Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone
04 Outubro 2023 - 7:50AM
Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an
innovative pharmaceutical company focused on developing, acquiring,
and commercializing products to address unmet needs in patients
suffering from rare diseases, today announced it has entered into
an agreement to acquire an abbreviated new drug application for
Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy
proceeding. The transaction has been approved by the bankruptcy
court and is expected to be effective on October 12, 2023. The
acquired product was approved by the U.S. Food and Drug
Administration (FDA) in May of 2023 for the treatment of hereditary
tyrosinemia type 1 (HT-1) in combination with dietary restriction
of tyrosine and phenylalanine. It is estimated that less than 500
patients in the United States suffer from this ultra-rare
condition.
“With a patient population of less than 500, Nitisinone is
another opportunity for Eton to deliver on its mission of providing
medicines to and supporting patients and families with rare
conditions. Nitisinone is our fourth FDA-approved product, and
further advances us toward our goal of having ten commercial rare
disease products on the market by the end of 2025. Nitisinone also
shares the same metabolic geneticist prescriber base as our
Carglumic Acid and Betaine products, so this is an attractive
opportunity to leverage our existing sales force and relationships
with prescribers,” said Sean Brynjelsen, CEO of Eton
Pharmaceuticals.
Eton expects to launch the product in the first quarter of 2024
and plans to offer its Eton Cares support program to all patients.
The program is designed to help patients access treatment,
providing prescription fulfillment services, insurance benefits
investigation, educational support, and help in obtaining financial
assistance for qualified patients, among other services. The
current Nitisinone market is estimated to be over $50 million
annually, and Eton believes the Company’s commercial advantages,
including its Eton Cares program, existing relationships with
prescribers, and experienced sales force should allow it to capture
a meaningful percentage of the market.
USE and IMPORTANT SAFETY INFORMATION
What is Nitisinone?Nitisinone is a prescription
medicine used to treat adults and children with a hereditary
disease called tyrosinemia type 1 (HT-1). Nitisinone should be
taken along with a diet limiting tyrosine and phenylalanine.
What is the most important information I should know
about Nitisinone?Tell your doctor or nurse right away if
you have any of these symptoms with Nitisinone:Increased levels of
plasma tyrosine, eye symptoms, developmental delay, and skin
changes:
- Inadequate restriction of tyrosine and phenylalanine intake can
result in raising plasma tyrosine levels.
- Plasma tyrosine levels above 500 micromol/L may lead to eye
signs and symptoms like corneal ulcers, corneal cloudiness,
inflammation of the cornea (keratitis), pink eye (conjunctivitis),
eye pain, and sensitivity to light (photophobia), intellectual
disability and developmental delay or painful thickening of the
skin (hyperkeratotic plaques) on the soles and palms.
- Your healthcare provider should not adjust Nitisinone dosage in
order to lower the levels of tyrosine in the blood.
Changes in blood profile
- You may develop a reduction in the number of white blood cells,
which form part of the immune system (leukopenia) and abnormally
low levels of platelets, which help the blood to clot (severe
thrombocytopenia).
Do not take Nitisinone if:
- you are allergic to nitisinone or any other ingredients. Stop
using Nitisinone and get medical help right away if you have any
symptoms of a serious allergic reaction, including swelling of the
face, lips, tongue, or throat; problems breathing or swallowing;
severe rash or itching; fainting or feeling dizzy; or very rapid
heartbeat.
Before taking Nitisinone, tell your doctor if
you:
- are pregnant or plan to become pregnant. Nitisinone may harm
your unborn baby. Tell your doctor if you become pregnant or
suspect you are pregnant during treatment with Nitisinone.
- are breastfeeding or plan to breastfeed. It is not known if
Nitisinone passes into your breast milk. Talk to your doctor about
the best ways to feed your baby during treatment with
Nitisinone.
- are aged 65 and older. Your doctor may need to adjust the dose
of Nitisinone based on your requirements.
- are taking other medicines since Nitisinone can interfere with
their effect. Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
dietary and herbal supplements.
What are the possible side effects of
Nitisinone?The most common side effects of Nitisinone
(≥1%) include high tyrosine levels, low platelets
(thrombocytopenia) or white cells in the blood (leukopenia), and
complaints related to the eyes, including pink eye
(conjunctivitis), corneal cloudiness, inflammation of the cornea,
eye pain and extreme sensitivity to light (photophobia), nosebleed
(epistaxis), itching (pruritus), skin inflammation (exfoliative
dermatitis), rash (maculopapular rash), dry skin and hair loss
(alopecia).
For more detailed information, please refer to the full
Prescribing Information.To report a suspected adverse
event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at:
1-855-224-0233 or the US Food and Drug Administration at
www.fda.gov/medwatch or call 1-800-FDA-1088.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on
developing, acquiring, and commercializing products to address
unmet needs in patients suffering from rare diseases. The Company
currently has three commercial rare disease products, ALKINDI
SPRINKLE® for the treatment of pediatric adrenocortical
insufficiency, Carglumic Acid for the treatment of hyperammonemia
due to N-acetylglutamate synthase (NAGS) deficiency, and Betaine
Anhydrous for the treatment of homocystinuria. The Company has four
additional product candidates in late-stage development: dehydrated
alcohol injection, which has received Orphan Drug Designation for
the treatment of methanol poisoning, ZENEO® hydrocortisone
autoinjector for the treatment of adrenal crisis, ET-400 for the
treatment of adrenocortical insufficiency, and ET-600 for the
treatment of diabetes insipidus. For more information, please visit
our website at www.etonpharma.com.
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 Relations:Lisa M. Wilson, In-Site
Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com
Source: Eton Pharmaceuticals.
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