Philip Morris International 9th announced the 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 more than 83 million people, in the US alone, at intermediate-to-high risk for myocardial infarction.

“The acquisition of OtiTopic is a step in PMI’s Beyond-Nicotine ambitions, said Jacek Olczak, CEO, PMI. “We have world-class expertise in research, development and commercialisation of aerosolisation and inhalable devices to help speed the delivery of this 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.

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 catalysed 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 the risk of heart attacks.

OtiTopic will complete its assessment programme and filing with the FDA using FDA’s 505 (b)(2) pathway, a pathway designed for drugs already available in 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 programme 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.

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 the best-in-class pre-clinical safety and inhalation models, PMI is developing a pipeline focussed on inhaled therapeutics for medical and wellness applications.