Philip Morris International Submits Applications to Commercialize IQOS ILUMA Tobacco Heating System to U.S. Food and Drug Administration
20 Outubro 2023 - 5:00PM
Business Wire
The applications mark the next step in the
company’s mission to offer adults who smoke a portfolio of
innovative, scientifically substantiated nicotine alternatives that
can help make America free from conventional cigarettes
Philip Morris International Inc. (PMI) (NYSE: PM) on October 20
submitted Premarket Tobacco Product Applications (PMTAs) and
Modified Risk Tobacco Product Applications (MRTPAs) for IQOS ILUMA
heated tobacco products with the U.S. Food and Drug Administration
(FDA).
A PMTA marketing order is required to commercialize any new
tobacco product in the United States. The company is also seeking
an order to market IQOS ILUMA products as modified risk products
that reduce exposure to harmful, and potentially harmful chemicals,
a claim authorized for previous versions of IQOS.
- Unlike conventional cigarettes, IQOS products heat — but do not
burn — tobacco
- IQOS ILUMA products are PMI’s most-innovative heated tobacco
products. They deliver substantially similar reductions in the
formation of harmful and potentially harmful constituents as
earlier versions of IQOS products authorized by FDA
- IQOS ILUMA has demonstrated higher rates of full switching by
adults who smoke and improved consumer satisfaction in countries
around the world
- IQOS ILUMA products rely on a fundamentally different heating
technology from previous versions of IQOS products and contain
numerous technological advancements including improved device and
battery longevity
- IQOS ILUMA products are currently available in 27 markets
internationally
- PMI’s applications are supported by a thorough scientific
assessment, including aerosol chemistry, in vitro toxicology, a
pharmacokinetic study, and consumer perception and behavior
studies, as well as the comprehensive scientific dataset generated
with previous versions of the IQOS system
- The IQOS ILUMA devices operate on the SMARTCORE INDUCTION
SYSTEM that heats tobacco from within TEREA SMARTCORE STICKS—heated
tobacco sticks designed to be used only with IQOS ILUMA
devices
- PMI has submitted applications for three ILUMA devices and five
variants of the tobacco sticks: TEREA BLUE, TEREA GREEN, TEREA
SIENNA, TEREA BRONZE, TEREA AMBER
Commenting on the IQOS ILUMA submission, Stacey Kennedy,
President Americas & CEO PMI U.S. Business, said:
“Tens of millions of American adults today smoke cigarettes and
will likely continue to do so. They should have a range of
scientifically substantiated better alternative nicotine products
to choose from, and PMI is committed to providing them with new
choices.
Internationally, IQOS ILUMA products have demonstrated how
ground-breaking consumer-centric innovation can lead more adults to
stop smoking. We believe that same success can be replicated in the
U.S. and drive a rapid decrease in smoking rates among adults.
These are strong applications, and we urge the FDA to prioritize
them for review.
Since 2008 PMI has invested more than $10.5 billion to
scientifically research, develop, and commercialize smoke-free
products, an investment that was further bolstered last year
through our acquisition of Swedish Match. We are focused on
providing adults who smoke with alternatives that can reduce their
risks compared with smoking and help make America
cigarette-free.”
Note to Editor
- PMI will have the full rights to commercialize all IQOS
products in the U.S. as of April 30, 2024, per the terms of an
agreement with Altria Group, Inc. ending the companies’ commercial
relationship covering IQOS in the U.S.
- Previous versions of IQOS products have been authorized by the
FDA both for sale in the U.S., and as modified risk tobacco
products with “reduced exposure” claims
- PMI has announced plans to commercialize these versions of IQOS
in two U.S. states in select key cities in Q2 next year
- IQOS was first launched internationally in 2014, is now
available in 70 markets globally, and has not triggered worrisome
levels of use by unintended audiences, including those beneath the
legal age of purchase
Philip Morris International: Delivering a Smoke-Free Future
Philip Morris International (PMI) is a leading international
tobacco company working to deliver a smoke-free future and evolving
its portfolio for the long term to include products outside of the
tobacco and nicotine sector. The company’s current product
portfolio primarily consists of cigarettes and smoke-free products.
Since 2008, PMI has invested more than USD 10.5 billion to develop,
scientifically substantiate and commercialize innovative smoke-free
products for adults who would otherwise continue to smoke, with the
goal of completely ending the sale of cigarettes. This includes the
building of world-class scientific assessment capabilities, notably
in the areas of pre-clinical systems toxicology, clinical and
behavioral research, as well as post-market studies. In November
2022, PMI acquired Swedish Match – a leader in oral nicotine
delivery – creating a global smoke-free champion led by the
companies’ IQOS and ZYN brands. The U.S. Food and Drug
Administration has authorized versions of PMI’s IQOS Platform 1
devices and consumables and Swedish Match’s General snus as
Modified Risk Tobacco Products. As of September 30, 2023, PMI's
smoke-free products were available for sale in 82 markets, and PMI
estimates that approximately 19.7 million adults around the world
had already switched to IQOS and stopped smoking. Smoke-free
products accounted for approximately 36.2% of PMI’s total
third-quarter 2023 net revenues. With a strong foundation and
significant expertise in life sciences, PMI announced in February
2021 its ambition to expand into wellness and healthcare areas and,
through its Vectura Fertin Pharma business, aims to enhance life
through the delivery of seamless health experiences. For more
information, please visit www.pmi.com and www.pmiscience.com.
Forward-Looking and Cautionary Statements
This press release contains projections of future results and
goals and other forward-looking statements, including statements
regarding expected financial or operational performance; capital
allocation plans; investment strategies; regulatory outcomes;
market expectations; and business plans and strategies. Achievement
of future results is subject to risks, uncertainties and inaccurate
assumptions. In the event that risks or uncertainties materialize,
or underlying assumptions prove inaccurate, actual results could
vary materially from those contained in such forward-looking
statements. Pursuant to the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, PMI is identifying
important factors that, individually or in the aggregate, could
cause actual results and outcomes to differ materially from those
contained in any forward-looking statements made by PMI.
PMI's business risks include: excise tax increases and
discriminatory tax structures; increasing marketing and regulatory
restrictions that could reduce our competitiveness, eliminate our
ability to communicate with adult consumers, or ban certain of our
products in certain markets or countries; health concerns relating
to the use of tobacco and other nicotine-containing products and
exposure to environmental tobacco smoke; litigation related to
tobacco use and intellectual property; intense competition; the
effects of global and individual country economic, regulatory and
political developments, natural disasters and conflicts; the impact
and consequences of Russia's invasion of Ukraine; changes in adult
smoker behavior; the impact of COVID-19 on PMI's business; lost
revenues as a result of counterfeiting, contraband and cross-border
purchases; governmental investigations; unfavorable currency
exchange rates and currency devaluations, and limitations on the
ability to repatriate funds; adverse changes in applicable
corporate tax laws; adverse changes in the cost, availability, and
quality of tobacco and other agricultural products and raw
materials, as well as components and materials for our electronic
devices; and the integrity of its information systems and
effectiveness of its data privacy policies. PMI's future
profitability may also be adversely affected should it be
unsuccessful in its attempts to produce and commercialize
reduced-risk products or if regulation or taxation do not
differentiate between such products and cigarettes; if it is unable
to successfully introduce new products, promote brand equity, enter
new markets or improve its margins through increased prices and
productivity gains; if it is unable to expand its brand portfolio
internally or through acquisitions and the development of strategic
business relationships; if it is unable to attract and retain the
best global talent, including women or diverse candidates; or if it
is unable to successfully integrate and realize the expected
benefits from recent transactions and acquisitions. Future results
are also subject to the lower predictability of our reduced-risk
product category's performance.
PMI is further subject to other risks detailed from time to time
in its publicly filed documents, including PMI's Annual Report on
Form 10-K for the fourth quarter and year ended December 31, 2022,
Quarterly Report on Form 10-Q for the second quarter ended June 30,
2023 and Quarterly Report on Form 10-Q for the third quarter ended
September 30, 2023, which will be filed in the coming days. PMI
cautions that the foregoing list of important factors is not a
complete discussion of all potential risks and uncertainties. PMI
does not undertake to update any forward-looking statement that it
may make from time to time, except in the normal course of its
public disclosure obligations.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231020701959/en/
Philip Morris International Media: Corey Henry U.S.: +1
(202) 679-7296 Email: corey.henry@pmi.com
Investor Relations: U.S.: +1 (203) 905 2413 Switzerland: +41
(0)58 242 4666 Email: InvestorRelations@pmi.com
Philip Morris (NYSE:PM)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Philip Morris (NYSE:PM)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024