Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative
pharmaceutical company focused on developing and commercializing
treatments for rare diseases and ANI Pharmaceuticals, Inc (Nasdaq:
ANIP), a bio-pharmaceutical company serving patients in need
through the development and manufacturing of high-quality generic
and branded medicines, today announced the commercial launch of
Carglumic Acid tablets.
The product will be marketed by Eton Pharmaceuticals and is the
first and only FDA-approved generic version of Carbaglu®. It was
approved by the FDA for the treatment of acute and chronic
hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency.
The product is AB-rated and is bioequivalent and therapeutically
equivalent to Carbaglu®, which allows pharmacies to substitute it
in place of Carbaglu® prescriptions. The product application is
owned by Novitium Pharmaceuticals, a subsidiary of ANI
Pharmaceuticals.
“We are excited to offer patients a convenient Carglumic Acid
product that does not require refrigeration and to provide it at a
lower price than the existing Carbaglu®. We believe the adoption of
our product will result in significant financial savings to the
U.S. healthcare system and to many patients through lower co-pay
and co-insurance costs,” said Sean Brynjelsen, CEO of Eton
Pharmaceuticals.
The product application was granted Competitive Generic Therapy
(CGT) designation by the FDA, and as a result, the product is
expected to receive 180 days of generic exclusivity. “This approval
further strengthens ANI’s focus on niche opportunities and
maintains our leadership position in Competitive Generic Therapy
approvals,” said Nikhil Lalwani, CEO Of ANI Pharmaceuticals.
Carglumic Acid tablets are available exclusively through Anovo,
a specialty pharmacy dedicated to serving patients with rare and
chronic conditions. Anovo will administer the Eton Cares Program in
partnership with Eton Pharmaceuticals. The program will provide
prescription fulfillment, insurance benefits investigation,
educational support, aid qualified patients to obtain financial
assistance along with other services designed to help patients
access treatment. Eton Cares will offer co-pay assistance to allow
for $0 co-pays for qualifying patients.
Clinicians seeking to prescribe Carglumic Acid tablets can
e-prescribe by selecting Anovo #5 or fax in a patient referral
form. Additional product details can be found on the product
website, www.carglumicacid.com.
For questions regarding prescription fulfillment, please contact
Anovo at 1-888-991-1330.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know
about Carglumic Acid?
- Carglumic Acid tablets are for
oral suspension and must be mixed in water before taking. Carglumic
Acid should not be mixed in any food or liquid
other than water.
- Do not swallow
Carglumic Acid tablets whole.
- Do not crush
Carglumic Acid tablets.
- Take Carglumic Acid right before
meals or feedings.
What are the possible side effects of Carglumic
Acid?
- The most common side effects of
Carglumic Acid include vomiting, abdominal pain, fever,
tonsillitis, anemia, diarrhea, ear infection, infections,
inflammation of the throat and nasal passages, decreased hemoglobin
in the red blood cells, and headache.
- This is not a complete list of
all possible side effects. Tell your doctor if you have any side
effect that bothers you or that does not go away.
Please visit www.carglumicacid.com for
more information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/safety/medwatch, or call the
FDA at 1-800-FDA-1088.
Please see the Full Prescribing Information,
including Instructions for Use, for Carglumic Acid.
USE
- Carglumic Acid is for pediatric
and adult patients as supplemental therapy to standard of care for
the treatment of acute hyperammonemia due to N-acetylglutamate
synthase (NAGS) deficiency.
- Carglumic Acid is for pediatric
and adult patients as maintenance therapy for the treatment of
chronic hyperammonemia due to NAGS deficiency.
Carbaglu® is a registered trademark of Recordati Rare Disease
Inc.
About Eton PharmaceuticalsEton Pharmaceuticals,
Inc. is an innovative pharmaceutical company focused on developing
and commercializing treatments for rare diseases. The company
currently owns or receives royalties from six FDA-approved
products, including ALKINDI SPRINKLE®, Carglumic Acid, Biorphen®,
Alaway® Preservative Free, Rezipres®, and Eprontia™, and has four
additional products that have been submitted to the
FDA.About ANI Pharmaceuticals ANI Pharmaceuticals
is a diversified bio-pharmaceutical company serving patients in
need by developing, manufacturing, and marketing high quality
branded and generic prescription pharmaceutical products, including
for diseases with high unmet medical need. For more information,
please visit www.anipharmaceuticals.com.
Eton’s 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.
ANI’s Forward-Looking StatementsTo the extent
any statements made in this release deal with information that is
not historical, these are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements include, but are not limited to, those relating to
the development, manufacturing and commercialization of the product
and any additional product launches from the Company’s generic
pipeline, other statements that are not historical in nature,
particularly those that utilize terminology such as “anticipates,”
“will,” “expects,” “plans,” “potential,” “future,” “believes,”
“intends,” “continue,” other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may face with
respect to importing raw materials; competition from other
products; acquisitions; contract manufacturing arrangements; delays
or failure in obtaining product approval from the U.S. Food and
Drug Administration; general business and economic conditions;
market trends; products development; regulatory and other approvals
and marketing.
More detailed information on these and additional factors that
could affect the Company’s actual results are described in the
Company’s filings with the Securities and Exchange Commission
(“SEC”), including its most recent annual report on Form 10-K and
quarterly reports on Form 10-Q, as well as other filings with the
SEC. All forward-looking statements in this news release speak only
as of the date of this news release and are based on the Company’s
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Eton Contact:David
Krempadkrempa@etonpharma.com612-387-3740ANI Media
Contact:Angela
Salerno-RobinASalerno-Robin@dna-comms.com212-445-8219
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