FDA Grants Fee Waiver for Tamsulosin DRS New Drug Application
March 22 2018 - 8:30AM
Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on
urology and oncology, announced that the U.S. Food and Drug
Administration (FDA) granted its application for a small business
waiver of the drug application fee of approximately $2.4 million
for the Company’s New Drug Application (NDA) for Tamsulosin Delayed
Release Sachet (DRS). This is the first in a series of NDAs
that the Company is planning on submitting over the next two
years.
Tamsulosin DRS is a new, proprietary, slow release oral granule
formulation that addresses the large population of men who have
benign prostatic hyperplasia (BPH) and who have dysphagia
(difficulty swallowing tablets or capsules).
“FDA’s grant of the fee waiver frees up resources to further
advance our drug development programs,” said Mitchell Steiner,
M.D., President and Chief Executive Officer of Veru. “We plan
to file the NDA for Tamsulosin DRS during the current calendar
year.”
About Tamsulosin DRS (Tamsulosin HCl
extended release for oral suspension)
Tamsulosin DRS is a new granule 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
adrenoreceptor antagonist specific to receptors located in prostate
and bladder smooth muscle. Symptoms associated with BPH occur
because of a change in the functioning of the prostate and bladder
smooth muscle that can lead to constricted urinary flow, urinary
retention, urinary infection, kidney damage and a life-threatening
blood infection called urosepsis. Blocking alpha1 adrenoreceptors
relaxes smooth muscle resulting in improved urinary flow and
reduction of BPH symptoms.
According to IMS Health sales data, FLOMAX® and their generics
have 84% market share of the multi-billion-dollar alpha1 blocker
market for BPH in the United States. FLOMAX® and their
generics are only available as slow release capsules for BPH. 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 dizziness. 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 68% 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 and Alzheimer’s disease 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 slow release granule formulation containing the
active pharmaceutical ingredient in FLOMAX®, it would provide a
more reliable way to deliver therapeutic levels of tamsulosin to
men who have BPH and who have difficulty swallowing tablets and
capsules.
About Veru Inc.Veru Inc. (Veru) is a
biopharmaceutical company focused on urology and oncology. 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, the
anticipated timeframe for clinical studies and FDA submissions,
future demand for FC2 and potential orders of FC2 by public sector
customers. 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 because 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: risks related to the development of the Company's
product portfolio, including clinical trials, regulatory approvals
and time and cost to bring to market; the expected timing of the
clinical studies and regulatory approval of products under
development; the outcome of the clinical trials and drug studies
and that such outcomes will support marketing approval and
commercialization; risks relating to the ability of the Company to
obtain sufficient financing or raising capital on acceptable terms
when needed to fund development and Company 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 from
the extensive governmental regulation, effects of healthcare
insurance and regulation, including reductions in reimbursement and
coverage. 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 covering the products and processes and in
successfully enforcing them against third parties; expectations
regarding patent coverages; the possibility of infringing a third
party’s patents or other intellectual property rights; 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 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; 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; 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 Company’s Annual Report on 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 Gilbert786-322-2213
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