Full Press Release Details
Blue Water Biotech Teams with UpScriptHealth
to Launch Telemedicine Platform for Benign Prostatic Hyperplasia Asset, ENTADFI
CINCINNATI, OH, July 25, 2023 - Blue
Water Biotech, Inc. ("Blue Water" or the "Company") (Nasdaq: BWV), a biotechnology and pharmaceutical company
focused on developing and commercializing transformational therapies to address significant health challenges globally, today announced
an agreement with UpScriptHealth ("UpScript") to generate a robust, online telemedicine platform to distribute Blue Water's
benign prostatic hyperplasia ("BPH") asset, ENTADFI .
Under this agreement, UpScript will build an online platform to support
BPH patients throughout the prescription and coverage process, as well as provide eligible patients access to ENTADFI
mailed directly to their homes. UpScript, a leading provider of telehealth services, has over 20 years of experience generating effective,
web-based campaigns for life science companies with a wide range of services, including virtual prescribing, coverage and benefit support,
as well as long-term adherence support.
"Telehealth, with its increasing popularity in recent years,
is a great opportunity to improve not only patient access to therapy, but improve patient lives throughout the entire treatment journey,"
said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. "Together with UpScript and through this platform, intend
to provide eligible BPH patients direct access to ENTADFI online, minimizing the need for specialist visits and trips
to the pharmacy that can be burdensome to patients. With UpScript's proven track record and unwavering dedication to easing patient
challenges through telehealth solutions, we are thrilled to take this next step with UpScript and look forward to launching this campaign."
It is estimated about 55 million men in the United States have or are
at risk for BPH, with affected patients suffering from challenges with urination flow, frequency, and urgency, along with sexual dysfunction
in many cases. Through this online platform, existing BPH patients will be able to communicate with a healthcare provider online and may
be eligible to receive ENTADFI without the need for another specialist visit and can receive their prescription in the
mail or through one of UpScript's partner pharmacies. This solution will be designed to not only increase access for ENTADFI
nationwide, but also offers patients a time-saving solution while still receiving administrative help during the coverage process through
UpScript's benefit support capabilities.
This agreement with UpScript represents a milestone reached by Blue
Water in its efforts to launch its commercial portfolio, highlighted by ENTADFI , that was previously announced in a letter
to shareholders from Mr. Hernandez earlier this month. With the official launch of ENTADFI scheduled in the coming months,
Blue Water's commercial team is executing on key strategies including sales force development, distribution capabilities, as well
as marketing and advertising development.
ENTADFI is a once daily, oral
treatment for 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/.
About UpScriptHealth
UpScriptHealth is a comprehensive, direct-to-consumer telehealth
and virtual prescribing platform that is innovating the way customers get the medications they need. UpScriptHealth has been innovating
telehealth for over 20 years and remains committed to improving the lives of consumers by providing immediate and long-term convenient
access to medical therapies. We embody values of transparency and integrity that have strengthened our core philosophy of care. To learn
more about UpScriptHealth, visit www.UpScriptHealth.com.
About Blue Water Biotech
Blue Water Biotech, Inc. is a biotechnology and
pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally.
Headquartered in Cincinnati, OH, the Company owns ENTADFI , an FDA-approved, once daily pill that combines finasteride and tadalafil
for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic
hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company is also in the process
of acquiring approved therapies from WraSer, LLC, and Xspire Pharma, LLC, including ZONTIVITY (reduction of thrombotic cardiovascular
events in patients with myocardial infarction or with peripheral arterial disease), OTOVEL (acute otitis media with tympanostomy
tubes), CETRAXAL (acute otitis externa), CONJUPRI (hypertension), TREZIX (moderate to severe pain) and NALFON (NSAID
treatment for pain and inflammation). The Company also has a robust preclinical vaccine pipeline. Blue Water 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. Blue Water is developing a Streptococcus pneumoniae vaccine candidate,
designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the
elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to
licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children's to develop
vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is 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 about Blue Water, visit www.bwbioinc.com.
Cautionary Note Regarding 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 (including, without limitation, the anticipated benefits of the Company's
agreement with UpScript, IQVIA, APS and bfw and the anticipated results of the Company's sales and marketing efforts for its commercial
stage products, each as described herein) are based on Blue Water'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 Blue Water's ability to realize the benefits of its acquisitions
of ENTADFI , ZONTIVITY , OTOVEL , CETRAXAL , CONJUPRI ,
TREZIX and NALFON ; risks related to Blue Water's ability to expand its business
scope, commercialize ENTADFI and integrate the assets and commercial operations being acquired from WraSer, LLC,
and Xspire Pharma, LLC into Blue Water's business; risks related to Blue Water's ability to attract, hire and retain skilled
personnel and establish an effective sales team; risks related to Blue Water's ability to establish, maintain and optimize key third
party commercial collaboration agreements (such as those with UpScript, IQVIA, APS and bfw); risks related to the Company's present
need for capital to close its asset acquisitions, commercially launch the Company's acquired products and have adequate working
capital; risks related to the development of Blue Water's vaccine candidates; the failure to obtain FDA clearances or approvals
and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; 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 commercial-stage pharmaceutical product or any product
candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of pharmaceutical
products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk
factors set forth in Blue Water'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 Blue Water'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
Media Contact Information:
Blue Water Media Relations
Telephone: (646) 942-5591
Investor Contact Information:
Blue Water Investor Relations
Email: investors@bwbioinc.com