Aytu BioScience (AYTU) announces the introduction of the Cotempla XR-ODT Manufacturing Site Transfer Supplement
Aytu BioPharma, Inc. (The Company or “Aytu”) (AYTU), a pharmaceutical company focused on developing and commercializing new therapies, has submitted the Cotempla XR-ODT� (“Cotempla”) prior approval (PAS) supplement to the United States Food and Drug Administration (FDA). If approved, PAS would enable Aytu to transfer Cotempla production to the company’s third-party manufacturer. The company expects to conduct a six-month review of the PAS submission, which will enable FDA approval by late calendar 2023 or early calendar 2024. The company previously announced FDA approval of the Adzenys XR-ODT relocation. (“Adzenys”) and has begun to shift production of Adzenys to the company’s contract manufacturer.
“I am pleased to report this additional achievement as we work to increase the profitability of our products by reducing cost of goods sold and expenses associated with producing ADHD products by leveraging contract manufacturer operating efficiencies,” said Josh Disbrow, CEO of Aytu. “With this additional step now achieved, we have greater visibility into the timing of the site move and expect to begin outsourcing manufacturing for Adzenys and Cotempla by late 2023 or early 2024. More importantly, we have already begun shifting Adzenys production to Aytu contract manufacturer Thus, we expect to begin realizing margin improvements for the ADHD brands in early calendar 2024. As we previously reported, upon completion of site transfers for both products and exit from the former Neos Therapeutics Grand Prairie, Texas facility, we expect to achieve an estimated fifteen percent improvement Margin for ADHD Brands I am grateful for the tremendous efforts of our team and commend their hard work in driving the transfer of these important brands to the site.”
About Articles BioPharma, Inc.
Aytu BioPharma is a pharmaceutical company that markets a range of commercial therapeutic drugs and consumer health products. The Company’s prescription products include Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets (see full prescribing information, including boxed warning) and Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets (see Full prescribing information, including Boxed WARNING) for the treatment of attention deficit-hyperactivity disorder (ADHD), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension used to treat several allergic conditions, and Poly-Vi-Flor and Tri-Vi -Flor, two lines of fluoride-based vitamin supplement products available in various formulations for infants and children with fluoride deficiency. Aytu’s Consumer Health segment markets a range of over-the-counter medicines and consumer health products that treat a range of common conditions including diabetes, allergies, hair regrowth and gastrointestinal ailments. To learn more, visit aytubio.com.
Forward-looking statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, or the Stock Exchange Act. All statements other than statements of historical fact made in this press release are forward-looking statements. Forward-looking statements are generally written in the future tense and/or preceded by words such as “may,” “will,” “should,” “predict,” “could,” “anticipate,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, negatives of these terms or other variations of such or similar terms. All statements other than statements of historical fact made in this press release are forward-looking statements. These statements are only predictions and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the risks associated with the Company’s ability to achieve cost savings and move the manufacture of its ADHD products to a third party contract manufacturer and the associated timing. We also refer you to (1) the risks described in Risk Factors in Part I, Section 1A of Aytu’s most recent annual report on Form 10-K and in reports and other documents you file with the Securities and Exchange Commission.
Contacts for investors:
Mark Oakey, Chief Financial Officer
Aytu BioPharma, Inc.
moki@aytubio.com
Robert Blum or Roger Weiss
Lytham Partners
AYTU@lythampartners.com
source: Aytu BioPharma, Inc.
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