sabato 22 giugno 2013

L'industria farmaceutica

June 19, 2013 10:11 pm, Innovation: Pharmaceutical groups become victims of their own success
By Andrew Jack
Every few months, the Hever Group – an informal gathering of the heads of research and development at the large pharmaceutical companies – comes together for what Jan Lundberg of Eli Lilly jokes is a collective crying session.
After the burst of productivity in drug development that followed the second world war – from antibiotics to blood pressure treatments – costs have risen while innovation has lagged behind.

That has left heads of R&D struggling to keep up, and cost many of them their jobs. Taking into account the expense of developing drugs that fail during testing and the cost of capital, industry estimates – while disputed by critics – put the average price tag for successfully producing each new treatment at more than $1bn.
Whatever the method of calculation or the precise figure arrived at per drug, the total of industry R&D investment – at $50bn a year, representing an average of 10-20 per cent of sales – generates a disappointing return. Fewer than 30 drugs were authorised by the US Food and Drug Administration last year.
To some, the crisis in innovation is the result of the end of a period of “low hanging fruit”. According to that view, the easier work was completed in the latter part of the 20th century, with the discovery of simpler molecules to tackle well understood diseases.
In the process, the industry became a victim of its own success. The first wave of new medicines raised the bar for future products.
They also produced considerable revenues which the industry reinvested in elaborate new laboratories and equipment.
The pressure to replace the previous generation of “blockbusters” with alternative sources of income grew. But the era of “high throughput screening” and other industrialised methods that replaced intuitive, artisanal drug design during the 1980s and 1990s did little to boost productivity.
Meanwhile, regulatory demands and costs continued to rise. At least since the identification of birth defects caused by thalidomide in the late 1950s, and through to the more recent concerns over heart attacks linked to the painkiller Vioxx in the mid 2000s, the level of scrutiny of approval for new drugs has risen.
That means much larger and longer clinical trials in ever more segmented subgroups of patients.
Companies have adopted a range of responses, most encompassing managerial efforts to boost accountability, increase incentives and cut the size of research units to create a more entrepreneurial feeling, such as GlaxoSmithKline’s Centres of Excellence in Drug Discovery. Eli Lilly has taken a lead in crowd-sourcing through the likes of its Innocentive unit, which used the web to find people to solve scientific problems, and has since been sold to outside investors.
Some innovative drugs have still emerged, from cholesterol-lowering statins and antiretroviral treatments for HIV to drugs for hepatitis C, melanoma, leukaemia, rheumatoid arthritis and a range of enzyme replacement therapies for those with rare diseases.
But much of the new millennium has been overshadowed by investor scepticism, with pharmaceutical companies collectively valued at little more than the future cash flows of their current drugs.
In other words, their pipelines of experimental treatments have been judged to offer few prospects of success. The industry in turn has cut back sharply the size and scope of research.
In the UK alone, Pfizer has been winding down its historic postwar Sandwich R&D site in Kent and, earlier this year, AstraZeneca announced the closure of its Alderley Edge complex. Both until recently had been injected with substantial investment for new infrastructure. GSK has announced its withdrawal from some difficult treatment areas such as depression. Like several of its peers, it has moved away from in-house early stage development towards greater reliance on the broader “ecosystem” of biotech companies, aiming to license in the promising experimental drugs they produce. One concern however is that smaller biotech groups will not be able to compensate for such internal cuts, especially since many of them struggle to raise finance.
Another is that much collective experience is lost, as those losing their jobs fail to find alternative employment in the sector and expertise is depleted.
Today, a number of initiatives are under way, many of them linked to broader partnerships between industry, academic and medical practitioners. Some are designed to better design clinical trials to cut costs. Others seek to mine “big data”. Still more focus on spanning the traditional competitive barriers between companies and the cultural divide between industry and universities.
Such moves have contributed to a re-rating of the pharmaceutical industry in recent months, with rising price to earnings ratios implying fresh confidence in companies’ pipelines.
Yet some observers warn that the new buoyancy is indiscriminate and more linked to broader stock market optimism than a focused and long-term return to favour of drug research. And while investors may be happier with pharma for now, the party could yet still end in tears.

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