Patient centricity: a winning formula

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Industry has taken a collective pause in an effort to re-evaluate and rethink longstanding approaches to drug development and commercialisation.

There has been considerable discussion about the concept of patient centricity in the pharmaceutical community, with attention being recalibrated on the ultimate goal — making it easier for the patient to reach improved health outcomes. This perspective is underpinned by the recognition that what is best for the patient will lead to beneficial outcomes for all stakeholders, including the drug company, the healthcare provider and the supporting community of associated service providers.

There is a famous quote from former United States Surgeon General, C. Everett Koop: “Drugs don’t work in people who don’t take them.” It is estimated that less than one third of all prescriptions written are actually filled at the pharmacy by patients. Wide-ranging studies have shown medication adherence rates for life-threatening diseases — including diabetes, heart disease and oncology — can be as low as 30–40%. With the benefit of interventional techniques and developing technologies, adherence rates have been shown to improve; however, these programmes are not broadly adopted within industry at scale and have neither significantly reduced the overall cost of healthcare nor benefitted large populations.

Patients may be non-adherent for a variety of reasons, some conscious and some unconscious. Certainly, we are all admittedly forgetful when it comes to taking our medicine on time or being diligent about timely refills of those prescriptions. Cost can also be a significant factor whereby patients will consciously stretch their medication supply or simply go off therapy. In either instance, doing so will hamper the health impact of their prescribed therapy or worse; taking a drug holiday while prescribed an anticoagulant could potentially put their life in jeopardy.

Other considerations may be unwanted side-effects or a lack of understanding about how to optimally take the medication, such as taking with food or alternatively avoiding food for some period of time, resulting in reduced effectiveness. Fear or general lack of understanding can also inhibit the path to improved health by affecting the patient’s perception of the medication and their willingness to be compliant.

Likewise, the patient may not physically experience the benefit of the drug and, in some instances, may have a negative perception owing to the unwanted side-effects. Hypertension is the classic example; the patient may have high blood pressure but generally not feel the effects of their disease. However, they may experience considerably unpleasant side-effects as a result of their course of treatment.

Likewise, a similar scenario plays out in popular cholesterol lowering medications. By scale, these two examples are noteworthy; in the US, with a population of more than 300 million people, of which 75% are adults, it is estimated that one in every three adults has hypertension, whereas 10–20% of adults have high cholesterol. A large-scale patient-centric approach to benefit medication adherence would have significant positive health and economic impacts.

Focusing patient centricity in clinical trials

In addition to challenges with patient adherence to medication in clinical trials, sponsors and study organisers are also constantly faced with hurdles such as patient recruitment and patient retention. As the industry is tasked with further expediting drug development and decreasing clinical study duration, FDA is increasingly requiring additional studies and further data to prove long-term safety and comparative effectiveness, including post-marketing studies once the drug is commercially available in the market.

This trend is coupled with an increasing percentage of drugs being brought to market for very specialised disease states and narrow therapeutic indications. This wave of specialised medicines and the ongoing need for treatment-naïve candidates, paired with cost pressures in the R&D sector, has increased the use of multinational studies. These complex studies in turn create the requirement for multilingual labelling. This can result in the creation of investigational medicinal product (IMP) study materials that may contain upwards of 16–20 languages on a single label.

Clinical trial professionals are left to balance all of these demands and creatively identify initiatives to keep the focus on the patient. At a surface level, these competing priorities may seem to be in direct conflict. However, when one looks at the situation from a broader perspective, the focus on patient centricity clearly generates tangible value and outweighs the short-term inefficiencies created by opting for a solution solely based on speed or cost.

Patient centricity in package design

A practical example of patient centricity in action can be found in package selection for investigational studies. When looking to initiate a clinical study, a sponsor company may be evaluating whether to choose a bottle or a unit dose blister in a calendarised format for their clinical study material.

Looking simply at the short-term criteria of expediting material for study initiation, when a difference of weeks or days can be considerable, the path of selecting a bottle would be a logical solution. It is a cost-effective packaging option, it is relatively “off the shelf” in its availability, it can be hand filled by a clinical packager with minimal start-up costs, has an acceptable stability profile for barrier properties and is child resistant.

Conversely, when evaluating the development of a unit dose adherence package, the company might find that it may involve a longer lead time for development and be more costly to produce. Looking from a short-term perspective and the immediate pressures of cost and expediting, the choice leaves little room for debate. However, if the sponsor company is taking a holistic approach with a focus on patient centricity, the broader economics absolutely point to the use of a patient-centric package.

Using a calendarised unit dose blister format or compliance/adherence packaging enables sponsor companies to both address the needs of the patient as well as positively impact the desire for better data, more efficient studies and lower total delivered cost. The use of this style of package allows patients to take medication exactly as prescribed and track their usage, rather than a bulk approach in a bottle format. Physicians can capture vital information on the package, including the specific date to start the therapy and any other pertinent notes for the patient. With the returned package, the patient can physically demonstrate to clinical providers that they have taken the product as prescribed. Furthermore, technologies are available that can provide real-time tracking of patient dosing, allowing for clinical interventions to ensure proper adherence while the study is in progress.

These technologies and principles extend to other delivery forms such as injectables. The ability to prompt, monitor and even track real-time information is a powerful tool. Likewise, with the advent of Bluetooth and nearfield communication technologies, packages with integrated technology can capture real-time information about side-effects or other vital information as patients take the medication during the course of treatment. Better adherence leads to healthier patients and more valuable study data.

Poor adherence can be rectified and corrected as it happens. Better information gathering can lead to improved patient retention, a significant cost in clinical trial administration and a persistent challenge in study duration. It is estimated that, in the industry, clinical studies on average have a 30% drop out rate. With more adherent investigational study patients, health outcomes are improved and better retention is realised, translating into reduced total delivered cost, more valuable data generated and studies executed more efficiently.

Patient centricity in clinical supply chain logistics

Another focus point for realising patient centricity in clinical trials is in the area of study design and administration. Considerable interest is being focused on Direct-to-Patient models, in which patients may minimise or in some instances avoid the need to come to a hospital or clinic to receive the study drug, as well as provide critical health feedback. In this scenario, patients are engaged by clinical trial or healthcare professionals in a home setting and the study drug is physically delivered to their home by a trained specialist. Clearly, this model is not applicable for all studies and disease states, but for certain programmes there can be considerable benefit to the patient and the study.

In certain geographies, patients in a traditional clinical study may have to travel significant distances to participate, which can considerably hamper patient recruitment and retention. In a Direct-to-Patient model, the study effectively comes to them. This model may increase the cost of study administration for the sponsor company; however, by executing the study in a more patient-focused approach, the sponsor company can realise significant benefit through patient recruitment and retention, again translating into better data, more efficient studies and a faster path to completion.

Patient centricity in a global world

One of the increasing challenges in taking a patient-centric approach to clinical study execution is the growth in multinational study execution. Often, supplies are designed to pool, so that multiple languages are provided and materials can be directed to individual countries as needed.

This scenario forces sponsor companies to either manage a multitude of language-specific supplies or focus on common supplies — whereby they condense information owing to the shear amount of text being added, often squeezed into a multi-page booklet.

Careful consideration must be paid to graphics that are common to all languages and cultures to ensure patients can clearly comprehend considerably distilled opening instructions, dosing regimens and other key information. Rather than a traditional pooled supply approach, some companies have developed newer strategies for just-in-time (JIT) labelling or late stage customisation logistics, whereby they label study materials according to country specific requirements at the time of drug dispatch.

This can reduce the complexity of a scenario in which they would be trying to accommodate 16 different languages on the same label in a multi-page booklet approach. This JIT strategy might decentralise supplies but may bring other benefits, such as meeting the language and cultural needs of patients in their geography, as well as those of the study administration.

Patient focus yields powerful results

The industry is only in the infancy of its journey towards patient centricity; but, it is clear that with a focus on the patient, many tangible benefits can be realised by drug companies in the development and commercialisation of life-saving medicines.

With so many significant breakthroughs during the past decade, it is exciting to see where this patient focused journey will lead as new patient breakthroughs are happening every day.

SOURCE: www.manufacturingchemist.com/news

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

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

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

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

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

GSK’s blockbuster HIV drug linked with birth defects

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Regulators in Europe and the US have issued warnings about a link between GlaxoSmithKline’s blockbuster HIV drug Tivicay (dolutegravir) and birth defects of the brain and spine.

The European Medicines Agency’s safety committee has said it is evaluating preliminary results from a study which found four cases of birth defects such as spina bifida – a malformed spinal cord – in babies born to mothers who became pregnant while taking Tivicay (dolutegravir).

The Pharmacovigilance Risk Assessment Committee (PRAC) has issued precautionary advice while assessing the study, saying Tivicay should not be prescribed to women seeking to become pregnant.

Women who can become pregnant should use effective contraception while taking Tivicay-based medicines, the PRAC said.

In a separate announcement the FDA said it was also issuing a warning following preliminary results of an ongoing observational study in Botswana, suggesting women who took Tivicay at the time of becoming pregnant, or early in the first trimester, appear to be at higher risk for these birth defects.

The US regulator warned against stopping Tivicay-containing regiments without first switching to alternative HIV medicines, as this could cause the virus to spread to the unborn baby.

Women of childbearing age should talk to healthcare professionals about other non-Tivicay containing medicines.

Tivicay, an integrase strand transfer inhibitor (INSTI) is an important drug for GlaxoSmithKline, which produces the drug through its ViiV joint HIV venture with Pfizer and Shionogi.

Tivicay (dolutegravir) is sold on its own for use as a component of combinations involving other drugs, and generated sales of £1.4 billion,

And Triumeq, which combines dolutegravir with nucleoside reverse transcriptase inhibitors abacavir and lamivudine, brings in sales of more than £2.4 billion.

There are alternatives from the same class such as Merck & Co’s Isentress (raltegravir) and combinations, and combinations containing Gilead’s elvitegravir.

These are still preliminary findings, and the warnings have been issued purely as a precaution.

But preventing HIV spreading to unborn children is important to the medical community, and if there is stronger evidence of a link with birth defects, doctors will surely look for alternative therapies.

SOURCE: www.pharmaphorum.com/news

AZ’s potassium drug Lokelma finally approved in US

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

AstraZeneca badly needs new drugs on the market as several former blockbusters have been hit by generic competition – and finally its high potassium treatment Lokelma has been approved by US regulators.

The drug, a highly selective potassium-removing agent, has been approved at the third time of asking by the FDA, which had been concerned about issues at its manufacturing plant in Texas.

European regulators approved the drug formerly known as ZS-9 in March after their concerns over the issues were resolved, and after two previous rejections the US regulator is also satisfied with the technical arrangements at the facility.

AZ gained rights to the drug after buying ZS Pharma in 2015 for $2.7 billion and is designed to treat hyperkalaemia, where high potassium levels threaten kidney and heart function.

Lokelma (sodium zirconium cyclosilicate) will compete with Vifor Pharma group member Relypsa’s rival Veltassa (patiromer), which has been on the market for a few years in the US and Europe.

The Anglo-Swedish pharma has predicted sales in excess of $1 billion annually for ZS-9, although some analysts say this is a conservative estimate.

The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take common medications for heart failure (HF), such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.

To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise cardio-renal outcomes and increase the risk of death.

Sean Bohen, chief medical officer at AstraZeneca, said: “The consequences of hyperkalaemia can be very serious and it’s reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors.”

AZ badly needs the new sales – sales of its Crestor (rosuvastatin), a former blockbuster were down 38% in Q1, to $338 million, and overall revenues fell 4% to just under $5.2 billion.

The company is selling off its old and unwanted drugs to prop up revenues and reduce costs – but this can only be seen as a short-term measure before new revenues come on stream.

CEO Pascal Soriot also faces a shareholder revolt, after more than 37% of shareholders voted against or abstained at the firm’s annual meeting when asked to approve a £9.4m pay package for Soriot, down from £14.3 million last year.

Soriot has set a sales target of above $40 billion by 2023, despite the struggles getting new drugs to the market.

SOURCE: www.pharmaphorum.com/news

New indication for evolocumab in established atherosclerotic cardiovascular disease

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Amgen has announced announced that the European Commission (EC) has approved a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels.

With the expanded label now in place, Amgen is working with payers in Europe to remove prescribing barriers and expand access in order to reach patients with established cardiovascular disease who are at risk of another event.

“With its proven ability to prevent heart attacks and strokes, Repatha offers hope for one of the greatest health challenges we face today. However, the majority of patients in Europe who could benefit from treatment with a PCSK9 inhibitor remain unserved and at risk of a cardiovascular event,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “To help ensure eligible patients around the world can access and benefit from Repatha, Amgen is willing to work in partnership with payers to help manage affordability concerns from increased patient access. Furthermore, we are committed to excellence in LDL-C management and collaborating with healthcare providers to deliver comprehensive solutions for patients.”

Of all the modifiable risk factors for heart attack and stroke, lowering high LDL-C is one of the most important and impactful.1,2 Yet, even among patients currently taking a lipid-lowering therapy, many patients still have high LDL-C levels and remain at risk for cardiovascular events. Repatha is a groundbreaking medicine proven to significantly lower “bad cholesterol” or LDL-C for high-risk patients who suffer from a combination of high LDL-C and cardiovascular disease, and who continue to struggle with lowering their LDL-C levels despite statin therapy.

“We know that patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year,”3-5 said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “With far too many patients at risk of recurrent cardiovascular events, we are pleased that the European Commission has approved Repatha to prevent heart attacks and strokes in adults with established atherosclerotic cardiovascular disease. The science clearly indicates that ‘lower LDL-C is better’ and this approval underscores the role for Repatha among high-risk patients for whom statins alone are not enough.”

The approval by the EC recognises the positive findings from the Repatha cardiovascular outcomes study (FOURIER), expanding the label to include data on the additional reduction and prevention of heart attacks, strokes and coronary revascularisations on top of maximally tolerated statin therapy. FOURIER showed reductions in the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularisation procedures by 22% in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.6

References

  1. National Heart, Lung, and Blood Institute. How To Prevent and Control Coronary Heart Disease Risk Factors. Accessed April 10, 2018
  2. Kuklina, EV. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol. United States, 1999–2002 and 2005–2008. MMWR. 2011;60(4):109–14
  3. Mohan KM, et al. Stroke. 2011;42:1489-94
  4. Bhatt DL, et al. JAMA.  2010;304:1350-7.
  5. Jernberg, T., et al. Eur Heart J. 2015. 36(19), 1163-117
  6. Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Celebrating 15 years of life-saving technology

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The experts in temperature controlled packaging Peli BioThermal, are celebrating 15 years of the Original Golden Hour container, developed to provide blood to critically wounded soldiers.

The award-winning Original Golden Hour container – the company’s flagship product – was recognised in 2003 as part of the US Army’s Greatest Inventions programme, has gone on to shape future product development, influencing the full range of Peli BioThermal reusable and single-use products.

“We developed the Original Golden Hour to address a critical need facing our military personnel — how to make blood available to treat the critically wounded within the crucial first hour after injury,” explained Kevin Lawler, Peli BioThermal VP of sales, “Today, the technology behind this product allows us to provide reliable temperature control not only for blood on the battlefield, but also for life-saving civilian applications, including the transport of biologics and temperature sensitive pharmaceuticals for clinical trials and commercial distribution.”

The technology is incorporated in a range of Peli BioThermal products, which are utilised by emergency first responders globally.

In 2003, the US Army needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The answer, The Original Golden Hour container was the answer to a proposal from the US Army in 2003, when they needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The container was subsequently included as part of the 2003 US Army’s Greatest Inventions program by the US Army Research, Development and Engineering Command (RDECOM) Public Affairs office.

“If you can make sure that someone doesn’t bleed out by giving a resupply of blood right there, you’ve exponentially impacted the ability to save that soldier’s life,” said sixteenth chairman of the joint chiefs of staff, retired US Marine general, Peter Pace, who also serves as chairman of the board for Pelican Products.

It truly makes a difference on the battlefield. And that’s as true today as it was 15 years ago.”

Patented Golden Hour Technology provides superior thermal protection for high value temperature-sensitive payloads between 2 and 1686 liters, from -50ºC to 25°C for up to seven days (168 hours). Today, Golden Hour Technology is integral to all of the company’s products, including reusable products like the Credo Cube shipper and the Credo ProMed series, as well as the Chronos range of single-use shippers.

SOURCE: www.manufacturingchemist.com/news

Ipsen receives European first-line approval for Cabometyx

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Ipsen has revealed that it has received approval for the use of Cabometyx for first-line use in patients with advanced renal cell carcinoma (RCC).

The approval builds on the second line approval it had previously received in 2016, although negotiations with numerous European countries over the price of medicine have delayed access for many nations until recently.

NICE gave approval for the use of the treatment in July 2017, close to a year after its EC approval.

Though sales so far have not been blistering, recording European sales of only £25 million in the first quarter, it is expected that this first-line approval and with numerous funding agreements falling into place with payers that the drug sales will grow quickly.

Part of the reason for this is the advantage it holds over a main competitor, in BMS’ Opdivo; Cabometyx is differentiated by being available in oral form, which makes it far more convenient than having to visit a hospital for IV infusion.

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen.  “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications.”

The approval is based on results from a Phase 3 trial that hit primary endpoint of extending progression-free survival (PFS). The data revealed that PFS was improved by 8.6 months, compared with 5.3 months of patients taking Pfizer’s Sutent. In terms of overall survival (OS), the company reported that it showed a favourable, though not statistically significant, trend – as OS with Cabometyx stood at 26.6 months against 21.2 months on Sutent.

In terms of further development, Ipsen is developing the treatment as an adjunct alongside immunotherapy.

SOURCE: www.pharmafile.com/news/517387

Life Sciences sector responds to report on the impact of Brexit

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The Business, Energy and Industrial Strategy (BEIS) Committee report calls on the Government to secure a post-Brexit deal to protect patients and the UK’s pharmaceutical industry.

“The impact of Brexit on the pharmaceutical sector’ makes several recommendations which industry welcomes. This includes the need to secure the closest possible regulatory alignment with the EU as well as minimum border friction. Patients are at risk of harm and the UK pharmaceutical sector could lose its status as a world leader,” the report says.

The Committee also concluded that “what little benefits there may be from regulatory divergence, these would be greatly overshadowed by the costs and loss of markets and influence the UK would face.”

A joint statement by the Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) – whose chief executives, Mike Thompson and Steve Bates, provided evidence to the Committee – said:

“Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way.

Today’s Select Committee Report is right – a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs.

“Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

The ABPI represents innovative research-based biopharmaceutical companies and is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, which supplies more than 80% of all branded medicines used by the NHS.

SOURCE: www.manufacturingchemist.com/news

Initiative launched to improve people’s understanding of eczema

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A scheme to raise awareness about the emotional and physical impact of the most common type of eczema has been launched by a leading charity and a global biopharmaceutical company this month.

Scratch Beneath the Surfaceis a public health initiative established by Sanofi in collaboration with Allergy UK. The scheme aims to improve people’s understanding of atopic dermatitis, from what’s happening inside the body, to the emotional and psychological symptoms that can lie beneath the surface.

The condition affects over 1.5 million people in the UK,1,2 and in a survey, 80% reported that it impacted on their mood, mental health and well-being.

By improving awareness of atopic dermatitis, which is the most common type of eczema3 the initiative aims “to shift any misconceptions among the general public and combat the stigma related to the disease, which will in turn, lead to those affected feeling a greater sense of support and understanding”, Sanofi said.

Commenting on the launch of the initiative, Carla Jones, Allergy UK’s chief executive said: “Atopic dermatitis is often dismissed as a simple skin condition or rash that can be soothed with moisturisers, but people don’t realise that it’s a long-term and potentially life-altering disease.”

“There is a huge sense of frustration amongst those affected, who feel that eczema and atopic dermatitis are often misunderstood. Even simple day-to-day tasks like walking up the stairs, bathing and getting dressed can be painful for someone experiencing a flare-up,” she said.

A UK-wide survey of people with moderate-to-severe atopic dermatitis4found that the disease can impact every aspect of an individual’s life. Difficulty sleeping emerged as a significant problem, affecting 75% of those surveyed; with the constant itching and pain when trying to sleep, leaving people feeling tired and restless in the day.4

For some people, the impact of unpredictable flare-ups and feelings of self-consciousness can also lead to symptoms of anxiety or depression.4

Some 80% of survey participants reported that atopic dermatitis has a direct impact on their mood. In interviews, participants reported feeling anxious, especially in public and social settings, and feeling that they’re being looked at and judged by others.4

57% admitted they feel depressed because of their skin with some taking antidepressants to try and help the situation.4 And 60% of male participants and 55% of female participants noted that their self-esteem and self-confidence is frequently impacted due to their skin condition.

Commenting on the findings, Dr Anthony Bewley, consultant dermatologist at Whipps Cross University Hospital, and the Royal London Hospital, said: “Despite affecting over one and a half million adults in the UK, too few people understand the inflammatory and unpredictable nature of atopic dermatitis.

“For many people, it’s the unseen consequences, the emotional and psychological impact hiding beneath the surface that makes the disease most difficult to live with. Itchy skin is considered to be one of the worst symptoms; it can be physically debilitating.

“However, the associated restlessness, sleepless nights, and sore, broken skin can have a severe impact on a person’s daily functioning, mental health and self-esteem,”  he said.

References

  1. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66 (suppl 1): 8-16.
  2. Office for National Statistics. 2014 UK mid-year population estimate. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationprojections/bulletins/nationalpopulationprojections/2015-10-29 (Accessed April 2018).
  3. NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at: https://www.nhs.uk/conditions/atopic-eczema/  (Accessed April 2018).
  4. Sanofi data on file, March 2018.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick