Blue Water Vaccines Inc. (“BWV” or “Blue
Water” or the “Company”), today announced the signing of an Asset
Purchase Agreement (the “Agreement”) with Veru Inc. (“Veru”) for
the purchase of ENTADFI®, an FDA-approved treatment for benign
prostatic hyperplasia (“BPH”) that counteracts negative sexual side
effects seen in men on alternative BPH therapies.
Under this Agreement, Blue Water will purchase
ENTADFI® for a total consideration of $100 million, with $20
million upfront, paid in defined tranches through September 2024,
and the possibility of an additional $80 million based on
predetermined annual sales milestones. Blue Water will also assume
royalty and milestone obligations under a previous asset purchase
agreement, including a royalty on all sales and sales milestone
payments of up to $22.5 million. In addition to all commercial
materials, contracts, intellectual property, and regulatory records
and filings, BWV will acquire all available inventory of ENTADFI®,
approximately 125,000 bottles.
BPH, a condition in men in which the prostate
gland is enlarged but not cancerous, is a common problem that
affects the quality of life in approximately half of men over the
age of 50 and over 90% of men over the age of 85. Men with BPH
suffer from challenges with urination flow, frequency, and urgency,
and about 70% of men with BPH also experience sexual dysfunction.
In 2022, according to IQVIA, there were approximately 44 million
total prescriptions and 20 million new prescriptions related to BPH
symptoms. ENTADFI® is designed to treat BPH and its associated
symptoms. Over 55 million patients in the United States have or are
at risk for BPH.
ENTADFI®, approved by the FDA in December 2021
for the treatment of BPH in men with an enlarged prostate, combines
finasteride, a traditional BPH medication, and tadalafil, a BPH and
erectile dysfunction medication, into a once daily pill. This
allows patients to receive BPH medication without the negative side
effects of traditional medication and has proven both safe and
effective in multiple clinical trials prior to its FDA approval. In
a pivotal Phase 3, double blinded, parallel-design clinical trial,
696 men, including those with co-morbid conditions, were randomized
to initiate either tadalafil plus finasteride or placebo with
finasteride over 26 weeks. Tadalafil and finasteride administered
together demonstrated statistically significant improvement in the
signs and symptoms of BPH compared to placebo with finasteride.
“With millions of men suffering from BPH and
facing adverse side effects associated with current treatments, we
are excited to support those patients and make ENTADFI® readily
available for all,” said Joseph Hernandez, Chairman and Chief
Executive Officer of Blue Water. “This purchase provides us an
opportunity to advance Blue Water into the commercial space and to
offset burn to provide key revenue supporting our vaccine candidate
pipeline. Our core mission of helping patients in need remains
strong and steadfast, and we look forward to developing this asset
and our pipeline for patients around the world.”
“With completion of this deal and subsequent
influx of capital, we are able to focus our efforts on advancing
our late-stage clinical drug pipeline within our key markets,
including Veru’s late-stage assets in oncology and infectious
diseases,” said Mitchell Steiner, M.D., Chief Executive Officer of
Veru. “With their commercially driven management team, we are
confident that Blue Water is the right partner to take on ENTADFI®
and continue to offer patients a new treatment for BPH with low
potential for sexual side effects.”
ENTADFI® is currently available at pharmacies
nationwide for prescription, but upon execution of this purchase,
Blue Water intends to optimize sales, distribution, and marketing
strategies to maximize access to ENTADFI® for BPH patients. Through
this transformative acquisition, Blue Water expands to become a
broader pharmaceutical company and will rely on its experienced
management and leadership to drive success.
In January 2023, Frank Jaeger joined Blue Water
as Vice President of Marketing and Business Development and is
expected to lead commercialization and sales of ENTADFI® with his
significant experience in men’s health products, such as JATENZO®
and AndroGel 1.62%. During his previous leadership position at
AbbVie, Mr. Jaeger doubled AndroGel 1.62% sales to $1.3 billion,
achieved industry-leading product conversion, eclipsed Viagra as
the largest global men’s health product in 2011 and 2012, and grew
his division at AbbVie to the second largest unit within the
company. In his new role at Blue Water, Mr. Jaeger is expected to
lead the growth and development of ENTADFI® with his expertise and
knowledge within both the drug commercialization and men’s health
spaces.
To reflect the company transformation and robust
pipeline, spanning multiple sectors, the Company’s Board of
Directors has approved a corporate name change and rebranding to
Blue Water Biotech. The name change is expected to take effect
during, and rebranding activities will continue through, the second
quarter of 2023. Prior to effectuating the name change, the
Company’s common stock will continue to trade under the ticker
symbol NASDAQ: BWV.
The Company will hold a conference call Today,
Thursday, April 20, 2023, to discuss the purchase of ENTADFI® and
outline clinical and commercial strategy moving forward. Details on
the webcast are provided below:
Date & Time: Thursday, April 20th at 8:30am EDTConference
ID: 2856646Participant Toll-Free Dial-In Number: 1 (888)
660-6390Participant Toll Dial-In Number: 1 (929) 203-1902
About ENTADFI®ENTADFI® is an
oral, once daily treatment for benign prostatic hyperplasia ("BPH")
that combines finasteride, a 5α-reductase inhibitor, and tadalafil,
a phosphodiesterase 5 (PDE5) inhibitor, offering a more effective
treatment option compared to other available therapies. Clinical
trials have shown that ENTADFI® is more effective in treating BPH
symptoms, including urinary frequency, urgency, weak stream, and
difficulty initiating or maintaining urination, compared to
finasteride monotherapy. Additionally, ENTADFI® has demonstrated a
favorable safety profile, with fewer adverse sexual side effects
compared to finasteride. ENTADFI® reduces potential for adverse
sexual side effects, making it a preferred choice for men seeking
relief from BPH symptoms without compromising their sexual health.
ENTADFI® has received FDA approval for the indication of initiating
treatment of the signs and symptoms of BPH in men with an enlarged
prostate for up to 26 weeks. More information about BPH and full
ENTADFI® prescribing information can be found on the product
website at https://entadfipatient.com/.
About Veru Inc.Veru is a biopharmaceutical
company focused on developing novel medicines for oncology focusing
on breast cancer and for SARS-CoV-2 and other viral and
ARDS-related diseases.
Oncology programThe Company’s late-stage breast
cancer development portfolio comprises enobosarm, a selective
androgen receptor targeting agonist.
- Enrolling Phase 3 ENABLAR-2 study
of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+
ER+ HER2- metastatic breast cancer (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 3 study of enobosarm
in nonmeasurable bone only metastatic breast cancer.
Infectious disease program
- COVID-19:
Sabizabulin is an oral, first-in-class, new chemical entity,
microtubule disruptor that has dual anti-inflammatory and host
mediated antiviral properties. Veru has conducted a positive
double-blind, randomized, placebo-controlled Phase 3 COVID-19
clinical trial in 204 hospitalized moderate to severe COVID-19
patients at high risk for ARDS and death. The primary endpoint was
the proportion of deaths by Day 60. Treatment with sabizabulin
resulted in a clinically meaningful and statistically significant
51.6% relative reduction in deaths (p=0.0046) and was well
tolerated. FDA granted Fast Track designation to the Company’s
COVID-19 program in January 2022. The Company is planning to
conduct a Phase 3 confirmatory clinical trial to evaluate
sabizabulin in hospitalized moderate to severe COVID-19 patients at
high risk for ARDS. Veru has been granted a meeting with U.S. FDA
in April 2023 to finalize clinical trial design and requirements
for an EUA submission and new drug application.
- Influenza: The
Company is planning a Phase 3 clinical trial to evaluate
sabizabulin in hospitalized influenza patients at high risk for
ARDS.
Sexual health program - UrevVeru also has a
commercial sexual health division - Urev - comprised of 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.
About Blue Water
Blue Water is a biopharmaceutical company
focused on developing transformational vaccines to address
significant health challenges globally. Headquartered in
Cincinnati, OH, the Company holds the rights to proprietary
technology developed at the University of Oxford, Cincinnati
Children’s Hospital Medical Center, St. Jude Children’s Hospital,
and The University of Texas Health Science Center at San Antonio.
The Company is developing a universal flu vaccine that will provide
protection from all virulent strains in addition to licensing a
novel norovirus (NoV) S&P nanoparticle versatile virus-like
particle (VLP) vaccine platform from Cincinnati Children’s to
develop vaccines for multiple infectious diseases, including
norovirus/rotavirus and malaria, among others. Additionally, Blue
Water is developing a Streptococcus pneumoniae (pneumococcus)
vaccine candidate, designed to specifically prevent the highly
infectious middle ear infections, known as Acute Otitis Media
(AOM), in children, and prevention of pneumonia in older people at
risk for contracting pneumococcal pneumonia, a significant unmet
medical need. The advantage of this technology includes a serotype
independent mucosal immunity that prevents colonization in the
upper respiratory tract as well as systemic immunity that can
confer serotype independent against invasive pneumococcal disease.
The Company is also developing a Chlamydia vaccine candidate with
UT Health Science Center San Antonio to prevent infection and
reduce the need for antibiotic treatment associated with
contracting Chlamydia disease. For more information, visit
www.bluewatervaccines.com.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on BWV’s current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, risks related to
BWV’s ability to realize the benefits of the transactions
contemplated by the Agreement, risks related to BWV’s ability to
expand its business scope, risks related to the development of
BWV’s vaccine candidates; the failure to obtain FDA clearances or
approvals and noncompliance with FDA regulations; delays and
uncertainties caused by the global COVID-19 pandemic; risks related
to the timing and progress of clinical development of our product
candidates; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and substantial
competition. As with any vaccine under development, there are
significant risks in the development, regulatory approval and
commercialization of new products. BWV does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in BWV’s Annual
Report on Form 10-K, filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2023 and periodic reports filed
with the SEC on or after the date thereof. All of BWV’s
forward-looking statements are expressly qualified by all such risk
factors and other cautionary statements. The information set forth
herein speaks only as of the date thereof.
Media and Investor Relations Contact
Information:Blue Water Media RelationsTelephone: (646) 942-5591
Email: Nic.Johnson@russopartnersllc.com
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