OtiTopic

History

2021: Philip Morris bought OtiTopic

In early August 2021, Philip Morris announced the acquisition of OtiTopic, a company developing acetylsalicylic acid (ASK )-based inhalation agents for the treatment of acute myocardial infarction. The proprietary OtiTopic dry powder ASK called Asprihale is designed for dilution and independent inhalation in the form of an aerosol.

"The acquisition of the company OtiTopic is an important step in the implementation of PMI's strategy to expand the line of nicotine-free products," said Jacek Olchak, chief executive officer of Philip Morris International. "Our international best practices in research, development, and commercial distribution of aerosol and inhalation drugs will help accelerate the market launch of this important product."

According to the press release, early clinical trials showed that the preparation Asprihale allows to achieve the maximum plasma concentration and the desired pharmacodynamic effect just two minutes after administration, in contrast to chewing aspirin, which takes 20 minutes to achieve the same therapeutic effect. Such an inhalation drug is expected to improve survival among patients at risk of heart attack.

Philip Morris acquired OtiTopic

The company plans to move from Asprihale clinical trials to filing for regulatory approval as early as 2022. If approved for use, the drug will help solve a significant problem and need that faces more than 83 million people with a medium to high risk of myocardial infarction - and this is only in the United States. Philip Morris, in turn, said it plans to use its expertise and the capabilities of other companies acquired in 2021 to successfully bring Asprihale to the market. Financial details of the acquisition of OtiTopic were not disclosed.

Major cigarette manufacturer Philip Morris explained that this deal is part of the company's plans to produce a line of inhalation therapeutics and respiratory drug delivery products called "Instead of nicotine." In July, the company also acquired the developer of inhalation drug delivery technology Vectura for $1.2 billion.

OtiTopic has developed a drug that begins to act much faster than oral drugs in conditions where every second is on the bill, "said Jorge Insuasti, chief specialist in biomedical sciences at Philip Morris. - By acquiring OtiTopic, Philip Morris hopes to complete Asprihale's planned enrollment program and bring it to market to meet significant demand in this area of health care.[1]

Upon completion of the test program, the OtiTopic will apply to the U.S. Food and Drug Administration under FDA procedure 505 (b) (2) for drugs already on the market but requiring re-approval due to changes in indications, dosage form, regimen, activity, compatibility with other drugs, and other unique characteristics. By applying this procedure, Philip Morris will be able to use available data on ASA-based reference drugs and focus on providing evidence that the inhalable form of Asprihale exceeds existing standards for ACA-based oral drugs.

According to PMI forecasts, the acquisition of OtiTopic will not have a significant impact on adjusted diluted earnings per share for the full year 2021.

"The deal aligns well with the company's OtiTopic goals of mastering what we believe are significant opportunities in inhalation therapy," said Cambiz Yadidi, chief executive of OtiTopic. - We are striking a deal to speed up the process of registering the drug Asprihale with the U.S. Food and Drug Administration and make available an innovative drug for people at moderate to high risk of developing myocardial infarction. "

Philip Morris International's strategy to expand beyond nicotine-containing products is part of a massive transformation in which the company's future development will go in the areas of health care, scientific and technological research and development, sustainable development - thus, the company will be able to offer consumers products and means that improve the quality of life and ultimately have a positive impact on society as a whole. PMI is developing a line of inhalation therapeutics for medical use and health products, building on the company's expertise in aerosol chemistry and physics, technology, clinical research, and best-of-breed preclinical safety models and inhalation delivery systems. As of August 2021, Philip Morris International has invested more than $8 billion in the creation of world-class research potential, including systemic toxicology at the preclinical stage, clinical trials, behavioral and post-marketing research.

2012: Foundation of the OtiTopic

The company OtiTopic founded in 2012 as an innovative company. pharmaceutical startup The company owns rights to a number of important patents and differentiated facilities; intellectual property it had received approval for procedure 505 (b) 2 through constructive interaction USA with the Food and Drug Administration.

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