NICE recommends hep C and bowel treatments

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Three drugs to treat chronic bowel condition ulcerative colitis and one for hepatitis C will be funded by the NHS following final guidance recommendations by NICE.

The UK health watchdog says Merck’s Remicade (infliximab), AbbVie’s Humira (adalimumab) and Merck’s Simponi (golimumab) should be recommended as an option for treating moderate to severe ulcerative colitis.

Professor Carole Longson who is NICE’s health technology evaluation centre director, says: “This recommendation will benefit tens of thousands of people who live with this debilitating condition. We are very pleased that we can recommend all three drugs to treat ulcerative colitis. Those with the condition will have more options available to them and a greater chance of controlling their symptoms, so they can have a much better quality of life.”

An estimated 146,000 people in the UK live with ulcerative colitis in which the large intestine becomes inflamed. Symptoms vary, but may include bloody diarrhoea, abdominal pain, weight loss, fatigue and an urgent need to go to the toilet.

Sporadic in nature, the condition disappears for months or even years at a time, but it is thought that half of people with ulcerative colitis will relapse at least once a year – and whilst it can develop at any age the peak age appears to be between 15 and 25-years-old.

On these approvals, Chris Probert who is a Professor of gastroenterology at the University of Liverpool and vice-chair of the clinical advisers committee for Crohn’s and Colitis UK, says: “This is great news for our patients with ulcerative colitis. It is the first new class of drugs to be approved by NICE for ulcerative colitis and is a valuable tool in our armamentarium in the fight against ulcerative colitis.”

Remicade, Humira and Simponi are all licensed to treat moderate to severely active ulcerGilead’sative colitis in adults who have had an inadequate response to conventional therapy, or are unable to take such treatments. Remicade is also licensed to treat children and adolescents aged 6-17 years.

This drug has also been in the news of late for its biosimilar version Remsima, which was just launched by Napp in the UK for the treatment of a range of illnesses including Crohn’s disease ­– which followed Hospira’s biosimilar monoclonal antibody launch just prior.

Meanwhile NICE has been extra busy of late, as along with its final guidance this week approving Sovaldi for hepatitis C, it has also given the final nod to Johnson & Johnson’s fellow hep C offering Olysio (simeprevir).

Olysio has UK marketing authorisation for use along with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C, but this latest guidance recommends its use in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

Olysio was in fact one of the stars in J&J’s full-year sales results, and the drug has seen the introduction of a novel ‘pay if you clear’ pricing agreement with the NHS, whereby NHS England will only pay for Olysio if patients are effectively cured of the virus after 12 weeks of treatment, with Janssen (J&J’s pharma wing) refunding the cost for those who aren’t.

By Brett Wells – Pharmafile online

FDA approves Eisai thyroid drug, fast-tracks Novartis heart pill

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The FDA has approved Eisai’s thyroid cancer drug Lenvima and also granted Novartis heart pill LCZ696 a priority review.

Lenvima (lenvatinib) has been approved in the US to treat the most common type of thyroid cancer – differentiated thyroid cancer (DTC) – and is for patients whose disease has progressed despite receiving radioactive iodine therapy.

DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” says Richard Pazdur, who is the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

“Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

Lenvima was evaluated under the FDA’s priority review programme, and the drug also received orphan product designation because it is intended to treat a rare disease.

The firm is now trialling the drug for other tumour types, and Lenvima is undergoing regulatory review worldwide and the EU (where it was also granted accelerated assessment).

Speedy FDA review for Novartis 

Meanwhile there’s good news for Novartis too as the FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF).

For LCZ696 this means a welcome reduction in the total review time from 12 to 8 months, meaning the FDA could make a decision on approval as early as in August this year.

David Epstein who is the division head at Novartis Pharmaceuticals, says: “The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients and Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”

In the EU the Committee for Medicinal Products for Human Use (CHMP) has also granted accelerated assessment for the heart pill.

Nearly six million people that live with heart failure in the US alone. The twice a day medicine is said to work by reducing the strain on failing hearts, and acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).

By Brett Wells, Pharmafile online

Apple hails health benefits of new watch

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Users of the upcoming Apple Watch will be prompted to be more active because ‘sitting is the new cancer’ according to Apple boss Tim Cook.

The California-based company’s chief executive told delegates at a recent Goldman Sachs Technology and Internet Conference that the device will “tap you on the wrist to remind you to get up and move”.

He explained that the gadget’s latest trick is to give you a small vibration encouraging the user to be more energetic and keep fit.

The long-awaited ‘smartwatch’ – set for release in April – will be able to calculate all kinds of data including heart rate, calories burned whilst also counting steps. Additionally it will send and receive messages, play music and make calls.

Cook explained that: “One of the biggest surprises for Apple Watch will be the breadth of what it can do.” Acknowledging that there are competitors already out there he said: “None have changed the way people live their lives.”

Apple has been pioneering its launch into healthcare for some time now, it was boosted late last year after new figures released by the Department of Health found that NHS England has spent over £1.2 million on its products since 2012.

Furthermore, a pilot programme for Apple’s mobile health platform HealthKit was rolled out across a number of US hospitals this month to help doctors monitor patients with chronic conditions.

The tech company also announced plans in early 2014 to manufacture a new health-monitoring device that will be built into a pair of headphones. The gadget will be able to track user activity during exercise and record various biometric data.

No better than smartphones?

New wearable technology benefits aside, recent work by the University of Pennsylvania investigated just how accurate the tools really are. One study got 14 participants to trial six wearables and six smartphones laden with gadgets to see how they compared.

Results found that the activity tracking systems of wearables are no better than that of smartphones. Nike’s Fuelband device was found to be the most inaccurate tracker followed by the Jawbone’s UP24, and Flex by Flitbit.

Any firms making exaggerated health claims of its wearable devices face scrutiny following new FDA guidelines on how the gadgets for medical purposes could be regulated. The rules will define what separates a healthcare device from a consumer offering.

The potential for this type of technology in the industry will only be realised if Apple and others engage effectively with consumers and healthcare authorities, and pharma will no doubt be following the developments closely.

By Tom Robinson – Pharmafile online

BREAKING NEWS: Pfizer to buy injectible drugmaker Hospira for around $17 billion

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

(Ref: First Word, Pfizer, CNBC, The Wall Street Journal, MarketWatch, StreetInsider, Yahoo!News, ABC News)

Pfizer entered a definitive merger agreement to acquire Hospira for $90 per share in cash, or a total enterprise value of approximately $17 billion, the companies reported Thursday.

“The proposed acquisition of Hospira demonstrates our commitment to prudently deploy capital to create shareholder value,” commented Pfizer CEO Ian Read.

The executive added that “Hospira’s business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets.” Pfizer noted that the deal will add Hospira’s generic sterile injectables product line, including acute care and oncology injectables, as well as its biosimilars portfolio.

The companies indicated that both boards of directors have unanimously approved the transaction, which is expected to close in the second half. Pfizer noted that the purchase is expected to be immediately accretive upon closing and will deliver $800 million in annual cost savings by 2018.

By: Matthew Dennis, First Word Pharma, online

GSK blames respiratory woes as sales drop

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

GlaxoSmithKline’s respiratory business has been flagged as the key factor in the firm’s fourth quarter financial misfortunes, as its total sales drop by 8% since the same period last year.

US losses relating to lung drug Advair and heart pill Lovaza have hit the British company hard, leaving adjusted net cash from its operations down 20%, raking in £5.9 billion for the year. Adding to that, profits have also seen a decline of £2.5 billion over prior year.

Speaking via a webcast on GSK’s website, chief executive Sir Andrew Witty declares: “Last year our environment was dynamic to say the least.” Before adding: “Having said that I am very pleased with the position we now have in terms of our contractual cover going forward into 2015 and 2016.”

Citing strong evidence of emerging market volume and with ‘demand that is growing’ however, Sir Andrew says this will present much opportunity for GSK as it expands its footprint there. “For 2015 we want to rebuild our sales growth momentum, after the challenges of last year we have some opportunities to do that. Especially from our recently-launched product portfolio.”

Tellingly he notes the pharma giant will “continue to focus on our costs and restructuring programmes, where we’ve already taken substantial costs out of the business”.

Last year was a tough one for GSK, which was saw the firm continue to get hit by both declining sales of blockbuster Advair, and a record fine over allegations of corruption in its business in China.

Sir Andrew confirmed on the back of these latest results that his target is now to return its respiratory business to growth next year, pinning hopes on newer products like its Anoro Ellipta inhaler and Breo to gain headway in the market, which have got off to a slow start.

Ketan Patel, an analyst at Ecclesiastical Investment Management, says of GSK’s future: “The key in 2015 will be the ability of management to deliver on the cost-cutting programme, the pipeline and stabilising the revenues in respiratory, all of which should not be underestimated.”

GSK’s other big news of course is its major pact with Swiss rivals Novartis, that is to see the manufacturers combine their consumer health units under GSK’s majority (63.5%) control, while also in effect swapping some of their major assets.

Patel says that the strategic options available to GSK post any deal with Novartis, include potential asset disposals, especially the HIV joint venture with Pfizer, which will naturally give the firm financial flexibility going forward.

That potential looks to be taking shape sooner rather than later now as Sir Andrew has just told Reuters his company would take the next two to three months to analyse the pros and cons of an initial public offering (IPO) regarding its HIV meds unit ViiV, along with deciding how much of it to sell.

Apparantly GSK will then decide around mid-year whether to go ahead with the float.

Patel adds: “If the board decide to cut the dividend in 2016 it would be a watershed moment, as no large cap pharmaceutical company has cut its dividend, excluding M&A deals, since the turn of the century.

Keen to highlight a company in the midst of a transformation, Sir Andrew says: “The Novartis transaction itself, once approved, will have a very substantial impact on the company. It changes the shape of the business. It is an important part of rebalancing the group’s future.”

By Brett Wells – Pharmafile online

Is asthma being overdiagnosed?

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A potentially alarming figure that emerged in the UK news last week was that “1 million” UK adults may have been wrongly diagnosed with asthma – a claim reported in various forms by BBC News, The Guardian, The Daily Telegraph, the Daily Mirror and the Mail Online. 

The headlines followed the publication of new draft guideline (PDF, 670kb) from the National Institute for Health and Care Excellence (NICE) on the diagnosis and management of asthma. Most of the media articles were true to the facts and explained that the guideline was aiming to improve asthma care by improving the accuracy of diagnosis.

So, where did the figure of 1 million come from? All the UK press rallied round a statement in the draft guideline that said: “studies of adults diagnosed with asthma suggest that up to 30% do not have clear evidence of asthma”. What followed was clearly a “back of the envelope” calculation extrapolating this to the number of people receiving treatment for asthma in the UK, which is around 4.1 million. This gave the magic figure of 1.23 million potentially misdiagnosed people.

Unfortunately, the 30% figure in the draft guideline is not referenced, so we can’t find out how accurate it is. We also don’t know whether it applies to specific asthma subgroups, such as those of a specific age, or the severity of a person’s symptoms. This makes it difficult to assess whether this calculation is accurate, or even reasonable.

The charity Asthma UK responded in a blog post, saying: “While we welcome the NICE guideline in the hope that it will help people with asthma to receive more personalised care, we are concerned that today’s headlines may make people think twice about taking their asthma medicines”.

“Although it is true that some people may receive treatment for asthma when they currently don’t have symptoms, this does not necessarily mean that they don’t have asthma. So it is vital that everyone diagnosed with asthma keeps taking their medication as prescribed and attends their annual asthma review”.

You should never stop taking any prescribed medication without first consulting with your GP or the doctor in charge of your care. This includes asthma medication.

 What is the basis for these current reports?

NICE recently released a draft guideline to improve asthma diagnosis and monitoring.

The draft guideline – NICE’s first on asthma – is now open for consultation until March 11 2015, so people and institutions can comment on its initial recommendations. The feedback and comments will be collated and incorporated into revised recommendations. Once agreed, these will form official NICE guidelines, which are expected to guide standard healthcare practice across the UK.

The draft guideline covers the diagnosis and monitoring of asthma in adults, children and young people. It draws on the best evidence available to determine the most clinical and cost-effective way to diagnose people with asthma and determine the most effective monitoring strategy to ensure optimum asthma control.

 What does it say?

The draft guideline outlines that there is currently no gold standard test available to diagnose asthma. At the moment, it is mainly based on a thorough history of symptoms taken by an experienced clinician.

However, the guideline stresses that to achieve a more accurate diagnosis, clinical tests should be used alongside symptom assessment. The process the healthcare professional should follow in the initial assessment, and the tests to use, are presented in simple flow charts.

This involves using a combination of tests, depending on the age of the person being assessed. Most commonly this will involve a test called spirometry, to test lung function. This will sometimes be repeated after a person has been given inhaled treatment to dilate the airways – known as a bronchodilator reversibility test. Other tests that may be used include measuring fractional exhaled nitric oxide, as a sign of airway inflammation, and looking at whether the airways are over-responsive to inhaled substances, such as histamine or methacholine.

The guidance also says that around one in 10 adults with asthma develop the condition because they are exposed to certain substances, such as chemicals or dust, in their workplace. Therefore, the draft guideline now recommends that healthcare professionals ask employed people how their symptoms are affected by work, to check if they may have occupational asthma.

 How does the guideline affect you?

If you have asthma, do not change your medication without first consulting a doctor. This could be dangerous, as untreated asthma can be fatal.

If you have concerns that you have been misdiagnosed or are taking medicines unnecessarily, the first thing to do is speak with your health professional.

At present, these guidelines are in a draft form, so may be revised based on feedback and comment over the next few months. In the meantime, there aren’t likely to be changes in the way asthma is diagnosed routinely across the NHS. However, if the changes proposed in this draft make it into the final version, this may lead to a change in practice – most likely, more standardisation around the diagnosis and monitoring of asthma.

The main implications of such a change would be that the accuracy of diagnosing new asthma cases should improve or standardise for people in the UK. The implications for people already diagnosed with asthma are less clear. It could potentially mean that cases where there was uncertainty around the diagnosis would be re-reviewed with further diagnostic tests. This could potentially lead them to be declared asthma-free, or to a change in their medications, as appropriate.

This is a good reminder to take full advantage of your asthma review, which is an appointment with your doctor or asthma nurse to talk about your asthma and discuss how you can better control your symptoms. This is something that everyone with asthma should do at least once a year or more if you have severe asthma symptoms.

NICE says it wants to hear your views. Information on how to comment on the draft guideline can be found here.

Analysis by Bazian. Edited by NHS ChoicesFollow Behind the Headlines on TwitterJoin the Healthy Evidence forum.

GSK-Novartis mega-deal signed-off by EC

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The European Commission has approved a GSK-Novartis M&A deal, in which GSK will purchase Novartis’ vaccines unit and Novartis will buy GSK’s oncology business.

Both firms announced the overhaul of their businesses in April. The multi-billion dollar contract will involve GSK acquiring Novartis’ global human vaccines business (except the influenza vaccines business) for $7.1 billion, and Novartis taking over GSK’s oncology business for up to $16 billion.

In a third part of the deal, GSK and Novartis will combine their global consumer health business in a new entity, over which GSK will have sole control.

Under the EU Merger Regulation the EC has a legal duty to assess mergers and acquisitions involving companies with a turnover above certain thresholds, and make sure that any arrangements would not significantly impede effective competition in Europe.

The EC had concerns that the GSK-Novartis deal would affect competition in the production of vaccines and promising oncology treatments. The Commission raised the potentially detrimental effect on competition for some vaccines.

To address this GSK agreed to sell its meningitis vaccines, Nimenrix and Mencevax, on a global basis. These are marketed outside of the US and generated annual global sales of £36m in 2013. In another condition set by the EC, GSK will also divest two Novartis diphtheria and tetanus vaccines in Italy and Germany.

The oncology tranche of the deal would also have affected competition, the Commission found, by reducing the number of companies developing and marketing two investigational skin cancer treatments, B-Raf and MEK inhibitors, from three to two.

The EC report notes that these treatments “are expected to become the standard of care for the treatment of skin cancer… [and] to reach peak sales of several hundreds of millions of euros in the next few years in the EEA”.

The Commission feared that Novartis’ purchase of GSK’s oncology portfolio, which includes B-Raf and MEK inhibitors would “lead to a duopoly between the merged entity and Roche”. It was also likely to result in Novartis abandoning its clinical trials of these treatments in ovarian, colorectal and lung cancer, which would have a ‘significant impact on innovation’.

As a condition of the deal Novartis agreed to return its rights over MEK162 to its owner and licensor Array BioPharma, and to divest LGX818 to Array. “This will ensure the worldwide development of LGX818 and MEK162 as well as the commercialisation of these inhibitors in the EEA”, the Committee report says.

The EC also signed-off another major pharma pact after concluding that Mylan’s purchase of Abbott’s generics business would not adversely affect European competition. The complex deal will mean Abbott will have a 21% share in ‘New Mylan’, which will become the parent company of Mylan and continue to operate from its base in Pittsburgh, Pennsylvania.

The Commission’s investigation found that for the majority of Abbott’s generic products no competition concerns arose. However, for five generic products in Germany, the UK and Ireland, France and Italy there are a lack of substitutable products and competitors present and low likelihood of competition.

To address these concerns, Mylan will divest its businesses and marketing authorisations in these countries. Both the GSK-Novartis and the Abbott-Mylan deals are conditional upon the companies complying with these commitments.

By Lilian Anekwe – Pharmafile online

Shire lifted by rare disease approvals

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Shire’s investigational drug for a rare neurological disease has been accepted into the FDA’s fast-track approval process.

The drug, SHP609, (idursulfase-IT, also known as HGT-2310) received an FDA Fast Track designation as a treatment for neurocognitive decline associated with Hunter syndrome, a rare genetic disorder.

SHP609 is a new formulation of Shire’s existing treatment for Hunter syndrome, Elaprase (idursulfase). It is designed to be used alongside Elaprase and administered directly into the cerebrospinal fluid.

Hunter Syndrome (also known as mucopolysaccharidosis II or MPSII) is a severely debilitating rare disease that affects 1 in 162,000 babies born. It is caused by the lack of an enzyme, and can lead to severe health problems and early mortality.

The FDA’s Fast Track program is designed to help companies to get drugs reviewed more quickly, especially drugs that “address serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs”.

Being given the designation boosts a company’s chances of getting a propriety review for a drug by granting more meetings with FDA regulators, if the clinical data is robust.

In Shire’s case it is currently enrolling patients in its Phase II/III pivotal trial to look at the effect of SHP609 children with Hunter syndrome and early cognitive impairment – who being treated with Elaprase.

“This is not only the first treatment being investigated to address the significant unmet need of slowing the cognitive decline in MPS II patients, but also the furthest a program for enzyme replacement has ever progressed,” says Philip Vickers, head of research and development at Shire.

“This Fast Track designation is further recognition of the critical need to develop new, effective therapy options for patients with Hunter syndrome with cognitive impairment.”

The Irish company also received good news from the FDA after NPS Pharma, the company Shire paid $5.2 billion for earlier this month, gained an FDA approval for Natpara (parathyroid hormone) as an additional treatment for hypocalcemia in patients with hypoparathyroidism.

In response to the NPS Pharma decision on Natpara, Shire chief executive Flemming Ornskov, comments:  “The Natpara label is in line with our expectations, and we believe this approval further validates Shire’s decision to acquire NPS Pharma, which is an excellent strategic fit allowing us to leverage our  market expertise, core capabilities in rare disease patient management, and global footprint.

“We look forward to combining our strengths with NPS Pharma to launch NATPARA in the US after the expected close of the transaction in Q1 of this year.”

By Lilian Anekwe – Pharmafile online

New vice-chair for Commission on Human Medicines

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Dr Angela Thomas has been appointed as vice-chair of the Commission on Human Medicines (CHM).

She replaces Professor Ian Weller who retired from the position and from CHM at the end of December last year.

The CHM advises on matters relating to safety, quality and the efficacy of medicines as well as the collection of adverse drug reactions.

Thomas is a consultant paediatric haematologist at the Royal Hospital for Sick Children in Edinburgh, a fellow of the Royal College of Physicians in Edinburgh, a former president of the British Society for Haematology and has been on the CHM since 2005, where she chairs the Clinical Trials, Biologicals & Vaccines Expert Advisory Group.

She has also served as a member and chaired many scientific and medical committees in the UK and Europe.

Thomas says: “I am delighted to be taking up this new role. The Commission plays a vital role in the licensing of new medicines and in monitoring drug safety.

“I have found my time as a member of CHM tremendously rewarding and am looking forward to the challenges offered in my new role as vice-chair.”

Pharmafile online

GSK double complaint ruled out by PMCPA

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Complaints questioning the promotion of two of GlaxoSmithKline’s chronic obstructive pulmonary disease (COPD) drugs have been ruled out by a PMCPA panel.

One objection accuses the UK pharma firm of trying to hide important safety information about Relvar (fluticasone furoate/vilanterol). The complainant argued that it is not made clear in any GSK marketing that the inhaler can cause pneumonia to asthma patients.

The other regards Seretide (salmeterol/fluticasone) and notes that the TORCH study – of which the device was trialled in – did not meet its primary endpoint. Despite this, promotional claims for Seretide have referred to favourable findings.

As the ruling and regulatory arm of the ABPI, the PMCPA concluded that not all marketing material for the treatment referenced secondary endpoint data from the study. But that high standards had not been maintained so a breach of Clause 9.1 – failing to maintain high standards at all times – was ruled, Clause 2 – discredit to the pharma industry – wasn’t.

The panel’s governing on Relvar concluded that information on pneumonia as a side-effect in patients with asthma is available, so did not warrant a breach of any clauses to the code. The information appears in the relevant sections of the company’s website, along with links to the Summary of Product Characteristics (SPC).

Both decisions will provide great relief to the British pharma firm which in 2012 was not so lucky, as it breached three clauses in the ABPI Code of Practice following a complaint from a member of its own staff.

GSK was found guilty of Clause 15.2 which deals with reps’ ethical conduct, after the employee protested that a representative had promoted the unlicensed use of blood disorder drug Revolade (eltromopag).

The complaint stemmed from an email sent referencing an individual funding request (IFR) for a patient. As a result the firm also breached Clauses 9.1 and 3.2, which states that the promotion of a medicine must be in accordance with the terms of its marketing authorisation.

However, the positive result from the PMCPA today for Relvar and Seretide mean that GSK can focus on the latter’s partial successor – Anoro (umeclidinium/vilanterol) – as it looks to compete in a market host to more than 21 million COPD patients.

Backed by the Committee for Medicinal Products for Human Use (CHMP) last year and given the nod in Europe just days later, the pharma firm’s new treatment – in partnership with biopharma Theravance – could generate worldwide annual sales of around $2.65 billion by 2019 according to Reuters.

By Tom Robinson – Pharmafile online