Eton Pharmaceuticals to acquire abbreviated NDA for Nitisinone Capsules

Eton Pharmaceuticals announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy proceeding. The transaction has been approved by the bankruptcy court and is expected to be effective on October 12, 2023. The acquired product was approved by the U.S. FDA in May of 2023 for the treatment of hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the United States suffer from this ultra-rare condition. Eton expects to launch the product in the first quarter of 2024 and plans to offer its Eton Cares support program to all patients. The program is designed to help patients access treatment, providing prescription fulfillment services, insurance benefits investigation, educational support, and help in obtaining financial assistance for qualified patients, among other services. The current Nitisinone market is estimated to be over $50M annually, and Eton believes the company’s commercial advantages, including its Eton Cares program, existing relationships with prescribers, and experienced sales force should allow it to capture a meaningful percentage of the market.