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PMIs Latest Clinical Results: Findings Add to Extensive Evidence Package on Risk Reduction

Philip Morris International (PMI)
(NYSE:PM) announces today the positive results from a new clinical study
on IQOS, the company’s most advanced smoke-free product. The
Exposure Response Study (ERS) measured the biological response of people
who switch to IQOS for six months compared with continued
smoking. The study met its primary objective, demonstrating that after
six months, eight measures of biological response (the primary clinical
risk endpoints) improved in those who switched to IQOS.

PMI’s Scientific Assessment Program has rigorously tested IQOS
over more than 7 years and supports that switching to our most advanced
smoke-free product is likely to present less risk of harm than
continuing to use cigarettes. Numerous aerosol chemistry and physics
measurements demonstrate that IQOS aerosol contains an average of
90-95% lower levels of harmful constituents. Our results support that
these reduced emissions translate to reduced toxicity in the laboratory
and to reduced exposure in clinical studies. The ERS contributes an
important new facet to PMI’s research: it begins to explore the impact
of these promising results by measuring the biological response of
people who switch to IQOS compared with those who continue to
smoke.

“These results are very encouraging. We believe this study on IQOS
is the first ever clinical study of this magnitude to directly assess
the risk-reduction potential of a smoke-free product in people who
switch to it. Everything we’ve seen, including these new results,
continues to point in the direction of risk reduction,” said Frank
Luedicke, PMI’s Chief Medical Officer. “We are sharing the results with
the scientific community at multiple conferences over the next few
months and we look forward to their feedback.”

On June 8th, PMI submitted the ERS results to the US FDA to
add to the extensive body of evidence already presented to the agency in
support of PMI’s pending application for authorization of IQOS as a
modified risk tobacco product. FDA is in the process of reviewing both
PMI’s modified risk tobacco product and our premarket tobacco
applications, but has not yet reached conclusion. The topline ERS
results have already been presented at recent conferences, including the 18th
International Symposium on Atherosclerosis in Toronto, Canada on
June 8-12, and the 1st
Scientific Summit on Tobacco Harm Reduction: Novel products, Research &
Policy on June 9th. The results will also be presented
today at the Global
Forum on Nicotine in Warsaw, Poland and other conferences in the
coming months.

About the Study

The ERS was a six-month randomized, controlled, two-arm parallel group,
multicenter US study in adults who switched from smoking cigarettes to IQOS
as compared to continuing to smoke cigarettes. The study followed 984
people who were randomized to either continue smoking cigarettes (n=
488), or switch to IQOS (n=496) for six months. The ERS assessed
a set of eight primary and numerous secondary clinical risk endpoints,
which were selected because of their association with smoking-related
diseases. These endpoints are negatively impacted by smoking and based
on literature are expected to improve within six months of smoking
cessation.

The study met its primary objective: all eight of the primary clinical
risk endpoints moved in the same direction as observed for smoking
cessation in the group who switched to IQOS, with statistically
significant changes in five of the eight endpoints compared with
on-going smoking. These clinical risk endpoints are associated with
diseases including heart and lung diseases, covering multiple organ
systems, disease pathways, and biological mechanisms such as
inflammation and oxidative stress.

The study was designed to address key questions related to the impact of
switching to IQOS, as it is actually used. The study included
people who had no intention to quit smoking and allowed them to freely
use IQOS as well as other tobacco and nicotine containing
products. The study met its primary objective and also saw favorable
changes in the secondary clinical risk endpoints, even though there was
a proportion of the IQOS users in the study who concomitantly
used cigarettes. For more information on the ERS go to www.clinicaltrials.gov
(Identifier: NCT02396381). The full results will be submitted for
publication in a peer-reviewed journal.

About PMI’s Research

These results contribute to the totality of evidence on IQOS and
were produced as part of PMI’s extensive research and assessment
program. This program is inspired by the well-recognized practices of
the pharmaceutical industry and in line with the draft guidance of the
U.S. FDA for Modified Risk Tobacco Product (MRTP) Applications. Over 430
PMI R&D experts are working to develop and assess new smoke free
products, and have published over 250 peer-reviewed scientific
publications and book chapters to-date.

PMI has spent more than USD 4.5 billion to develop, substantiate and
build manufacturing capacity for a wide portfolio of smoke-free
products. To date, PMI’s portfolio includes 2,900 granted patents
worldwide, and a pipeline of 4,600 pending patent applications. PMI Is
the 58th largest patent filer in the EU, and the only tobacco
company in the top 100 on this list. Under agreements with PMI, PM USA,
an affiliate of Altria Group, Inc., is licensed to sell IQOS in
the U.S. should PMI receive a marketing authorization order from the FDA.

Philip Morris International: Who We Are

We are a leading international tobacco company engaged in the
manufacture and sale of cigarettes and other nicotine-containing
products in markets outside the United States of America. We’re building
our future on smoke-free products. Through multidisciplinary
capabilities in product development, state-of-the-art facilities and
scientific substantiation, we aim to ensure that our smoke-free products
meet adult consumer preferences and rigorous regulatory requirements.
Our vision is that these products ultimately replace cigarettes. For
more information, see our PMI
and PMIScience
websites.

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