Eton Pharmaceuticals Announces FDA Approval of ZONISADE™ (Zonisamide Oral Suspension)

DEER PARK, Ill., July 18, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved ZONISADE™ (zonisamide oral suspension).

“We are proud to have another product approval from our team’s development efforts. This is now the eighth product approval that our team has contributed to, and we are excited for Azurity to bring the product to patients. The proceeds from the launch milestone will be used to further grow our rare disease portfolio,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

ZONISADE™ was included in Eton’s multi-product neurology oral solution partnership with Azurity Pharmaceuticals announced in February of 2021. Under the agreement, Eton is entitled to receive an additional $5 million payment upon the launch of ZONISADE™, royalty on net sales, and up to $15 million of commercial milestones tied to the combined sales of all three products in the partnership. Azurity Pharmaceuticals will be responsible for the commercialization of ZONISADE™, and no marketing expenses will be incurred by Eton.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The product currently commercializes ALKINDI SPRINKLE^® and Carglumic Acid tablets and has two additional rare disease products under development, dehydrated alcohol injection and the ZENEO^® hydrocortisone autoinjector. In addition, the company’s royalty segment is entitled to receive milestone payments or royalties on six different products.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740