While respiratory diseases are clinically distinct, there are important pathophysiological features that span them, and our ambition is to have the most comprehensive portfolio of medicines to address a diverse range of respiratory diseases. To achieve this, we are focusing on targeting the underlying disease-driving biological processes to develop medicines with applicability across multiple respiratory diseases. This approach requires extensive bioinformatics, data analytic capabilities, careful patient selection and stratification by phenotype in our clinical trials. Important Safety Information (isi the following isi is based on the highlights section of the us prescribing Information for FF/umec/VI. Please consult the full Prescribing Information for all the labelled safety information. Trelegy Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or any of the ingredients. Laba monotherapy increases the risk of serious asthma-related events. Trelegy Ellipta should not be initiated in patients experiencing episodes of acutely deteriorating copd.
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Managing these aspects of the disease drives physician treatment choice. Long-term exposure to deforestation inhaled irritants that damage the lungs and the airways are usually the cause of copd. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from business the environment or workplace can all contribute to copd. Most people who have copd are at least 40 years old when symptoms begin.5. Every person with copd is different, with different needs, different challenges and different goals. Understanding this and providing support to help meet these needs is the foundation of gsks work. Gsks commitment to respiratory disease, gSK has led the way in developing innovative medicines to advance the management of asthma and copd for nearly 50 years. Over the last five years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry-leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment. We remain at the cutting-edge of scientific research into respiratory medicine, working in collaboration with patients and the scientific community to offer innovative medicines aimed at helping to treat patients symptoms and reduce the risk of their disease worsening.
It is also indicated to reduce exacerbations of copd in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma. Full us prescribing Information, including Patient Information is available at: fF/umec/vi is approved in Europe as a maintenance treatment in adult patients with moderate to severe copd who are entry not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The european Summary of Product Characteristics is available at: /emc/medicine/34357, regulatory applications for once-daily single inhaler triple therapy ff/umec/VI have been submitted and are undergoing assessment in a number of other countries worldwide. About copd, copd is a progressive lung disease that is thought to affect around 384 million people worldwide.4. For people living with copd, the inability to breathe normally can consume their daily lives and make simple activities, like walking upstairs, an everyday struggle. Patients with copd suffer from symptoms of breathlessness and many have a significant risk of exacerbations.
Impact ) study is the paper first study to directly compare three commonly-used copd combination treatment classes delivered using the same dose and inhaler. It is the second of two Phase iii studies designed to investigate the efficacy and safety of FF/umec/vi in a single inhaler compared to other commonly-used copd combination treatments.2. Impact evaluated as its primary endpoint the annual rate of on-treatment moderate/severe exacerbations for FF/umec/VI (100/62.5/25mcg) compared with FF/VI (100/25mcg) and umec/VI (62.5/25mcg two once-daily dual copd therapies from gsks existing portfolio. Results from impact were recently published in the new England journal of Medicine. 3, about FF/umec/vi, fF/umec/vi is the first copd treatment to provide a combination of three molecules in a single inhaler that is taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in gsks Ellipta dry powder inhaler, which is used across gsks new portfolio of inhaled copd medicines. Data from across multiple clinical programmes have demonstrated the benefit of the molecules in FF/umec/vi, both alone and in combination, for the treatment of copd. FF/umec/vi is approved in the us for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with copd, including chronic bronchitis and/or emphysema.
In the overall study population, ff/umec/VI was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/laba relvar/Breo ellipta (FF/vi and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (lama/laba anoro Ellipta (umec/vi on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality. Similar trends were observed in the japanese population for the primary endpoint as well as across multiple secondary and supportive efficacy endpoints. Dr Ted Witek, senior Vice President and Chief Scientific Officer at Innoviva added, we are delighted to have filed a new drug application for the first single inhaler triple therapy for the treatment of copd in Japan where the prevalence of copd is of public. We look forward to a decision from the mhlw, which, if positive, would provide a new therapeutic option for appropriate patients with copd in Japan. The proposed indication is for the relief of various symptoms with copd (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of inhaled corticosteroid, long-acting inhaled beta2-agonist and long-acting inhaled anticholinergic drug is required.). FF/umec/vi is currently licensed for use in the us, eu and a number of other countries under the brand name Trelegy Ellipta. It contains three molecules, an ics, a lama and a laba, delivered in the Ellipta dry powder inhaler which is used across gsks new portfolio of inhaled copd medicines. About impact, the landmark 10,355-patient InforMing the pathway of copd treatment (.
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We have a proven track record of success with: new product launches market access, where we bring specific expertise in pricing, reimbursement, and health outcomes patient access to medicines, book ranging from assisting patients with medicines they cannot afford to providing biosimilars and branded generics. Our regions and areas of interest. We are committed to working with you across different collaboration structures, bringing in support when and where needed from the rest of our organisation. Our aim is to find a tailored approach that fits your needs, making your experience personal. In North America, we are interested in marketed products and assets in late-stage development.
In Europe, we are focused on recently launched products and assets in late-stage development. In the Emerging Markets and Asia pacific region, we are looking for marketed or late life-cycle products, biosimilar candidates, and branded generics. In Japan, we are interested in marketed products and assets in the clinical development bad stage, as well as early-stage candidates and technologies for our global organisation). Dave allen, head, respiratory Therapy Area r d, gsk said: copd is a debilitating lung disease affecting over five million people in Japan. Many patients require combination treatment with different types of medicines to reduce both symptoms and exacerbations but there is currently no triple therapy available in Japan delivered in a single inhaler. If approved, once-daily ff/umec/VI delivered in the Ellipta would be an important innovation in the management of copd in Japan alongside our current range of treatments.1. The new Drug Application is primarily based on data from the Phase iii impact study which included 378 patients from Japan.
We are interested in opportunities for both small and large molecule research, development, and manufacturing. Our strengths, in Pharmaceuticals r d, our business development professionals are embedded in individual therapy areas. Our team will work side by side with you throughout the entire process from due diligence to negotiations and deal management. What to expect from our collaboration. The best science is the foundation of all our partnerships, and it drives our flexible approach to how we collaborate. Our expertise includes option-based deals, early and late-stage licensing deals, co-development, co-promotions, equity investments and acquisitions.
Our partnership management teams manage assets from early stage through to marketed products, and across a wide range of collaboration structures. They help connect partners with the broader gsk community, driving smooth deal execution throughout the relationship. One unique resource that partners frequently access is our r d-based Scinovo group. This team is built on a dedicated scientific support model that gives partners access to our pre-clinical and drug development expertise. Scinovo, to ensure our current and potential partners engage with the full capabilities of gsk, we have a group of research and development consultants called Scinovo to help them maximise our resources. The group assembles skills and knowledge from across gsk, to offer both strategic and tactical options for our partners to consider as they move their programmes and projects along. Pharmaceuticals commercial opportunities, our commercial operating model, divided into four regions (North America, europe, emerging Markets and Asia pacific, and Japan gives our partners the global reach they need, balanced with the local support and attention that mark any successful collaboration. Whether you looking to launch, promote or expand access for your product, we can help. We are open to collaborations at a global, regional, and individual country level.
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For example, we led the orchid alliance (Open Collaborative model for Tuberculosis lead Optimization) a research partnership co-funded by the european Union and completed in 2015. The work of this alliance included repurposing existing medicines as potential tb treatments, using the 200 hits from our compound collection to identify starting points for future drug discovery programmes, best and creating a portfolio of promising compounds. In 2012, we also joined the tb drug Accelerator programme a groundbreaking partnership with a number of other pharmaceutical and public sector with research institutions and the bill melinda gates foundation, aiming to speed up the discovery of new medicines by collaborating on early stage research. Another important initiative were key members of is Predict tb a project created by the eus largest public-private partnership aiming to improve the drug development process, the Innovative medicines Initiative. This group is one of the worlds only initiatives focused on tackling some of the very early-stage barriers to the discovery of new tb treatments. We know, from great collaborative efforts in other challenging fields, that when the best scientific minds join forces, great strides can be taken to improve global health. We believe that tb is another area of research where if we show a united a front opening up our labs, and sharing our resources, our data and our expertise well be better placed to tackle this disease head. We are committed to discovering and developing innovative medicines to treat a broad range of diseases. We understand the value of partnering, and we look for creative, mutually beneficial pharmaceutical collaborations that will provide the best medicines for patients.
We have an active pipeline of english potential new medicines, which are being developed in our r d unit in Tres Cantos, Spain a site dedicated to developing treatments for diseases of the developing world. Were also researching potential new vaccines for. But we know we cant succeed in tackling this disease alone. As with other major health challenges, such as dementia, to combat tb we must be more open to working together. This is one of the areas where we believe taking a more open-minded approach to sharing information and engaging in public-private partnerships will help address some of the key barriers to the development of a new generation of tb medicines. To this end, in 2012, our scientists screened our entire library of more than 2 million compounds the building blocks for future medicines for any showing signs of activity against. The 200 compounds they identified also known as hits were made freely available online, for external scientists to carry out their own research. To date, weve shared copies of these compounds with 30 research groups around the world, who are also working to tackle. Were also active members of several collaborations focused on developing new treatments for tb, including multi-drug resistant forms of the infection.
its Sales, Global Manufacturing Services (gms pharma division and Consumer health Care functions. Our Global Manufacturing Services (GMS) in pakistan consists of three facilities; West Wharf, f-268 site and Korangi. The tb challenge, the reasons for this resurgence are complicated. One cause is the lengthy and complicated course of antibiotics that is the current treatment for many infections. A typical course of treatment for this illness involves taking as many as four different medicines, for around six to nine months. About 20-30 of patients dont finish their treatment. This failure rate opens up new opportunities for deadlier, drug-resistant strains to develop, and this, added to the lack of new treatment options in recent years, is what has led to the surge of new cases. Our commitment to developing new treatments, at gsk, were committed to helping solve the tb challenge.
Our legacy company Glaxo laboratories pakistan Ltd. Was the first pharmaceutical company to be listed on the karachi Stock Exchange in 1951. Gsk pakistan operates mainly in two industry segments: Pharmaceuticals (prescription drugs and vaccines) and consumer healthcare (over-the-counter-medicines, oral care and nutritional care). In pakistan, the company deals in Anti-infective, respiratory, vaccines, dermatological, Gastrointestinal, Analgesics, Oncology, urology, central Nervous System, Allergy, cardiovascular and Vitamins therapy areas. We are committed to our mission of providing patients quality products to help improve the quality of their lives. Some of our leading pharmaceutical brands include augmentin, seretide, amoxil, velosef, zantac and Calpol and renowned consumer healthcare brands, which include panadol, horlicks, sensodyne and eno. Prominent vaccines include synflorix, Infanrix Hexa, rotarix, Engerix-B, Havrix and Priorix Tetra. Today gsk pakistan is highly thesis successful business and a market leader by value and volume share in the country. Major competitors are mncs such as Abbott, novartis, Pfizer, sanofi and local companies like getz and Sami.
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On we completed a 3-part transaction with novartis type which reshapes our business. We acquired novartiss vaccines business (excluding influenza vaccines) and combined our Consumer healthcare businesses to create a new company. By substantially strengthening Vaccines and Consumer healthcare, we can deliver far-reaching benefits to patients and consumers, and further value to shareholders. In addition, novartis acquired our marketed Oncology portfolio. More information will be added to this website over the coming weeks. The vaccines, medicines and consumer healthcare products that we research and develop can improve peoples health and well-being, ultimately helping them to live life to its fullest and contribute to the prosperity of their communities. Gsk pakistan, glaxoSmithKline pakistan Limited was created January 1st, 2001 through the merger of SmithKline and French of pakistan Limited, beecham pakistan (Private) Limited and Glaxo wellcome (pakistan) Limited and stands today as the largest pharmaceutical company in pakistan. Gsk is a long established investor in pakistan.