Press release
Eton Pharmaceuticals Announces Fourth Quarter and Full Year 2019 Financial Results
DEER PARK, Ill., March 05, 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., March 05, 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 fourth quarter ended December 31, 2019 and provided an update on business progress.\n “2019 was an important year for Eton. Our team achieved a number of major milestones in the advancement of our pipeline, the most significant of which was the approval and launch of Biorphen, our first commercial product,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We are excited to transition to a commercial revenue company and we look forward to earning additional product approvals in 2020.” Fourth Quarter Milestones FDA approval and commercial Launch of Biorphen. Biorphen, Eton’s first commercial product, was launched in December. More than 100 different institutions have already placed orders for Biorphen.DS-300 ANDA filing. In December, Eton submitted an ANDA for DS-300. The application was accepted for review and was confirmed to be the first-to-file ANDA against the innovator product. The innovator product represents an estimated market size of more than $60 million.EM-100 amendment submitted. In December, Eton’s licensing partner submitted an amendment to the EM-100 application in response to the Complete Response Letter received in July 2019. Eton believes the amendment fully addressed all issues raised by the FDA and expects EM-100 to be approved in 2020. Biorphen Commercial Launch Update During the fourth quarter, Eton launched Biorphen, the first and only FDA-approved ready-to-use formulation of phenylephrine injection. The product was approved in October and launched in December. Initial customer demand for the product has resulted in more than 100 different institutions purchasing the product. Customers have specifically cited Biorphen’s lack of dilution, three-year shelf-life, and FDA-approved status as significant benefits that led to their institutions’ conversion to the product. Eton recently announced that it entered into a co-promotion arrangement with Xellia Pharmaceuticals for the promotion of Biorphen. Under the arrangement, Xellia’s existing U.S hospital-based sales force is actively promoting Biorphen to certain customer segments. Eton expects the arrangement to significantly r...