The expertise of PMI and the Beyond Nicotine portfolio companies to accelerate the commercialization of ASPRIHALE®
LAUSANNE, Switzerland – Philip Morris International Inc. (PMI) (NYSE: PM) today announced the acquisition of OtiTopic, a US respiratory drug development company with a late-stage inhalable acetylsalicylic acid (ASA) treatment for acute infarction of myocardium. If approved, the treatment can address the significant unmet medical need of more than 83 million people, in the US alone, with intermediate to high risk of myocardial infarction.
“The acquisition of OtiTopic is an exciting step in PMI’s Beyond Nicotine ambitions,” said Jacek Olczak, PMI CEO. “We have world-class experience in the research, development and commercialization of inhalable and aerosolization devices to help accelerate the delivery of this exciting product to market.”
This acquisition is part of PMI’s strategic plan to leverage its inhalation expertise, scientific knowledge and capabilities to grow a line of inhaled therapeutics and respiratory drug delivery beyond nicotine. Following the completion of clinical trials and pending approvals from the US 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 the market.
ASPRIHALE®–A proprietary AAS dry powder inhalation delivered via a unique self-administered aerosol–it is expected to move from clinical trials to submission to the FDA for approval in 2022. The first clinical trials have shown that the product system catalyzed the maximum plasma concentration and the desired pharmacodynamic effect, that is, the inhibition of aggregation. platelet in two minutes compared to 20 minutes for coated. chewable aspirin. This speed is unprecedented and has important potential implications for improving survival in patients at risk of heart attack.
OtiTopic will complete its evaluation program and filing with the FDA using the FDA 505 (b) (2) pathway, a pathway designed for drugs that are already available on the market but requesting approval for a new indication, dosage form. or regimen, concentration, 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 providing evidence that the inhalable form, ASPRIHALE®, exceeds the current standard of care (oral administration) 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 active that promises to have a much faster onset of effect compared to oral ASA ”, said Jorge Insuasty, director of biological sciences at PMI. “With the acquisition of OtiTopic, PMI hopes to complete the planned ASPRIHALE® registration program and bring 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 the science of inhaled therapeutics,” said Kambiz Yadidi, CEO of OtiTopic. “We are initiating this transaction to accelerate the submission to the FDA of ASPRIHALE®, with the goal of offering innovative therapies for people with intermediate to high risk of myocardial infarction.”
PMI’s Beyond Nicotine vision is part of a broader transformation that places health, science, technology and sustainability at the heart of PMI’s future, offering products and solutions that aim to improve people’s lives and generate a positive net 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 product line focused on inhaled therapies for medical and wellness applications.
To date, PMI has invested more than $ 8 billion in building a world-class research and development capacity, including preclinical systems, toxicology and clinical capabilities, behavioral research, and post-market studies. The company has also met the most stringent regulatory requirements, including in the US, where the Food and Drug Administration licensed a version of our lead smokeless tobacco product as a modified risk tobacco product in 2020.
OtiTopic was founded in 2012 as an innovative pharmaceutical 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 OtiTopic acquisition on its adjusted diluted EPS for full year 2021 to be irrelevant.
Preventive and forward-looking statements
Statements in this press release that are not strictly historical, including statements regarding the OtiTopic acquisition 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 such forward-looking statements. These factors include related risks and uncertainties, 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 the PMI’s desired entry into additional smoke-free platforms and beyond nicotine as fast as anticipated; (2) the possibility that ASPRIHALE® will not receive FDA approval in anticipation, if at all; (3) PMI’s ability to retain key OtiTopic personnel; and (4) other factors that may affect the 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 Form 10-Q for the quarter ended June 30, 2021, and other PMI filings with the Securities and Exchange Commission. Forward-looking statements made in speak only as of the date hereof, and PMI assumes no 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: for 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 for 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 dedicated to 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 of 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 US, where these products have received marketing authorizations from the US Food and Drug Administration (FDA) under the route of requesting tobacco products before marketing (PMTA); the FDA has also cleared a version of IQOS and its consumables as a Modified Hazard Tobacco Product (MRTP), finding that an exposure modification order for these products is appropriate to promote public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a far better option than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and scientific foundation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI’s smoke-free portfolio includes vapor-free products that do not burn and contain nicotine. As of June 30, 2021, PMI’s smoke-free products are available for sale in 67 markets in key cities or across the country, and PMI estimates that approximately 14.7 million adults worldwide have already switched to IQOS and quit smoking. For more information please visit www.pmi.com other www.pmiscience.com.
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