Veru Inc. (NASDAQ:VERU) today announced the results of the
bioequivalence (BE) clinical trial of the company’s proprietary
Tamsulosin Delayed Release Sachet (DRS) (Tamsulosin HCl
extended-release oral suspension) formulation versus FLOMAX®.
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).
Dosing with Tamsulosin DRS fasted and Tamsulosin DRS fed were
successfully shown to be bioequivalent with FLOMAX Fed based on
AUC. The AUC equivalence is the key determinant of drug exposure
over time. The Tamsulosin DRS formulation did not meet the
remaining bioequivalence criterion for the peak value (Cmax). The
BE clinical trial was a 21-day single dose comparison of Tamsulosin
DRS slow release granule formulation versus FLOMAX® capsules in 36
patients who have either fasted or eaten prior to dosing. 34
subjects completed the study.
“Having met bioequivalence for AUC, we have the ability to
adjust the blend of particle sizes in the proprietary granule
formulation to address the Cmax difference, because Cmax is
dependent upon particle size,” said Lynn Gold PhD, Vice President
of Scientific and Regulatory Affairs, Camargo Pharmaceutical
Services. Veru licensed Tamsulosin DRS and has a co-development
agreement with Camargo. “We are enthusiastic about the
results and look forward to advancing Tamsulosin DRS based on this
new data.”
The current formulation registration batch that is undergoing
stability testing is still acceptable for NDA submission. The time
required to test stability remains our time limiting step. The new
BE study to validate the revised formulation should be accomplished
by the first quarter of calendar 2018 which is within the current
stability time window that will allow us to remain on track with
our planned NDA submission.
“Today’s announcement supports the clinical advancement of
Tamsulosin DRS. The expected timing of the additional formulation
adjustment should allow us to remain on track for a pre-NDA meeting
in early 2018 and an NDA submission in the first half of calendar
2018,” said Mitchell Steiner, M.D., President and Chief Executive
Officer of Veru. “Tamsulosin DRS compared to FLOMAX® has the
potential to improve patient compliance and the safety profile by
not having to be taken with meals. Tamsulosin DRS granule
formulation addresses the unmet medical need of men who have BPH
but who also have difficulty swallowing capsules or tablets.
FDA approval of Tamsulosin DRS would allow us to participate
meaningfully in the multi-billion dollar BPH market.”
Supported by the Stage 1 and Stage 2 BE clinical trial results,
the company also plans to request a meeting with the European
Medicines Agency in the first half of calendar 2018.
“Because Veru has a novel slow release granule formulation of
Tamsulosin that does not have a food requirement, we will also
begin development of an oral capsule containing these granules. The
planned NDA filing would be for both drug products - the granule
formulation and the capsules,” said Harry Fisch, M.D., Chief
Corporate Officer at Veru. “This will allow us to also expand this
advantage to men who have BPH and who can swallow capsules in the
larger urology and primary care markets.”
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. 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. Veru utilizes FDA's 505(b)(2)
regulatory approval pathway to develop and commercialize drug
candidates. FDA's 505(b)(2) regulatory approval pathway is designed
to allow for potentially expedited, lower cost and lower risk
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
drug product candidates for benign prostatic hyperplasia (BPH or
enlarged prostate), hot flashes associated with prostate cancer
hormone treatment, male infertility and novel oral chemotherapies
(alpha & beta tubulin inhibitor) for a variety of malignancies,
including metastatic prostate, breast and ovarian
cancers.
To help support these clinical development programs, the company
markets and sells the FC2 Female Condom® (now available by
prescription in the US including through the virtual doctor
smartphone app “HeyDoctor” at www.fc2.us.com) 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. In addition, the company markets and sells
the PREBOOST® medicated individual wipe which is a male genital
desensitizing drug product for the prevention of premature
ejaculation that is being co-promoted with Timm Medical
Technologies LLC. More information about Veru and its
products can be found at www.veruhealthcare.com, www.PREBOOST.com
and www.fc2.us.com. For corporate and investor-related information
about the Company, please visit
https://veruhealthcare.com/investors.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of
experts providing comprehensive drug development services
specialized for the 505(b)(2) approval pathway and global
equivalent processes. By assessing the scientific, medical,
regulatory, and commercial viability of product development
opportunities, Camargo systematically builds and executes robust
development plans that align with business strategies and ensure
Agency buy-in every step of the way. With alignment through
pre-Investigational New Drug (pre-IND) meeting planning and
preparations, Camargo maintains and ensures consistency throughout
the drug development program, which increases the likelihood of NDA
and future market success. Routinely holding three to six pre-IND
meetings a month, Camargo works with product developers across more
than 25 countries. For more about Camargo Pharmaceutical Services,
visit http://camargopharma.com
"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 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, 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 Gilbert786-322-2213
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