Blue Water Biotech Teams with Advantage Point Solutions to Provide Healthcare Payer Coverage Support
July 11 2023 - 8:00AM
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 the
signing of an agreement with Advantage Point Solutions, LLC (“APS”)
to support Blue Water’s market access strategy for its commercial
pharmaceutical portfolio.
Since the purchase of the approved product
ENTADFI® in April and additional approved therapies purchased in
June, Blue Water has made significant progress in the advancement
of its commercial strategy through the establishment of key
relationships and agreements. Blue Water’s agreement with APS
follows its recently announced agreements with IQVIA for the
development of its medical sales representative team to market
products to physicians and bfw Advertising (“bfw”) for marketing
and advertising services. Most recently, Blue Water was granted a
license to operate as a pharmaceutical wholesaler in its home state
of Ohio and will look to expand its licenses nationwide in the
future. With these agreements in place, Blue Water believes it is
assembling the key pieces to commercially launch and drive revenue
from its approved product portfolio.
APS will support market access for ENTADFI®,
including assistance in formulary negotiations with key healthcare
payers and pharmacy benefit managers (“PBM”) in the commercial and
government sectors. With its robust network of relationships, APS
helps commercial stage pharmaceutical companies build long-term
relationships with payers with the goal of maximizing access and
reimbursement for approved pharmaceutical products. APS also has
decades of experience advising companies on product launches across
a broad spectrum of therapeutic areas.
“Establishing proper payer and PBM coverage is
critical to the success of any product launch, as well as continued
coverage throughout the product life cycle to make sure patients
can access affordable therapy,” said Joseph Hernandez, Chairman and
Chief Executive Officer of Blue Water. “As we progress towards the
launch of ENTADFI®, we will look to secure placement on key
formularies to enable the execution of our commercialization
strategies and aim to expand existing formulary coverage for the
newly acquired products. APS, with their proven track record of
success in the market access space, will be an invaluable partner
for us as we move through the commercial landscape. Moreover, we
are grateful that industry veterans like APS, IQVIA and bfw are
joining with us and validating our commercial plans.”
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 the 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 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.
About Advantage Point Solutions
(APS)
APS launched in 2012 with a singular focus: to
help pharmaceutical manufacturers bring new products to market in
an ever-changing and complex payer environment. Our team has
extensive real-world payer experience, which enables us to define
ground-breaking clinical, formulary, coverage, contracting and
financial strategies, as well as pull-through initiatives.
APS has extensive experience assisting
pharmaceutical manufacturers to optimize their U.S. market access
through effectively planning the payer pre-launch, launch and
post-launch strategies, resulting in successful outcomes for our
clients. APS can help manufacturer’s looking to outsource their
managed care account facing teams by working on behalf of our
clients directly with payers on the full complement of formulary
access and positioning responsibilities including the following:
development of the pricing and contracting strategies as well as
the planning and execution of the payer engagement to achieve the
optimal access possible. For more information about APS, visit
www.apsconsulting.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 APS 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
establish, maintain and optimize key third party commercial
collaboration agreements (such as those with 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 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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