Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
Eton Pharmaceuticals recently 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 US FDA in May of 2023 for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the US suffer from this ultra-rare condition.
“With a patient population of less than 500, Nitisinone is another opportunity for Eton to deliver on its mission of providing medicines to and supporting patients and families with rare conditions. Nitisinone is our fourth FDA-approved product, and further advances us toward our goal of having ten commercial rare disease products on the market by the end of 2025. Nitisinone also shares the same metabolic geneticist prescriber base as our Carglumic Acid and Betaine products, so this is an attractive opportunity to leverage our existing sales force and relationships with prescribers,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
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 $50 million 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.
Eton is an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases. The Company currently has three commercial rare disease products, ALKINDI SPRINKLE for the treatment of pediatric adrenocortical insufficiency, Carglumic Acid for the treatment of hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency, and Betaine Anhydrous for the treatment of homocystinuria. The Company has four additional product candidates in late-stage development: dehydrated alcohol injection, which has received Orphan Drug Designation for the treatment of methanol poisoning, ZENEO hydrocortisone autoinjector for the treatment of adrenal crisis, ET-400 for the treatment of adrenocortical insufficiency, and ET-600 for the treatment of diabetes insipidus. For more information, visit www.etonpharma.com.
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