PMI’s expertise and Beyond Nicotine portfolio companies to speed ASPRIHALE® to market
“The acquisition of OtiTopic is an exciting step in PMI’s Beyond Nicotine ambitions,” said
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
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
“This transaction aligns well with OtiTopic’s goals of unlocking what we believe to be a significant opportunity in inhaled therapeutics science,” said
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
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
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