On October 1, 2024 Aytu BioPharma, Inc., a pharmaceutical company focused on commercializing novel therapeutics, and Lupin Pharma Canada Ltd, a subsidiary of global pharma major Lupin Limited, announced the signing of an exclusive collaboration, distribution and supply agreement for Aytu's Adzenys XR-ODT® and Cotempla XR-ODT® product lines in Canada. Wilson Sonsini Goodrich & Rosati advised Aytu BioPharma on the transaction.
Adzenys XR-ODT extended-release orally disintegrating tablets is a prescription medicine used for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and above and the only brand FDA-approved as bioequivalent to Adderall XR®. Cotempla XR-ODT is the only extended-release orally disintegrating tablet methylphenidate and is FDA-approved as a once-daily ADHD treatment for patients 6 to 17 years of age. Aytu's ADHD portfolio has experienced rapid growth over the past two years, with prescriptions increasing 16.5 percent during that time. This agreement extends Aytu's reach through the expansion into one of the world's largest ADHD markets outside the United States. In 2023, the Canadian ADHD stimulant market recorded 4.5 million units and $1.1 Billion CAD in gross sales. (Source: IQVIA Canada). Lupin will seek local regulatory approvals and marketing authorizations for both Adzenys XR-ODT and Cotempla XR-ODT, which is expected to occur over the next 18 to 24 months.
The Wilson Sonsini team that advised Aytu BioPharma, Inc. includes Seth Flaum and Nguyen Pham.
For more information, please see Aytu BioPharma’s press release.