Average time-line for MS drug development

“In response to the comment regarding the duration of each phase involved in MS drug development. The following is an average estimate; for MS it takes longer because our phase 2 and 3 trials are longer than in other diseases.”

“Each step takes longer than you realise and costs a small fortune! The following is a figure showing the high drug development costs and attrition rates of drugs entering the development pipeline.”

“It makes you realise why only big Pharma with deep pockets can afford to develop drugs. The down side is that the era of cheap or affordable drugs is gone. Do you find this alarming?”

Source: DiMasi et al. The price of innovation: new estimates of drug development costs. J Health Econ. 2003 Mar;22(2):151-85.

6 thoughts on “Average time-line for MS drug development”

  1. Re "the era of cheap or affordable drugs is gone. Do you find this alarming?"Well, it's not as if there were any drugs for ppms regardless of the cost. I don't effect me.

  2. How do Genzyme justify their proposed price for alemtuzumab for MS? The development and pre clinical testing had all been done and they had a price for it for leukaemia use. Or is the high price they are quoting just the first round in bargaining game to get the best price/most users?

  3. Prof G,We really should see this sort of investment by big pharma as high risk.Recent Biogen results: Third quarter [2011] revenues increased 11% to $1.3 billion.The company had cash or cash equivalents of $2.9 billion.These MS drugs are cash cows. Avonex only reduces the relapse rate by c.30%. Would we buy anything that only did a third of the job? I'd gladly flog my house and give Biogen c.£300,000 if they could give me a drug which mean't I no longer had MS / no deficits. But why would they do this if they can sell me (NHS) an injectible drug at c.£12,000 for the next 10 years (at that point I'll be SPMS and nothing around).When I worked in the health sector 20 years ago there was a body called the Prescription Pricing Authority – role was to ensure prices paid by the NHS were fair. Like most regulators e.g. Ofcom etc, they were toothless. Surely the NHS as the only buyer of drugs in the UK can drive down the prices. I don't mind Biogen (and others) making a 5% return on their investment, but what we are seeing is rip off Britain at its best – desperate MS patients; ineffective drugs (don't address progression), rip off prices.

  4. Yeah, I too have PPMS and there is nothing for us. We have been told to just live with it and plan for the worse. The NHS, doctors, pharmas and now even Parliment (threatening disabled folk by taking away ESA) have all failed us. Campaining for the right to die will be more productive.

  5. I agree that PPMS'ers are not really on the radar when it comes to developing drugs. Though I'm not for assisted suicide, I do understand why people want it. There is nothing to look forward to. We hear there are drugs coming, but when? And even if they do N.I.C.E. will refuse to fund them. The system is not geared in our favour. The only winners are the pharmas.I'm so sick of hearing about promising treatments for RRMS'ers. I rage with jealousy knowing they will always be a priority over us progressive sufferers.

  6. If you remember pre-beta interferons, virtually all trials were in progressive MSers. Unfortunately they were trying drugs that could not work in progressive MS and doomed the drugs to failure.That was because Neuros did not understand MS enough and because they did not know how to do trials to show an effective drug.Neuros now know how to do these trials and know that RRMS responds to certain types of drugs. So the good news stories of more and more drugs working for RR MS is likely to happen more often.When Pharma has a drug working in RRMS and are making money, they invariably look in progressive MS.This is indeed the cases now and there are currently alot of studies ongoing in progressive MS. The problem is that Neuros don't know how best to do trials to show an active drug in progressive MS, so some of the trials will fail because of this. Once they know how to do the trials the trickle of drugs will flow forth.I know this isn't happening fast enough but it is happening and treating progressive MS is a priority for a lot of labs including ours

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