Full Press Release Details
Blue Water Biotech Issues CEO Shareholder Letter
Providing Update on Commercial Launch Activities
CINCINNATI, OH, July 17, 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 issued the
following letter to shareholders from its Chairman and Chief Executive Officer, Joseph Hernandez.
Dear Fellow Shareholders,
In recent months, Blue Water Biotech, Inc. ("Blue
Water") has evolved from a preclinical vaccine development company to a commercial stage pharmaceutical company after the purchase
of several FDA approved assets spanning multiple treatment areas. Capital raises in 2022, resulting in a strong cash position at the beginning
of 2023, enabled us to pursue these strategic acquisitions. We believe the acquisition of these assets will generate tremendous value
for Blue Water, and we are pleased to provide an update on our commercial launch progress thus far and milestones we intend to achieve
in the coming months.
Our recent acquisitions include ENTADFI ,
an FDA approved, once daily pill combining finasteride and tadalafil for the treatment of benign prostatic hyperplasia ("BPH"),
and six additional FDA approved assets across multiple indications, including cardiology, inner and outer ear infections, and pain management.
While each product has unique considerations for launch and we have analyzed each closely, we have developed a core framework for commercial
operations as we progress towards official launch.
To begin, the core for any successful commercial
operation is a dedicated, experienced management team to steer operations and make strategic decisions that will benefit Blue Water in
the long run. In February 2023, we appointed Frank Jaeger to the team as Senior Vice President of Marketing and Business Development,
bringing with him over 25 years of biopharmaceutical experience from start-up to large global pharma and targeted launch experience in
Men's Health. Mr. Jaeger has been instrumental in developing our launch strategy for these assets, and we look forward to his continued
strong leadership as we reach launch and beyond.
With our commercial leadership team in place,
we have identified key areas on which to focus our efforts, including expanding product availability for our patients, as well as marketing
and advertising to increase awareness for our products through multiple channels.
Expanding Product Availability for Patients
We have taken key steps to ensure that patients
have proper access to therapy, including securing a license from the Ohio State Board of Pharmacy, allowing us to operate as a pharmaceutical
wholesaler in our home state of Ohio. As we look to gain additional licenses, we are also making significant progress in identifying vendors
and solidifying agreements with key players in the distribution channel, including third party logistics providers and wholesalers to
serve our retail pharmacy customers nationwide.
In addition to the traditional retail pharmacy
channel, our commercial team has identified telemedicine as a potential solution for select patients to access therapy without having
to step into a healthcare provider's office. Telemedicine is helpful for remote patients, those with timing constraints, or those
who may have difficulty scheduling an appointment with a specialist. This approach is particularly relevant for current BPH patients who
may be eligible for ENTADFI . We are in the process of identifying the right telemedicine partner for ENTADFI
and potentially other assets in our portfolio, so that our patients can benefit from this platform upon official launch.
In order to help patients access our products,
we plan to partner with a hub provider to not only address the challenges that patients may have during the treatment journey, but also
to help ease the administrative burden on healthcare providers. The payer coverage process is very complex and can be extremely time consuming
for providers, and our goal in utilizing a hub will be to help providers navigate this process and help alleviate subsequent treatment
delays for patients. Additionally, as many of our products are long-term medications, we will lean on our selected hub vendor to serve
patients throughout the treatment journey and provide support to them and their prescribers, with an eye to optimizing revenue for Blue
Water with recurring prescriptions.
Regardless of the channel our patients utilize
to access our therapies, our commercial team recognizes that payer coverage and market access is critical to the success of any pharmaceutical
launch. To this end, we recently signed an agreement with Advantage Point Solutions, LLC to support our market access strategy and to
assist in formulary negotiations with key healthcare payers and pharmacy benefit managers for ENTADFI . With their robust
network of relationships, we are confident that they are the right partner for this endeavor and will help us secure placement on key
formularies in the commercial and government sectors.
Increasing Product Awareness Through Marketing
In addition to our patient- and provider-focused
approach to ensure proper access to therapy, we are developing an extensive marketing and advertising strategy with industry leading organizations
to support our commercial portfolio. This approach includes the creation of a robust sales team capable of reaching physicians nationwide,
as well as the generation of powerful marketing material designed to maximize impact and drive sales.
In June 2023, we announced a collaboration with
IQVIA to build our medical sales representative team, covering key geographies that account for a large percentage of prescriptions in
target markets of urology and cardiology. We are in the process of finalizing the targeted launch plan for this team, but we believe they
will be instrumental in the success of our products as they identify physicians across the country and increase awareness. We fully intend
to provide our team with proper sales materials, including extensive disease state and product education, access to a robust customer
relationship management software, updated prescribing data and trends, as well as effective marketing material to educate physicians.
In addition to establishment of our sales team
with IQVIA, we have made significant progress on the marketing and advertising front through the signing of a Master Services Agreement
with bfw Advertising Inc. ("bfw") and generating an action plan for our commercial portfolio. Bfw has more than three decades
of experience supporting life science companies of various sizes and stages, and we are working closely with them to generate new and
effective marketing materials for our products, as well as improve on current materials for these products. With bfw, we look forward
to rolling out patient-facing materials, website updates, social ads, targeted provider engagement, as well as materials to support our
sales team with IQVIA, in the coming weeks and months.
To summarize, the last few months have certainly
been an exciting time for Blue Water, filled with acquisitions, growth, and execution. Although we have made significant progress on our
launch plans in a short period of time, we also look forward to achieving the key milestones outlined above and generating additional
value for our shareholders.
We thank you for your continued support of Blue
Chairman and Chief Executive Officer
ENTADFI is an oral, once daily
treatment for BPH that combines finasteride, a 5 -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 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 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