Press release
Eton Pharmaceuticals Announces First Quarter 2020 Financial Results
DEER PARK, Ill., May 14, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and
About this update from Eton Pharmaceuticals, Inc.
[{"type":"text","content":"DEER PARK, Ill., May 14, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today reported financial results for the first quarter ended March 31, 2020 and provided an update on business progress.\n “The first quarter was an exciting period for Eton. We acquired marketing rights to orphan drug Alkindi Sprinkle and strengthened our balance sheet with an additional $9.8 million of liquidity,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “While COVID-19 has impacted our Biorphen commercial launch, we remain in a strong financial position and we look forward to the potential for multiple additional product launches later this year.” First Quarter Milestones Acquired U.S. marketing rights to Alkindi® Sprinkle. Eton acquired U.S marketing rights to the product from Diurnal Group plc in March. Alkindi Sprinkle is an orphan product that is currently under review with the U.S. Food and Drug Administration (FDA) for use as a replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH) in patients from birth to less than 17 years of age. The application was assigned a Prescription Drug User Fee Act (PDUFA) date of September 29, 2020.Secured $9.8 million of additional liquidity. In conjunction with the Alkindi Sprinkle transaction, Eton closed a $7.8 million equity raise, and amended its existing credit facility to grant Eton the immediate option to access $2.0 million at its discretion.Announced first-to-file status on cysteine hydrochloride injection ANDA (DS-300). During the quarter, Eton’s Abbreviate New Drug Application (ANDA) was accepted for review by the FDA. Eton was confirmed to be the first Paragraph IV ANDA filer referencing Exela Pharma Sciences’ Elcys product, which entitles Eton to 180 days of generic exclusivity upon successfully challenging the patent. In addition, Eton announced it plans to file Post Grant Reviews (PGR) with the U.S. Patent and Trademark Office (USPTO) to challenge the patents, which, if successful, could allow Eton to launch the product in 2021. Biorphen Commercial Launch Eton launched Biorphen, the only FDA-approved formulation of ready-to-use phenylephrine injection, in December 2019. Unfortunately, the commercial launch has been neg...