Blue Water Biotech Secures License from Ohio State Board of Pharmacy to Operate as Pharmaceutical Wholesaler for its FDA Approved Products
July 06 2023 - 5:05PM
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.
Headquartered 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 company.
“Securing 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 to our products.”
In 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 treatment areas.
In 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.
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 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.
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 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
RelationsTelephone: (646) 942-5591 Email:
Nic.Johnson@russopartnersllc.com
Investor Contact Information:Blue Water Investor
RelationsEmail: investors@bwbioinc.com
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