Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
breast and prostate cancer, today announced that the U.S. Food and
Drug Administration (FDA) has granted Fast Track designation to the
Phase 3 registration program for the investigation of enobosarm, a
selective androgen receptor targeting agonist, for the treatment of
androgen receptor positive, estrogen receptor positive, human
epidermal growth factor receptor 2 negative (AR+ER+HER2-)
metastatic breast cancer patients who have shown previous disease
progression on a nonsteroidal AI, fulvestrant, and CDK 4/6
inhibitor therapy, and who have AR% nuclei staining ≥40% in breast
cancer tissue (third-line metastatic setting).
“We are very pleased that enobosarm has received Fast Track
designation from the FDA, a distinction that underscores the urgent
need for new, novel, targeted therapies for this important patient
population suffering from this aggressive disease,” said Mitchell
Steiner, MD, Chairman, President and Chief Executive Officer of
Veru Inc. “We look forward to ongoing, productive regulatory
interactions with the FDA, which are further enabled with this
designation.”
About Fast Track DesignationFast Track
designation aims to expedite the development and review of new
drugs that are intended to treat serious or life-threatening
conditions and demonstrate the potential to fill unmet medical
needs. The purpose is to get important new drugs to patients
faster. Filling an unmet medical need is defined as providing a
therapy where none exists or providing a therapy which may be
potentially better than available therapy. Drugs that are granted
this designation are given the opportunity for more frequent
meetings with FDA to discuss the drug's development plan and ensure
collection of appropriate data needed to support drug approval:
more frequent written communication with FDA about such things as
the design of the proposed clinical trials and use of biomarker;
Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met; and, Rolling Review, which means that a
drug company can submit completed sections of its New Drug
Application (NDA) for review by FDA, rather than waiting until
every section of the NDA is completed before the entire application
can be reviewed. NDA review usually does not begin until the drug
company has submitted the entire application to the FDA.
About EnobosarmEnobosarm is an oral,
first-in-class, new chemical entity, selective androgen receptor
agonist that targets the androgen receptor in AR+ ER+ HER2-
metastatic breast cancer without unwanted masculinizing side
effects. Enobosarm is in clinical development for three
indications: (i) a Phase 3 ARTEST clinical study evaluating
enobosarm for the treatment of 3rd line metastatic AR+ER+HER2-
breast cancer patients whose disease has progressed after treatment
with a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6
inhibitor with an androgen receptor nuclei staining of ≥40% which
is enrolling; (ii) a planned Phase 3 ENABLAR-2 clinical study
evaluating enobosarm + abemaciclib combination therapy as treatment
of 2nd line metastatic AR+ER+HER2- breast cancer patients whose
breast cancer has progressed after treatment with palbociclib and
either a nonsteroidal aromatase inhibitor or fulvestrant
combination with an androgen receptor nuclei staining of ≥40%; and
(iii) a planned Phase 2 clinical study of enobosarm + sabizabulin
combination therapy in metastatic triple negative breast cancer
after two systemic chemotherapies.
About Breast CancerBreast cancer is the most
commonly diagnosed cancer in women with an estimated 284,200 new
cases and 44,130 deaths expected for 2021 in the U.S. It is
expected that one in eight women will develop invasive breast
cancer in their lifetime. Breast cancer is a heterogenous disease
with diverse clinical and molecular characteristics. Estrogen is
one of the main drivers of breast cancer proliferation, tumor
progression, and metastasis. Consequently, treatments that target
the estrogen receptor (ER) have been the mainstay of breast cancer
therapy, but unfortunately almost all women will eventually develop
resistance to endocrine therapies and alternative treatment
approaches will be required including IV chemotherapy.
About Veru Inc.Veru is an oncology
biopharmaceutical company with a principal focus on developing
novel medicines for the management of breast and prostate
cancers.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin, a cytoskeleton disruptor.
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% (third-line metastatic setting)
- Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm +
abemaciclib (a CDK 4/6 inhibitor) in AR+ ER+ HER2- metastatic
breast cancer with AR ≥ 40% (second-line metastatic setting)
- Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% (third-line metastatic
setting)
- Planned Q2 2022 Phase 2 study of sabizabulin + enobosarm
combination therapy in metastatic triple negative breast cancer
after two systemic chemotherapies.
The Company has determined that patients who have ≥ 40% androgen
receptor nuclei staining by immunohistochemistry in their breast
cancer tissue, a measure of AR expression, are most likely to
respond to enobosarm. Consequently, Veru is developing a companion
diagnostic to determine a patient’s androgen receptor expression
status. We have partnered with Roche/Ventana Diagnostics, a world
leader in oncology companion diagnostics, which will develop and,
if it is approved, commercialize the companion AR diagnostic.
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 and ongoing Phase 2 studies of
sabizabulin 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 in men with
advanced prostate cancer undergoing androgen deprivation therapy
who suffer from hot flashes
In addition, sabizabulin, which has dual antiviral and
anti-inflammatory effects, is currently enrolling in a Phase 3
study for the treatment of hospitalized COVID-19 patients at high
risk for acute respiratory distress syndrome, also known as the
cytokine storm.
Veru also has a commercial sexual health division, the proceeds
of which help fund our drug development programs. Its two main
products are:
- ENTADFI™ (finasteride and tadalafil) capsules for oral use, a
new treatment for benign prostatic hyperplasia
- 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 enobosarm
will be approved by FDA for the treatment of certain breast cancers
and the timing of the Company’s submissions to FDA and FDA’s review
of such submissions; whether the Company’s current or future
clinical development program results will demonstrate sufficient
efficacy and safety and potential benefits to secure FDA approval
of the Company’s drug candidates; and whether the companion
diagnostic for enobosarm will be developed successfully or be
approved by the FDA for use. 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 trials possibly being unsuccessful or
insufficient to meet applicable regulatory standards or warrant
continued development; the ability to enroll sufficient numbers of
subjects in clinical trials 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 trials, 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; 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.
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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