|From: Giants1967||3/19/2020 11:12:02 AM|
|AYTU Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures.|
Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the 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). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.
The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."
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 is CE marked.
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|From: Giants1967||4/13/2020 10:02:01 AM|
|AYTU News! 4/13|
Aytu BioScience Consumer Health Subsidiary Launches Regoxidine(R), an FDA Approved Hair Regrowth Treatment Foam that Contains 5% Minoxidil and Targets Over 11 Million U.S. Consumers Who Purchased Hair Regrowth Products in 2019.
Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today the launch of Regoxidine®, an over-the-counter foam formulation of minoxidil available for use by both men and women. Regoxidine® is indicated for hair treatment and regrowth and is available through the company's recently acquired, wholly-owned subsidiary Innovus Pharmaceuticals. Regoxidine® is a branded alternative to hair regrowth treatment Rogaine®. Regoxidine® is available for purchase through the product's website regoxidine.com. The product is also available through its Beyond Human® marketing and sales platform and through Amazon. Over 11 million Americans purchased and used hair regrowth products in 2019.
Regoxidine® for Men and Regoxidine® for Women are the second and third FDA-approved, over-the-counter drugs Innovus Pharmaceuticals has launched to date following the launch of FlutiCare® (fluticasone propionate 50 mcg nasal spray) in 2017. FlutiCare is indicated to treat nasal and allergy-related symptoms.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are excited about the launch of Regoxidine® OTC and the expansion of our consumer health product portfolio. Regoxidine® represents the first consumer product launch since completing the merger between Aytu and Innovus, and the consumer health team will continue its focus on developing and launching new products that address large segments of consumers. Through the expansion of the over-the-counter product portfolio, and the growth of our existing prescription and consumer healthcare products, we anticipate continued revenue growth with strong contribution from both of Aytu's business segments, expected to accelerate our path to profitability."
About Regoxidine® 5% Minoxidil Foam for Men and Women
Regoxidine® is a topical foam containing 5% minoxidil that is approved by the FDA as a hair regrowth treatment and is used to grow hair on the top of the scalp. The active ingredient is 5% minoxidil and is comparable to the Rogaine®* line of similar products from Johnson & Johnson. The product comes in a 60g canister and will be sold as a 90-day supply for men and as a 120-day supply for women. Regoxidine® is available as a foam for men and women.
The American Hair Loss Association (AHLA) reported that more than 95% of hair loss is caused by androgenetic alopecia. Also, approximately 35 million men and 21 million women 35 years of age and older experience hair loss. The 5% minoxidil market segment of the hair regrowth treatment market is projected to grow more than 4.5% annually through 2024. According to Global Market Insights the US market is valued at $0.5 billion with approximately 50 million retail units sold. The 5% foam products are the newest means of minoxidil delivery and are proven to be more effective against androgenic alopecia among men than other minoxidil formulations.
For more information visit www.regoxidine.com
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