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Manufacture Business Practice, Small Molecules, Trends & Forecasts

What Price Glory?

The British Pharmacological Society’s Industry Committee, of which I was chair until the end of 2015, launched the Drug Discovery of the Year award in 2012 to recognize the hard work of scientists in research and drug discovery. By the time a new drug is launched, the commercial team often receives the majority of the feedback on the new drug from doctors and patients. You rarely hear about the individuals involved in the early stages of the drug’s development, which is why our award is given to the R&D team, rather than the company as a whole.

This year’s winners – a team of scientists who worked on Gilead’s sofosbuvir (Sovaldi) – were easily the top choice for the Industry Committee, for two reasons. The first is the drug’s significant impact on an obvious unmet medical need – hepatitis C – and the second is that it is a great example of pharmacological principles being applied to move the drug from discovery, through development, and into the clinic.

Sovaldi is highly effective in 90 to 100 percent of patients, and brings about a complete cure in many. It is very well tolerated, with an excellent safety profile, and a high barrier to resistance. The drug is so effective that a number of companies have abandoned their hepatitis C research programs altogether in favor of hepatitis B; they have been advised that Solvaldi has effectively removed the medical need for further hepatitis C therapies.

In terms of the pharmacology, the researchers have been very clever. They’ve made a pro-drug that facilitates entry of the molecule into hepatocytes (where the hepatitis C virus resides) at which point it is metabolized into the active drug, which means that it only works at the site of disease and is thus very effective and has a good side effect profile. It acts against all six genotypes of hepatitis C, it’s a once-a-day tablet, and there are no food effects or drug interactions – it’s simply a really good drug. Fifteen years ago when I left GlaxoSmithKline, there was no good treatment for hepatitis C, so this has been a remarkable step change.

In my view, these positive stories are not given enough attention. Hepatitis C is not the only disease to witness a revolution over the past decade; we have made huge strides in multiple sclerosis and rheumatoid arthritis, for example. I spoke with a doctor who told me he regularly walks through the rheumatoid arthritis clinic on his way to oncology. Ten years ago, he was constantly tripping over wheelchairs, but now almost none of the patients are wheelchair-bound, thanks to disease-modifying therapies like anti-TNF drugs. And yet few people sit down and write about those successes. The pharma industry itself can often be cautious, failing to communicate just how amazing some of these advances are – and that leaves the media to concentrate on negative stories rather than celebrating success.

I think there is an element of that negativity in the controversy over the pricing of Sovaldi. The drug is expensive; there is no disputing that. But compared with the direct medical and economic cost associated with ongoing hepatitis C infection – the lost days of work, the drug treatments, the risk of liver cirrhosis or cancer – Sovaldi represents large savings for healthcare systems. Factor in the huge improvements to quality of life, which are harder to put a price on, and Sovaldi starts to look like pretty good value. What the public often don’t realize is the enormous costs of bringing a drug to market, taking into account just how few drugs make it into the clinic, and how few of these make a substantial profit. It’s a difficult argument – healthcare systems are being stretched and need to keep costs down, but pharma companies are also facing tough times. If the industry stops investing in drug discovery and development, who will fund these activities? Ultimately, the key factor is the value that the drug brings to patients – and Sovaldi brings huge value to patients.

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About the Author
Ann Hayes

Is a pharmaceutical consultant at the Ann Hayes Consultancy, UK. She is the former head of R&D at GlaxoSmithKline and was included on the judging panel of the British pharmacological society’s recent Drug Discovery of the Year Award 2015.

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