Full Press Release Details
Blue Water Biotech Secures License from Ohio
State Board of Pharmacy to Operate as Pharmaceutical Wholesaler for its FDA Approved Products
First state license is a key achievement
as Blue Water continues to
expand its business into commercial activities
OH, July 6, 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 that the Ohio State Board of Pharmacy has granted Blue
Water a license to operate as a pharmaceutical wholesaler in the State of Ohio.
in Cincinnati, OH, Blue Water recently acquired multiple FDA-approved pharmaceutical assets across various indications, including urology,
cardiology, inner ear infections, and pain management to establish itself as a commercial stage pharmaceutical company. This license allows
Blue Water to conduct business in the State of Ohio and is the first granted to the Company since its establishment as a commercial state
this license in our home state is a very important first step for patients and providers to access Blue Water products nationwide,"
said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. "We are keenly focused on building out our sales team
and aligning ourselves with the right commercial partners as we prepare for launch, and these licenses are critical for us to deliver
on our proposed strategies. We look forward to securing additional state licenses and expanding further to maximize availability and access
April 2023, Blue Water acquired ENTADFI , an FDA-approved treatment for benign prostatic hyperplasia ("BPH")
that counteracts negative sexual side effects seen in men on alternative BPH therapies. Following this acquisition, Blue Water recently
announced an Asset Purchase Agreement with WraSer, LLC and Xspire Pharma, LLC for the purchase of six FDA-approved assets across various
recent months, Blue Water has signed key agreements to work towards commercialization of its products, including an agreement with IQVIA
to establish a medical sales representative team to market Blue Water's products. Additionally, the Company yesterday announced
the signing of a Master Services Agreement with bfw Advertising Inc. to generate marketing and advertising material for its portfolio
and expects to launch these materials in the coming months. These agreements, along with the granted license in Ohio and any future state
licenses, will help ensure proper awareness and access to all of Blue Water's products.
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 also has a robust 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.
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 Ohio license, statements about the Company's plans to secure future state licenses and the anticipated
results of the Company's sales and market efforts, 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 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 enter into a definitive agreement with
IQVIA and optimize its collaboration with IQVIA; 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; 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 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 date thereof.
Media Contact Information:
Blue Water Media Relations
Telephone: (646) 942-5591
Investor Contact Information:
Blue Water Investor Relations
Email: investors@bwbioinc.com