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 Knipper Health, Inc. (“Knipper Health”) to manage
the inventory and distribution of product samples to sales
representatives for ENTADFI® and ZONTIVITY®.
Knipper Health has more than 35 years of
experience building and maintaining operations for healthcare
clients, including sample management, custom pharmacy solutions and
3PL services. As part of Blue Water’s product roll-out plans,
Knipper Health will oversee sample inventory and ship samples on
request to the sales force in the field. This will help to expedite
physicians’ initiation of therapy for their patients while
increasing familiarity with the products.
“This agreement is another step toward placing
our commercial products into the hands of physicians and the
patients in need,” said Joseph Hernandez, Chairman and Chief
Executive Officer of Blue Water. “We are moving forward with our
aggressive timelines and will continue to provide updates on our
launch progress. Most importantly is our collaboration with proven
industry partners such as Knipper Health, that will help to make
the product launches successful. These agreements and partnerships
will be critical to ensure not only the successful launch of these
products, but to maximize long term access to potentially
life-saving medications for patients.”
Blue Water purchased ENTADFI® in April 2023,
followed by an asset purchase agreement for six FDA-approved
assets, including ZONTIVITY®, that is expected to close later this
year. Since the execution of those agreements, the Company has made
significant commercialization progress with market access and
distribution. Blue Water has executed agreements that cover market
access and payor coverage, marketing and advertising, telehealth
services generation and sales force development.
About ENTADFI®
ENTADFI® is a once daily, oral treatment for BPH
that combines finasteride, a 5α-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
ZONTIVITY®
ZONTIVITY® is a once daily, oral treatment
indicated for the reduction of thrombotic cardiovascular events for
patients with a history of myocardial infarction (MI) or with
peripheral arterial disease (PAD). ZONTIVITY® has been shown to
reduce the rate of a combined endpoint of cardiovascular death, MI,
stroke, and urgent coronary revascularization when used with
aspirin and/or clopidogrel. More information about MI, PAD, and
full ZONTIVITY® prescribing information can be found on the product
website at https://zontivity.com/.
About Knipper Health
Knipper Health is a leading healthcare solutions company serving
the pharmaceutical, biotechnology, and medical device industries
for more than 35 years, with a focus on sample management and
marketing, custom pharmacy solutions and 3PL services. Knipper has
become the single source-provider of samples management services
for many small, to large pharmaceutical customers. KnippeRx is a
highly nimble, independent specialty pharmacy that serves both
commercial and non-commercial needs. KnippeRx helps overcome the
complex barriers to patient access by providing the shortest path
from initiation of a prescription to delivery of essential therapy.
Knipper 3PL provides storage and distribution of CRT, Cold Chain,
Frozen, and DEA III-V products along with full order to cash,
chargebacks, and contract management services.
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 agreements
with Knipper, UpScript, IQVIA, APS and bfw and the anticipated
results of the Company’s sales and marketing efforts for its
commercial stage products 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 Knipper, 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 date thereof.
Media Contact Information:Blue Water Media RelationsTelephone:
(646) 942-5591Email: Nic.Johnson@russopartnersllc.com
Investor Contact Information:Blue Water Investor RelationsEmail:
investors@bwbioinc.com
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