Company Expects to Pursue Commercial Use Under FDA's Emergency Use Authorization

ENGLEWOOD, CO / ACCESSWIRE / March 10, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it signed an exclusive distribution agreement for the right to commercialize a clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation), which licensed North American rights from product developer Zhejiang Orient Gene Biotech Co., Ltd. The test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This exclusive agreement grants Aytu the exclusive right to distribute the product in the United States for a period of three years, with additional three-year autorenewals thereafter.

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 113 patient clinical trial and has received CE marking. It is currently one of only a few tests used for coronavirus screening in China.

Test Features:

Results reported in 2-10 minutes

Facilitates patient treatment decisions quickly

Simple, time-saving procedure

Small specimens, only 5 µL of serum/plasma or 10 µL of whole blood specimens required

All necessary reagents provided & no equipment needed

High sensitivity and speciﬁcity

Clinical Results

The COVID-19 IgG/IgM Rapid Test was evaluated with 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms. All samples were tested using the Orient Gene diagnostic device, and the results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs and symptoms) of Novel Coronavirus pneumonia.

Clinical results using the COVID-19 IgG/IgM Rapid Test show:

The sensitivity of the lgM test is 87.9% (87/99) and specificity is 100% (14/14) when compared to RT-PCR. The sensitivity of the lgG test is 97.2% (35/36) during patients' convalescence period and specificity is 100% (14/14).

The Company expects to pursue U.S. regulatory clearance and expects to consult with the U.S. Food and Drug Administration about qualifying the test under FDA's Emergency Use Authorization.

The Company expects to receive an initial product shipment in three to four weeks, pending the timing of required regulatory, customs, and importation activities.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "The safety and health of every American is of paramount importance to the company as we face the threat of the coronavirus. We are excited to be able to work with U.S. regulatory authorities, and we will work to make this important test available in the U.S. as soon as possible. Coronavirus is a major global health concern, and we are proud to be in a position to help clinicians address this very serious public health concern."

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 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.

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