Philip Morris International (PMI) has acquired inhaled drug developer OtiTopic, as “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,” the company said. PMI recently announced a £1 billion offer for inhalation CDMO Vectura.
OtiTopic’s Asprihale dry powder aspirin is in development for the treatment of myocardial infarction, and the company had also announced plans to develop the DPI for the treatment of lung cancer. In 2019, OtiTopic announced that a Phase 1 study had demonstrated that Asprihale inhibited platelet aggregation at 2 minutes post dose compared to 30 minutes post dose for a chewable aspirin tablet. PMI said that it expects OtiTopic to submit a 505(b)(2) NDA for Asprihale in 2022.
PMI CEO Jacek Olczak said, “The acquisition of OtiTopic is an exciting step in PMI’s Beyond Nicotine ambitions. 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.”
PMI Chief Life Sciences Officer Jorge Insuasty commented, “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. 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.”
OtiTopic CEO Kambiz Yadidi said, “This transaction aligns well with OtiTopic’s goals of unlocking what we believe to be a significant opportunity in inhaled therapeutics science. 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.”
Read the Philip Morris International press release.
