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| 8-K - FORM 8-K - AYTU BIOPHARMA, INC | aytu_8k.htm |
Exhibit 99.1
Aytu
BioScience Confirms Export and Incoming Delivery of COVID-19
IgG/IgM Rapid Tests
Chinese Officials Confirm China Won’t Restrict Exports of
Medical Products Needed to Fight Coronavirus
Company in Late-Stage Negotiations
to Secure Distribution Agreement for Additional COVID-19 IgG/IgM
Rapid Test Which is Approved by China’s National Medical
Products Administration (NMPA)
ENGLEWOOD, CO / ACCESSWIRE / April 17, 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 export and delivery of the
Company’s incoming COVID-19 rapid tests remains on track as
previously announced.
Additionally, the Company is in late-stage negotiations to secure
rights to distribute a second COVID-19 IgG/IgM rapid test, which is
approved by China’s National Medical Products Administration
(NMPA).
Josh Disbrow, Chief Executive Officer of Aytu BioScience,
commented, “Since the Company began taking the fight to
COVID-19, we have continued to aggressively search for and evaluate
diagnostic tests and other novel technologies that may complement
our current product offering and benefit COVID-19 patients. Also,
given the nationwide shortage of tests, we believe we are obligated
to secure as many additional tests as we can to help with this
shortage. To that end, I am excited to say we’re in the final
stages of securing yet another IgG/IgM antibody rapid test for U.S.
distribution. This test is already approved by China’s NMPA,
is being regularly exported from China, and has strong clinical
performance. By securing this additional antibody test, we expect
to have an even greater supply to fulfill the substantial demand
we’re experiencing. We all need to continue to do the very
best we can to help COVID-19 patients and those medical
professionals for whom they care.”
Mr. Disbrow continued, “On March 31, an announcement was made
by China's Ministry of Commerce restricting the export of medical
materials that have not obtained approval from the NMPA. It is
important to note that just yesterday the Associated Press released
an article titled, ‘China says
no plans to limit export of anti-virus supplies.’ The article states: ‘Commerce
Ministry spokesman Gao Feng said Beijing has taken steps to
speed up customs clearance while ensuring the quality of exported
epidemic-prevention goods. Gao said Thursday, ‘China has not and will not restrict the export of
epidemic prevention materials.’ These statements provide us
with confidence and are consistent with the information we continue
to receive from our test kit licensor. We remain confident about
the timely delivery of the Company’s incoming order of
COVID-19 IgG/IgM tests,” commented Mr.
Disbrow.
Mr. Disbrow concluded, “We have received further confirmation
that the COVID-19 IgG/IgM Rapid Test manufactured by Zhejiang
Orient Gene is in the approval process with NMPA. We remain highly
confident in the test’s clinical performance as recently
demonstrated in a published, third-party peer-reviewed study
and believe that the Zhejiang Orient
Gene COVID-19 IgG/IgM Rapid Test is a reliable test in detecting
COVID-19 antibodies. The independent study demonstrates test accuracy of 98.0% and 94.1% for
IgG and IgM, respectively, when using PCR-positive cases as true
positives, which we believe establishes strong clinical utility of
the test.”
The Company will continue to inform our stakeholders about our
continuing developments relating to our COVID-19 fight and the
progress of the Aytu BioScience business.
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.
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:
James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com