Philip Morris (NYSE:PM) announced today that it acquired OtiTopic and its late-stage inhalable acetylsalicylic acid (ASA) treatment.
Los Angeles-based OtiTopic develops the Asprihale patented dry powder inhalation ASA treatment to treat acute myocardial infarction as a self-administered aerosol.
According to a news release, early clinical trials have shown that the product catalyzed peak plasma concentration and the desired pharmacodynamic effect in two minutes, compared to 20 minutes for coated, chewable aspirin, offering potential improvements in survival for patients at risk of heart attacks.
The company expects to move from clinical trials of Asprihale to filing for FDA approval at some point in 2022. Financial details of the acquisition of OtiTopic were not disclosed.
New York-based Philip Morris — a major cigarette manufacturer — said the acquisition constitutes part of its plan to leverage its foothold in the inhalation space to grow a pipeline of inhaled therapeutics and respiratory drug delivery called “Beyond Nicotine.” The company last month agreed to acquire inhaled drug delivery technology developer Vectura for $1.2 billion — a move that was met by resistance from the American Lung Association.
“The acquisition of OtiTopic is an exciting step in PMI’s Beyond Nicotine ambitions,” Philip Morris CEO Jacek Olczak said in the release. “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.”
Once OtiTopic completes its clinical trials and the approval processes with the FDA, Philip Morris said it plans to leverage its expertise and the capabilities of other companies within the Beyond Nicotine portfolio to bring Asprihale to market. OtiTopic will complete its assessment program and filing with the FDA using its 505(b)(2) pathway for drugs already available on the market but requesting approval for either a new indication, dosage form or regimen, strength, combination with other products, or other unique traits.
“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,” Philip Morris chief life sciences officer Jorge Insuasty said. “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,” added OtiTopic CEO Kambiz Yadidi. “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.”