veru expects to
enroll the first patient in the VERU-111 Phase 1b/2 clinical trial
in January 2019.
Veru is also advancing new drug formulations in its
specialty pharmaceutical pipeline addressing unmet medical needs in
urology. Tamsulosin DRS granules and Tamsulosin XR capsules are
formulations of tamsulosin, the active ingredient in FLOMAX®, which
Veru has developed to avoid the “food effect” inherent in currently
marketed formulations of the drug, allowing for potentially safer
administration and improved patient compliance (NDA submission
expected in 2019). Veru is also developing Tadalafil/Finasteride
combination tablet. Tadalafil (CIALIS®) is currently approved for
treatment of BPH and erectile dysfunction and finasteride (PROSCAR®
and PROPECIA®) is currently approved for treatment BPH and male
pattern hair loss. The co-administration of tadalafil and
finasteride has been shown to be more effective for the treatment
of BPH than either drug alone*(NDA submission expected in
2019).
Veru’s Female Health Company Division markets the FC2 Female
Condom / FC2 Internal Condom®, an FDA-approved product for the dual
prevention of unwanted pregnancy and sexually transmitted
infections, and the PREBOOST® medicated individual wipe for the
prevention of premature ejaculation. The FC2 Female Condom /
FC2 Internal Condom is marketed commercially and in the public
health sector both in the U.S. and globally. FC2 is available
by prescription in the U.S. including through the virtual doctor
smartphone app “HeyDoctor” at www.fc2.us.com. FC2 improves
the lives, health and well-being of women around the world.
For PREBOOST® Veru has a co-promotion and distribution agreement
with Timm Medical Technologies, Inc., a specialty urology sales
organization, and the Company also recently entered into a US
distributor agreement with a premier and fast-growing men’s health
and telemedicine company that discreetly sells men’s health
products via the internet. To learn more about these products
please visit www.verupharma.com.
*Casabé A et al. Journal of Urology 191:727-733 2014
"Safe Harbor" statement under the Private Securities
Litigation Reform Act of 1995:The statements in this
release that are not historical facts 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, the
anticipated timeframe for clinical studies, clinical study results
and FDA submissions, and the potential for cash flow from the sales
of urology specialty pharmaceuticals to support Company growth. 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 extensive governmental regulation,
and effects of healthcare insurance and regulation, including
reductions in reimbursement and coverage or reclassification of
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 or award; 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, 2018. These documents
are available on the "SEC Filings" section of our website at
www.verupharma.com/investors.
Contact:Kevin Gilbert
786-322-2213
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