Aytu BioPharma has signed an exclusive agreement with Fabre-Kramer Pharmaceuticals to commercialise Exxua (gepirone) extended-release tablets, a new antidepressant, to the US market for major depressive disorder (MDD).
Exxua, developed by Fabre-Kramer Pharmaceuticals, is a selective serotonin 5HT1a receptor agonist that has gained approval from the US Food and Drug Administration (FDA) for treating MDD in adults.
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Aytu issued an initial payment to Fabre-Kramer Pharmaceuticals upon closure and will make another payment on the first anniversary of Exxua’s market release.
Aytu is committed to royalty payments based on net sales as stipulated in their definitive agreement, including a product transfer cost.
Contingent on reaching specific revenue milestones over the duration of their partnership, Aytu will disburse variable milestone fees to Fabre-Kramer Pharmaceuticals.
Aytu CEO Josh Disbrow stated: “We believe that the licensing of EXXUA represents a transformative milestone for Aytu and a significant advancement for patients suffering from major depressive disorder.
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By GlobalData“More importantly, given the compelling and novel product profile of EXXUA and the unmet needs of MDD patients, we believe EXXUA can become a very important treatment option for the over 21 million Americans affected by MDD. We look forward to launching EXXUA later this year and to our exciting partnership with Fabre-Kramer Pharmaceuticals.”
Funding for the transaction comes from cash reserves, accompanied by financing from healthcare-focused investors such as Nantahala Capital Management and Stonepine Capital Management, along with contributions from Aytu management and new institutional shareholders.
Preparations are underway to introduce Exxua into the US market swiftly, aiming for pharmacy and patient access by late 2025.
Fabre-Kramer Pharmaceuticals co-founder and CEO Stephen Kramer stated: “We believe EXXUA will be a very important addition to physicians managing the millions of patients with depression in the US and worldwide.” The therapeutic effect of Exxua is attributed to its modulation of serotonin activity through strong binding affinity for 5HT1a receptors — crucial components in mood regulation.
