Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on
developing novel medicines for COVID-19 and other viral and
ARDS-related diseases and for the management of breast and prostate
cancers, today announced that in a Pre-EUA meeting held May 10,
2022, FDA has agreed that the efficacy and safety data from the
completed Phase 3 clinical study in hospitalized COVID-19 patients
at high risk for acute respiratory distress syndrome are sufficient
to support the submission of a request for Emergency Use
Authorization (EUA).
“The discussion with FDA in the Pre-EUA meeting has established
a direct path forward to expedite the availability of sabizabulin
to the high risk hospitalized patients with COVID-19,” said
Mitchell Steiner, M.D., Chairman, President, and Chief Executive
Officer of Veru. “In the Phase 3 COVID-19 clinical study,
sabizabulin demonstrated a clear mortality benefit in hospitalized
moderate to severe COVID-19 patients on current standard of care
with no significant safety signals,” Dr. Steiner continued.
Regulatory Discussion and PlanningFDA agreed
that the Phase 3 COVID-19 study that was stopped by the Independent
Data Monitoring Committee for overwhelming efficacy is sufficient
to support the efficacy portion of a request for EUA submission and
for an NDA submission.
FDA agreed that the current safety data available for
sabizabulin is sufficient to support the safety portion of a
request for EUA submission. FDA informed the Company that
additional safety data that would be collected during the use of
sabizabulin under the EUA, if granted, will be sufficient to
support an NDA submission, and furthermore, that no additional
safety clinical studies are required. The Company plans to submit a
request for an EUA application in calendar 2Q 2022.
The Company has scaled up manufacturing processes and will be
able to produce commercial drug supply to address anticipated drug
needs following potential FDA authorization in U.S. and subsequent
authorizations in other countries and regions.
The Company has initiated discussions with government agencies
to discuss government purchases of sabizabulin in the U.S. and
other countries around the world.
Event DetailsThe Company will further discuss
the outcome of the Pre-EUA meeting and next steps in the conference
call tomorrow, Thursday, May 12, 2022, at 8:00 am ET. Interested
parties may access the call by dialing 1-800-341-1602 from the U.S.
or 1-412-902-6706 from outside the U.S. and asking to be joined
into the Veru Inc. call. The call will also be available through a
live, listen-only audio broadcast via the Internet at
www.verupharma.com. Listeners are encouraged to visit the website
at least 10 minutes prior to the start of the scheduled
presentation to register, download and install any necessary
software. A playback of the call will be archived and accessible on
the same website for at least three months. A telephonic replay of
the conference call will be available, beginning the same day at
approximately 12 p.m. (noon) ET by dialing 1-877-344-7529 for U.S.
callers, or 1-412-317-0088 from outside the U.S., passcode 8215063,
for one week.
About Veru Inc.Veru is a biopharmaceutical
company focused on developing novel medicines for COVID-19 and
other viral and ARDS-related diseases and for the management of
breast and prostate cancers.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19
clinical trial was conducted in approximately 210 hospitalized
COVID-19 patients with moderate to severe COVID (≥ WHO 4
supplemental oxygen) at high risk for ARDS and death. The primary
endpoint was the proportion of deaths by Day 60. Based on a planned
interim analysis of the first 150 patients randomized, the
Independent Data Monitoring Committee unanimously halted the study
for overwhelming efficacy and safety. Treatment with sabizabulin
9mg once daily, an oral, first-in-class, new chemical entity,
cytoskeleton disruptor that has dual anti-inflammatory and
antiviral properties, resulted in a clinically meaningful and
statistically significant 55.2% relative reduction in deaths. The
Company is seeking FDA emergency use authorization. FDA granted
Fast Track designation to the Company’s COVID-19 program in January
2022.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin.
Current studies on the two drugs include:
- Enrolling Phase 3 ARTEST study of enobosarm in androgen
receptor positive, estrogen receptor positive, and human epidermal
growth factor receptor two negative (AR+ ER+ HER2-) metastatic
breast cancer with AR ≥ 40% expression (third-line metastatic
setting), and which has been granted Fast Track designation by the
FDA.
- Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a
CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast
cancer with AR ≥ 40% expression (second-line metastatic setting).
The Company and Eli Lilly and Company have entered into a clinical
study collaboration and supply agreement for the ENABLAR-2 study.
Lilly will supply Verzenio® (abemaciclib).
- Planned Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% expression (third-line
metastatic setting).
Veru’s late-stage prostate cancer portfolio comprises
sabizabulin, VERU-100, a long-acting GnRH antagonist, and
zuclomiphene citrate, an oral nonsteroidal estrogen receptor
agonist.
Current studies on these drugs include:
- Enrolling Phase 3 VERACITY study in metastatic castration and
androgen receptor targeting agent resistant prostate cancer prior
to IV chemotherapy.
- Enrolling Phase 2 dose-finding study of VERU-100 in advanced
hormone sensitive prostate cancer.
- Planned Phase 2b study of zuclomiphene citrate to treat hot
flashes in men with advanced prostate cancer undergoing androgen
deprivation therapy.
Veru also has a commercial sexual health division - Urev, the
proceeds of which help fund its drug development programs,
comprised of 2 FDA approved products:
- ENTADFI™ (finasteride and tadalafil) capsules for oral use, a
new treatment for benign prostatic hyperplasia, for which
commercialization launch plans are underway.
- FC2 Female Condom® (internal condom), for the dual protection
against unplanned pregnancy and the transmission of sexually
transmitted infections which is sold in the U.S. and globally.
Forward-Looking StatementsThe 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 regarding: whether and when the Company
will receive an emergency use authorization or any approval from
FDA or from any regulatory authority outside the U.S. for
sabizabulin for certain COVID-19 patients; whether and when
sabizabulin will become an available treatment option for certain
COVID-19 patients in the U.S. or anywhere outside the U.S.; whether
the Company will have sufficient supply of sabizabulin to meet
demand, if an emergency use authorization or other approval is
granted; whether the Company will secure any advance purchase
agreement with the U.S. government or any foreign government;
whether the current and future clinical development and results
will demonstrate sufficient efficacy and safety and potential
benefits to secure FDA approval of the Company’s drug candidates
and companion diagnostic; whether the drug candidates will be
approved for the targeted line of therapy; the anticipated design
and scope of clinical studies and FDA acceptance of such design and
scope; whether any regulatory pathways, including the accelerated
Fast Track designations, to seek FDA approval for sabizabulin,
enobosarm or any of the Company’s drug candidates are or continue
to be available; whether the expected commencement and timing of
the Company’s clinical studies, including the Phase 3 ENABLAR-2
study, the sabizabulin monotherapy Phase 2b clinical study for 3rd
line treatment of metastatic breast cancer, the Phase 2
registration clinical study for VERU-100, and the development of
the companion diagnostic will be met; when clinical results from
the ongoing clinical studies will be available, whether
sabizabulin, enobosarm, VERU-100, zuclomiphene, and ENTADFI will
serve any unmet need or, what dosage, if any, might be approved for
use in the U.S. or elsewhere, and also statements about the
potential, timing and efficacy of the rest of the Company’s
development pipeline, and the timing of the Company’s submissions
to FDA and FDA’s review of all such submissions; whether any of the
selective clinical properties previously observed in clinical
studies of sabizabulin, enobosarm, VERU-100 or other drug
candidates will be replicated in the current and planned clinical
development program for such drug candidates and whether any such
properties will be recognized by the FDA in any potential approvals
and labeling; whether the companion diagnostic for enobosarm will
be developed successfully or be approved by the FDA for use; and
whether and when ENTADFI will be commercialized successfully. These
forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: the development of the
Company’s product portfolio and the results of clinical studies
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical studies and
the ability to enroll subjects in accordance with planned
schedules; the ability to fund planned clinical development; the
timing of any submission to the FDA and any determinations made by
the FDA or any other regulatory authority; the possibility that as
vaccines become widely distributed the need for new COVID-19
treatment candidates may be reduced or eliminated; government
entities possibly taking actions that directly or indirectly have
the effect of limiting opportunities for sabizabulin as a COVID-19
treatment, including favoring other treatment alternatives or
imposing price controls on COVID-19 treatments; the Company’s
existing products and any future products, if approved, possibly
not being commercially successful; the effects of the COVID-19
pandemic and measures to address the pandemic on the Company’s
clinical studies, supply chain and other third-party providers,
commercial efforts, and business development operations; the
ability of the Company to obtain sufficient financing on acceptable
terms when needed to fund development and operations; demand for,
market acceptance of, and competition against any of the Company’s
products or product candidates; new or existing competitors with
greater resources and capabilities and new competitive product
approvals and/or introductions; changes in regulatory practices or
policies or government-driven healthcare reform efforts, including
pricing pressures and insurance coverage and reimbursement changes;
the Company’s ability to successfully commercialize any of its
products, if approved; risks relating to the Company's development
of its own dedicated direct to patient telemedicine and
telepharmacy services platform, including the Company's lack of
experience in developing such a platform, potential regulatory
complexity, and development costs; the Company’s ability to protect
and enforce its intellectual property; the potential that delays in
orders or shipments under government tenders or the Company’s U.S.
prescription business could cause significant quarter-to-quarter
variations in the Company’s operating results and adversely affect
its net revenues and gross profit; 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 concentration of accounts receivable
with our largest customers and the collection of those receivables;
the Company’s production capacity, efficiency and supply
constraints and interruptions, including potential disruption of
production at the Company’s and third party manufacturing
facilities and/or of the Company’s ability to timely supply product
due to labor unrest or strikes, labor shortages, raw material
shortages, physical damage to the Company’s and third party
facilities, COVID-19 (including the impact of COVID-19 on suppliers
of key raw materials), product testing, transportation delays or
regulatory actions; 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 from time to time in the
Company’s press releases, shareholder communications and Securities
and Exchange Commission filings, including the Company’s Form 10-K
for the fiscal year ended September 30, 2021 and subsequent
quarterly reports on Form 10-Q. These documents are available on
the “SEC Filings” section of our website at
www.verupharma.com/investors. The Company disclaims any intent or
obligation to update these forward-looking statements.
Verzenio® is a registered trademark of Eli Lilly and Company
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
Veru (NASDAQ:VERU)
Historical Stock Chart
From Mar 2024 to Apr 2024
Veru (NASDAQ:VERU)
Historical Stock Chart
From Apr 2023 to Apr 2024