PMI’s expertise and Beyond Nicotine portfolio
companies to speed ASPRIHALE® to market
Philip Morris International Inc. (PMI) (NYSE: PM) today
announced its acquisition of OtiTopic, a U.S. respiratory drug
development company with a late-stage inhalable acetylsalicylic
acid (ASA) treatment for acute myocardial infarction. If approved,
the treatment can address the significant unmet medical need of the
over 83 million people, in the U.S. alone, at intermediate to high
risk for myocardial infarction.
“The acquisition of OtiTopic is an exciting step in PMI’s Beyond
Nicotine ambitions,” said Jacek Olczak, CEO, PMI. “We have
world-class expertise in the research, development, and
commercialization of aerosolization and inhalable devices to help
speed the delivery of this exciting product to market.”
This acquisition is part of PMI’s strategic plan to leverage its
expertise, scientific know-how, and capabilities in inhalation to
grow a pipeline of inhaled therapeutics and respiratory drug
delivery Beyond Nicotine. Following the completion of clinical
trials and pending approvals by the U.S. Food and Drug
Administration (FDA), PMI can leverage its expertise and the
capabilities of other companies in the Beyond Nicotine portfolio to
bring ASPRIHALE® to market.
ASPRIHALE®—a patented, dry powder inhalation of ASA
delivered through a unique self-administered aerosol—is
expected to move from clinical trials to filing with FDA for
approval in 2022. Early clinical trials have shown that the product
system catalyzed peak plasma concentration and the desired
pharmacodynamic effect, i.e., inhibition of platelet aggregation in
two minutes compared with 20 minutes for coated chewable aspirin.
This speed is unprecedented and has significant potential
implications for improving the survival of patients at risk of
heart attacks.
OtiTopic will complete its assessment program and filing with
the FDA using FDA’s 505 (b)(2) pathway, a pathway designed for
drugs already available on the market but requesting approval
either for a new indication, dosage form or regimen, strength,
combination with other products, or other unique traits. This
pathway will allow PMI to build on existing data available for ASA
reference products and focus on delivering the evidence that the
inhalable form, ASPRIHALE®, outperforms the current standard of
care—oral delivery—of ASA.
“In the United States alone, someone has a heart attack every 40
seconds. With its inhalable version of acetylsalicylic acid (ASA),
OtiTopic has developed an asset that promises to have a much faster
onset of effect compared to oral ASA,” said Jorge Insuasty, chief
life sciences officer, PMI. “With its acquisition of OtiTopic, PMI
looks forward to completing the planned ASPRIHALE® registration
program and bringing this important treatment to market to address
a significant unmet medical need in a clinical condition where
every second counts.”
“This transaction aligns well with OtiTopic’s goals of unlocking
what we believe to be a significant opportunity in inhaled
therapeutics science,” said Kambiz Yadidi, CEO, OtiTopic. “We are
entering this transaction to accelerate ASPRIHALE®’s FDA filing,
with the goal of delivering innovative therapies for people with
intermediate to high risk for myocardial infarction.”
PMI’s Beyond Nicotine vision is part of a larger transformation
that puts health, science, technology, and sustainability at the
heart of PMI’s future, delivering products and solutions that aim
to improve people’s lives and deliver a net positive impact on
society. Building on the company’s investment and expertise in
aerosol chemistry and physics, device technology, clinical
research, and best-in-class preclinical safety and inhalation
models, PMI is developing a pipeline focused on inhaled
therapeutics for medical and wellness applications.
To date, PMI has invested more than $8 billion in building a
world-class research and development capability, including
pre-clinical systems toxicology and clinical capabilities,
behavioral research, and post-market studies. The company has also
met the strictest of regulatory requirements, including in the
U.S., where the Food and Drug Administration authorized a version
of our lead smoke-free tobacco product as a Modified Risk Tobacco
Product in 2020.
OtiTopic was founded in 2012 as an innovative pharmaceutical
start-up company and holds several key patents, differentiated
intellectual property, and has confirmed a 505(b)2 pathway through
constructive interactions with the FDA.
PMI expects the impact of the acquisition of OtiTopic on its
full-year 2021 adjusted diluted EPS to be immaterial.
Forward-Looking and Cautionary Statements
Statements in this press release that are not strictly
historical, including statements regarding the acquisition of
OtiTopic, and any other statements regarding events or developments
that we believe or anticipate will or may occur in the future, may
be “forward-looking” statements within the meaning of the Private
Securities Litigation Reform Act of 1995, and involve a number of
risks and uncertainties.
There are a number of important factors that could cause actual
events to differ materially from those suggested or indicated by
such forward-looking statements, and you should not place undue
reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things: (1)
the possibility that the integration of OtiTopic and its operations
with those of PMI may be more difficult and/or take longer than
anticipated, and may not accelerate PMI’s desired entry into
additional smoke-free and beyond nicotine platforms as quickly as
anticipated; (2) the possibility that ASPRIHALE® may not receive
FDA approval when anticipated, if at all; (3) the ability of PMI to
retain key personnel of OtiTopic; and (4) other factors that may
affect future results of the combined company described in the
section entitled “Risk Factors” in PMI’s Annual Report on Form 10-K
for the fiscal year ended December 31, 2020, PMI’s Form 10-Q for
the quarter ended June 30, 2021, and other filings of PMI with the
Securities and Exchange Commission. The forward-looking statements
made herein speak only as of the date hereof and PMI does not
assume any obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
and developments or otherwise, except as required by law.
Philip Morris International: Delivering a Smoke-Free
Future
Philip Morris International (PMI) is leading a transformation in
the tobacco industry to create a smoke-free future and ultimately
replace cigarettes with smoke-free products to the benefit of
adults who would otherwise continue to smoke, society, the company,
its shareholders and its other stakeholders. PMI is a leading
international tobacco company engaged in the manufacture and sale
of cigarettes, as well as smoke-free products, associated
electronic devices and accessories, and other nicotine-containing
products in markets outside the U.S. In addition, PMI ships
versions of its IQOS Platform 1 device and consumables to Altria
Group, Inc. for sale under license in the U.S., where these
products have received marketing authorizations from the U.S. Food
and Drug Administration (FDA) under the premarket tobacco product
application (PMTA) pathway; the FDA has also authorized the
marketing of a version of IQOS and its consumables as a Modified
Risk Tobacco Product (MRTP), finding that an exposure modification
order for these products is appropriate to promote the public
health. PMI is building a future on a new category of smoke-free
products that, while not risk-free, are a much better choice than
continuing to smoke. Through multidisciplinary capabilities in
product development, state-of-the-art facilities and scientific
substantiation, PMI aims to ensure that its smoke-free products
meet adult consumer preferences and rigorous regulatory
requirements. PMI’s smoke-free product portfolio includes
heat-not-burn and nicotine-containing vapor products. As of June
30, 2021, PMI’s smoke-free products are available for sale in 67
markets in key cities or nationwide, and PMI estimates that
approximately 14.7 million adults around the world have already
switched to IQOS and stopped smoking. For more information, please
visit www.pmi.com and www.pmiscience.com.
# # #
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210809005323/en/
Philip Morris International
David Fraser
T. +41 (0)79 843 8603 E. david.fraser@pmi.com
Philip Morris (NYSE:PM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Philip Morris (NYSE:PM)
Historical Stock Chart
From Apr 2023 to Apr 2024