Philip Morris International Inc. (PMI) 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.
“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, the company said.
“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.”
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.
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