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| 8-K - FORM 8-K - AYTU BIOPHARMA, INC | aytu_8k.htm |
Exhibit
99.1
Aytu BioScience Signs Exclusive
Global License with Cedars-Sinai for Potential Coronavirus
Treatment
Cedars-Sinai-Developed ‘Healight’ Medical Device
Platform Technology Being Studied as a Potential First-in-Class
COVID-19 Treatment
Conference Call Scheduled for Tuesday, April 21, 2020 at 4:30 pm
ET
ENGLEWOOD,
CO / ACCESSWIRE / April 20, 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 has signed an
exclusive worldwide license from Cedars-Sinai to develop and
commercialize the Healight Platform Technology
(“Healight”). This medical device technology platform,
discovered and developed by scientists at Cedars-Sinai, is being
studied as a potential first-in-class treatment for coronavirus and
other respiratory infections.
The company will host a live conference call and webcast Tuesday,
April 21, 2020 at 4:30 p.m. ET. Conference call details are
provided at the end of this press release.
Led by
Mark Pimentel, MD, the research team of the Medically Associated
Science and Technology (MAST) Program at Cedars-Sinai has been
developing the patent-pending Healight platform since 2016 and has
produced a growing body of scientific evidence demonstrating
pre-clinical safety and effectiveness of the technology as an
antiviral and antibacterial treatment. The Healight technology
employs proprietary methods of administering intermittent
ultraviolet (UV) A light via a novel endotracheal medical device.
Pre-clinical findings indicate the technology’s significant
impact on eradicating a wide range of viruses and bacteria,
inclusive of coronavirus. The data have been the basis of
discussions with the FDA for a near-term path to enable human use
for the potential treatment of coronavirus in intubated patients in
the intensive care unit (ICU). Beyond the initial pursuit of a
coronavirus ICU indication, additional data suggest broader
clinical applications for the technology across a range of viral
and bacterial pathogens. This includes bacteria implicated in
ventilator associated pneumonia (VAP).
“Our team has shown that
administering a specific spectrum of UV-A light can eradicate
viruses in infected human cells (including coronavirus) and
bacteria in the area while preserving healthy cells,” stated
Dr. Pimentel of Cedars-Sinai. Ali Rezaie, MD, one of the inventors
of this technology states, “Our lab at Cedars-Sinai has
extensively studied the effects of this unique technology on
bacteria and viruses. Based on our findings we believe this
therapeutic approach has the potential to significantly impact the
high morbidity and mortality of coronavirus-infected patients and
patients infected with other respiratory pathogens. We are looking
forward to partnering with Aytu BioScience to move this technology
forward for the benefit of patients all over the
world.”
The
company believes the Healight platform technology has the potential
to positively impact outcomes for critically ill patients infected
with coronavirus and severe respiratory infections. The company
licensed exclusive worldwide rights to the technology from
Cedars-Sinai for all endotracheal and nasopharyngeal indications.
Patents have been filed by Cedars-Sinai Department of Technology
Transfer, and Aytu BioScience will manage all aspects of
intellectual property prosecution and filing globally. Aytu
BioScience expects to partner the product outside the
U.S.
“We
are honored to be partnering with Cedars-Sinai as we believe the
Healight therapeutic platform has the potential to help many
patients during this coronavirus pandemic and beyond,” said
Josh Disbrow, Chairman and CEO of Aytu BioScience.
The
Company is engaging with the research team at Cedars-Sinai and the
FDA to determine an expedited regulatory process to potentially
enable near-term use of the technology initially as a coronavirus
intervention for critically ill intubated patients.
Disbrow
continued, “This first-in-class technology has the potential
to be a game changer for clinicians treating patients infected with
coronavirus and other respiratory conditions, and our team is
working tirelessly alongside the Cedars-Sinai team to determine the
safety and effectiveness of this device in
humans.”
Conference Call Information
The
company will host a live conference call at 4:30 p.m. ET Tuesday,
April 21, 2020. The conference call and webcast can be accessed by
dialing either number below or via the weblink:
1-
877-407-9124 (toll-free)
1-201-689-8584
(international)
https://www.webcaster4.com/Webcast/Page/2142/34401
The
webcast will be accessible live and archived on Aytu BioScience's
website, within the Investors section under Events &
Presentations, at aytubio.com, for 90 days.
A
replay of the call will be available for fourteen days. Access the
replay by calling 1-877-481-4010 (toll-free) and using the replay
access code 34401.
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 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 126 patient
clinical trial in China 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 Healight and COVID-19 Related Inquiries:
COVID-19@aytubio.com
SOURCE: Aytu BioScience, Inc.