Full Press Release Details
Pharmaceuticals Confirms First-to-File Patent Challenge on Elcys (Cysteine Hydrochloride Injection)
confirms first-to-file ANDA referencing Exela Pharma Sciences' Elcys product
plans to file Post Grant Reviews in the U.S. Patent & Trademark Office challenging the validity of Exela's listed patents,
which, if successful, could allow Eton to launch in 2021
believes Exela Pharma Sciences is improperly stifling competition on a decades-old drug
PARK, Ill., May 7, 2020 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company
focused on developing and commercializing innovative drug products, today disclosed that it has been confirmed as the first filer
of an Abbreviated New Drug Application (ANDA) against Exela Pharma Science's Elcys (cysteine hydrochloride injection).
Paragraph IV certifications challenge the validity of U.S. Patent Nos. 10,478,453 and 10,583,155, which were issued to Exela Pharma
Sciences in 2019 and 2020, respectively.
is the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV
certification with the U.S. Food and Drug Administration (FDA). If successful, this would entitle Eton to 180 days of generic
hydrochloride injection is an old molecule that was sold in the United States for decades as an unapproved product before Exela's
New Drug Application (NDA) approval in 2019. Exela did not conduct any new clinical studies to support its NDA filing, and instead
relied on historic published literature to support its safety and efficacy claims. Eton's own development partner had manufactured
and commercialized cysteine hydrochloride injection over fifteen years ago in the same formulation that was claimed to be novel
by Exela Pharma Sciences, and as a result, Eton is highly confident that the Exela Pharma Science patents will be invalidated.
addition, Eton expects to file Post Grant Reviews (PGRs) with the U.S Patent and Trademark Office (USPTO) later this month. The
PGR process is an abbreviated pathway to challenge the validity of patents issued by the USPTO. The USPTO is generally required
to make a final ruling on a PGR challenge within eighteen months of a challenger's PGR submission, which would allow for
Eton to potentially launch its product as early as November 2021.
injection has been sold in the United States in its current form since at least 1990. These baseless patents are an attempt by
Exela to stifle competition on a decades-old product and jack-up the price," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
"We look forward to overturning Exela's patents related to Cysteine injection and providing a lower cost alternative
known as Eton's DS-300 project, cysteine hydrochloride is an injectable product used as an additive to amino acid solutions
to meet the nutritional requirements of newborn infants. Currently, Exela is the only supplier of the product in the United States
and the market is estimated to be more than $50 million annually. Eton's ANDA was submitted in December 2019 and was assigned
a Generic Drug User Fee Act date in October 2020.
Eton Pharmaceuticals
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products.
Eton is primarily focused on hospital injectable and pediatric rare disease products. The company's first commercial product,
Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The
company's lead pediatric product is the orphan drug Alkindi Sprinkle, which is currently under review with the FDA.
The company has an additional eight products under development, including three that are under review with the FDA.
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