The largest manufacturer of the generic version of Lipitor has been forced to halt production after glass particles were found in certain batches of tablets.

The US FDA announced that Ranbaxy Pharmaceuticals had ceased production of atorvastatin after fragments the size of sand contaminated the popular generic.

Ranbaxy, a subsidiary of Daiichi Sankyo, said “the probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out.”

More than 40 batches of the generic have now been recalled, although the FDA said it had not received any reports of patients being harmed by the contamination.

The New Jersey-based company (part of India-based Ranbaxy Laboratories) declined to reveal where the contaminated drugs were manufactured or why the problem occurred. However, the FDA said that the company has now stopped making the pill’s active ingredient – which is made in India – until an investigation has been completed.

It is not the first time that the quality of Ranbaxy’s products has come under scrutiny. The company has been working under a US court-ordered consent decree after a number of manufacturing issues were found at sites in America and in India. The decree prevents Ranbaxy from producing any more medication at these sites until it meets US standards.

Ranbaxy became one of the first generic manufacturers of the cholesterol lowering Lipitor when the blockbuster drug lost patent protection in November 2011. It now holds a market share of approximately 43%, according to IMS Health data.

Mylan has launched a generic version of Roche’s Bonviva tablets for the treatment of osteoporosis.

The Ibandronic Acid Film Coated Tablets have been released on the day the patent for Bonviva expired.

Didier Barret, Mylan EMEA President, said the manufacturer is “excited” to add the tablets to its portfolio of more than 350 products in the UK.

The treatment is used in postmenopausal women with osteoporosis who are at an increased risk of fracture.

The drug had sales of around £7.5 million in the UK for the year ending March 2012, according to IMS Health.

Mylan, the first company to launch a generic Ibandronic Acid formulation in the UK, recently launched the product in Spain after Bonviva’s protection expired there.

Spending on medicines in the US increased by 3.7% to $320 billion last year after a raft of new drugs entered the lucrative market, a new report has found.

The report, The Use of Medicines in the United States: Review of 2011, showed that spending on branded medicines increased by 2.2% to $14.9bn and on generics to reach $5.6bn.

Michael Kleinrock, Director, Research Development, IMS Institute for Healthcare Informatics, said that “2011 was a remarkable year” for the number of drugs which entered the market.

Research found there were 34 New Molecular Entities launched in the US last year – the most in a decade. Orphan drugs also saw more launches in 2011 than in the last ten years.

They were joined by several new types of therapies to treat cancer, multiple sclerosis, hepatitis C and cardiovascular conditions.

Nearly a third of total healthcare spending was spent on medicines treating cancer, asthma and COPD, dyslipidaemia and diabetes, and mental health medication for psychoses and bipolar disorders.

Each of these therapy areas increased faster than the overall market, and showed a range of dynamics related to new treatment options and growing diagnosis of related diseases.

The increase in drug spending in the US is in contrast to that of NHS, where spending dropped to £8.81 billion in 2011 from £8.83 billion in 2010.

How do you view CRM: as a chore, as a way of saving effort, or as a valuable window on your customers’ world? Leading CRM vendors tell Pf where the pharmaceutical industry sometimes gets it wrong – and how a combination of new business thinking and new technology can turn customer data into powerful insight.

Customer Relationship Management (CRM) is more than an electronic system for data handling. It’s a well-established business strategy for collecting and utilising the most relevant information about the market. As such, it is a function of the whole company that lends itself well to an integrated commercial strategy. A glance at the industry’s news shows that customer and sales data affect every aspect of a pharmaceutical company. Moreover, how a company uses those data to develop its products and communicate their value to customers can have a significant impact on customer relationships.

But is CRM in danger of going stale? Has it become something that only sales people use, and even then not whole-heartedly? Is a perceived lack of progress with CRM due to problems with the technology, the people using it, or companies’ approach to it?

The answer, according to the specialist CRM suppliers Pf spoke with, is all three. But as they also told us, these drivers of fail need to change. A new ‘golden age’ of CRM is on the way.

Dead-end data
According to David Round, General Manager at Cegedim UK, the most common problem of CRM use in the pharma industry is poor awareness of its potential: “If you have a particular group of users who don’t feel the system works for them, and therefore don’t put in the richness of information that they could, that has a bigger impact on the CRM project as a whole.” Unless the company is using CRM to its best advantage, field sales professionals may lack confidence in it as a tool. 

In addition, Round argues, not every CRM system is fit for purpose: “Where technology can be a hindrance is where the way that it works is relatively fixed or determined in some dark room somewhere, and it doesn’t match the day to day process of the people who are using it. The technology, if it’s not designed correctly with the end users in mind, can actually contribute to a lack of return or a reduced return on investment for the CRM solution.”

Adam Nicholson, Commercial Director at Conigi, identifies four sources of CRM blues: CRM only seen as a sales team tool, thinking limited by previous CRM experiences, fear of the system’s complexity and (conversely) fear/perception that it cannot deal with new commercial realities. All of these, he says, are consequences of narrow thinking: “The reality is that if you pick the right vendor and the right solution, you have enough headroom for development to build what you need now and as your business changes.”
Not seeing the wood for the trees, the insights for the data, is another source of CRM frustration. Dan Goldsmith, General Manager at Veeva Europe, argues that the most successful pharma companies are able to derive “rich and insightful information” from CRM by moving “beyond the operational or transactional information” to a deeper analysis of customer behaviours – with the CRM supplier “not just supporting their business processes but helping them innovate the way they engage and architect the customer experience”. 

Nick Plank, Director, C&C Group, says that CRM systems, like pharma’s operational model, have evolved to meet the needs of a changing NHS in the past decade – and will evolve further as technology continues to advance. “Ten years ago, the environment was very much focused on the rep and in particular on the traditional one-to-one face-to-face style of territory organised sales forces. Fast forward to the present and CRM looks very different, with KAM structured teams engaging with customers on an account basis as opposed to a geographical brick structure, plus a variety of new stakeholders in CRM from medical development advisors to medical science liaison. A fully-integrated CRM accessible to multiple stakeholders is now essential if business functions throughout the enterprise are to have holistic visibility of the account and contribute data from their specific areas such as information gathered during digital engagement.”

Keep taking the tablets
All relevant stakeholders are agreed on the revolutionary importance of the iPad and similar tablet computers for CRM in the context of field sales. These devices take CRM out of the office and onto the road more effectively than ever before. They also have the power to support closed-loop marketing and related strategies, giving CRM a more dynamic role in the customer relationship and in the pharma company.

David Round comments: “I think that CRM is about to enter a pretty golden age, because the birth of the tablet computer and the iPad in particular means that the rep can use the system much more effectively on the go. Reps are more inclined to enter information just after the call than wait until they get home, and what the iPad does is give them the ability to record this information with much more richness and much quicker after the interaction. Obviously, mobile access to the internet is still limited in many medical locations, and for this reason, the CRM must be able to provide most of its functionality in an office mode. As many reps would point out – what’s the point of having a mobile CRM that only really works online?”

In addition, the iPad gives the field-based sales rep rapid access to market information at a time when the UK drug market is going through dramatic change. The ability to keep track of the changing customer base and to structure new relationships with new types of customer is essential, and new technology is vital for this. As Adam Nicholson observes: “Gone are the days when you had a linear customer relationship in place and a linear CRM system to manage that. With the changes in the NHS, you’re going to have to have dynamic processes in place and a dynamic solution to manage it as you move forward.”

The iPad is arguably the first technology to make mobile CRM an effective reality. Dan Goldsmith argues that “it really hasn’t been until the introduction of the iPad that we’ve seen both widespread adoption and significant results delivered to pharma”. There are three reasons for that, he says: the mainstream adoption of mobile technology, the industry’s new appetite for “advances in digital and interactive presentations with customers”, and the reliability and simplicity of the iPad itself – “the ideal device at the ideal time”.    

A recent IMS report highlighted the growing importance of embedded business intelligence within the fully-integrated CRM. “This is where hosted European sales data warehouses are particularly useful, because they reduce costs by providing a single integration for analytical CRM across Europe,” says Nick Plank. “A managed hosted European approach to analytical CRM means employees across Europe can access market intelligence online when and where they need it without installing software. It also aligns well with the current move from on-premise systems to Cloud CRM because analytical data can be passed directly to the operational vendor using site-to-site integration – giving reps access to information immediately, wherever they are, via their mobile CRM tools or mobile business intelligence apps.”

Building dynamic relationships
What makes for an effective CRM system? The answer depends on how the sales professional and the company use the system. CRM is not about customer data: it’s about customer relationships.
David Round emphasises the need for “human-centred design”: it’s essential for the CRM user to be able to see the data in context and react appropriately. He uses the analogy of a sat nav system: it’s a superb tool to get you through unknown territory, but you also have to keep your eyes on the road. So the best systems support customer relationships instead of providing an electronic surrogate for them.

Round also warns against being too well-informed. If a rep greets a new customer they have never met before with the words Hi, I’m Jo. How are your children Sally and Billy? the relationship will get off to a bad start. What the rep really needs is the relevant background information to understand the customer’s role and make proactive suggestions from the start.

As Adam Nicholson observes, the CRM system has to deliver insights at both the quick overview and the deeper insight level: “We are rich with data within the industry; the old challenge has always been how you turn that data into information. Successful solutions should allow an individual to look at their data at a top level when they need it, but give them the ability to drill down into the customer data or the sales data to gain more in-depth analysis when needed.” 

The best CRM solutions are able to serve the needs of the most ambitious sales professionals and companies. Dan Goldsmith comments that cutting-edge CRM systems are enabling “interactive presentations, delivering better segmentation and targeting down to a more individual level, as well as collecting more psychographic or behavioural information”. The ultimate (and realisable) goal is a “behavioural profile” of each customer that feeds back into the sales message and interaction.

The bigger picture
The closed-loop marketing model implied by this approach cannot begin and end with sales. Adam Nicholson speaks for all forward-thinking CRM vendors when he says: “If you really want to make CRM work, it’s about engaging all the functions, be that marketing, medical, regulatory or finance, because if you implement the theory of CRM it actually impacts and improves business processes across all the functions.”

If you started reading this article with the mental image of a lonely sales rep (that’s you, that is) wrestling with interminable on-screen figures on a laptop in a hotel room, or on a tiny mobile phone screen in a rail station café, maybe it’s time for you and your company to consider upgrading your hardware, software and probably footwear. New CRM systems are able to support an integrated strategy of commercial interaction at every level of your company, and mobile devices exist to make the most sophisticated CRM systems easily applicable wherever you are.

With the right CRM system, the right mobile platform and the right attitude, you can: research each customer’s needs and behaviours; gain up-to-date information on the rapidly changing customer base; be fully primed with the right clinical information and tailored marketing messages; read and record key information without eyestrain or signal problems; and fit the technology to your individual needs and your company’s business goals. It’s up to you.

Arrow Generics UK has launched generic versions of AstraZeneca’s Zomig (Zolmitriptan) and Zomig Rapimelt (Zolmitriptan Orodispersible) in the UK and France.

Arrow, part of the Watson Group, released the generics after the patent expired for the two treatments indicated for patients with migraine headache with or without aura.

Last year, the two treatments had sales in the UK and France of around $107 million in the two markets, according to IMS Health data.

The two generics are also set to be launched in the Nordic region later this month on the date of expiry.

Joining Zolmitriptan and Zolmitriptan Orodispersible, Arrow has also launched a generic alternative of GSK’s Naramig (Naratriptan) – indicated for the same condition.

A quarter of the NHS drugs spending of £4.1 billion last year went on just ten medicines, according to a new report.

IMS Health found that total prescribing costs in England, including primary care and community prescriptions, reached a record £12.86 billion in 2010, an increase of 4.8% from the previous year.

This total in English hospitals has increased by 7.7%.

The report, commissioned by the NHS, says that this growth is likely to be related to the introduction of new, more expensive treatments.

The top 10 drugs (Figure 1) were mainly biologics used to treat either autoimmune diseases or cancers.

The most expensive were two arthritis drugs, Abbott’s Humira (adalimumab), with an increase of 19% to £180.5 million, and Pfizer and Amgen’s Enbrel (etanercept), costing £179.6 million.

Novartis’ Lucentis (ranibizumab) treatment for eye disease cost £128.9 million, overtaking Roche’s breast cancer medicine Herceptin.

The report noted the difficulty in biologics, as they are unlikely to be copied and manufactured into generics, consequently costing for the NHS more for branded medication. Manufacturers are likely to make more innovative forms of existing drugs, which would also push prices up.

However, the primary care drugs bill, which takes up 66% of the £12.9 billion spending of medicines in the English NHS, is expected to decrease by £1 billion over the next four years due to a series of patent expiry dates.

Pfizer is set for a cash boost of up to £800 million after the European patent for its cholesterol drug Lipitor (atorvastatin) was extended until May 2012.

The pharma company has sought a Supplementary Protection Certificate in several EU countries and will now launch a chewable low-dose version for children with familial hypercholesterolaemia in November.

Dermot Neely from Heart UK says that Pfizer has “certainly pulled off a bit of a coup” by gaining the certificate.

Paediatric regulations were introduced in the EU in 2007 with the offer of extended exclusivity to encourage pharma companies to ensure they expended testing of medicines to include children.

The system was not expected to provide such significant rewards set to be earned by Pfizer and may now tempt more companies to conduct additional tests focused on children to obtain the Certificate.

Lipitor is primarily used in adults with high levels of cholesterol. Pfizer’s tests have not led to significant changes in its indication; however, it can now be used in children with familial hypercholesterolaemia, estimated to affect 1 in every 500 Caucasians, according to research.

The drug has already lost its patent in Spain, Finland and Norway, but remains protected in at least 11 other markets, including the UK and Germany. Data from IMS shows that approximately 20,000 children are currently prescribed Lipitor in the EU.

Global spending on medicines is expected to grow at a slower rate by 2015, a new report issued by the IMS Institute predicts.

The Global Use of Medicines: Outlook Through 2015 expects growth to reduce to between 3% and 6% by the end of 2015 as a result of slow US sales and patent expiries.

Murray Aitken, Executive Director, IMS Institute for Healthcare Informatics, says future spending levels have “striking implications” for healthcare and past patterns offer “few clues” to future trends.

The global amount spent on medicine has been increasing by an average of 6.2% over the last five years and is expected to reach $1.1 trillion by the end of 2015.

The report found that by the end of 2015, current leading branded medicine will have a progressively smaller share of the market. In 2005, approximately 70% of drug spending was on branded products. But the market share is expected to drop to 53% in the space of a decade.

The impact of patent expiries in developed markets will see payers save $98 billion, with the US in particular expected to see a huge expansion in generic spending.

Health policies throughout the world are also expected to have a major impact, as governments look to reduce the amount they spend on healthcare.

Emerging markets – known as pharmerging markets – are also expected to overtake those of Germany, France, Italy, Spain and the UK by 2015.

“There are unprecedented dynamics at play, which are driving rapid shifts in the mix of spending by patients and payers between branded products and generics, and across both developed and pharmerging markets,” said Murray Aitken.

The IMS Institute also predicts that oncology will still be the leading therapy class by 2015, although growth will also slow to between 5% and 8%. Acceleration will also slow in asthma and COPD treatments to between 2% and 5% with sales of lipid regulators also expected to drop from $37 billion in 2010 to $31 billion. Although the news is more positive for diabetes treatments, with new oral antidiabetic agents boosting growth from 4% to 7%.

The global pharmaceutical market is expected to recover in 2011, with a predicted growth of 5-7%, according to the latest release of IMS Market Prognosis.

IMS Health has estimated a market value of $880 billion for 2011 and accelerated growth compared to the 2010 rate of 4-5%.

However, the five major European markets (Germany, France, Italy, Spain, and the UK), along with Canada, are expected to experience the lowest growth rate, of just 1-3%.

IMS Senior Vice President Murray Aitken said: “In 2011, we will see the loss of exclusivity for some iconic brands and a promising new wave of innovation. It also will be a critical year for gauging how healthcare reform initiatives in key markets evolve and play out amid the expected macroeconomic recovery. For pharmaceutical manufacturers, an unrelenting focus on bringing distinct value to patients and health systems will be essential to navigating this dynamic market.”

IMS Market Prognosis is the leading annual industry indicator of market dynamics and therapy performance. It takes into account macroeconomic conditions, changing levels of patient access, availability of drug treatment options, and pricing factors.

Due to variable rates of economic recovery, there is expected to be wider differences between growth rates in different countries. The 17 pharmerging countries are forecast to grow at a 15-17% rate in 2011, with a growth rate of 25-27% in China. The US will remain the single largest pharmaceutical market, with 3-5% growth.

Various blockbuster products will face patent expiry in 2011, however, IMS predicts that the full impact of the switch to generic alternatives will not be felt till 2012. On a positive note, five potential blockbuster products, in areas that include metastatic melanoma, multiple sclerosis and acute coronary syndrome, are expected to be launched globally by the end of next year.

For more information, including an audio podcast on IMS’s 2011 market forecast, go to http://www.imshealth.com/media.

The global market for pharmaceuticals is expected to grow nearly $300 billion over the next five years, reaching $1.1 trillion in 2014, says IMS Health.

The market analysts predict a global growth rate of 5-8% during this time, due to the impact of leading products losing patent protection in developed markets, as well as strong overall growth in the world's emerging countries.

However, the forecast is worsening for the UK market, where IMS estimates annual growth will drop from 3.2% in 2009, to 1-1.7% between 2010 and 2014.

These conclusions are included in the latest release of IMS Market Prognosis, the company's series of strategic market forecasting publications.

Global pharma sales growth of 4-6% is expected this year, consistent with IMS's prior forecast. In 2009, the market grew 7.0% to $837 billion, compared with a 4.8% growth rate in 2008.

“Patient demand for pharmaceuticals will remain robust, despite the ongoing effects of the economic downturn being felt in many parts of the world,” said IMS's Murray Aitken, Senior Vice President, Healthcare Insight. “In developed markets with publicly funded healthcare plans, pressure by payers to curb drug spending growth will only intensify, but that will be more than offset by the ongoing, rapid expansion of demand in the pharmerging markets.

“Net growth over the next five years is expected to be strong – even as the industry faces the peak years of patent expiries for innovative drugs introduced 10-15 years ago and subsequent entry of lower-cost generic alternatives.”

Key drivers

In its analysis, IMS identifies several key market dynamics.

• Pharmerging markets – IMS predicts pharmerging markets will grow at a pace of 14-17% through to 2014, while major developed markets will grow at just 3-6%. The US is expected to remain the single largest market, with 3-6% growth annually in the next five years and reaching $360-390 billion in 2014, up from $300 billion in 2009.
• Therapy areas – Due to the wide availability of low-cost generics in many chronic therapy areas, R&D focus will switch to areas where there is significant unmet clinical need, high-cost burden of disease and innovative science that can bring new treatment options. In oncology, diabetes, multiple sclerosis and HIV, annual growth is expected to exceed 10% through to 2014 as new drugs are brought to market, patient access is expanded and funding is redirected from other areas.
• Spending cuts – Under increased pressure to save money, countries with publicly-funded healthcare systems may seek to cut spending on medicines. Turkey, Spain, Germany and France, as well as others, have already announced plans to apply across-the-board restrictions on access or reductions in reimbursements.
• The generic threat – Over the next five years, products with sales of more than $142 billion are expected to face generic competition in major developed markets. The impact of this shift to generics in major therapy areas such as cholesterol regulators, antipsychotics and anti-ulcerants will reduce total drug spending by about $80–100 billion worldwide through to 2014. This will particularly impact the US, where six blockbuster products are expected to hit patent expiry in 2011-2012.
• Rigorous assessment – The number of new molecular entities launched annually over the next five years is expected to remain in the range of 30 to 35 products. However, these will be subject to more rigorous and complex assessments by payers before being accepted and reimbursed. As funding and implementation of healthcare at regional or local levels becomes more significant, the time it takes for new medicines to be made available will extend.

Aitken added: “The expected global economic recovery removes an element of uncertainty for the industry over the next five years, although the way payers address lingering budget deficits will remain an issue in many markets. Health system reforms, such as those to be implemented in the US, can spur fundamental change in the market – but the full impact may not be felt until the latter half of this decade.”

Leading up to 2020, IMS forecasts a continuing shift toward biopharmaceuticals, specialty-driven products, and changes in the mix of disease areas of interest.

IMS Market Prognosis offerings are subscription-based, strategic market forecasting publications that provide unparalleled insights into the economic and political issues affecting the pharmaceutical and healthcare industries. Based on a rigorous evaluation of the key events affecting the marketplace, IMS Market Prognosis provides a five-year forecast at the country, regional and global level.