Heartening news of new drug exposes flaws in the innovation system

A new drug for treating prostate cancer, discovered by scientists funded by the charity Cancer Research UK (CRUK), was officially launched in the UK yesterday (21 September).

This is heartening news, since the drug Zytiga – administered as a once-daily pill – has shown a significant impact in extending the lives of men with advanced prostate cancer that has become resistant to standard hormone treatment.

Among these is John Ward from London, who was told he had only one to two years to live when he was diagnosed with prostate cancer nine years ago. He started taking Zytiga as part of a clinical trial in 2007, and four and half years later is not only still alive, but healthy enough to hold down a job.

It’s evident from this single example that the health and social benefits that will flow from having the drug registered in the UK and elsewhere in Europe represent a huge return on the investment CRUK and other public and charitable funders have put in.

But the rhetoric now – from the CEO of CRUK Harpal Kumar last week in his call for the UK to shape up its medical research infrastructure - and from national governments and EU Research Commissioner Máire Geoghegan Quinn, is that public investment in life sciences R&D is also about creating a virtuous circle of financial returns and economic growth.

So what of the financial benefits of Zytiga? Despite being discovered and patented in the UK in 1993, the drug is owned by the US pharmaceutical company Johnson & Johnson. Some of hard cash from Zytiga will flow back to the UK, in a small royalty stream to the biotech company BTG plc. CRUK will get a share of this, to invest in more research.

Zytiga is not the only example of how Europe’s innovation system fails to retain and build up the financial value of public investment in R&D. The fact is, most European biotech companies have neither the financial firepower or the clinical development or regulatory skills to get drugs to market. They must give up rights and control to pharma partners.

In the case of UK biotech this has invariably meant the financial benefits accrue to companies outside the UK. Zytiga is but one example. Another is Humira, the blockbuster treatment for rheumatoid arthritis, discovered by Cambridge Antibody Technology Group plc, but commercialised by US pharma Abbott. Or to take an all-European example, Cimzia, also for treating for rheumatoid arthritis, which was discovered and largely developed by Celltech plc, but then commercialised by the Belgian pharma UCB, following its acquisition of Celltech.

The UK biotech sector is currently being told to look to the positives, rather than moaning about the shortcomings of the environment – particularly the funding environment – in which it strives to operate.  And it’s true; there are many, many good things – most notably the high quality science – to celebrate.

But this just makes it all the more galling that high value research keeps falling through the gaps in the innovation system to emerge on the bottom line of companies based elsewhere.

There are a host of reasons why it took so long to go from its discovery and patenting by CRUK-funded scientists in 1993 to the European launch of Zytiga in 2011. Many shortcomings in the technology transfer process have been addressed in the meantime. CRUK itself is one of the leaders when it comes to thinking up new approaches to shaping the basic research it funds through donations from the British public, into packages that will interest industry.

It’s impossible for CRUK as the original discoverer of a compound to do anything about those ups and downs of the pharma and biotech industry that play such a large role in the rate of progress of compounds along the development pipeline, and the risk that products will be side lined or sold.

And indeed, attracting the attention of industry is but a small initial step in translating basic research through to new drugs, as the 18 years it took Zytiga to go from patenting to market illustrates.

But if Europe’s politicians and administrators really expect science to deliver economic growth they must improve the innovation system, not only so effective drugs get to market as quickly as possible, but also to ensure the financial benefits are not diverted elsewhere.