Business Wire

PMI Presents to US FDA Advisory Committee; Important Milestone in the Scientific Review of IQOS

Del

On January 24 and 25, experts from Philip Morris International Inc. (PMI) and Philip Morris USA Inc. presented to the Tobacco Products Scientific Advisory Committee (TPSAC) before the US Food and Drug Administration (FDA).

The meeting was part of the FDA’s review of PMI’s request to commercialize IQOS in the US as a “Modified Risk Tobacco Product”. U.S. law and policy recognize product innovation as important to the 40 million American men and women who smoke.

To advise the Agency on PMI’s applications, the Committee covered a wide range of scientific, technical, and consumer-communications topics. It raised questions and probed the likelihood and magnitude of potential benefits as well as how best to address possible unintended use.

Although the Committee did not agree with some of the specific language of proposed risk and harm consumer communications, it confirmed that the evidence supported the statement that switching completely to IQOS significantly reduces exposure to harmful chemicals.

“The Committee’s two-day discussion was a milestone event. We thank the Agency and the Committee for their interest in our scientific dossier and our determination to enable adults who smoke to have access to and information about better alternatives,” said André Calantzopoulos, PMI’s Chief Executive Officer, who added: “I am deeply grateful to my colleagues for their exceptional work on our application to the FDA and for the presentations last week. Our science and the commitment of our people give me confidence that we will realize our vision of a smoke-free future.”

We believe the Committee’s interactions with presenters and its discussion reflected respect for our scientific data and commitment to bring IQOS to the U.S. The Committee delved into such areas as inferences about long-term health outcomes, quantification and comparison of risk, the best way to formulate consumer information, and areas for post-market surveillance. At the end of the meeting, the Members of the Committee discussed and voted on particular questions on which the Agency requested the Committee’s views. TPSAC recommendations and votes are not binding on the FDA.

“As a next step, we look forward to working with the Agency to clarify outstanding points so as to best assist in their ongoing decision-making process, which inherently entails a certain degree of scientific uncertainty pre-market,” said Mr. Calantzopoulos, who concluded: “As the FDA routinely does with regard to the many products it regulates, I believe the Agency will ultimately address that uncertainty in the best interest of people who smoke.”

Since 2008, PMI has invested more than USD 3 billion in scientific research, product and commercial development, and production capacity related to IQOS and other smoke-free products. In 2017, over 70% of global R&D expenditure and over 30% of global commercial expenditure was allocated to smoke-free products, and we plan to invest more than USD 1.7 billion in facilities to manufacture them.

Nearly 4 million adult smokers have already switched to IQOS. Our ambition is that all those who would otherwise continue smoking abandon cigarettes and switch completely to scientifically substantiated smoke-free products as soon as possible. Regulatory policies and decisions can substantially accelerate the speed and magnitude of this historic change.

Note to the editor

The FDA is reviewing PMI’s MRTP applications pursuant to the provisions of a 2009 Statute that granted the Agency authority with respect to tobacco products. Under the Statute, the FDA’s decision takes account of scientific evidence as well as comments, data, and information submitted by interested persons.

As previously announced, in 2018 PMI will complete a 12-month exposure response study designed to measure clinical risk markers in adult smokers who switch to IQOS.

PMI has also submitted a Pre-Market Tobacco Application (PMTA) to the FDA which, if granted, will permit the commercialization of IQOS in the US without modified risk messages. This application was not before the Committee as it follows a separate regulatory pathway.

Under agreements with PMI, PM USA is licensed to sell IQOS in the U.S. should PMI receive a PMTA marketing order from the FDA.

Philip Morris International: Who We Are

We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We’re building our future on smoke-free products that are a much better choice than continuing to smoke cigarettes. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirements. Our vision is that these products ultimately replace cigarettes to the benefit of adult smokers, society, our company and our shareholders. For more information, see our PMI and PMIScience websites.

Contact information

Media enquiries
Philip Morris International media office
T: +41 (0)58 242 4500
E: media@pmi.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

ResMed-sponsored Studies Show Combining Home Oxygen and Home Non-invasive Ventilation is a Cost Effective Treatment for COPD20.5.2018 21:15Pressemelding

ResMed (NYSE: RMD, ASX: RMD) announced today the results of two clinical analyses conducted for the U.K. and U.S., demonstrating the cost effectiveness of combining home oxygen therapy and home non-invasive ventilation (NIV) therapy for patients with persistent hypercapnia following a life-threatening exacerbation of chronic obstructive pulmonary disease (COPD). The ResMed-backed Home Oxygen Therapy – Home Mechanical Ventilation (HOT-HMV) health economic studies, presented today at the ATS 2018 International Conference, build on earlier data demonstrating the clinical and cost effectiveness of HOT-HMV therapy (i.e. combining home oxygen therapy with home NIV), compared to treating with oxygen alone. The U.K. study found that HOT-HMV treatment reduced exacerbation frequency and 28-day hospital readmission. The U.S. analysis found a 58.3 percent reduction in 30-day readmissions for HOT-HMV patients compared to those on home oxygen alone – and that HOT-HMV can actually save patients money

WELL Building Standard Gaining Momentum in Europe18.5.2018 14:47Pressemelding

As Greenbuild Europe came to a close in Berlin, the International WELL Building Institute™ (IWBI™) used the occasion to highlight how the WELL Building Standard™ (WELL™) has elevated health and well-being to the forefront of sustainability conversations across Europe. WELL continues to advance the healthy building movement as the premier standard for buildings, interior spaces and communities seeking to implement, validate and measure features that promote human health and wellness. The resonance of the program has spurred innovations across the building, design and construction industries, providing projects with customizable approaches to address geographical and cultural health concerns. To date, WELL has enrolled more than 830 projects encompassing over 155 million square feet of real estate in 32 countries worldwide. In Europe nearly 190 projects across 13 countries are engaged with WELL, representing 25% of global WELL project square footage. The strong growth of WELL over the pa

Utimaco Announces Intent to Acquire Atalla from Micro Focus18.5.2018 09:03Pressemelding

Utimaco, the global #2 in Hardware Security Modules (HSMs), today announced the intent to acquire the Atalla HSM and ESKM business lines from Micro Focus, which were previously owned by Hewlett Packard Enterprise (HPE) prior to the September 2017 merger of its Software business with Micro Focus. Germany-based Utimaco, active in the HSM market for over 35 years, is a global manufacturer of general purpose HSMs. Utimaco has built its market leading position focusing on indirect sales through OEM or channel business partners and selling its SecurityServer product line into industries as diverse as automotive, government, media & entertainment, smart metering, semiconductors, telecommunications and the banking and financial services sectors. Utimaco is traditionally strong in its German home market based on its longstanding German banking association certification (DK) and has recently achieved PCI accreditation for the SecurityServer product line. With the acquisition of Atalla, one of th

Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections18.5.2018 07:00Pressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson, today announced 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1-5. New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica® (ibrutinib), Darzalex® (daratumumab), and Zytiga® (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers. Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Wald

Karisma Hotels & Resorts to Open Allure Palazzi Kotor Bay Hotel by Karisma in June 201818.5.2018 06:00Pressemelding

Karisma Hotels & Resorts, an award-winning luxury hotel collection which owns and manages properties in Latin America, the Caribbean and Europe, is pleased to announce the opening of Allure Palazzi Kotor Bay Hotel by Karisma in June 2018. Built from the ground up in Montenegro’s idyllic Dobrota, the exclusive five-star beachfront property seamlessly blends stunning architecture and design with its mountainous landscape, offering spellbinding views of Kotor Bay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180517006456/en/ Rendering of Allure Palazzi Kotor Bay (Photo: Business Wire) Sitting on Kotor Bay’s only private beach, the resort features 89 premium guestrooms, 10 villas with private beachfront access, and three breathtaking penthouse suites, each with a balcony or terrace. Allure Palazzi Kotor Bay’s accommodations encompass sumptuous bedding, divine amenities, and carefully selected color palettes bringing the sunny

Siemens Financial Services Selects GTC’s @GlobalTrade Platform for Management of Export Documentary Credits18.5.2018 04:00Pressemelding

GlobalTrade Corporation (GTC) has announced today that Siemens Financial Services (SFS) has selected its @GlobalTrade Multi-bank Trade Finance Platform for management of its export documentary credits. The platform will be initially rolled out in Germany and thereafter expanded to Siemens entities globally. The system will electronically aggregate all incoming documentary credits in a global database, facilitate review and approval, assist in preparation of compliant documents and enable faster presentation of documents electronically to advising and issuing banks. Gerhard Heubeck, Head of Trade Finance Advisory at Siemens Financial Services, reasons the need for the new system implementation as follows: "After many years of using one of the first standard IT systems available for export documentary credits, the time has come to find a successor tool capable to meet the new requirements such as multi-client capability, processing of new SWIFT message formats, global accessibility, and