A Single-dose, Open-label, Multi-center, Randomized, 2-treatment Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Adult Subjects With Obstructive or Restrictive Pulmonary Function

The goal of this clinical trial is to compare the pharmacokinetics (PK) pharmacodynamics (PD), safety and tolerability of acetylsalicylic acid powder for oral inhalation (I-ASA) with non-enteric-coated chewable aspirin (C-ASA) in adult subjects with obstructive or restrictive pulmonary function.
In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.

Start Date11 Mar 2023

Sponsor / Collaborator

Vectura Group Ltd.

[+1]

NCT05625334 / CompletedPhase 1

A Single-dose, Open-label, Randomized, Multi-center, 2-treatment Crossover Study to Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Healthy Adults

The goal of this clinical trial is to compare the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of acetylsalicylic acid powder for oral inhalation (i-ASA) with non-enteric-coated chewable aspirin (C-ASA) in healthy adults by demonstrating bioequivalence.
In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.

Start Date14 Oct 2022

Sponsor / Collaborator

Vectura Group Ltd.

[+1]

CTR20201498 / CompletedPhase 3

评估Cevira？对宫颈高级别鳞状上皮内病变（HSIL）的疗效及安全性的一项随机、双盲、前瞻性、安慰剂对照、多中心的III期临床研究

[Translation] A randomized, double-blind, prospective, placebo-controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of Cevira? for high-grade squamous intraepithelial lesions (HSIL) of the cervix

帮助组织病理学确诊且阴道镜检查充分的HSIL患者，保留支撑细胞的基质，从而保留了宫颈的功能，避免了与外科手术相关的副作用。证明产品的有效性和安全性与现有治疗方法相比，Cevira？疗法具有明显的潜在优点。

[Translation]

Helps HSIL patients with histopathological diagnosis and adequate colposcopy to preserve the matrix of supporting cells, thereby preserving the function of the cervix and avoiding the side effects associated with surgery. Prove the effectiveness and safety of the product. Compared with existing treatments, Cevira? Therapy has obvious potential advantages.

Start Date20 Oct 2020

Sponsor / Collaborator

Bioglan AB /Drug Delivery Business/

[+2]

100 Clinical Results associated with Vectura Group Ltd.

0 Patents (Medical) associated with Vectura Group Ltd.

Literatures (Medical) associated with Vectura Group Ltd.

01 Dec 2020·Journal of controlled release : official journal of the Controlled Release SocietyQ1 · MEDICINE

In vitro and in vivo antitubercular activity of benzothiazinone-loaded human serum albumin nanocarriers designed for inhalation

Q1 · MEDICINE

Article

Author: Dailey, Lea Ann ; Woods, Arcadia ; Keegan, Gemma ; Childerhouse, Nick ; Forbes, Ben ; Redinger, Natalja ; Richter, Adrian ; Imming, Peter ; Patel, Ayasha ; Neumann, Paul Robert ; Schaible, Ulrich E

The aim of this study was to investigate the potential of human serum albumin (HSA) as a solubilising agent/drug delivery vehicle for pulmonary administration of antimycobacterial benzothiazinone (BTZ) compounds. The solubility of four novel BTZ compounds (IR 20, IF 274, FG 2, AR 112) was enhanced 2 to 140-fold by incubation with albumin (0.38-134 μg/mL). Tryptophan 213 residue quenching studies indicated moderate binding strength to Sudlow's site I. Nanoparticle manufacture achieved 37-60% encapsulation efficiency in HSA particles (169 nm, zeta potential -31 mV). Drug release was triggered by proteases with >50% released in 4 h. The antimycobacterial activity of IR 20 and FG 2 loaded in HSA nanoparticles was enhanced compared to DMSO/phosphate buffered saline (PBS) or albumin/PBS solutions in an in vitro M. tuberculosis-infected macrophage model. Intranasal instillation was used to achieve pulmonary delivery daily over 10 days to M. tuberculosis infected mice for FG2 HSA nanoparticles (0.4 mg/kg), FG 2 DMSO/saline (0.4 and 8 mg/kg) and a reference compound, BTZ043, DMSO/saline (0.4 and 8 mg/kg). A lower lung M. tuberculosis burden was apparent for all BTZ cohorts, but only significant for BTZ043 at both doses. In conclusion, mechanisms of HSA nanoparticle loading and release of BTZ compounds were demonstrated, enhanced antimycobacterial activity of the nanoparticle formulations was demonstrated in a biorelevant in vitro bioassay and the effectiveness of BTZ by pulmonary delivery in vivo was established with pilot evidence for effectiveness when delivered by HSA nanoparticles. Finally, the feasibility of developing an inhaled nanoparticle-in-microparticle powder formulation was ascertained.

01 Dec 2020·Journal of aerosol medicine and pulmonary drug deliveryQ4 · MEDICINE

Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine

Q4 · MEDICINE

Review

Author: McKiernan, Paul ; Ehrmann, Stephan ; Kuehl, Philip J. ; Fink, James B. ; Corcoran, Timothy E. ; MacLoughlin, Ronan ; Dailey, Patricia ; Muellinger, Bernhard ; Darquenne, Chantal ; Häussermann, Sabine ; Martin, Andrew R. ; Dhand, Rajiv ; Rothen-Rutishauser, Barbara ; Smaldone, Gerald C. ; Li, Jie

National and international guidelines recommend droplet/airborne transmission and contact precautions for those caring for coronavirus disease 2019 (COVID-19) patients in ambulatory and acute care settings. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, an acute respiratory infectious agent, is primarily transmitted between people through respiratory droplets and contact routes. A recognized key to transmission of COVID-19, and droplet infections generally, is the dispersion of bioaerosols from the patient. Increased risk of transmission has been associated with aerosol generating procedures that include endotracheal intubation, bronchoscopy, open suctioning, administration of nebulized treatment, manual ventilation before intubation, turning the patient to the prone position, disconnecting the patient from the ventilator, noninvasive positive-pressure ventilation, tracheostomy, and cardiopulmonary resuscitation. The knowledge that COVID-19 subjects can be asymptomatic and still shed virus, producing infectious droplets during breathing, suggests that health care workers (HCWs) should assume every patient is potentially infectious during this pandemic. Taking actions to reduce risk of transmission to HCWs is, therefore, a vital consideration for safe delivery of all medical aerosols. Guidelines for use of personal protective equipment (glove, gowns, masks, shield, and/or powered air purifying respiratory) during high-risk procedures are essential and should be considered for use with lower risk procedures such as administration of uncontaminated medical aerosols. Bioaerosols generated by infected patients are a major source of transmission for SARS CoV-2, and other infectious agents. In contrast, therapeutic aerosols do not add to the risk of disease transmission unless contaminated by patients or HCWs.

01 Dec 2019·Journal of controlled release : official journal of the Controlled Release SocietyQ1 · MEDICINE

Targeted PEG-poly(glutamic acid) complexes for inhalation protein delivery to the lung

Q1 · MEDICINE

Article

Author: Monteiro, C J ; Mantovani, G ; Nieto-Orellana, A ; Li, H ; Williams, H ; Bosquillon, C ; Keegan, G ; Stolnik, S ; Wauthoz, N ; Childerhouse, N ; Rosiere, R ; Coghlan, D

Pulmonary delivery is increasingly seen as an attractive, non-invasive route for the delivery of forthcoming protein therapeutics. In this context, here we describe protein complexes with a new 'complexing excipient' - vitamin B₁₂-targeted poly(ethylene glycol)-block-poly(glutamic acid) copolymers. These form complexes in sub-200nm size with a model protein, suitable for cellular targeting and intracellular delivery. Initially we confirmed expression of vitamin B₁₂-internalization receptor (CD320) by Calu-3 cells of the in vitro lung epithelial model used, and demonstrated enhanced B₁₂ receptor-mediated cellular internalization of B₁₂-targeted complexes, relative to non-targeted counterparts or protein alone. To develop an inhalation formulation, the protein complexes were spray dried adopting a standard protocol into powders with aerodynamic diameter within the suitable range for lower airway deposition. The cellular internalization of targeted complexes from dry powders applied directly to Calu-3 model was found to be 2-3 fold higher compared to non-targeted complexes. The copolymer complexes show no complement activation, and in vivo lung tolerance studies demonstrated that repeated administration of formulated dry powders over a 3 week period in healthy BALB/c mice induced no significant toxicity or indications of lung inflammation, as assessed by cell population count and quantification of IL-1β, IL-6, and TNF-α pro-inflammatory markers. Importantly, the in vivo data appear to suggest that B₁₂-targeted polymer complexes administered as dry powder enhance lung retention of their protein payload, relative to protein alone and non-targeted counterparts. Taken together, our data illustrate the potential developability of novel B₁₂-targeted poly(ethylene glycol)-poly(glutamic acid) copolymers as excipients suitable to be formulated into a dry powder product for the inhalation delivery of proteins, with no significant lung toxicity, and with enhanced protein retention at their in vivo target tissue.

News (Medical) associated with Vectura Group Ltd.

05 Dec 2024

·www.accesswire.com

Dry Powder Inhaler Market Set for Steady Growth Through 2034 | Future Market Insights, Inc.

Major companies in the dry powder inhaler market are focusing on innovation, developing products with muscarinic antagonists for the treatment of chronic obstructive pulmonary disease (COPD), and expanding their product portfolios. Muscarinic antagonists are drugs that inhibit the muscarinic acetylcholine receptor and are used to treat various illnesses, including COPD NEWARK, DE / ACCESSWIRE / December 5, 2024 / The Dry Powder Inhaler Market is poised for significant growth, with a market value of USD 20.83 billion in 2024, projected to climb to USD 29.95 billion by 2034, representing a steady CAGR of 3.70% over the forecast period. This growth is underpinned by rising prevalence of respiratory diseases such as asthma and COPD, combined with technological advancements in drug delivery systems.Regulatory approvals for patient-friendly inhalation devices, increasing awareness of chronic respiratory diseases, and a rising geriatric population are also boosting the adoption of dry powder inhalers globally. With the growing focus on reducing hospital stays and providing efficient home-care treatments, these devices are becoming an essential tool in respiratory disease management.Regionally, the market sees diverse opportunities. Emerging economies in Asia-Pacific demonstrate the fastest growth due to increasing healthcare expenditure and heightened awareness about respiratory health. Developed regions, particularly North America and Europe, continue to dominate the market due to their advanced healthcare infrastructure and strong presence of key industry players.The shift toward environmentally friendly propellants and the development of digitalized inhalers equipped with dose-tracking and usage monitoring are reshaping the landscape, offering additional revenue streams for manufacturers.With the utilization of dry powder inhalers in the treatment of a diverse range of diseases, the development of technologically innovative products is surfacing. These "smart technologies" are set to satisfy specific market requirements for the development of cost-effective drug products. The deep penetration of digital systems into the inhaler market has been advantageous in terms of ruling out several device and design errors. The implementation of microprocessors in inhalers for supporting patients with device usage and handling is positively impacting compliance and product satisfaction.The development of next-generation inhalers with the integration of smart technologies is likely to drive the growth of the dry powder inhaler market. The integration is set to establish a breakthrough in drug delivery with the primary basis being a tailored performance based on the patient's/user's variable breathing patterns.Technologically advanced dry powder inhalers with digitally enabled platforms along with a friendly user interface will help in preventing or compensating actuation errors that, in turn, will enhance compliance. The growth of digitally operated inhalers devices is also supported by the recent upsurge in digitalization in the healthcare and industrial sectors. This factor will drive the dry powder inhaler market.The dry powder inhalers are a preferred method of treatment of respiratory ailments over pressurized metered dose inhalers and nebulizers owing to the rising concerns related to the environmental impact of inhaler devices which utilize chloroflouro carbons as propellants.Thus, the production and design of dry powder inhalers is set to witness a growth over the forecast period, and is expected to offer product manufacturers or key players in the dry powder inhaler market with an optimistic growth opportunity.Request a Sample of this Report Now: https://www.fmisamplereport.com/sample/rep-gb-5150Key Takeaways from Market StudyMarket Growth: Projected to grow from USD 20.83 billion in 2024 to USD 29.95 billion by 2034, at a CAGR of 3.70%.Technology Focus: Smart inhalers and eco-friendly propellants are driving innovations in the market.Disease Prevalence: Rising cases of asthma and COPD are a key determinant of demand.Regional Growth: North America and Europe lead the market, while Asia-Pacific exhibits the highest growth rate.Segment Dominance: Capsule-based inhalers continue to capture a significant market share due to their ease of use and cost-effectiveness."Dry powder inhalers are witnessing a transformation driven by the convergence of healthcare and technology. The emergence of smart inhalers, coupled with increasing adoption in developing markets, positions the industry for robust growth over the next decade. Companies that can successfully innovate while addressing environmental concerns will lead the charge in shaping the future of this vital healthcare segment." SaysSabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.)What Are The Key Opportunities For Dry Powder Inhalers Manufacturers?Confounding problems are existent in clinical trials for dry powder inhalers, specifically, where the possibility of errors by patients with respect to inhaler handling can be high. Distinguishing handling errors by patients from existing clinical effects is complex, particularly in phase III trials where support to patients cannot be contracted.The impact of digital systems thus presents an opportunity to assist with monitoring and control over all phases of clinical studies. Digital technology can improve clinical outcomes by improving adherence and reducing patient errors through mobile applications connected to the device, which will deliver useful tools including reminders and step-based guidance for the appropriate technique of usage.On the other hand, medical providers can track patient compliance to the therapeutic regimen in real time. Additionally, the monitoring of symptoms and their worsening is registered along with the compliance tracker and it assists with the prevention of severe disease exacerbations, thus leading to a satisfying patient outcome.The development of inhalation products poses the possibility of significant errors for drug-device combinations related to the usage of the device by patients, variations in the delivery of drugs, as well as flawed data collection.These errors may deliver distorted information regarding the therapeutic efficacy of drug formulations and device-based effects in clinical trials. The introduction of programmed tools for use in clinical trials will contribute to an improved understanding of drug-device combinations and their efficiency.These tools may assist with enhanced data collection processes without being influenced by poor patient compliance as well as administration issues. These automated tools can include incorporated audio-based technologies and devices for monitoring medication compliance.Connected wearable devices can be beneficial in tracking patient activity and thus evaluating the effect on clinical efficacy with integrated companion applications to capture patient-reported outcomes.Thus, the change in the landscape of clinical trials is set to be positively impacted by the monitoring of data all through the product life cycle along with patient-reported data in real-time conditions, thus presenting an opportunistic growth for the dry powder inhaler market.What Are The Factors Restraining Demand For Dry Powder Inhalers?Technological advancements are progressively growing in terms of increasing novel and innovative, integrated, alternative good manufacturing practice-ready approaches, which are associated with next-generation analytical and modelling skills. However, regulations encompassing such progressions are yet to catch up with the developing complex clinical requirements.This trend is intensified by the acceleration of complexity and the cost of approval for the formulation of orally inhaled and nasal drug products and by the scientific disparity that still exists, particularly for locally acting dry powder inhaler products.Considering this, despite existing development, animal models are not applicable to humans and perceptive methods for assessing clinical efficiency along with in-vitro and in-vivo association for inhaled medicines are still inadequate.In this concern, the outcome of the clinical approach is intensely predisposed by the ambiguous correlation between efficiency and selected clinical endpoints. This risk is greater for therapies in which the pattern of deposition of the drug is directly associated with efficiency.In spite of thorough assessments and a focus on advances in device design as well as formulation, the impact on the patient in terms of their adherence to therapy, inspiration rate, and correct use of the inhaler are yet to be quantified. This poses a restrictive impact on the growth of the dry powder inhaler market, given the wide-ranging factors associated with the intensity of the impact of disease on the patient, affecting their inspiration rate.Country-wise InsightsWhat Makes the U.S. the Largest Market for Dry Powder Inhalers?The U.S. dominates the North American region with a total market share of about 90.5% in 2020, and is projected to continue experiencing high growth throughout the forecast period. U.S. is the most lucrative market for dry powder inhalers owing to the combination of a robust healthcare infrastructure accompanied with technologically advanced procedure, an increasing number of patients with respiratory disorders, strictly enforced guidelines by regulatory authorities pertaining to medical devices attributed with respiratory disorder therapeutics, and comparatively high government healthcare spending.Furthermore, due to the increased prevalence of asthma and other respiratory disorders, as well as the growing geriatric population, the dry powder inhaler market in the United States is expected to develop significantly over the next decade.Why is Spain Considered a Lucrative Market for Dry Powder Inhalers in Europe?Spain. is set to exhibit a CAGR of nearly 2.90% in the European dry powder inhaler market during the forecast period. The rising research and development activities to generate a sustainable base of drug delivery devices in the country as well as an established healthcare infrastructure are some of the factors aiding the growth of dry powder inhalers in the country.What Makes China an Emerging Market for Dry Powder Inhalers?China holds 38.9% share in the East Asia dry powder inhaler market in 2020, and is projected to increase at a CAGR rate of 5.4% during the forecast period. This growth is associated with the rising deployment of automated systems and devices into an integrated platform for patient monitoring as well as drug delivery devices, rising healthcare costs and rapidly improving medical infrastructure. All these factors are expected to drive market growth in the coming years in China.CountriesForecast CAGRs from 2024 to 2034India5.20%Indonesia4.7%Canada3.1%Spain2.90%France2.40%Competitive LandscapeThe dry powder inhaler market is marked by robust competition as both established pharmaceutical leaders and emerging biotech innovators vie to capture market share. Key players drive innovation by focusing on research and development, improving device functionality, and expanding the therapeutic scope of their products.Strategic collaborations, regulatory compliance, and technological progress are crucial factors shaping this competitive environment. With an increasing emphasis on sustainability and patient-centric solutions, companies strive to differentiate themselves in a rapidly evolving market. As global demand for respiratory medications rises, competition fuels innovation, propelling advancements in dry powder inhaler technologies.Product PortfolioGlaxoSmithKline Plc is a global leader in healthcare innovation, offering a wide range of pharmaceuticals, vaccines, and consumer health products. With a strong commitment to patient-focused solutions, GSK delivers cutting-edge therapies that enhance well-being and improve quality of life worldwide.AstraZeneca Plc is a renowned biopharmaceutical company focused on transforming healthcare through advanced treatments in respiratory, oncology, cardiovascular, and other critical areas. Leveraging research and collaboration, AstraZeneca addresses unmet medical needs to improve patient outcomes globally.Novartis AG redefines medicine with its diverse portfolio that spans pharmaceuticals, generics, and eye care. By harnessing cutting-edge technology and science, Novartis creates innovative solutions aimed at tackling the most urgent healthcare challenges and delivering better health outcomes.Key Companies ProfiledGlaxoSmithKline PlcAstraZeneca Plc;Novartis AG;Teva Pharmaceutical Industries Limited;Boehringer Ingelheim GmbH;Cipla Limited;Chiesi Farmaceutici S.p.A.;Elpen S.A.;Vectura Group Plc;Beximco Pharmaceuticals Ltd.;Hovione;AptarGroup, Inc.;Iconovo AB (Stevanato Group);Sava Healthcare Ltd.;MannKind Corporation;Mylan N.V;PharmaxisSegmentation Analysis of the Dry Powder Inhaler IndustryBy Product:Single Dose Dry Powder InhalersMulti Dose Dry Powder InhalersBy Indication:AsthmaChronic Obstructive Pulmonary Disease (COPD)Pulmonary Arterial HypertensionDiabetesCystic FibrosisBy Function:Manually Operated Inhaler DevicesDigitally Operated Inhaler DevicesBy End User:Institutional SalesHospital PharmaciesCancer ResearchOffice based Specialty ClinicsRetail SalesRetail PharmaciesDrug StoresMail Order PharmaciesBy Region:North AmericaLatin AmericaWestern EuropeEastern EuropeSouth Asia & PacificEast AsiaThe Middle East & AfricaAuthorSabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.Explore FMI's Extensive Coverage in the Healthcare Domain:The global respiratory inhaler devices market size is anticipated to attain an impressive valuation of USD 37,258.5 million in 2023 and is projected to reach USD 60,114.7 million by 2033The global Dry Eye Syndrome Treatment Market is estimated to capture a CAGR of 6.4% over the forecast period. The global market is worth USD 5,120 million in 2023The anticipated size of the metered dose inhalers market in 2022 was USD 25,208.9 million and is estimated to be USD 26,322.9 million in 2023.Expanding at a high CAGR of 8.2%, the global Dual and Multi-energy Computed Tomography (CT) Market is projected to increase from a valuation of USD 1.5 Billion in 2022 to USD 2.6 Billion by 2029.The positron emission tomography (PET) scanners market is estimated to be valued at USD 1.3 billion in 2023 and is rising to USD 2.1 billion by 2033.The global optical coherence tomography market size reached USD 1,311.70 million in 2023.The global photoacoustic tomography market is projected to reach USD 79.2 million in 2022.A 5.8% compound annual growth rate (CAGR) is projected for the global mobile tomography market from 2022 to 2032, with 2022 revenues of USD 295.2 Million and 2032 revenues of USD 595.1 Million.The global medical automation market is estimated to secure a valuation of USD 48,626.2 million in 2023 and reach up to USD 103,052.3 million by 2033.As per the analysis, the electronic medical record market is set to account for a current valuation of USD 18.82 billion in 2024.About Future Market Insights (FMI)Future Market Insights (FMI) is a leading provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in Dubai and has delivery centres in the United Kingdom, the United States, and India. FMI's latest market research reports and industry analysis helps businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. Our customized and syndicated market research reports deliver actionable insights that drive sustainable growth. A team of expert-led analysts at FMI continuously tracks emerging trends and events in a broad range of industries to ensure that our clients prepare for the evolving needs of their consumers.Join us as we commemorate 10 years of delivering trusted market insights. Reflecting on a decade of achievements, we continue to lead with integrity, innovation, and expertise.Contact UsFuture Market Insights Inc.Christiana Corporate, 200 Continental Drive,Suite 401, Newark, Delaware - 19713, USAT: +1-347-918-3531For Sales Enquiries: [email protected]Website:https://www.futuremarketinsights.comLinkedIn| Twitter| Blogs | YouTubeSOURCE: Future Market Insights, Inc.

Phase 3

17 Sep 2024

·www.businesswire.com

Molex, a Parent to Phillips Medisize, Announces Agreement to Acquire the Vectura Group Limited, Expanding Its Drug Delivery Capabilities in Inhalation

HUDSON, Wis.--( BUSINESS WIRE )--Molex, a parent to Phillips Medisize, a leader in the design, engineering and manufacturing of pharmaceutical drug delivery, in vitro diagnostic and medtech devices, announced that, through its affiliate Molex Asia Holdings LTD., it has signed an agreement to purchase Vectura Group Limited (Vectura) from Vectura Fertin Pharma Inc., a subsidiary of Philip Morris International (PMI) (NYSE: PM). Vectura is a leader in inhalation drug device design and formulation, based in Chippenham, United Kingdom. “Combining the strengths of Phillips Medisize and Vectura will enhance our ability to deliver a broader portfolio of inhalation combination drug devices and solutions to our pharmaceutical customers and support our mission to help people live healthier, more productive lives,” said Paul Chaffin, President of Phillips Medisize. “With our global reach, manufacturing scale, and engineering expertise, Phillips Medisize is uniquely positioned to help Vectura in developing innovative new products for their customers, ultimately benefiting people who suffer with chronic and acute diseases such as asthma and COPD.” Vectura brings to Phillips Medisize its unique inhalation expertise that includes formulation and device development for dry powder inhalers (DPI), pressurized metered dose inhalers (pMDI), nasal and nebulizer products for small molecules, biologics, complex combinations and generic products. The company also offers pharmaceutical analysis, process development, technical transfer, clinical trial supplies and regulatory services. Phillips Medisize is a global company that designs, engineers and manufactures products for the pharmaceutical and broader healthcare industry. The company’s 6,000+ employees collaborate with customers at 29 sites located throughout North America, Europe and Asia. Being part of Molex also allows the business to leverage market leading capabilities across a range of specialty electronics and optical fiber applications for the medical industry. “The acquisition of Vectura is the latest step in building an industry-leading capability in medical. It also demonstrates Molex’s commitment to acquiring opportunities to better serve market needs across our portfolio,” said Joe Nelligan, CEO of Molex, which acquired Phillips Medisize in 2016 to build a scale healthcare business. “We are excited by the significant growth potential that comes with a wider range of formulation, device design, combination product development and manufacturing services to support the increasing need for inhalation therapies. We look forward to welcoming the Vectura team, who brings a celebrated reputation of inhalation expertise and experience.” The acquisition is expected to close by the end of 2024, subject to regulatory approvals and other customary closing conditions. About Phillips Medisize Phillips Medisize, a Molex company, collaborates with leading pharmaceutical, medical technology and in vitro diagnostic companies to design, engineer and manufacture life-saving innovations. A contract development and manufacturing organization (CDMO), Phillips Medisize leverages its 60 years of expertise and globally renowned capabilities to deliver products and solutions that annually help millions of patients, healthcare professionals and individuals live healthier, more productive lives. For more information, visit www.phillipsmedisize.com . About Molex Molex is a global electronics leader committed to making the world a better, more-connected place . With a presence in more than 40 countries, Molex enables transformative technology innovation in the automotive, data center, industrial automation, healthcare, 5G, cloud and consumer device industries. Through trusted customer and industry relationships, unrivaled engineering expertise, and product quality and reliability, Molex realizes the infinite potential of Creating Connections for Life . For more information, visit www.molex.com .

Acquisition

17 Sep 2024

·www.businesswire.com

Vectura Fertin Pharma, Inc., a Subsidiary of Philip Morris International, Announces Agreement for Sale of Vectura Group to Molex

STAMFORD, CT--( BUSINESS WIRE )--Vectura Fertin Pharma, Inc., an affiliate of Philip Morris International Inc. (PMI) (NYSE: PM), today announces the sale of its subsidiary Vectura Group Ltd. (Vectura) to Molex Asia Holdings Ltd., and the establishment of master service agreements to develop Vectura Fertin Pharma’s inhaled therapeutics proprietary pipeline. Vectura will be operated by Phillips Medisize, a Molex company. The sale includes upfront cash consideration of GBP 150 million, subject to customary purchase price adjustments, and potential deferred payments of up to GBP 148 million. The transaction is subject to customary closing conditions, including regulatory approval. “ In line with our ambitions, Vectura has enabled us to develop a proprietary pipeline of inhaled therapeutics, and we remain committed to driving innovation in this space over the long-term,” said Jacek Olczak, PMI Chief Executive Officer. PMI’s 2021 acquisition of Vectura has been instrumental in kick-starting Vectura Fertin Pharma’s development of inhaled therapeutics, bringing to the company specialist knowledge, technologies, and formulation science. However, despite the investment and commitment to developing products and therapies vital to patients, unwarranted opposition to PMI’s transformation has impacted Vectura’s scientific engagement and commercial CDMO relationships. Mr. Olczak added: “ With its experience in pharmaceutical drug delivery devices and its global manufacturing footprint, Phillips Medisize is best placed to lead Vectura into the future— while releasing it from the unreasonable burden of external constraints and criticism related to our ownership.” The remaining units of Vectura Fertin Pharma will continue to operate as a separate company under PMI’s ownership and will be given a new corporate identity. This business will focus on developing and commercializing oral consumer health and wellness offerings and inhaled prescription products for therapy areas that include pain management and cardiovascular emergencies. Phillips Medisize is a global company that designs, engineers, and manufactures drug delivery systems, medical devices, and in vitro diagnostic products. The company’s more than 6,000 employees collaborate with customers at 29 sites throughout North America, Europe, and Asia. Adding the Vectura team and its market-leading capabilities in inhalation aligns with Phillips Medisize’s stated mission of working with customers to develop innovative products that help people live healthier, more productive lives. Notes to Editor Definitions: CDMO: contract development and manufacturing organization Philip Morris International: Delivering a Smoke-Free Future Philip Morris International (PMI) is a leading international tobacco company, actively delivering a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector. The company’s current product portfolio primarily consists of cigarettes and smoke-free products. Since 2008, PMI has invested over $12.5 billion to develop, scientifically substantiate, and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of completely ending the sale of cigarettes. This includes the building of world-class scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies. In 2022, PMI acquired Swedish Match—a leader in oral nicotine delivery—creating a global smoke-free champion led by the companies’ IQOS and ZYN brands. The U.S. Food and Drug Administration has authorized versions of PMI’s IQOS devices and consumables and Swedish Match’s General snus as Modified Risk Tobacco Products, and renewal applications for these products are presently pending before the FDA. As of June 30, 2024, PMI’s smoke-free products were available for sale in 90 markets, and PMI estimates that 36.5 million adults around the world use PMI’s smoke-free products. Smoke-free business accounted for approximately 38% of PMI’s total first-half 2024 net revenues. With a strong foundation and significant expertise in life sciences, PMI announced in February 2021 its ambition to expand into wellness and healthcare areas and, through its Vectura Fertin Pharma business, aims to enhance life through the delivery of seamless health experiences. “PMI” refers to Philip Morris International Inc. and its subsidiaries. For more information, please visit www.pmi.com and www.pmiscience.com . About Phillips Medisize Phillips Medisize, a Molex company, collaborates with leading pharmaceutical, medical technology and in vitro diagnostic companies to design, engineer and manufacture life-saving innovations. A contract development and manufacturing organization (CDMO), Phillips Medisize leverages its 60 years of expertise and globally renowned capabilities to deliver products and solutions that annually help millions of patients, healthcare professionals and individuals live healthier, more productive lives. For more information, visit www.phillipsmedisize.com . About Molex Molex is a global electronics leader committed to making the world a better, more connected place. With a presence in more than 40 countries, Molex enables transformative technology innovation in the automotive, data center, industrial automation, healthcare, 5G, cloud and consumer device industries. Through trusted customer and industry relationships, unrivaled engineering expertise, and product quality and reliability, Molex realizes the infinite potential of Creating Connections for Life. For more information, visit www.molex.com . Forward-Looking and Cautionary Statements This press release contains projections of future results and goals and other forward-looking statements, including statements regarding the timing of and ability to complete the Vectura sale transaction; expected benefits of the transaction and of the continuing commercial relationship; the receipt of deferred payments; expected operational performance; and business plans and strategies. Achievement of future results is subject to risks, uncertainties and inaccurate assumptions. In the event that risks or uncertainties materialize, or underlying assumptions prove inaccurate, actual results could vary materially from those contained in such forward-looking statements. Pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, PMI is identifying important factors that, individually or in the aggregate, could cause actual results and outcomes to differ materially from those contained in any forward-looking statements made by PMI. The factors that may adversely impact the anticipated outcomes include, among others: the occurrence of any event, change or other circumstances that could give rise to the termination of the transaction agreement; the outcome of any legal proceedings that may be instituted against the parties or others related to the transaction agreement; conditions to the completion of the transaction may not be satisfied, or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; the parties' ability to meet expectations regarding the timing, completion and other elements of the transaction may be different than currently planned; and the possibility that the expected benefits of the transaction, of the continuing commercial relationship between the parties, or of PMI’s business plans and strategies may not materialize in the expected manner or timeframe, if at all. PMI is further subject to other risks detailed from time to time in its publicly filed documents, including PMI's Annual Report on Form 10-K for the fourth quarter and year ended December 31, 2023, and the Quarterly Report on Form 10-Q for the second quarter ended June 30, 2024. PMI cautions that the foregoing list of important factors is not a complete discussion of all potential risks and uncertainties. PMI does not undertake to update any forward-looking statement that it may make from time to time, except in the normal course of its public disclosure obligations.

Acquisition

100 Deals associated with Vectura Group Ltd.

100 Translational Medicine associated with Vectura Group Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 2

Phase 3

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Fenofibrate ( PPARα )	Hypertriglyceridemia More	Approved
Hexaminolevulinate Hydrochloride	Squamous Intraepithelial Lesions More	Phase 3
Glycine/lysine acetylsalicylate inhalation(Vectura)	Influenza B virus infection More	Phase 2
VR-506 ( GR )	Asthma More	Discontinued
CTL-102-GDEPT ( NOS )	Head and Neck Neoplasms More	Discontinued

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