Organon (NYSE: OGN), a global healthcare company with a mission to
improve the health of women throughout their lives, today announced
the successful completion of its acquisition of Dermavant Sciences
Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated
to developing and commercializing innovative therapeutic solutions
in immuno-dermatology. Please see our prior announcement for a
summary of the transaction terms.
VTAMA® (tapinarof) cream, 1%, is a novel
nonbiologic, non-steroidal topical therapy approved by the U.S.
Food and Drug Administration (FDA) for treatment of mild, moderate,
and severe plaque psoriasis in adults with no safety label warnings
or precautions and without restrictions on location and duration of
use or body surface area. The FDA is reviewing a supplemental New
Drug Application (sNDA) for VTAMA cream as a potential treatment
for atopic dermatitis (AD) in adults and children two years of age
and older, with Prescription Drug User Fee Act (PDUFA) action
expected in the fourth quarter of calendar year 2024.
Plaque psoriasis and atopic dermatitis-commonly known as
eczema-are common chronic inflammatory skin diseases affecting
millions of people in the U.S. and around the globe.1,2 Psoriasis
presents a significant impact to quality of life and atopic
dermatitis is associated with a higher disease burden for women
compared to men.3,4“The future of dermatology depends on innovative
treatments like VTAMA, and Organon’s acquisition of Dermavant
allows us to further expand our existing portfolio of established
brands and biosimilar dermatology treatments,” said Kevin Ali,
Chief Executive Officer of Organon. “Integrating the expertise of
Dermavant into Organon’s U.S. organization marks the beginning of a
new chapter in dermatology. We are excited to bring this
nonbiologic non-steroidal topical option to the millions of
patients suffering from a chronic skin condition like plaque
psoriasis and, potentially in the future, atopic dermatitis.”
“I would like to thank Kevin and the entire Organon team for
their partnership in the acquisition of Dermavant,” said Mayukh
Sukhatme, MD, President and Chief Investment Officer of Roivant.
“This deal represents a true win-win outcome for Organon and
Roivant in our mutual goal to address patient needs and is
emblematic of Roivant’s ability to form non-traditional,
value-enhancing collaborations on important medicines. We believe
that Organon’s strong global commercial footprint will maximize the
impact of VTAMA for patients globally, and we are excited to
continue to share meaningfully in the success of VTAMA along the
way.”
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
with 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
StatementsExcept 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 about Organon’s
acquisition of Dermavant (including statements regarding the
timing, benefits, and financial impact of such acquisition),
potential regulatory approvals and other actions relating to VTAMA
(including the expected timeframe thereof), and Organon’s expected
financial results and condition. Forward-looking statements may be
identified by words such as “pursuing,” “foresees,” “future,”
“potential,” “potentially,” “expected,” “expects,” “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, an
inability to execute on our business development strategy or
realize the benefits of our acquisition of Dermavant or any other
planned acquisitions; weakening of economic conditions that could
adversely affect the level of demand for Dermavant’s products; the
risk that the business will not be integrated successfully; risks
related to the ability to realize the anticipated benefits of the
acquisition, including the possibility that the expected benefits
from the acquisition will not be realized or will not be realized
within the expected time period; the ability to retain key
personnel; unknown liabilities; the risk of litigation and/or
regulatory actions related to the completed acquisition; pricing
pressures globally, including rules and practices of managed care
groups, judicial decisions and governmental laws and regulations
related to Medicare, Medicaid and health care reform,
pharmaceutical reimbursement and pricing in general; an inability
to fully execute on Organon’s product development and
commercialization plans in the United States, Europe, and elsewhere
internationally; an inability to adapt to the industry-wide trend
toward highly discounted channels; changes in tax laws or other tax
guidance which could adversely affect Organon’s cash tax liability,
effective tax rates, and results of operations and lead to greater
audit scrutiny; expanded brand and class competition in the markets
in which Organon operates; and governmental initiatives that
adversely impact Organon’s marketing activities. 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, available at the SEC’s Internet site
www.sec.gov. 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
About Roivant Roivant is a biopharmaceutical
company that aims to improve the lives of patients by accelerating
the development and commercialization of medicines that matter.
Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human
monoclonal antibodies targeting FcRn in development across several
IgG-mediated autoimmune indications; brepocitinib, a potent small
molecule inhibitor of TYK2 and JAK1 in development for the
treatment of dermatomyositis and non-infectious uveitis; and
mosliciguat, an inhaled soluble sGC activator in development for
pulmonary hypertension associated with interstitial lung disease,
in addition to other clinical stage molecules. We advance our
pipeline by creating nimble subsidiaries or “Vants” to develop and
commercialize our medicines and technologies. Beyond therapeutics,
Roivant also incubates discovery-stage companies and health
technology startups complementary to its biopharmaceutical
business. For more information, www.roivant.com.
Roivant Forward-Looking Statements This press
release contains forward-looking statements. Statements in this
press release may include statements that are not historical facts
and are considered forward-looking within the meaning of Section
27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), which are usually identified by the
use of words such as “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “potential,” “predict,” “project,” “should,” “would”
and variations of such words or similar expressions. The words may
identify forward-looking statements, but the absence of these words
does not mean that a statement is not forward-looking. We intend
these forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future, and
statements that are not historical facts, including statements
about the clinical and therapeutic potential of our product
candidates, the availability and success of topline results from
our ongoing clinical trials and any commercial potential of our
product candidates following applicable regulatory approvals. In
addition, any statements that refer to projections, forecasts or
other characterizations of future events, results or circumstances,
including any underlying assumptions, are forward-looking
statements. Actual results may differ materially from those
contemplated in these statements due to a variety of risks,
uncertainties and other factors, including (i) the possibility that
the transaction may involve unexpected costs or liabilities, (ii)
the risk that disruptions from the transaction will harm
relationships with employees, customers and suppliers and other
business partners or (iii) the risk that the achievement of the
specified milestones or royalties described in the definitive
agreement for the transaction may take longer to achieve than
expected or may never be achieved and the resulting contingent
milestone payments or royalties may never be realized.
Although we believe that our plans, intentions, expectations and
strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a number of risks, uncertainties and assumptions,
including, but not limited to, those risks set forth in the Risk
Factors section of our filings with the U.S. Securities and
Exchange Commission. Moreover, we operate in a very competitive and
rapidly changing environment in which new risks emerge from time to
time. These forward-looking statements are based upon the current
expectations and beliefs of our management as of the date of this
press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. Except as required by
applicable law, we assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contacts: InvestorsKeyur Parekh
keyur.parekh@roivant.com
MediaStephanie Leestephanie.lee@roivant.com
1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S.,
Griffiths, C. Psoriasis Prevalence in Adults in the United States.
JAMA Dermatol. 2021 Aug; 157(8):1-7.
doi:10.1001/jamadermatol.2021.2007 2 Eczema Prevalence.
National Eczema Foundation. Eczema Prevalence, Quality of Life and
Economic Impact.3 Carole, G., Corsin, S., Meienberger, N., Valeska
Maul, L., Maul, J-T. The Impact of Gender and Sex in Psoriasis:
What to be Aware of When Treating Women with Psoriasis. Int J
Women’s Dermatol. 2022 Jun; 8(2): e010.
doi: 10.1097/JW9.0000000000000010.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112394/ 4 Urban, K.,
Chu, S., Giesey, RL., Mehrmal, S., Uppal, P., Nedley, N., Delost,
GR. The Global, Regional, and National Burden of Atopic Dermatitis
in 195 Countries and Territories: An ecological study from the
Global Burden of Disease Study 2017. 2021 Mar; 2: 12-18. JAAD
International. doi: https://doi.org/10.1016%2Fj.jdin.2020.10.002.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362298/
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