Saturday, 22 December 2012

BPA: drug repurposing

#MSBlog: to repurpose or not, that is the question?

"The length of time it takes to develop new drugs is frustratingly long and expensive. A short-cut is to repurpose existing drugs; i.e. drugs that have already been through development and are either licensed for another indication or sitting on the shelf. If you repurpose these drugs for MS, the development time and costs are potentially shortened. The incentive for repurposing drugs is already in place if the Pharma company can get a new patent on the drug. 

There are many examples were repurposing is working in MS. For example:

1. Fampridine; the slow-release formulation of 4-aminopyridine.
2. Teriflunomide; the active metabolite of lenflunomide.
3. Alemtuzumab; an oncology drug.
4. BG12; a modification of a drug for psoriasis
5. Ocrelizumab; a newer version of rituximab an oncology drug that also is licensed for rheumatoid arthritis.
6. Daclizumab; an earlier version of the drug was used in transplantation
7. Fingolimod; this was originally developed for the field of transplantation.

All these repurposed drugs are protected by patents, which prevents cheaper generic equivalents or biosimilars from entering the market for a pre-determined period of time. This is very important for the Pharma companies concerned as is allows them to get a return on investment and to make a profit. 

Do you think these repurposed drugs are any cheaper than novel drugs?

A problem arises with the repurposing of drugs that are off patent; it is not possible to protect them from generic competition under the currently regulatory framework. For example, simvastatin, phenytoin, oxcarbazepine, amiloride and riluzole; all of these drugs are currently being tested in progressive MS. 

I hope you can see why it is important to have a patent? A patent defines a period of market exclusivity, which allows the Pharma company, or organisation, a period of time to claw back their investment in the development programme of the drug and to pay for any post-marketing requirements that the regulators may ask for. For example, the latter may include a safety and pregnancy register. 

What the Big Pharma Alternative is trying to address is the lack of incentives to repurpose off-patent drugs. How do we raise the necessary resources to test off-patent drugs in phase 3 and if positive to get them licensed for MS and to finance the post-marketing requirements that may come with a license? If we don't address this problem we are unlikely to speed up drug development for progressive MS and we are going to have to discard several potentially effective drugs for progressive MS."


8 comments:

  1. You have illustrated the problem. I wonder if there is a way of putting a monetary figure on the amount of money lost to the economy and increased costs of PwMS that could somehow be put into the equation? That ignores the cost of human frustration, pain and suffering, of course, which is another cost that is not so easy to quantify. And doesn't answer the fundamental question of what agency could pay for this work, if there is little potential profit in the outcome. Frustrating, but surely not beyond the intelligence of mankind?

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  2. Yes, because look how easy it is to access Fampridine for MSers with walking difficulties. Thank heavens that Big Pharma companies got such a great return on their investment that they jacked up the price and made sure non of us can get hold of it. It's happening again with Alemtuzumab.

    Prof G, do you really empathise with the MS community, because I really sense you don't see the full picture? What's happening is to purely incentivise greed. We are not benefiting. I'm seriously losing my faith in all the developments happening in the name of MS. We are doomed as a disease.

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    1. The following sentence does not make sense: "Prof G, do you really empathise with the MS community, because I really sense you don't see the full picture?"

      Does he empathise or not? Does he see the big picture or not?

      I think he empathises and sees the big picture.

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    2. I disagree. He's supporting Big Pharma's unfair practices. The comment above has validity and I agree with what was said. The way Prof G talks is like someone saying we have to stick with a dictator because there is no alternative.

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  3. I think you need to explain BPA one more time (differently, a litte more clearly and with more detail)

    For example, when you talk of a provisional licence: who will give the licence, and to whom? Are you proposing that the drug goes back into patent?

    "This will allow the necessary data to be collected at the same time the drug is being marketed under controlled conditions" : Who will collect the data?

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  4. Why are you so interested in patent? Lots of drugs eg paracetamol are off patent but are still manufactured. If any of the drugs you mention show efficacy regarding neuro protection then all you need is a manufacturer to continue production. This is why I can buy paracetamol in any shop. It's cheap but there's money in it for the manufacturer.


    Here's my model - you guys identify the most promising drug for neuro protection eg amilioride. This is tested in trials funded by ms societies. The drugs already have a safety record. The drug gets approved for use in MS and the NHS buys the drug (cheap) from the manufacturer.

    As long as safety and efficacy is shown and the drug is still in production eg a generic version why is it such a problem? Whenever MS is involved the tendency is to complicate everything! Go for simple / uncomplicated. Don't worry about patents or profits. Focus of MS research should be identifying effective treatments.




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  5. Small victories that turn into defeats, long walks to gain little ground, little wounds that get deeper every day - that is what life with progressive MS is like. We are confronted with the inevitable cruelty of nature. It's a shame so little has been achieved.

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  6. When I started my first job my boss told me "don't just bring me problems, bring me the solutions". The researchers with the title Professor are the ones who can challenge the current arrangements and develop more efficient systems which start focusing on the needs of patients. Don't just accept the current processes - challenge them. If there are drugs available that offer potential to impact progression, let's start making them available to patients. Patients can understand the risks and will sign he relevant disclaimer. I'd be happy to start one of the blood pressure / epilepsy drugs tomorrow if it helped slow progression. Waiting another ten years isn't an option - it will be too late.

    As Gandhi said "be the change you want to see in the world".


    Let's stop all the navel-gazing and pontificating. Let's ditch Prof G the academic and see the rise of Prof G the doctor. For too long the former has been in the spotlight, my interest is getting hold of good treatments so I need the latter.

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