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8-K - FORM 8-K - AYTU BIOPHARMA, INC | aytu_8k.htm |
Exhibit 99.1
Aytu BioScience Submits Notice of
Commercialization to the FDA, Allowing for Company’s
Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care
Rapid Test
Commercial Distribution of First 100,000 Tests to Commence Upon
Receipt of Inbound Product Shipment
ENGLEWOOD,
CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU), a specialty pharmaceutical company focused on
commercializing novel products that address significant patient
needs
announced today that it has received confirmation
from the U.S. Food and Drug Administration (FDA) that the company
may begin distribution of its Coronavirus Disease 2019
(“COVID-2019”) IgG/IgM Rapid Test throughout the United
States. The COVID-19 IgG/IgM Rapid Test is intended for
professional use and delivers results between 2 and 10 minutes at
the point-of-care.
Aytu
expects delivery of its first shipment of 100,000 tests this week.
The initial product shipment is in transit from the manufacturer
and, upon receipt, will undergo FDA and U.S. Customs and Border
Protection (CBP) clearance processes. The test kits will then be
repackaged to comply with FDA’s labeling requirements under
the most recent coronavirus guidance for serological test kit
manufacturers. The Company has been in discussions with healthcare
distributors, healthcare institutions, medical practices, and
government agencies and is working rapidly to distribute the test
into the U.S. healthcare supply chain.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
“We are moving as quickly as we can to bring the COVID-19
IgG/IgM Rapid Test to the U.S. professional medical community. With
product now in transit to our warehouse in Colorado we’re
optimistic that we can have test kits ready for sale in the very
near term. In the two short weeks since signing our distribution
agreement, we have ordered our first 100,000 tests and have
received confirmation from FDA that we may begin distribution. We
are optimistic that we’re now just days away from placing
these COVID-19 test kits into the hands of healthcare
professionals.”
The
COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic
assay used in the rapid, qualitative and differential detection of
IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole
blood, serum or plasma. This point-of-care test has been validated
in a 126 patient clinical trial and is CE marked.
About Aytu BioScience, Inc.
Aytu
BioScience is a commercial-stage specialty pharmaceutical company
focused on commercializing novel products that address significant
patient needs. The company currently markets a portfolio of
prescription products addressing large primary care and pediatric
markets. The primary care portfolio includes (i) Natesto®, the
only FDA-approved nasal formulation of testosterone for men with
hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist™,
the only FDA-approved oral spray prescription sleep aid, and (iii)
Tuzistra® XR, the only FDA-approved 12-hour codeine-based
antitussive syrup. The pediatric portfolio includes (i)
AcipHex® Sprinkle™, a granule formulation of rabeprazole
sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor,
a second-generation cephalosporin antibiotic suspension; (iii)
Karbinal® ER, an extended-release carbinoxamine
(antihistamine) suspension indicated to treat numerous allergic
conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two
complementary prescription fluoride-based supplement product lines
containing combinations of fluoride and vitamins in various for
infants and children with fluoride deficiency. Aytu recently
acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM
Rapid Test. This coronavirus test is a solid phase
immunochromatographic assay used in the rapid, qualitative and
differential detection of IgG and IgM antibodies to the 2019 Novel
Coronavirus in human whole blood, serum or plasma. This
point-of-care test has been validated in a 113 patient clinical
trial and has received CE marking.
Aytu
recently acquired Innovus Pharmaceuticals, a specialty
pharmaceutical company commercializing, licensing and developing
safe and effective consumer healthcare products designed to improve
men's and women's health and vitality. Innovus commercializes over
thirty-five consumer health products competing in large healthcare
categories including diabetes, men's health, sexual wellness and
respiratory health. The Innovus product portfolio is commercialized
through direct-to-consumer marketing channels utilizing the
company's proprietary Beyond Human® marketing and sales
platform.
Aytu's
strategy is to continue building its portfolio of
revenue-generating products, leveraging its focused commercial team
and expertise to build leading brands within large therapeutic
markets. For more information visit aytubio.com and visit
innovuspharma.com to learn about the company's consumer healthcare
products.
Forward-Looking Statement
This
press release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, or the
Exchange Act. All statements other than statements of historical
facts contained in this presentation, are forward-looking
statements. Forward-looking statements are generally written in the
future tense and/or are preceded by words such as ''may,''
''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,''
''suggest,'' ''believe,'' ''estimate,'' ''continue,''
''anticipate,'' ''intend,'' ''plan,'' or similar words, or the
negatives of such terms or other variations on such terms or
comparable terminology. These statements are just predictions and
are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These risks and
uncertainties include, among others: market and other conditions,
the completion of the registered direct offering, the satisfaction
of customary closing conditions related to the registered direct
offering and the intended use of net proceeds from the registered
direct offering, the regulatory and commercial risks associated
with introducing the COVID-19 Rapid Test, effects of the business
combination of Aytu and the Commercial Portfolio and the recently
completed merger ("Merger") with Innovus Pharmaceuticals, including
the combined company's future financial condition, results of
operations, strategy and plans, the ability of the combined company
to realize anticipated synergies in the timeframe expected or at
all, changes in capital markets and the ability of the combined
company to finance operations in the manner expected, the diversion
of management time on Merger-related issues and integration of the
Commercial Portfolio, the ultimate timing, outcome and results of
integrating the operations the Commercial Portfolio and Innovus
with Aytu's existing operations, risks relating to gaining market
acceptance of our products, obtaining or maintaining reimbursement
by third-party payors for our prescription products, the potential
future commercialization of our product candidates, the anticipated
start dates, durations and completion dates, as well as the
potential future results, of our ongoing and future clinical
trials, the anticipated designs of our future clinical trials,
anticipated future regulatory submissions and events, our
anticipated future cash position and future events under our
current and potential future collaboration. We also refer you to
the risks described in ''Risk Factors'' in Part I, Item 1A of the
company's Annual Report on Form 10-K and in the other reports and
documents we file with the Securities and Exchange Commission from
time to time.
Contact for Media and Investors:
James
Carbonara
Hayden
IR
(646)
755-7412
james@haydenir.com
Contact for COVID-19 IgG/IgM Rapid Test-Related
Inquiries:
COVID-19@aytubio.com