Eton Pharmaceuticals Announces FDA Approval of ZONISADE™ (Zonisamide Oral Suspension)
18 July 2022 - 9:05PM
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 PharmaceuticalsEton 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
StatementsStatements 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
Krempadkrempa@etonpharma.com612-387-3740
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