Category Archives: Collaborations

Seven million euros for research into chronic inflammatory bowel conditions

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A new collaborative research centre/Transregio 241 ‘Immune-epithelial communication in inflammatory bowel diseases’ is due to commence its research at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) in July 2018.

In conjunction with the Charité hospital in Berlin, doctors and biotechnologists at FAU will be conducting research in order to better understand the interaction between cells in mucous membranes and immune cells in the bowel and to develop more effective therapy methods for chronic inflammation. The German Research Foundation (DFG) is providing funding worth 11.5 million euros for the first funding period until 2022, and FAU has been allocated nearly 7 million euros of this amount.

Number of patients with IBD is increasing

Severe diarrhoea, stomach pain, cramps – these are the most common symptoms of inflammatory bowel disease (IBD) such as Morbus Crohn or Colitis ulcerosa. Around 40,000 people in Germany suffer from IBD and this number continues to rise. Patients of IBD often suffer from flare-ups of their condition, which severely affects their quality of life and physical capabilities. ‘Despite the use of strong medication, chronic inflammatory bowel conditions remain difficult to treat’, says Prof. Dr. Christoph Becker, lead researcher at the Department of Medicine 1 at FAU’s Universitätsklinikum Erlangen and spokesperson of the collaborative research centre. ‘Acute flare-ups are often treated with corticosteroids that ease symptoms only in some cases. Many patients have to take several immunosuppressive substances.’ In addition, their symptoms are often accompanied by other conditions such as arthritis, acute inflammation of fatty tissue and chronic inflammation of the biliary tract in the liver.

Little research to date on molecular and cellular mechanisms

IBD is difficult to treat because the interactions between various cell populations in the bowel are not yet fully understood. ‘Newer findings show that the intestinal mucosa cannot be regarded as merely a physical barrier. In fact, it is highly-dynamic tissue that reacts to a large number of environmental stimuli including intestinal flora and local or systemic signals,’ explains Christoph Becker. ‘The immune system in the intestine regulates the barrier function of the intestinal wall and the composition of intestinal flora and vice versa as the intestinal barrier influences the immune system.’ However, there is a lack of knowledge of how the interactions between the epithelium and immune cells influence the long-term cellular reactions that contribute to controlling chronic inflammation processes.

New concept for new therapies

This is the starting point for the researchers from Erlangen and Berlin. During the next few years, they aim to integrate findings about the regulation and function of the immune system in the bowel and current data about anti-microbial defence on the mucous membrane barrier into a new concept. The individual projects will focus in particular on the role of misdirected communication between epithelium and immune cells during the pathogenesis of IBD. The researchers’ long-term aim is to develop medication that targets the causes of bowel inflammation while retaining the ability of the immune system to fight infections and cancer cells. In addition, they hope to find diagnostic methods that predict patients’ response to therapies – a goal that not only serves to relieve symptoms quickly, but should also contribute to lowering treatment costs.

Researchers from Erlangen involved in 14 projects

The scientific programme of CRC/TRR 241 is divided into three research areas: Area A ‘Immune regulation of intestinal barrier functions’, comprises projects focusing on the effects of acute and chronic inflammation on epithelial cells, in particular on their cell homeostasis and barrier-forming functions. Area B ‘The epithelium as a regulator of immunity and inflammation in the bowel’ examines the effects of disruptions to the barrier function and antigen translocation on the mucosal immune system. The objective of research area C ‘Diagnosis and therapeutic intervention of IBD’ is to develop innovative therapeutic and diagnostic approaches and evaluate them in a clinical setting. CRC/TRR 241 comprises a total of 22 projects, 14 of which are either based in Erlangen or involve researchers from Erlangen. The Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology, Department of Medicine 3 – Rheumatology and Immunology, the Department of Surgery and the Department of Dermatology and the Institute for Medical Biotechnology are all involved. 23 jobs and 9 scholarships are being funded during the next four years with the nearly 7 million euros allocated to the FAU.

SOURCE: www.eurekalert.org/pub_releases

Roche SMA drug shines in study as costly new therapies advance

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A drug being co-developed by Roche to treat spinal muscular atrophy (SMA) helped improve development scores in babies with the genetic disease, a study released on Monday showed, as the race heats up for therapies destined to be among the drug industry’s most expensive.

PTC Therapeutics, which struck a licensing deal with Roche in 2011 for its SMA program, said more than 90 percent of babies with severe Type 1 SMA given the RG7916 drug achieved a greater than four-point increase in a test to measure their neuromuscular progress six months after treatment began.

PTC shares, which are listed on the Nasdaq, rose as much as 30 percent.

The companies hope their medicine, also known as risdiplam, will be approved to take on rival drug Spinraza from Biogen, which sells for $750,000 for the first year of therapy and about $375,000 annually after that.

Novartis is also quickly advancing in the SMA field with its $8.7 billion acquisition this year of U.S.-based Avexis that is working on a gene therapy for the disorder.

Analysts from Barclays project Novartis’s one-time treatment could run to $1.25 million per patient.

“We are delighted that up to 6.5-fold increase of protein production has translated into clinical impact for these babies,” PTC Chief Executive Stuart Peltz said in a statement about the RG7916 study, adding no babies required a tracheostomy or permanent ventilation since the study began, and no baby lost his or her ability to swallow.

SMA is an often-deadly genetic neuromuscular disorder caused by a missing or defective gene that normally produces a protein needed for development of motor neurons in the spinal cord. This leads to muscle wasting. Many babies with the severest form of the disorder die, while others never stand or walk.

Barclays analyst Emmanuel Papadakis expects that if Roche and PTC’s data holds up on RG7916 with regulators, it could become a fierce competitor to Spinraza, now the only licensed SMA therapy.

Cowen analysts also said on Monday they view PTC’s update as very encouraging for approval — and for competitiveness versus Spinraza, which is administered into the spine about four times a year. Roche’s and PTC’s drug is taken orally.

Novartis Chief Executive Vas Narasimhan also has high hopes for his own newly acquired SMA treatment, saying in April after the Swiss company bought Avexis that its gene therapy has “multi-billion dollar peak sales potential”.

SOURCE: www.pmlive.com/pharma_news

AbbVie trial backs chemo-free Imbruvica combo regimen

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The pairing of of AbbVie’s Imbruvica and Roche’s Gazyva has hit the mark in a chronic lymphocytic leukaemia trial – raising the prospect of a new chemotherapy-free combination regimen for previously untreated CLL patients.

The iLLUMINATE trial showed that oral BTK inhibitor Imbruvica (ibrutinib) plus anti-CD20 injection Gazyva (obinutuzumab) was more effective than Gazyva plus chemo (chlorambucil) in treatment-naïve, older patents (aged 65 or more) with either CLL or small lymphocytic leukaemia (SLL) – a different form of the same disease.

The top-line data isn’t being made available just yet, but in a statement AbbVie said the duo extended progression-free survival (PFS) compared to the active control arm, adding that it will be sharing the data with regulators, in the hope of bringing “the first chemotherapy-free CD20 combination in first-line CLL treatment” to market.

The trial ties in with AbbVie’s strategy of expanding use of Imbruvica as a first-line CLL treatment and, while Gazyva has been something of a slow burner for Roche since its launch in that setting in 2014, it has started to gain momentum with sales rising 41% to CHF 278m last year.

The combination of Gazyva and chlorambucil is now recommended as a first-line therapy for CLL by the US National Comprehensive Cancer Network, which deems it a category 1 treatment, ie one with a high level of evidence backing its use, so outperforming it is a big win for the combination.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” said John Gribben of Barts Cancer Institute in the UK, the lead investigator for the iLLUMINATE study.

“It’s exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients,” he added.

Imbruvica is already approved for all lines of therapy in CLL, and beating out chlorambucil is not a big surprise as AbbVie’s drug comprehensively outperformed the chemotherapy as a monotherapy in the head-to-head RESONATE-2 trial.

The trial was the basis of Imbruvica’s approval in 2016 as a chemo alternative in treatment-naïve CLL, and the disease accounts for the lion’s share of the drug’s sales, which grew almost 39% to $762m in the first quarter of this year, topping estimates. AbbVie is predicting sales of $3.3bn this year, well on course for its peak sales target of $6bn-$7bn.

AbbVie’s head of R&D Michael Severino said on the company’s first-quarter results call that the strategy is to build a “body of evidence” for Imbruvica – both as a monotherapy and in combination – across different CLL segments “including young and fit patients and the watch-and-wait population”.

SOURCE: www.pmlive.com/pharma_news

Prothena guts workforce by more than half, after trial failure

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Prothena Therapeutics has acted drastically by slashing staff numbers by more than half, after the failure of two pivotal trials for its lead candidate.

The company subsequently ditched NEOD001, when trials revealed that placebo treatment outperformed the drug candidate in the treatment of AL amyloidosis.

The reorganisation sees 63 positions cut away from the Dublin-based company, representing a shedding of 57% of the entire staff at the company.

As is usually the case, the process was necessitated to stymie cash losses during 2018 – it projected its estimated net cash burn for the year to be $40 million to $50 million, driven by a net loss of $170 million to $185 million.

Luckily for the biotech, it’s had some backers that were betting that its work would produce results and so estimates that it still have a relatively healthy $421 million in cash to end the year on.

One notable backer is renowned UK investor, Neil Woodford, who had to defend his investment in biotech in a blog post immediately after the trial failures were announced – pointing out strengths from within the Prothena’s pipeline and suggesting its partnership with Roche was one reason to keep faith with the biotech.

In the announcement regarding its restructuring, Prothena followed suit, with Gene Kinney, President and Chief Executive Officer of Prothena, saying: “As we move forward, we have the resources to support the advancement of our pipeline through meaningful milestones and we will focus on developing neuroscience programs that we believe have a potential to offer significant benefit to patients. This includes our two clinical-stage programs PRX002/RG7935, currently in Phase 2 development in the PASADENA study in patients with early Parkinson’s disease, and PRX004, which recently initiated a Phase 1 study in patients with ATTR amyloidosis.”

PRX002/RG7935 is both being developed in collaboration with Roche and there will be significant hopes placed on this candidate to pull the biotech out of a tricky spot; however, with the treatment being for patients with Parkinson’s disease, it’s a fairly risky bet given the dearth of disease-modifying treatments for the condition.

SOURCE: www.pharmafile.com/news/517476

ABPI expert urges to find new ‘blockbuster treatments’ for brain tumors

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With the Government set to invest an additional £20 million into the research, diagnosis and development of treatments for brain tumours, we need to talk more about how we are going to find the next blockbuster treatments for these devastating diseases.

Nearly 11,500 people are diagnosed with a brain tumour every year in the UK with fewer than 15% surviving beyond 10 years. This week’s announcement from the from the Department of Health and Social Care – following the death of Dame Tessa Jowell – that they would be doubling investment for brain cancer research to £40 million is a welcome commitment to helping achieve a goal our industry shares: finding innovative new treatments and cures for these diseases.

The science is advancing in laboratories here in the UK and around the world, funded and supported by charities, universities and the pharmaceutical industry, collectively we are working to fight back against this terrible disease.

Among the 7,000 medicines currently being developed by the global pharmaceutical industry, there are 58 medicines in the pipeline for brain tumours, including gliomas. Companies are actively working to find better ways to speed up medicines development to get treatments to patients sooner.

In her speech to the House of Lords in January, Dame Tessa Jowell talked candidly about her glioblastoma diagnosis and called for greater collaboration in the fight against cancer. She also talked about the speeding up of drug trials by testing more than one at a time, saying: “I am not afraid, but I am fearful that this new and important approach may be put into the ‘too difficult’ box.”

The type of clinical trials Tessa Jowell talked about have many different names: adaptive randomisation, drop-the-loser, adaptive dose-finding, adaptive seamless and the list goes on.

The one thing they all have in common is flexibility. In trials like this – that we call adaptive design clinical trials – researchers can see how patients are responding to treatments and then change or stop parts of the trial in real time.

When used appropriately, trials like this may improve efficiency, reduce cost, maximize information gained and minimize risk to the patients and sponsors. Ultimately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients. The UK is seen as a pioneer of innovative clinical trials and this involves collaboration between academia, the NHS, industry and medical research charities –  we must ensure we keep it that way in the future.

The issue is that these clinical trial types are not easy to design, plan or execute. An adaptive design will not rescue a poorly planned trial or ineffective treatment.

We need to make sure the regulatory authorities in the UK are not seen as a barrier to innovation; the MHRA and HRA are open to discussion and we need to encourage researchers and pharmaceutical companies to start conversations with them early in the process of planning an innovative clinical trial.

We think that adaptive design clinical trials could be the solution to speeding up the research and development of not only brain tumor treatments, but for all sorts of diseases. Research into small or rare patient populations could really benefit from these trials since they help us quickly rule out the drugs or drug combinations that aren’t working and give more patients the option to contribute to research and clinical trials.

We’re not alone. In February, the Department of Health and Social Care published their brain tumor research report which stated that, because brain tumors are one of the areas that have small patient populations, we need to think differently about how we conduct clinical trials and incorporate innovative trial designs.

The report provided practical recommendations for how we can work collaboratively to make quicker progress in this area. The next steps are to build on the UK’s existing strengths, ensure we have access to researchers with the right skills, and make sure that the right infrastructure is in place for us to make really make progress in this area.

Alongside their funding announcement, we welcome the Government’s commitment this week to accelerate the use of adaptive design trials. When used appropriately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients – and that’s where the real benefit lies.

As we look to the future of cutting-edge research and development for blockbuster treatments, we know we need to make the case for innovative clinical trial design, talk more about the amazing science our researchers, companies and NHS are pioneering and encourage them to have open conversations with the UK regulators to ensure that innovative clinical research is safe and effective.

Together, we won’t rest until devastating brain tumours are a thing of the past.

SOURCE: www.news-medical.net/news

Boehringer partners with Bactevo on drug discovery

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Boehringer Ingelheim is bolstering its drug discovery efforts with a new collaboration with UK tech-enabled research firm Bactevo.

Enabled by advance machine learning, Bactevo claims that its Totally Integrated Medicines Engine platform (TIME) will be able to bring about a paradigm shift in the speed, efficiency and quality of drug discovery, as well as dramatically enhanced safety profiling.

Aiming to identify novel small molecule lead compounds, the deal will see Bactevo use its TIME and synthetic chemistry technology to further enhance speed, efficiency and quality when detecting novel in vivo enabled leads.

In addition to working with partners to develop novel first-in-class medicines, Bactevo is also developing breakthrough medicines for the treatment of diseases that involve defects in mitochondrial function, such as MELAS and LHON. It is also targeting diseases of the central nervous system, such as Parkinson’s, Alzheimer’s and Amyotrophic Lateral Sclerosis (ALS).

Bactevo will receive upfront payments and research funding, although that specific amount was not disclosed at the time of writing.

The tech group could also be eligible to receive payments for certain research, development and commercialisation milestones.

David Williams, chief executive officer of Bactevo, said: “We are pleased to be commencing this highly complementary collaboration with Boehringer Ingelheim.

“It combines our cutting-edge TIME drug discovery platform with the powerful therapeutic drug development and commercialisation experience at Boehringer Ingelheim to create much needed new medicines in areas outside of our current therapeutic focus.”

SOURCE: www.pmlive.com/pharma_news

Pfizer eyes AI-powered drug discovery and development software

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Pfizer has partnered with a ‘computation-driven’ pharmaceutical technology company to develop a drug discovery platform powered by artificial intelligence (AI).

Its collaboration with Cambridge, Massachusetts-based XtalPi will see the firms work on molecular modelling software that can be applied to drug-like small molecules.

Charlotte Allerton, Pfizer’s head of medicine design, said: “The XtalPi collaboration is an opportunity to enhance our computational modelling capabilities.

“We are looking forward to potentially utilising new tools to increase our effectiveness in small molecule drug discovery and development.”

In addition to supporting its own efforts, Pfizer plans to make available to the wider academic community some of the molecular mechanics parameters it will generate with public-domain compounds.

The new software platform will combine quantum mechanics, machine learning algorithms and cloud computing architecture to help Pfizer predict pharmaceutical properties that would be relevant for drug discovery and development.

Shuhao Wen, XtalPi’s co-founder and chairman of the board, said: “The collaboration allows us to apply our expertise in molecular modelling, AI, and cloud computing towards improving existing computational methods while exploring new algorithms to address a wide range of drug design challenges.

“We look forward to helping expedite research into novel therapeutics as our intelligent digital drug discovery and development platform continues to expand and succeed.”

The deal builds on XtalPi’s existing work with Pfizer on crystal structure prediction (CSP), with that project aiming to advance the partners’ capabilities in computation-based rational drug design and solid-form selection.

Founded in 2014 by a group of quantum physicists from MIT, XtalPi’s team combines expertise in physics, chemistry, pharmaceutical R&D, and algorithm design.

The company, which counts Google and Chinese internet conglomerate Tencent among its investors, is one of a swathe of AI players looking to innovate drug discovery and development processes.

These include BenevolentAI, Hitachi and Scotland’s Exscientia, with the latter working with the likes of GlaxoSmithKline, Sanofi and Evotec.

At stake is a share in market for healthcare AI applications that’s predicted to be worth more than $10 billion by 2024, driven by the rise in precision medicine and the need to reduce healthcare costs.

SOURCE: www.pharmaphorum.com/news

Medigene in for up to $1.5 billion under broader pact with Bluebird Bio

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German biotech firm Medigene has secured a wider remit under a collaboration with U.S. peer Bluebird Bio on a technology that boosts the immune response to cancer, increasing the pool of potential milestone payments to $1.5 billion.

The number of projects in the alliance, which has Medigene contributing screening tools to identify promising T-cell receptors (TCR), will rise from four to six, Medigene said in a statement on Monday, sending its shares 8 percent higher.

“If successfully developed and marketed through several indications and markets, Medigene could receive up to $250 million in milestone payments per TCR program in addition to tiered royalty payments on net sales up to a double-digit percentage,” Medigene said.

Medigene agreed its alliance with Bluebird in September 2016, working on modified T cells, one of the immune system’s main weapons, to better target specific tumor cells.

The extended collaboration contract validates Medigene’s technology platform, analysts at Baader Helvea said, confirming their “buy” recommendation.

Bluebird is best known for its progress in a class of customized cancer drugs known as chimeric antigen receptor T-cells, or CAR-Ts.

Other companies working on T cell receptor (TCR) technologies include GlaxoSmithKline, Britain’s Immunocore, which is backed by the Bill & Melinda Gates Foundation, or U.S. biotech group ImmunoCellular .

As part of the broadened contract, Medigene will receive an additional one-time payment of $8 million plus increased research and development funding.

SOURCE: www.uk.reuters.com/article

New partnership offers improved serialisation support

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Pharma customers can now experience track and trace systems first hand in a production facility, following a partnership between Mettler Toledo and R-Pharm Germany.

Product inspection specialist Mettler Toledo and contract manufacturer R-Pharm Germany are working together under a new partnership agreement to provide pharmaceutical customers with the support they need in the conception and planning of serialisation and aggregation solutions.

As a result of the collaboration, customers can now experience track and trace systems first hand in a live production facility, enabling them to understand the available options and develop solutions to meet their specific requirements more effectively.

Implementing or upgrading serialisation systems is becoming more time-critical as the industry prepares for compliance with the Falsified Medicines Directive, which comes into effect in February 2019.

In addition to helping customers develop their own track and trace solutions, the R-Pharm facility – equipped with the latest Mettler Toledo technology can also provide a bridging service for pharmaceutical customers until their own plant is upgraded.

Contract manufacturer R-Pharm, once part of the Pfizer production network, has been implementing Mettler Toledo systems and solutions for guidance-compliant serialisation and aggregation of pharmaceutical packaging for more than 7 years.

In that time, nine packaging lines at its Illertissen, Germany plant have been updated to offer more flexible operation and rapid product changes. As a result, all of the globally valid scenarios for pharmaceutical coding can be realised at this one site. Because R-Pharm works for many different clients, particular value is placed on flexible data management in the selection and implementation of the solutions from Mettler Toledo.

“Our clients expect from us a direct connection to their own ERP or MES systems, or would like to use serial numbers of cloud systems such as Tracelink,” explained Michael Unbehaun, Engineering Manager at R-Pharm.

“Therefore we make sure that our software systems are always state of the art and successively expand the interface palette. In this way, we can ensure efficient and rapid onboarding of new clients and enable them to exploit the potential of our lines.”

The new partnership agreement ensures that the experience gained by R-Pharm and Mettler Toledo in recent years are passed on to its customers.

Interested parties can now see – live in the production plant – the performance and functional scope of the PCE systems within the framework of reference visits at R-Pharm.

Accompanying presentations provide visitors with comprehensive background information on conception and implementation options and inform them of the organisational requirements that R-Pharm uses in the implementation of global track and trace orders.

R-Pharm and Mettler Toledo have now also started to offer combined workshops to provide a more intensive discussion of selected topics, from line integration and its process organisation to data exchange with cloud providers.

For those who want to delve even deeper, subject-specific training will be offered via a new T&T User Academy, including sessions on topics ranging from the development of standard operating procedures to pharmaceutical validation of machines or OEE management tactics.

SOURCE: www.manufacturingchemist.com/news

GlaxoSmithKline and Innoviva publish positive new IMPACT data

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GlaxoSmithKline, alongside Nasdaq-listed partner Innoviva, announced the publication of the landmark IMPACT study – one of the biggest ever conducted in patients with chronic obstructive pulmonary disease with a history of exacerbation – in the New England Journal of Medicine on Thursday.

The FTSE 100 pharmaceutical giant said that in the study, ‘Trelegy Ellipta’ (fluticasone furoate/umeclidinium/vilanterol) achieved superiority to members of two different classes of dual combination therapy, Relvar/Breo and Anoro, on the primary endpoint of reduction in the annual rate of on-treatment moderate/severe exacerbations and a range of other clinically important outcomes, including lung function and health-related quality of life.

It said results from additional secondary and other endpoints included a “statistically significant” 34% reduction in COPD hospitalisations for Trelegy compared to Anoro, and a reduction of 13% compared to Relvar/Breo, which was not statistically significant.

They also included a “significant” reduction in the risk of on-treatment all-cause mortality, observed for both inhaled corticosteroid containing arms compared to Anoro.

A 42.1% reduction in the risk of on-treatment all-cause mortality was observed for Trelegy compared to Anoro as well.

To fully understand the implications of the all-cause mortality observation, off-treatment data also needed to be considered, GSK explained.

Work was ongoing to investigate that further, and would be presented at future scientific meetings.

“Reducing exacerbations to keep patients out of hospital is a key goal of COPD management alongside improving lung function and quality of life,” said Dave Allen, GSK’s head of respiratory therapy area research and development.

“The IMPACT study shows how Trelegy Ellipta can help patients with a history of exacerbation achieve these goals.

“We believe its publication in NEJM is an important addition to the evidence base that informs the management of this progressive and debilitating disease.”

Dr Fernando Martinez, chief of the division of pulmonary and critical care medicine at the New York-Presbyterian Hospital/Weill Cornell Medical Center, said IMPACT “significantly advances” medicine’s understanding of COPD management by addressing a number of key evidence gaps.

“By comparing various combinations of effective medications in the same device the study clarifies which type of patient gains greatest benefit from each class of medicine,” Dr Martinez explained.

“As many patients experience frequent exacerbations or ‘flare ups’, which can often result in hospitalisation, these data will be highly relevant to patients and clinicians as they consider the optimal treatment.”

GSK and Innoviva said the safety profile of single inhaler triple therapy was consistent with the safety profile of the individual components.

The most common adverse events across the treatment groups were viral upper respiratory tract infection, worsening of COPD, upper respiratory tract infection, pneumonia and headache.

Consistent with previous studies, the incidence of pneumonia as a serious adverse event was 4%, 4%, and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.

“The role of inhaled corticosteroids in COPD have long been debated, and this landmark trial provides further evidence of their benefit in the population studied and compelling data towards clarifying the role of ICS containing regimens in the COPD treatment paradigm,” said Dr Ted Witek, Innoviva’s senior vice president and chief scientific officer.

“We congratulate our partners at GSK for this vital contribution to the field of respiratory medicine.”

Results from IMPACT were submitted to the regulatory authorities in the US and EU in November 2017 and February this year, respectively.

Further regulatory submissions in other countries were expected during 2018.

SOURCE: www.uk.webfg.com/news/news-and-announcements