Attached files
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| 8-K - CURRENT REPORT - AYTU BIOPHARMA, INC | aytu_8k.htm |
Exhibit 99.1
Aytu BioScience Announces Exclusive Distribution Agreement for
COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics
Limited
ENGLEWOOD, CO / ACCESSWIRE / April 23, 2020 / Aytu
BioScience, Inc. (NASDAQ: AYTU) (the “Company”),
a specialty pharmaceutical company
focused on commercializing novel
products that address significant patient needs, announced the signing of a definitive
agreement (the “Agreement”) with Singapore-based
Biolidics, Limited (SGX: 8YY; “Biolidics”) to
exclusively distribute Biolidics’ COVID-19 IgG/IgM Rapid Test
in the United States.
Under
the terms of the Agreement, Aytu will exclusively distribute
Biolidics’ COVID-19 IgG/IgM rapid antibody test in the United
States. Aytu has committed to purchase 500,000 tests within one
business day from the date of signing of the Agreement. As an
additional component of Aytu’s exclusivity, the Company has
committed to purchase a minimum of 1,250,000 tests within the first
three months of the Agreement.
Biolidics’
COVID-19 IgG/IgM Rapid Test has been issued Provisional
Authorization for distribution by Singapore’s Health
Science’s Authority (HSA), and the product has been
authorized for export from Singapore. Biolidics’ COVID-19
IgG/IgM Rapid Test will be supplied from Biolidics’ facility
in Singapore.
Aytu
will collaborate with Biolidics and lead the U.S. clinical trials
processes and plans to complete and obtain U.S. Food and Drug
Administration (“FDA”) 510k regulatory filing clearance
of the COVID-19 IgG/IgM rapid test kits.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
“We are pleased to be partnering with Biolidics in
distributing this COVID-19 rapid test in the U.S. With the
continued call in the United States for increased COVID-19 testing,
we are entering this distribution Agreement at an excellent time.
We have experienced significant demand for our current COVID-19
rapid test, so adding this test to our product offering will enable
us to better meet the high demand in the U.S. We look forward to a
productive working relationship with Biolidics and thank them for
their confidence in allowing Aytu to take this product to market in
the United States.”
Incorporated in 2009 and listed on the Singapore Stock Exchange,
Biolidics Limited is a Singapore-based precision medicine medical
technology company with a focus in developing a portfolio of
innovative diagnostic solutions to lower healthcare costs and
improve clinical outcomes.
About Aytu BioScience, Inc.
Aytu
BioScience, Inc. 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 U.S. distribution rights to two
COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid
phase immunochromatographic assays 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.
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 and Healight-Related
Inquiries:
COVID-19@aytubio.com