Philip Morris acquires inhaled drug specialist OtiTopic

Philip Morris International Inc on announced its acquisition of OtiTopic, a US respiratory drug development company with a late-stage inhalable acetylsalicylic acid (ASA) treatment for acute myocardial infarction. If approved, the treatment can address the significant unmet medical need of the over 83 million people, in the US alone, at intermediate to high risk for 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 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 market.

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 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.”