Most of the “affected” positions (3750) will be in selling, general, and administrative areas. One change already underway at the company is the simplification of its global commercial organisation structure by reducing the number of its sales and marketing regions from five to three. Small countries have also been clumped together in a move that AstraZeneca hopes will optimise its resources by increasing shared services and reducing cost bases.

Another 2200 positions will come from R&D. The statement says, “The R&D function will accelerate its transformation, which the company unveiled in January 2010. Under the new programme announced today, further changes will create a simpler and more innovative R&D organization with a lower and more flexible cost base. Excess capacity in certain R&D functions will be reduced, matching resources to AstraZeneca’s more focused R&D portfolio.”

One of the main focuses for R&D restructuring will be in the company’s neuroscience area. Although AstraZeneca recognises that there is much need in this area for better medicines, it adds that advances have been “elusive”. In response, the company will close one R&D site in Montreal (Canada) and wind down R&D activity at its Södertälje (Sweden) site.

In a more positive note for neuroscience, however, the company added that it will continue to pursue innovation in this area by combining internal expertise with “innovative external science” using a virtual neuroscience Innovative Medicines (iMed) unit. The unit will be made up of around 40–50 AstraZeneca scientists, who will conduct discovery and development externally using a global network of academia and industry.

Martin Mackay, president of Research and Development, AstraZeneca, said: “We’ve made an active choice to stay in neuroscience though we will work very differently to share cost, risk and reward with partners in this especially challenging but important field of medical research,” Martin Mackay, AstraZeneca’s president of research and development, said in the statement. “The creation of a virtual neuroscience iMed will make us more agile scientifically and financially – we will be able to collaborate flexibly with the best scientific expertise, wherever it exists in the world.”

The remaining job cuts will be in operations as AstraZeneca seeks to make its supply chain more efficient. In particular, the company says it will be looking at its support functions.

The restructuring is expected to deliver around $1.6 billion in annual benefits by the end of 2014, but that will be little consolation for those losing their jobs. An article in the Wall Street journal estimates that around 30000 jobs have been lost at AstraZeneca over the past five years.

In April 2011, the EMA’s Committee for Medicinal Products for Human Use recommended a label update for Biogen and Elan’s multiple sclerosis drug Tysabri (natalizumab). Late in January 2012, the FDA also approved the label change in the US.

Although touted as an effective treatment, Tysabri has also been associated with the risk of developing a serious and, often fatal, brain infection called progressive multifocal leukoencephalopathy (PML). The new label identifies that a certain antibody status (presence of anti-JCV antibodies) is a risk factor for developing PML. A test to detect these antibodies can identify at-risk patients, which is a development that marks a step towards personalised medicine — matching the right treatments with the right patients to maximize therapeutic effect.

In their press statement, Biogen and Elan added that Quest Diagnostics will be producing the STRATIFY JCV Antibody ELISA testing service in the US, which is the first blood test authorised by the FDA for the qualitative detection of JCV antibodies. When used with other clinical data from the patient, the test can help healthcare providers determine the risk for developing PML. Such testing has already been used in Europe since the label was updated last year.

Biogen and Elan have also identified two other PML risk factors: over two years of treatment with Tysabri, and previous treatment with medicines known to weaken the immune system.

Tysabri has had a rickety life. It was voluntarily withdrawn from the US market in 2005 because of concerns over PML, but relaunched in 2006 with a black box warning and a strict monitoring plan. In Europe, Tysabri was approved in 2006 but has been under close scrutiny by the EMA. The EMA has also kept a tight watch and finalised a review of the medicine in January 2010, concluding that the benefits of the medicine outweigh the risks.

As well as improving the safety of patients, the new label could also help to boost Tysabri sales. According to an article by Bloomberg, financial analysts have forecast that Tysabri could see its global sales grow to as much as $3 billion by 2016. Without the label change, the drug may only have seen sales of $1.5 to 2 billion.

The JCV diagnostic test is a good example of how pharma companies can improve their medicines. All drugs, unfortunately, have side effects but a lot can be gained by understanding how those effects occur—and in which patients. Biogen and Elan are not the only companies making efforts to personalise their medicines. As was well publicised last year, Sanofi’s Avastin had its breast cancer indication removed in the US. However, Sanofi is looking hard at the drug in order to evaluate a potential biomarker that could help identify which people might derive more substantial benefit from the drug. Interestingly, Avastin was in the headlines yesterday with Bloomberg running a news piece about how Avastin studies have pointed to potential benefits when used in early-stage breast cancer.

No doubt there is more to come in the world of biomarkers, diagnostics and personalized treatments.

They’ve also overlooked a lot of the positive aspects of the project. Deen will be offering diabetes-friendly recipes that do not comprise taste and appearing at diabetes cooking events across the US. The initiative is called Diabetes in a New Light.

But if you’re familiar with Deen’s cooking, you’ll be aware that a lot of her dishes are not exactly promotional of a healthy diet (examples include bacon cheeseburger meatloaf and southern fried chicken – you can take a look at the recipes on her website), which is where media criticism has been directed. Deen herself was also diagnosed with Type II diabetes three years ago, but only revealed this to the public this week, another aspect that has attracted criticism since she’s maintained her cooking style, despite the fact that diet is an important part of managing diabetes.

However, Deen makes a good point of saying in a press statement that “diabetes does not have to stop you from enjoying the things you love”.

At a time when obesity is rising, it’s important for us to be aware of healthy food, and chefs need to take some responsibility. Let’s be honest though, most of us don’t want to be healthy all the time, so we want to know how to make the best of our butter!

In their criticism, a lot of news sources have overlooked the contributions Deen is making to the diabetes battle. She claims to have made small dietary changes and to have worked more exercise into her day. Being a celebrity spokesperson for diabetes will also be a good influence – some sources have made snide comments about the connection between Deen’s weight, her recipes and diabetes, which will no doubt influence some people into avoiding unhealthy foods.

And with all the attention being focused on the responsibility of celebrities and chefs to promote healthy eating, Novo Nordisk and the pharmaceutical industry has gotten a bit lost. The pharma industry also has a responsibility to promote good health; indeed, this focus is becoming increasingly important in pharmaceutical business strategies as non-traditional companies, such as food and IT companies, muscle into the healthcare sector. Ernst and Young has a really good report about this trend available on their website.

Even though the diabetes campaign is partly to promote Novo Nordisk’s diabetes drug, Victoza, it’s also a step towards health education. According to one news report, many diabetes patients have trouble managing their diet. Havilah Clarke, senior manager, product communications at Novo Nordisk is quoted in the report as saying, “Based on what were hearing from some primary research we were doing, people living with diabetes thought that food was one of the most difficult challenges to address in their social lives. They thought they had to deprive themselves.”

Whatever Novo Nordisk’s intentions, it remains to be seen whether using Paula Deen will be a successful strategy given the amount of criticism the partnership has received. But there’s no such thing as bad publicity, right?

I always seem to be writing about GSK in my blogs but this is a much more sombre subject compared with the recent news of GSK CEO Andrew Witty’s knighthood. This week’s attention on GSK is focused on the COMPAS (Clinical Otitis Media and PneumoniA Study) study, which involved almost 24 000 children and was completed in Argentina in June 2011. The fine issued by the Argentinean National Administration of Medicines, Food and Medical Technology (ANMAT) related to administrative procedures in place for the study in 2007 and 2008. According to media reports (Sky News, CNN), some consent forms were signed by illiterate parents or people who did not have custody of the children. Claims have also been made that some children feeling unwell after vaccination were not seen by doctors.

Fourteen children are reported to have died during the study. Because the trial involved children, it is an extremely sensitive and emotional topic that has evoked strong reactions from some media sources that accuse GSK of “killing” babies and “experimenting with humans”.

But there are two sides to every story. Personally, I don’t believe that any reputable pharmaceutical company would experiment on humans.

GSK emphasised in a press statement that the fine relates to administrative procedures and “does not question the safety of the study vaccine”. Indeed, according to the statement, any deaths in the study were thoroughly investigated and both an independent data monitoring committee and ANMAT both concluded that none of the deaths were related to the vaccine.

The administration irregularities with obtaining informed consent were identified by GSK in 2007 and 2008 as part of routine monitoring, which takes place at 6-week intervals.

“The company proactively reported these findings to ANMAT and immediately put in place a corrective action plan which involved reconfirming informed consent of patients in the study and retraining doctors… where necessary,” explained GSK’s press statement. “The safety of patients participating in the study was not put at risk and ANMAT agreed that the study could continue as planned.”

Some media sources have also accused GSK — and other Western pharma companies — of taking advantage of developing countries to experiment with new treatments. In the case of GSK’s Synflorix, however, developing countries are a logical choice for a clinical trial. Estimates from the World Health Organisation claim that more than 500,000 young children die each year from pneumococcal infection, with the vast majority of these deaths occurring in developing countries. The GAVI Alliance also explains that although a vaccine against pneumococcal disease has been widely used in Europe and the US since 2000, it was not optimal for developing countries because it lacked different strains of pneumococcal bacteria that are common in developing countries.

Although Argentina is not really considered a developing country, it still has a large number of people living in poverty and pneumococcal disease is a significant health burden.

GSK says that it “respectfully disagrees” with the court ruling in favour of ANMAT and will appeal to the Supreme Court of Argentina. However, if unethical practices did take place during the trial then GSK has said it will pursue the matter.

“We are also concerned by allegations that treatment was delayed for some children in the trial if they were unwell and, if true, these events are shocking… we will be looking into this further,” said the GSK statement.

For Andrew Witty, the CEO of British pharma giant GlaxoSmithKline, the year is definitely off to a good start after he was knighted for services to the UK economy and pharmaceutical industry. Sir Andrew as he will now be known received the royal recognition in the UK’s 2012 New Year’s Honours List. Almost 1000 people received awards of varying kinds. 

This year, science and healthcare were well represented with other recipients of knighthoods including, among others, two physics professors, Professor Andre Konstantin Geim and Professor Konstantin Novoselov from the University of Manchester, Professor Stephen Robert Bloom from Imperial College London for services to medical science, and Dr Venkatraman Ramakrishnan from the Medical Research Council’s Laboratory of Molecular Biology for services to molecular biology. Julie Moore, the chief executive of the University hospitals Birmingham NHS foundation was also made a dame. Varying awards were also given out to other researchers and other pahrmaceutical industry particiants, including Richard Barker, the former director general of the Association of the British Pharmaceutical Industry (ABPI). There’s a full list available in The Telegraph. 

If you’re not familiar with the UK’s honours list, it’s a way of recognising merit, gallantry and service to the country. The lists are published twice a year at New Year and on the Queen’s official birthday in mid-June. The lists always comprises a number of film and sports celebrities, but it also reflects a range of skills and talents from across the UK.

The awards are also generally subject to a large amount of cynicism. For instance, The In Vivo Blog says, “Cynics may be suspicious of the timing of this flurry of biopharma-focused decorations. They came only a couple of weeks after the UK government outlined its new Life Sciences Strategy, in which much hope was placed on the sector helping to pull the UK economy out of the doldrums.”

I’ve also read some very cynical pieces that talk about the involvement of the British government in the honours process and the fact that Witty serves on an economic committee for the UK’s Prime Minister David Cameron.

However, most of the negative attention on the honour’s list this year has focused on other award recipients, such as Paul Ruddock who received a knighthood for services to the arts for his work as chairman of the Victoria and Albert museum. Ruddock’s hedge fund management company Landsdowne Associates made around £100 million after betting on the collapse of the bank Northern Rock. News reports have also pointed out that Ruddock has donated nearly £500,000 to the Conservative party. Some scathing has also been directed at the knighting of Paul Bazalgette, a TV executive who brought Big Brother to the UK. 

As a blog on our sister site Pharmaceutical executive points out, Sir Andrew could be seen as a bit of a knight in shining armour compared with other names on the list! GSK has pledged loyalty to the UK economy and has also sought to help developing economies by improving access to medicines. He’s also looking at some innovative ways to improve the company’s R&D by partnering with the McLaren Group. The knighthood will certainly be a good thing for GSK’s reputation, which has taken a bit of battering in the last year. In 2011, the company had to pay £1.6 billion to settle litigation cases concerning Avandia, which has been banned in Europe, while in the US the company has agreed to pay $3 billion to settle investigations into the way the company marketed certain products.

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GSK isn’t the first pharma company to set its eyes on the automobile industry. In 2009, AstraZeneca borrowed some experts in lean manufacturing from Jaguar Land Rover, who were to apply their knowledge of efficient car production techniques to medicines. I’m researching at the moment how the project went so watch this space and hopefully I’ll be able to provide an update on this in the near future.

So what is it that cars and pharmaceuticals have in common? Today, the majority of a car’s value is attributable to suppliers but before this the industry used to be dominated by Western companies, much like the pharma industry. As the industry found the need to implement aggressive streamlining and cost cutting, carmakers now maintain only a few core operations, with everything else taking place across a huge network of contractors.

In the pharma industry, we’re already seeing greater numbers of companies outsourcing certain functions, such as clinical trials, or in-licensing new compounds from smaller companies.

The article (available here) pulls out a lot more similarities between the two industries. If you like pharma and cars then it’s definitely worth a read!

The article doesn’t provide any updates on the GSK partnership, which is a shame because it’s something I’m really looking forward to hearing more about. Where as AstraZeneca was looking to cars for lean expertise, GSK is hoping to extrapolate some of the technology using in Formula 1 racing to improve its R&D, such as seeing whether real-time monitoring technologies can be applied to human studies.

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One pharma company that does seem to love social media though is Germany-based Merck KGaA—so much so that the company was prepared to go to court when its Facebook page was recently taken over by US rival Merck & Co.

Merck KGaA had entered into an agreement with Facebook for exclusive rights to the Facebook.com/merck page in March 2010. On October 11, however, the company realised it had lost administrative rights and that the page was now populated with Merck & Co. content. Although Merck KGaA complained to Facebook, the matter was not resolved. In a news story, the UK’s BBC claimed that Merck KGaA’s lawyer, Robert Horowitz, said that respondents at Facebook “either did not understand the problem… [or were] intentionally giving unresponsive answers.”

On November 21, Merck KGaA filed a lawsuit against Facebook with a New York state court requiring “pre-action disclosure” from Facebook to reveal how the administrative rights were lost.

If Facebook had not understood the situation before, it quickly swatted up on the issue. On Monday, November 28, it held its hands up and apologised for the situation, claiming it was an administrative error.

So who gets the page? According to a news report from AFP, Facebook has told the Mercks to battle it out themselves — or they are free to create a new profile page. Until that time, Facebook.com/Merck will be unavailable to all.

This whole incident may seem a little over the top—and it’s easy to see how Facebook could have made an error since the two companies sound so similar. Although they both originated from the same German company, they were split into different entities after World War I. However, it just goes to show how important social media platforms are to businesses—including big pharma. In several news reports from sources including Reuters and BBC News, Merck KGaA is quoted as saying, “Because Facebook is an important marketing device, the page is of great value to Merck…”

Personally, I think it’s great that pharma companies are taking an active interest in social media (although I suppose we’re all more likely to take an interest in something after we discover it’s been stolen by one of our neighbours… absence makes the heart grow fonder after all). Many companies are still reluctant to fully embrace these platforms, particularly as regulators, such as the aforementioned FDA, have not issued any guidelines but seem to be ever vigilant. Earlier this year, however, the Association of the British Pharmaceutical Industry (ABPI) published a guidance suggesting best practices for managing adverse events and other pharmacovigilance data from the internet and social media tools. Slowly but surely, progress is being made in laying out firmer ground for pharma companies looking to find a path to social media success.

Statistics are currently available for January–September 2011. So far, the EMA has issued 74 positive opinions on marketing authorisation applications. Overall, the agency has started 76 marketing authorisation applications and finalised a further 79. So, what kind of picture do these statistics paint? Quite a bright one, actually, particularly in comparison to the bleakness of 2010 when the EMA issued only 51 positive opinions for marketing authorisation applications.

2011’s number of finalised marketing authorisation applications (79) has overtaken 2010’s low figure of 54; indeed, the year has also beaten 2008’s 72 finalised applications. However, there’s still a long way to go to outdo 2009’s 125 finalised applications, which were partly driven by a high number of applications (51) for generic products. This year, there has once again been a considerable number of marketing authorisation applications for generic products, with 28 finalised compared with only 20 in 2008.

There has also been a noticeable increase in the number of applications for new products, which is positive considering the amount of criticism that has been directed at the pharma industry’s innovative pipeline. So far, the agency has finalised 32 applications for new drugs compared with just 21 last year. New orphan medicinal products are also on the rise: 11 applications have already been finalised this year compared with six in 2010.

For started marketing authorisation applications, it’s a little different: 76 started applications in 2011 compared with 90 in 2010. Breaking down the numbers, however, the EMA starts roughly 8 applications per month, so the total could theoretically rise to 100 or more. We’ll have to wait until the end of the year to find out. Importantly, however, the number of started applications for new products is high at 36 applications compared with 2010’s 34.

There’s still a long way to go before anyone can safely say that the innovation drought is over, but given that the US has also seen greater drug approval rates this year compared with last, perhaps 2011 marks an important step towards this goal.

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EvaluatePharma expects Pfizer’s prescription and over-the-counter (OTC) sales to drop to $49.8 billion in 2012, mainly due to the patent expiry on Lipitor, the blockbuster cholesterol-lowering statin that holds the record for the world’s biggest selling medicine. Meanwhile, Sanofi’s sales will grow from $47.9 billion in 2011 (which ranked it as third in terms of the world’s top pharmaceutical companies) to $51.6 billion in 2012. The French company has been moving up the rankings for some time, boosted by a decade of mergers, which began in 1990 with the deal between Sanofi and Synthelabo and culminated with the $20 billion acquisition of Genzyme in February this year.

“The takeover of Genzyme this year was an aggressive cross-border move that revealed just how much the culture of Sanofi has changed in the last few years,” explains the EvaluatePharma analysis. “The traditionally inward looking French drug maker has, like many of its peers, taken big strides to acquire and license innovation from beyond its own labs in an attempt to revive flagging R&D productivity.”

The analysis adds that sales of Genzyme’s enzyme replacement therapies should be enough to keep the crown on Sanofi’s head until at least 2016, with the blockbuster products of Cerezyme and Myozyme helping to offset revenue of Plavix, which will lose US patent protection next year, as well as the ongoing generic erosion of Lovenox and Taxotere.

Pfizer, on the other hand, will fall further behind in terms of sales. By 2016, Sanofi is expected to have sales of $58.4 billion while Pfizer will scrape $51.9 billion, representing a minute 1% compound annual growth rate (CAGR) over 2011–2016. Sanofi, on the other hand, will have a CAGR of 4%. Pfizer will also face competition from GlaxoSmithKline and Roche. By 2016, GlaxoSmithKline is expected to rank fourth with sales of $50.9 billion (compared with ranking fifth in 2011 with sales of $39.3 billion) while Roche will come in fifth with $49 billion (up from sixth in 2011 with $39.1 billion).

As for Novartis, the company will see strong growth from Gilenya and Tasigna over the next few years and will also be bolstered by its $48-billion acquisition of eyecare company Alcon, which will boost sales in areas outside of prescription and OTC drugs. Novartis was ranked second in 2011 with sales of $49.5 billion and is predicted to maintain this ranking at least until 2016, when it is expected to have sales of $54.8 billion.

Meanwhile, there will also be some shuffling in the league table among the other drugmakers too. Merck, currently ranked fourth, will drop to sixth place by 2016, and Eli Lilly, tenth, will fall to fifteenth. The analysis also highlights generics giant Teva, which is expected to rise from twelfth position in 2011 to ninth in 2016 as it grows at a CAGR of 7%. Novo Nordisk will also experience a high growth rate—currently ranked in seventeenth place, the Danish diabetes specialist will climb up to fourteenth place by 2016 with a CAGR of 9%.

It’s a shame that so many communication platforms quickly become corrupted with spam. Of course, it’s not always pharmaceuticals that are being advertised – I’ve had emails about jewellery, fake inheritances and lottery funds, among other things. In the study, however, the authors cite Symantec, which claims that pharmaceutical spam accounts for 65% of all traditional spam email sent.

Since Twitter is a relatively new platform, spam hasn’t reached the same level of annoyance that it now occupies in email inboxes. However, the situation is getting worse as spammers learn how to exploit certain Twitter features.

For those of you who aren’t familiar with twitter, it’s possible to ‘mention’ another user by placing @username in a post. Twitter collects all of these mentions and feeds them back to the user so they know what is being discussed. It’s a really useful feature and I monitor mentions of our Twitter feed PharmTechGroup. Increasingly though, a lot of these mentions contain spam messages. Scammers have realised that using the @username is an effective (and irritating) way to get their spam message noticed.

Spammers also have many other tricks up their sleeve, such as embedding buzz words within the tweet that may be picked up by user searches. It’s frustrating that a platform with so much potential is being corrupted in this way. By the time pharma companies do get a firmer grip on Twitter, any posts to do with medicines may already have a bad reputation. In addition, the proliferation of spam pharmaceutical messages will also make it difficult for users to find official medicines information.

The Akron research is an insightful read (available here) if you’re interested in social media and goes on to describe how to classify and identify pharmaceutical spam. Hopefully, research such as this will eventually help to subdue the spam storm that is building around Twitter, as well as other social media platforms. Most of us just consider spam an annoyance, but a small number of people do follow the links from spam emails to purchase medicines online. There are a number of reasons why people choose to do this, including embarrassment (particularly for impotence drugs) and price.

In the next issue of Pharmaceutical Technology Europe, we will be looking at the danger of counterfeit pharmaceuticals in a special feature on packaging security. We’ll also look at why consumers buy medicines online and what procedures the industry is putting in place to safeguard its products and reputation. The issue is almost ready for print so keep an eye on our website!

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