Full Press Release Details
Blue Water Announces
Acquisition of ENTADFI , an
FDA-Approved Benign Prostatic Hyperplasia Asset
Transforms the Company into a Broader Pharmaceutical Company Spanning Multiple Sectors
Corporate Name Change to Underscore Broader Focus
Host a Conference call Today, April 20th, at 8:30am EDT to Discuss Asset Purchase and Company Transformation
CINCINNATI, OH, April 20, 2023 -- 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
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.
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.
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.
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."
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."
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
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.
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.
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 EDT
Conference ID: 2856646
Participant Toll-Free Dial-In Number: 1 (888) 660-6390
Participant Toll Dial-In Number: 1 (929) 203-1902
is an oral, once daily treatment for benign prostatic hyperplasia ("BPH") that combines finasteride, a 5 -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/.
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
late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist.
Infectious disease program
Sexual health program - Urev
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.
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