Organon (NYSE: OGN), a global healthcare company with a mission
to improve the health of women throughout their lives, today
announced that the U.S. Food and Drug Administration (FDA) extended
by three months the target action date of its review of the
supplemental New Drug Application (sNDA) for VTAMA® (tapinarof)
cream, 1% as a treatment for atopic dermatitis (AD) in adults and
children two years of age and older. The new target date is March
12, 2025, revised from the original target action date of December
12, 2024. The FDA has not raised any concerns regarding the safety
and efficacy of VTAMA nor have they raised any concerns regarding
the approvability of this indication.
As part of its review process, the FDA requested the final
datasets and clinical study report from the long-term extension
study for VTAMA. After receiving the datasets, the FDA determined
that the additional information requested constitutes a major
amendment to the sNDA resulting in a standard three-month extension
to the original target action date.
“Organon remains confident in the robust efficacy and safety
data package that has been submitted to the agency to support the
review of VTAMA for AD and we are committed to working with the FDA
ensure the agency has all the information it needs for its review,”
said Juan Camilo Arjona Ferreira, MD, Head of Research &
Development at Organon.
With an assumed PDUFA date of March 12, 2025, the company
expects that revenue contribution for VTAMA for the full year 2025
will be approximately $125 million and that the transaction will
result in an approximate 75 basis point headwind to Adjusted EBITDA
margin in 2025. This is an update to the company's prior
commentary, provided during its third quarter earnings call held on
October 31, 2024. The company will provide a more detailed outlook
for 2025 expected consolidated financial performance, including
revenue growth and expense optimization plans, in February 2025
when it reports full year 2024 results.
About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is one
of the most common inflammatory skin diseases, affects over 26
million people in the U.S. alone and up to 10% of adults worldwide.
AD occurs most frequently in children, affecting up to 20%
worldwide. The disease results in itchy, red, swollen, and cracked
skin, often affecting the folds of the arms, back of the knees,
hands, face, and neck. Itching is an especially bothersome symptom
in AD, and tends to worsen at night, disturbing sleep and causing
fatigue, which in children can lead to inattention at school.
People with AD may also experience social and emotional distress
due to the visibility and discomfort of the disease.
About VTAMA® (tapinarof) cream, 1%
VTAMA cream is a non-steroidal once-daily topical treatment. The
safety and effectiveness of VTAMA cream was evaluated in
randomized, double-blind, vehicle-controlled trials, PSOARING-1 and
2 for plaque psoriasis. The safety and efficacy of VTAMA for the
treatment of atopic dermatitis was also evaluated in ADORING-1 and
ADORING-2 Phase III clinical studies and is currently under review
by the FDA.
Important Safety Information
Indication: VTAMA® (tapinarof) cream, 1% is an aryl
hydrocarbon receptor agonist indicated for the topical treatment of
plaque psoriasis in adults. VTAMA cream is for use on the skin
(topical) only. Do not use VTAMA cream in your eyes, mouth, or
vagina. Adverse Events: The most common adverse reactions
(incidence ≥ 1%) in subjects treated with VTAMA cream were
folliculitis (red raised bumps around the hair pores),
nasopharyngitis (pain or swelling in the nose and throat), contact
dermatitis (skin rash or irritation, including itching and redness,
peeling, burning, or stinging), headache, pruritus (itching), and
influenza (flu).
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Organon
Organon is an independent global healthcare company with a
mission to help improve the health of women throughout their lives.
Organon’s diverse portfolio offers more than 60 medicines and
products in women’s health, biosimilars, and a large franchise of
established medicines across a range of therapeutic areas. In
addition to Organon’s current products, the company invests in
innovative solutions and research to drive future growth
opportunities in women’s health and biosimilars. In addition,
Organon is pursuing opportunities to collaborate with
biopharmaceutical partners and innovators looking to commercialize
their products by leveraging its scale and agile presence in fast
growing international markets.
Organon has geographic scope with significant reach, world-class
commercial capabilities, and approximately 10,000 employees with
headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
Cautionary Note Regarding Forward-Looking Statements and
Non-GAAP Information
Except for historical information, this press release includes
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about management’s
expectations regarding Organon’s recent acquisition of Dermavant
Sciences Ltd. (“Dermavant”) and potential regulatory approval from
the FDA for the use of VTAMA® in the treatment of atopic dermatitis
(including the expected timeframe thereof). Forward-looking
statements may be identified by words such as “targets,”
“foresees,” “outlook,” “expects,” “intends,” “anticipates,”
“plans,” “believes,” “seeks,” “estimates,” “will” or words of
similar meaning. These statements are based upon the current
beliefs and expectations of Organon’s management and are subject to
significant risks and uncertainties. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements. Risks and uncertainties include, but
are not limited to, those relating to the FDA regulatory approval
process, including the uncertainty of FDA approval or any extension
of time to receive such approval; difficulties implementing or
executing on Organon’s acquisition strategy, including the recent
acquisition of Dermavant, or any other failure to recognize the
benefits of such acquisitions; recent Supreme Court decisions and
other developments impacting regulatory agencies and their rule
making, including related financial market reactions; and the
impact of the 2024 United States presidential election and any
resulting public policy changes affecting health care decisions,
including changes in financial outcomes resulting from candidate
positions on healthcare topics and the possible impact on related
laws, regulations and policies following the election. Organon
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements
can be found in Organon’s filings with the Securities and Exchange
Commission (“SEC”), including Organon’s most recent Annual Report
on Form 10-K and subsequent SEC filings.
References and links to websites have been provided for
convenience, and the information contained on any such website is
not a part of, or incorporated by reference into, this press
release. Organon is not responsible for the contents of third-party
websites.
Adjusted EBITDA is a “non-GAAP financial measure.” For
additional information about the company’s use of non-GAAP
financial measures, please refer to the company’s press release
regarding its results for the quarter ended September 30, 2024,
issued on October 31, 2024.
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Media Contacts: Felicia Bisaro (646) 703-1807
Kim Hamilton (908) 391-0131
Investor Contacts: Jennifer Halchak (201) 275-2711
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