In early December the coalition government launched its new Life Sciences Strategy, described by the Prime Minister as an attempt to improve patient care, foster innovation and catalyse the medical breakthroughs necessary for the industry to remain “a jewel in the crown of our economy”.
While the UK’s economic crown is looking a little tarnished at present, the British life sciences industry has traditionally been something of a gem – from Watson and Crick to Dolly the sheep, the UK has consistently punched above her weight in the field of biochemical innovation, and the industry remains the third largest contributor to UK economic growth with more than 4,000 companies currently employing over 165,000 people, according to Number 10.
So, the announcement of grand plans to improve medical care while protecting hundreds of thousands of UK jobs might be expected to be seen as good news, right?
Wrong. Public enthusiasm for David Cameron’s announcement has been muted, with the majority of media coverage focusing on plans to make NHS patient data available to third parties, including industry. While the proposed patient data policy would include an opt-out clause for those preferring to keep their records private, there has nevertheless been impassioned outcry at the perceived compromise of patient-doctor confidentiality, reflecting both genuine concerns for privacy and a widespread – and not altogether unwarranted – suspicion of big business generally, and drug companies in particular.
Nestled in the detail of the PM’s announcement, however, and drowned out by the clamour over patient data, was news of a much more interesting and potentially far-reaching development in the evolving relationship between academic and commercial biomedical research.
On the same day that the new strategy for life sciences was published, the Medical Research Council (MRC) announced a “landmark agreement” with pharmaceutical giant AstraZeneca (AZ), in which 22 biologically active chemical compounds owned by the drug-maker would be made available to UK medical researchers, free of charge. The compounds, which have already cost hundreds of millions of pounds to develop, have been passed over by AZ for further commercial development despite in some cases having reached late-stage clinical trials for diseases such as prostate cancer, diabetes, schizophrenia and Alzheimer’s. According to David Brennan, AZ CEO, it is hoped that “in sharing these valuable clinical compounds with academic scientists … new discoveries will be made by exploring additional uses of these compounds”.
Corporate altruism, however, certainly isn’t the whole story. AZ, along with other major drug companies, is facing significant pressure to innovate in the face of creaking global healthcare systems and wide-spread recession, and while the pharmaceutical industry has historically been one of the most profitable sectors around, the so-called “patent cliff” has hit hard. One month ago the patent on Lipitor, the best-selling drug in history, expired, leaving its parent company Pfizer with a potential $11bn revenue gap to plug. In total, “blockbuster” drugs worth an estimated $170bn in annual sales will go off-patent by 2015, with AZ facing a particularly steep drop as products currently accounting for over a third of sales tip over the patent-cliff in the next five years.
So, now may seem like an odd time for AZ to be giving away potentially valuable intellectual property for free. But the AstraZeneca/MRC deal bears all the hallmarks of a rare thing in business: a genuine win-win situation.
Under the terms of the deal, researchers will be provided with up to £10m in funding by the MRC to investigate the use of the compounds in new therapeutic areas, giving the research community access to a huge body of scientifically valuable, if not yet commercially realised, work that can be used as the basis for further research. Any profits generated as a result of the collaboration will be shared between the researchers and AstraZeneca. So, scientists gain a treasure-trove of precious information, AZ receive a return on the huge investment they have already made in these compounds, and the public, at worst, benefit from the furtherance of scientific knowledge and, at best, gain access to a number of new drugs as a direct result of the initiative.
One of the compounds being made available through the deal is Zibotentan, an endothelial-A (ETA) receptor antagonist. Endothelin-1, the protein on which ETA receptors act, is a vital agent in the growth and progression of several types of tumour and, as a result, ETA receptor antagonism has been an area of intense clinical investigation, particularly cancer research. Following successful Phase II trials, which suggested the compound’s safety and efficacy in the treatment of hormone-resistant prostate cancer, Zibotentan was progressed to Phase III, the final stage of testing prior to a new drug’s submission to the regulatory authorities for approval for sale. However, the drug fell at the final hurdle, failing to meet the necessary efficacy targets and leaving AZ to foot the bill for most of the estimated £630m it costs to take a drug from lab-bench to market.
Nevertheless, despite the compound’s commercial failure to date, ETA receptor antagonism remains a promising area of investigation, both in cancer and in other ailments in which the ETA-pathway is thought to be involved, for example chronic kidney disease and cardiovascular disease. So, while Zibotentan is not currently enough of a sure thing for AZ to risk throwing good money after bad in an attempt to get it to market, the significant body of work collected by the company’s scientists could be invaluable to other researchers working in related fields.
The loss of public confidence in both science and big business means that initiatives such as the AstraZeneca/MRC deal are at risk of being brushed under the carpet by a cynical public as just another attempt by corporate bullies to manipulate governments and NGOs into financing their commercial activity. One reader of an online article detailing the deal commented: “I suppose if the wealthy bankers can get free tax payers [sic] money then why not the wealthy drug companies!” But reactions such as this, in addition to being inaccurate, miss the point. While there is much that big pharma can be justly criticised for, the huge cost of drug development means that companies like AstraZeneca remain our best (and perhaps only) hope if novel, effective drugs are to continue making it to market. Moreover, if a £10m investment by the MRC leads to real medical advances, then surely that’s tax-money well spent, even if some of the profits do make their way back to AZ? So, instead of berating the “pharmaceutical fat cats” for deigning to make money while making us better, perhaps it is time to recognise mutually beneficial collaborations like this as the exciting prospects that they really are.
Image: flickr | hitthatswitch
More > In Trials We Trust, a Science From the Archives feature on research ethics in drug trials, and Vive la Difference, a post from Curious & Curiouser on the need for racial diversity in medical research.