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| 8-K - CURRENT REPORT - AYTU BIOPHARMA, INC | aytu_8k.htm |
Exhibit 99.1
Aytu BioScience Announces First Commercial Shipment of its 2-10
Minute COVID-19 IgG/IgM Point-of-Care Rapid Test
First COVID-19 Rapid Tests Delivered to Denver First
Responders
ENGLEWOOD,
CO / ACCESSWIRE / April 3, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU), (the “Company”), a specialty pharmaceutical
company focused on commercializing novel products that address
significant patient needs
announced today that it began shipping its
Coronavirus Disease 2019 (“COVID-2019”) IgG/IgM Rapid
Test to U.S. customers. Upon receipt of the initial 100,000 tests,
the company completed product relabeling to ensure compliance with
FDA guidance on COVID-19 serology test kits.
The
Company has received orders for the COVID-19 IgG/IgM Rapid Test
from a broad range of healthcare customers including large medical
centers, municipalities, first responders, medical practices, and
other healthcare customers. The Company expects to have all
customer backorders filled in the coming days.
The
Company’s first 2,750 COVID-19 Rapid Tests have been
purchased by the Denver Police Department for use in screening
Denver’s first responders. The test kits were delivered to
Denver Chief of Police Paul Pazen and members of his leadership
team at Aytu BioScience’s corporate headquarters on April 2,
2020.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
“Upon receipt of our initial product shipment on March
31st, we
immediately went to work to prepare the test kits for commercial
distribution. The Aytu team has worked very hard over the last two
days to relabel all 100,000 tests, and we’re now shipping
product to our customers across the country. Importantly, we are
proud to be assisting our first responders here at home as we
delivered over 2,000 tests to Denver Police Chief Pazen and his
team. Our public safety personnel are doing outstanding work in our
communities throughout this crisis, so we’re glad to be
partnering with Denver’s first responders in this
fight.”
Mr.
Disbrow continued, “The demand for the COVID-19 IgG/IgM Rapid
Test has been substantial, so we have increased our order size to
500,000 tests (20,000 kits) to provide a larger supply to
healthcare professionals and first responders in
need.”
The
COVID-19 IgG/IgM Rapid Test is a serology test 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 in China and is CE marked.
The
Company believes that serology tests are a potentially powerful
tool for identifying anyone who has been infected, whether they had
symptoms or not. Antibodies to coronaviruses typically remain in
humans for up to 90 days or more. The Company believes that
serological testing is important in identifying the total number of
people who have been infected with COVID-19. This type of testing
could be particularly important for the immune surveillance of
health care workers, first responders, government workers, and
others whose infection risks could be heightened by working with
COVID-19 infected individuals.
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.
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