Blue Water Biotech, Inc. (Nasdaq: BWV), a biotechnology company
spanning multiple sectors, today announced the signing of an Asset
Purchase Agreement (the “Agreement”) with WraSer, LLC and Xspire
Pharma, LLC (together, “WraSer”) for the purchase of six
FDA-approved assets across multiple indications, including
cardiology, otic infections, and pain management (the “WraSer
Assets”).
Under the terms of the Agreement, Blue Water Biotech, Inc.
(“Blue Water” or the “Company”) will purchase the WraSer Assets for
a total of $8.5 million cash consideration payable in three
tranches: at signing, upon closing and within one year of closing.
In addition, WraSer shall receive 1.0 million restricted shares of
Blue Water’s common stock on the closing date. The closing of the
transaction is subject to certain customary closing conditions, as
well as WraSer’s delivery of 2022 audited financial statements for
WraSer’s parent company, Legacy-Xspire Holdings, LLC, to Blue
Water. Blue Water will assume management of the WraSer Assets
during the audit period. The audited financial statements will be
publicly filed promptly after completion of the audit. The assets
under the Agreement include the patents related to ZONTIVITY®, a
medication for the reduction of thrombotic cardiovascular events in
patients with a history of myocardial infarction (“MI”) or with
peripheral arterial disease (“PAD”), as well as additional products
for the treatment of hypertension, otitis media, and pain
management.
ZONTIVITY®, a once daily pill approved in 2014, is a
first-in-class protease activated receptor-1 inhibitor which
mediates the cellular effects of thrombin to reduce the risk of
major adverse cardiovascular events and major adverse limb events
when used in addition to aspirin and/or clopidogrel in patients
with PAD. In a pivotal Phase 3 clinical trial, ZONTIVITY® was shown
to reduce the rate of a combined endpoint of cardiovascular death,
MI, stroke, and urgent coronary revascularization, with 13,186
patients evaluated for safety and 2,187 patients treated with
ZONTIVITY® for more than three years.
This Agreement also includes the purchase of licenses to market
and distribute two antibiotic otic products, OTOVEL® and CETRAXAL®,
and their authorized generics currently marketed and distributed by
WraSer. OTOVEL®, ciprofloxacin and fluocinolone acetonide, is used
to treat acute otitis media (“AOM”) in children 6 months of age and
older who have a tiny cylinder tube, known as a tympanostomy tube,
inserted in their eardrum that prevents excess fluid in the middle
ear. While tympanostomy tubes are typically placed as a result of
multiple ear infections within a short timeframe, they do not
prevent AOM, and one study found that over 80% of children had an
episode of AOM within 18 months of tympanostomy tube placement.
OTOVEL®, which contains an antibiotic to treat the infection and an
anti-inflammatory to reduce pain and swelling, is the first and
only antibiotic and steroid ear drop available in single use
vials.
In two clinical studies of pediatric patients with AOM with
tympanostomy tubes, children who took OTOVEL® were clear of
otorrhea in a median of 3.75 and 4.94 days, whereas those on
antibiotic alone were not clear until a median of 7.69 and 6.83
days. The clinical studies also showed that the combination of
medicines in OTOVEL® had similar side effects as the separate
medicines. Blue Water is currently developing a vaccine to prevent
acute otitis media regardless of tympanostomy tube insertion, and
the Company intends to leverage this experience and expertise in
the future commercialization and marketing for OTOVEL®.
The second otic product included in the Agreement, CETRAXAL®,
ciprofloxacin otic solution available in individual unit dosing
vials, is used to treat otitis externa, more commonly called
swimmer’s ear, in children with an intact tympanic membrane.
Swimmer’s ear is characterized by redness or swelling, irritation,
or infection of the outer ear canal and can be very painful if left
untreated, primarily impacting children that spend a lot of time in
the water.
In addition to ZONTIVITY® and otic products, Blue Water will
purchase the licensed rights to market and distribute CONJUPRI®, a
calcium channel blocker that can be used alone or in combination
with other antihypertensive agents for the treatment of
hypertension to lower blood pressure. Lowering blood pressure
reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and MIs. Additionally, Blue Water will purchase
two pain medications, TREZIX™ (acetaminophen, caffeine, and
dihydrocodeine bitartrate), for the treatment of moderate to
moderately severe pain for which non-opioids are inadequate, and
NALFON® (fenoprofen calcium), for relief of mild to moderate pain
in adults, as well as relief of the signs and symptoms related to
rheumatoid arthritis and osteoarthritis.
“The team at WraSer has developed a strong pipeline across
cardiology, otic products, as well as pain management, and we are
thrilled to add these assets to our portfolio at Blue Water,” said
Joseph Hernandez, Chairman and Chief Executive Officer of Blue
Water. “In recent months, we have invested significant efforts to
build our corporate infrastructure to support our transition into a
commercial-stage company, including key hires with extensive
experience in commercial operations. We are confident that bringing
these assets into our portfolio will strengthen Blue Water’s
financial position, allow us to advance our robust vaccine
pipeline, and help millions of patients around the world receive
proper access to critical treatments.”
“Our products have been developed to provide patients with life
changing, and potentially lifesaving, treatments, and we are happy
to partner with Blue Water to continue this mission,” said Greg
Stokes, Chief Executive Officer of WraSer. “Their management team
has extensive experience with commercial products across a wide
range of treatment areas, and we look forward to supporting them
through this transition, as well as seeing the continued success of
these products for patients in need.”
Blue Water, with its recent purchase of ENTADFI® and through
this acquisition, has established itself as a commercial-stage
biopharmaceutical company. The Company intends to leverage its
robust management and commercial team curated to maximize sales and
success of all products acquired from the Agreement, as well as
ENTADFI®, to further develop corporate infrastructure and to
support and its extensive vaccine pipeline.
About Blue Water Biotech
Blue Water Biotech, Inc. is a biological and pharmaceutical
technology company focused on developing and providing
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.
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 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 acquired from WraSer into Blue Water’s
business, risks related to the development of Blue Water’s vaccine
candidates; the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; 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 vaccine under development, there are significant risks in the
development, regulatory approval and commercialization of new
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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/d66c95d4-fd36-4f08-9971-f362edf2a98a
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