Veru Submits Emergency
Use Authorization (EUA) Application to U.S. FDA for Sabizabulin, its
Novel, Oral Antiviral and Anti-Inflammatory Drug Candidate for
Hospitalized COVID-19 Patients at High Risk for ARDS
-- The EUA Submission Follows Positive
Phase 3 COVID-19 Clinical Trial in which Sabizabulin Demonstrated a
55.2% Reduction in Death in Hospitalized COVID-19 Patients --
--
The Company is in Discussions with Other Regulatory Agencies Around the
World Regarding Emergency Use Authorization for Sabizabulin Including
the European Medicines Agency --
-- Company Prepares for U.S. Commercial Launch if EUA is Granted --
MIAMI,
June 07, 2022 (GLOBE NEWSWIRE) -- 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 is has
submitted an emergency use authorization (EUA) application to the U.S.
Food and Drug Administration for its sabizabulin oral 9mg treatment of
moderate to severe hospitalized COVID-19 patients at high risk for
developing Acute Respiratory Distress Syndrome (ARDS).
The EUA
submission to the FDA is based on the positive results from the
double-blind, randomized, multicenter placebo-controlled Phase 3
COVID-19 clinical trial evaluating the efficacy and safety of
sabizabulin, an oral, first-in-class, new chemical entity, cytoskeleton
disruptor that has dual anti-inflammatory and antiviral properties, in
approximately 204 hospitalized COVID-19 patients with moderate to severe
COVID (≥ WHO 4-supplemental oxygen) at high risk for ARDS and death.
The primary efficacy 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 which showed that sabizabulin 9mg
once daily treatment resulted in a clinically meaningful and
statistically significant 55.2% relative reduction in deaths.
Sabizabulin was well tolerated.
“COVID-19 new cases and
hospitalizations are on the rise again with a summer and fall-winter
peaks expected. Unfortunately, the death rate in hospitalized patients
with moderate to severe COVID-19 who are at risk for ARDS remains and
will continue to be unacceptably high with current standard of care,”
said Mitchell Steiner, M.D., Chairman, President, and Chief Executive
Officer of Veru. “By reducing deaths in hospitalized COVID-19 patients,
sabizabulin has great potential to play a critical role in the battle
against COVID-19. We are moving as quickly as possible to get this
potential treatment to patients by expeditiously submitting this request
for EUA application. We have also scaled up manufacturing of
sabizabulin 9mg capsules to meet the needs of patients in the U.S. and
are building our U.S. infectious disease commercial franchise. We look
forward to working with the FDA during its review of our request for EUA
application. We have also begun seeking EUA and approvals with other
regulatory agencies around the world.”
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.
The Company announced
today that it has submitted an EUA request to the FDA for its novel,
oral, once daily sabizabulin treatment of moderate to severe
hospitalized COVID-19 patients at high risk for ARDS.
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 is providing clinical supply of
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 Statements 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 regarding: whether 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 or other regulatory
authorities and any determinations made by the FDA or any other
regulatory authority, including the risk that the Company may not be
able to obtain an EUA from the FDA or similar authorizations from other
regulatory authorities on a timely basis or at all; any agreements or
positions taken by the FDA in a pre-EUA meeting does not bind the FDA or
prevent it from later taking a different position, asking for more data
or delaying or denying the application; 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 lacks experience in scaling up or
commercializing a drug product and may not be able to successfully
commercialize sabizabulin as a COVID-19 treatment; the Company may be
unable to manufacture sabizabulin as a COVID-19 treatment in sufficient
quantities or at sufficient yields; 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 Fisch Executive Director, Investor Relations and Corporate Communications Email: [email protected]
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
Print Page
Email to a Friend
