Philip Morris International Acquires Inhaled Drug Specialist OtiTopic; Growing Pipeline of “Beyond Nicotine” Inhaled Therapeutic Products
Philip Morris International Inc. (PMI) (NYSE: PM) today announced its acquisition of OtiTopic, a U.S. 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 U.S. 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 U.S. 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 catalyzed 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 risk of heart attacks.
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.”
“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 best-in-class preclinical safety and inhalation models, PMI is developing a pipeline focused on inhaled therapeutics for medical and wellness applications.
To date, PMI has invested more than $8 billion in building a world-class research and development capability, including pre-clinical systems toxicology and clinical capabilities, behavioral research, and post-market studies. The company has also met the strictest of regulatory requirements, including in the U.S., where the Food and Drug Administration authorized a version of our lead smoke-free tobacco product as a Modified Risk Tobacco Product in 2020.
OtiTopic was founded in 2012 as an innovative pharmaceutical start-up company and holds several key patents, differentiated intellectual property, and has confirmed a 505(b)2 pathway through constructive interactions with the FDA.
PMI expects the impact of the acquisition of OtiTopic on its full-year 2021 adjusted diluted EPS to be immaterial.
Forward-Looking and Cautionary Statements
Statements in this press release that are not strictly historical, including statements regarding the acquisition of OtiTopic, and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements, and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: (1) the possibility that the integration of OtiTopic and its operations with those of PMI may be more difficult and/or take longer than anticipated, and may not accelerate PMI’s desired entry into additional smoke-free and beyond nicotine platforms as quickly as anticipated; (2) the possibility that ASPRIHALE® may not receive FDA approval when anticipated, if at all; (3) the ability of PMI to retain key personnel of OtiTopic; and (4) other factors that may affect future results of the combined company described in the section entitled “Risk Factors” in PMI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, PMI’s Form 10-Q for the quarter ended June 30, 2021, and other filings of PMI with the Securities and Exchange Commission. The forward-looking statements made herein speak only as of the date hereof and PMI does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events and developments or otherwise, except as required by law.
Philip Morris International: Delivering a Smoke-Free Future
Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products, associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the U.S., where these products have received marketing authorizations from the U.S. Food and Drug Administration (FDA) under the premarket tobacco product application (PMTA) pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a Modified Risk Tobacco Product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI’s smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of June 30, 2021, PMI’s smoke-free products are available for sale in 67 markets in key cities or nationwide, and PMI estimates that approximately 14.7 million adults around the world have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.
# # #
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Philip Morris International
T. +41 (0)79 843 8603
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Celltrion Awarded up to $626 Million From the Department of Defense to Supply COVID-19 Point-of-Care (POC) Rapid Antigen Test Kits23.9.2021 09:00:00 CEST | Press release
Celltrion (KRX:068270) announced today that the Defense Logistics Agency (DLA) under the Department of Defense has awarded Celltrion USA, Inc., a subsidiary company of Celltrion, a procurement contract for its DiaTrustTM COVID-19 Ag Rapid Test. Celltrion USA will make deliveries to approximately 25,000 U.S. CONUS locations to support military bases, long-term care facilities, community testing sites, critical infrastructure, and other designated places on a weekly basis. The DLA estimates its order volume to be as much as $626 million considering the change in demand by the COVID-19 community transmission rate in the U.S. Celltrion believes that this procurement contract underscores Celltrion's quality, production and supply capabilities as the deal has been awarded after the Department of Defense’s rigorous verification. Celltrion has already proven the quality and safety of DiaTrustTM earlier this year as the product obtained Emergency Use Authorization (EUA) from the US Food and Dru
Temenos, Vodeno and Aion Bank Announce Strategic Collaboration to Accelerate the Adoption of Banking as a Service in Europe23.9.2021 08:30:00 CEST | Press release
Temenos (SIX: TEMN), the banking software company, Vodeno, a fully cloud-native BaaS provider and Aion Bank, a European licensed digital bank and credit institution, today announced a strategic collaboration to accelerate Banking as a Service (BaaS) deployment in Europe. The first banking services to be launched combine The Temenos Banking Cloud with Vodeno's card management and payment processing services. This will enable banks and businesses across industries to broaden their portfolio of products offered to their customers by automating and embedding new payments and card services seamlessly in their customer journey. The collaboration across all three parties removes the complexities and regulatory overheads of deploying embedded financial services in Europe. Clients will benefit from faster time to market and the business agility to develop new customer propositions. Temenos and Vodeno are already engaged in several proof of concepts with banks and fintechs across Europe. The Tem
The Guide to Unlocking E-Commerce Growth in Markets Across Africa, Asia, Latin America, and the Middle East23.9.2021 07:00:00 CEST | Press release
dLocal, a technology-first payments platform that enables global enterprise merchants to connect with billions of consumers in emerging markets, in partnership with Americas Market Intelligence (AMI), released today an exclusive industry report to fix the lack of trustworthy data about eCommerce in core and high-potential emerging markets. The countries covered are Egypt, Morocco, Nigeria, and South Africa in Africa; India in Asia; Argentina, Brazil, Chile, Colombia, Mexico, Paraguay, Peru, and Uruguay in Latin America; and Turkey in the Middle East. Here are some of the report highlights: In 2020, the 14 core emerging markets added up to US$350 billion in processed payments The total pay-outs made from merchants to individuals in 2020 was equivalent to US$812 billion Local payment methods represent 83% of total eCommerce expenditure in the 14 core markets Although the global economy contracted by 3.5% in 2020, eCommerce growth remained positive, averaging 27% YoY among the 14 core mar
Galderma Announces Exclusive Agreement With Sofregen to Develop the Next Generation of Biostimulator Fillers Using Silk-Based Technology23.9.2021 07:00:00 CEST | Press release
Galderma, the world’s largest independent dermatology company, and Sofregen Medical, Inc., a medical device company pioneering the use of silk protein for tissue building and regeneration, announced today they have signed a co-development and option-to-acquire agreement. This collaboration will further expand Galderma’s capabilities built on decades of science-based aesthetics innovation and a unique heritage in biostimulator and hyaluronic acid (HA) fillers. The novel platform harnesses the unique power of silk protein to enable immediate volume restoration and provide structure that facilitates new tissue generation. “At Galderma, we’re committed to advancing dermatology through constant innovation and joining forces with other industry pioneers. Combining Galderma’s capabilities and scale with Sofregen’s novel silk platform represents a watershed moment for the aesthetics market through the development of a new category of biostimulator fillers designed to make an impact for healthc
EngageSmart Announces Pricing of Initial Public Offering23.9.2021 02:48:00 CEST | Press release
EngageSmart, Inc., a leading provider of vertically-tailored customer engagement software and integrated payments solutions, today announced the pricing of its initial public offering of 14,550,000 shares of its common stock at a price of $26.00 per share. Of the offered shares, 13,000,000 shares are being offered by EngageSmart and 1,550,000 shares are being offered by certain of EngageSmart’s existing stockholders. In addition, the underwriters will have a 30-day option to purchase from EngageSmart and the selling stockholders up to an additional 2,182,500 shares of their common stock at the initial public offering price, less underwriting discounts and commissions. EngageSmart will not receive any proceeds from the sale of shares of common stock by the selling stockholders. The shares are expected to begin trading on the New York Stock Exchange on Thursday, September 23, 2021, under the ticker symbol “ESMT.” The offering is expected to close on September 27, 2021, subject to customa
InvestaX Gets Closer to Tokenizing the World with MAS Fintech Sandbox23.9.2021 02:00:00 CEST | Press release
InvestaX (IC SG Pte Ltd) launches exchange in the Monetary Authority of Singapore (MAS) sandbox, providing key infrastructure for bringing liquidity to digital securities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005600/en/ Next Generation Digital Assets (Photo: Business Wire) InvestaX is a Singapore-headquartered, MAS-licensed* online investment and trading platform for Digital Securities (DSO) and Security Tokens (STO) of global private markets deals, focusing on exciting growth industries including crypto, gaming, blockchain, digital assets, venture, private equity and real estate. InvestaX, announces entry in the sandbox for its exchange, and now provides a one-stop shop solution for the issuance and trading of digital securities, for global products and global investors. Targeting the $8T USD tokenization of the private markets, InvestaX is built with open infrastructure for scalability and interoperability,
AWS to Open Data Centers in New Zealand23.9.2021 00:52:00 CEST | Press release
Today, Amazon Web Services (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), announced plans to open an infrastructure region in Aotearoa New Zealand in 2024. The new AWS Asia Pacific (Auckland) Region will consist of three Availability Zones (AZs) and join the existing 81 Availability Zones across 25 geographic AWS Regions at launch. The Region will be owned and operated by a local AWS entity in New Zealand. Globally, AWS has announced plans for 24 more Availability Zones and eight more AWS Regions in Australia, India, Indonesia, Israel, Spain, Switzerland, the United Arab Emirates, and the new AWS Region in New Zealand. The new AWS Asia Pacific (Auckland) Region will enable even more developers, startups, and enterprises as well as government, education, and nonprofit organizations to run their applications and serve end users from data centers located in New Zealand, ensuring that customers who want to keep their data in New Zealand are able to do so. AWS also released an economic
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom