Discontinuation of licensed supplies of alemtuzumab or campath

D
This post is to inform you that Genzyme, a Sanofi company, has surrendered the licence for all presentations of alemtuzumab effective as of August 8th 2012. 



What does this mean?

This means that alemtuzumab will no longer be available as a licensed product in the UK once existing supplies run out. This action is not being taken for any reasons related to product safety, efficacy or supply, but as part of the Genzyme’s plans for bringing alemtuzumab forward as a treatment for MS. In agreement with the MHRA, Genzyme will continue to supply alemtuzumab commercially until existing stocks run out; following that alemtuzumab will be available through a named patient access programme for cancer and transplant indications. Genzyme will continue manufacturing sufficient quantities of alemtuzumab to supply this patient access program.

Source: NHS

What does this mean for MSers?

This means that the off-label use of alemtuzumab will not be possible. MSers will have to wait for the new formulation of alemtuzumab (Lemtrada) to be licensed by the EMA and to be given a green light by NICE to be used in the NHS before they can access the drug.

Is the removal of access to the off-label preparation of alemtuzumab a good or bad thing?

“This is a complex issue and will depend on your view of pharma and the repurposing of old drugs for new indications.”

“It is clear from exchanges on this blog and reading of various analysts reports that when the new MS formulation of alemtuzumab, Lemtrada, is launched it will cost more than the old formulation (Mabcampath). If you are a cynic you would say that Genzyme simply withdrew the old formulation to be able to increase the price of the new formulation. This is probably correct, but until we know what Lemtrada is going to cost any discussion on this issue is moot.”

“A major reason why Genzyme has withdrawn the off-label use of alemtuzumab in MS is safety. As you are aware there are serious, but treatable, adverse events that occur in MSers who have received alemtuzumab. One of the conditions of getting a licence for the marketing of alemtuzumab for MS will be the implementation of a very strict and rigorous post-marketing surveillance programme for Lemtrada. Genzyme would have difficulty implementing this programme if there was off-label use of Mabcampath. MSers treated with alemtuzumab will need to have monthly blood tests performed for at least 5 years to monitor for these events.”

Why shouldn’t Genzyme be allowed to charge more for Lemtrada than Mabcampath?

“The cost of running the clinical development programme for Lemtrada is not insignificant. Paying for a large phase 2, two large phase 3 and the extension studies of alemtuzumab (Lemtrada) is very expensive. In addition, Genzyme will have to set-up the post-marketing surveillance programme to monitor for potential adverse events from Lemtrada. Genzyme has the right to recoup these costs and make a profit for their shareholders and to support their other R&D programmes? If we want Pharma to repurpose existing drugs for new indications we have to create incentives for them to do so. The costs of running a drug development programme are simply too high and too risky for academic institutions, or healthcare systems, for example the NHS, to take on.” 

“I would also encourage you to take a broader perspective on the issues the Lemtrada case raises and to think about the role Pharma plays in the world’s economy and in particular the UK’s economy. A successful (new products) and profitable pharma industry (shareholder dividends and R&D expenditure) does not only improve the health of the population it also generates income for governments and provides jobs. Pharma-related jobs tend to be high-skilled jobs the kind modern economies need, which is why countries compete with each other so intensely to attract Pharma companies to set-up shop.”

“An issue that is often overlooked is the enormous sums of money that Pharma companies spend on R&D; if Pharma were not allowed to make profits on their licensed drugs then their R&D expenditure would go down and the number of innovative new products would decrease. The incentives that have been put in place by the EU to encourage Pharma to repurpose old drugs for new indications have been done with this perspective in mind. Do you agree with this perspective?”

“One things that makes many peoples hackles rise is the annual profits Pharma companies make and the sums they pay their top executives as a result of this. This issue is not unique to the Pharma industry and is a global issue that seems to be the result of globalisation of capitalism and the international market that has been created for talent. The forum for tackling the widening disparity between the rich and poor is a political one and I am not sure how the previous debates on this issue on this blog helps the cause of MS. I would, therefore, encourage you to focus on celebrating the success of the alemtuzumab clinical development programme in MS; it is a wonderful story that was started in Britain by an amazing group of scientists. The reality is that a US-based Company, had to complete the job; a typical tale of large number of British innovations. Regardless of this we need to congratulate the Cambridge and Genzyme teams for their perseverance and for getting alemtuzumab this far.”

CoI: multiple and ongoing

Other posts of interest in relation to Alemtuzumab on this blog:

ENS platform presentation: alemtuzumab vs. IFNbeta-1a
11 Jun 2012
I see that 74% of alemtuzumab treated patients are CDA free at 2 years, but only 51% are MRI activity free. Would you expect this MRI activity to result in CDA at some later stage, or do you think the MRI activity would reduce …

Multiple Sclerosis Research: CAM-THY a new alemtuzumab …
24 Jun 2012
When alemtuzumab-treated MSer’s immune systems recover or reboot themselves, it begins to attack other parts of their body; most commonly the thyroid gland. Dr Coles, in Cambridge, believes that they can reduce the risk …

Multiple Sclerosis Research: Research: Alemtuzumab (formerly …
13 Apr 2012
Conversely, mean magnetization transfer ratio was stable in 20 alemtuzumab-treated patients (grey matter: -0.01 pu/year, p = 0.87; white matter: -0.02 pu/year, p = 0.51). The gradient difference in grey matter was 0.25 pu/year …

Multiple Sclerosis Research: Alemtuzumab 5 year follow up
26 Mar 2012
OBJECTIVE: To report the long-term safety and efficacy results from CAMMS223 comparing alemtuzumab with interferon β-1a in early, active relapsing-remitting multiple sclerosis (RRMS). What are the long-term effects of …

Multiple Sclerosis Research: Making alemtuzumab or campath …
20 Jan 2012
As you know alemtuzumab or campath-1h has remarkable efficacy in relapsing MS. In clinical trials and off-label use in MS, alemtuzumab has been administered intravenously (IV). Alemtuzumab is approved for chronic …

Multiple Sclerosis Research: NICE and the new DMTs
06 Aug 2012
The drugs concerned are teriflunomide, BG12, laquinimod and alemtuzumab. Is this good or bad news … All in all this is not good news for MSers wanting to access to these oral therapies or alemtuzumab. I can see why NICE …

Multiple Sclerosis Research: Alemtuzumab results – further analysis
18 Jul 2011
“This was not a negative study; Alemtuzumab is still a very promising disease-modifying therapy! The patients in this trial were less active than previously therefore the trial lacked power to detect a difference in relation to …

Multiple Sclerosis Research: Immune complications of alemtuzumab
03 Oct 2011
The average times from initial and last alemtuzumab exposure to ITP diagnosis were 24.5 and 10.5 months, respectively. Five patients developed severe thrombocytopenia. Four were symptomatic, including fatal intracranial …

Multiple Sclerosis Research: News: Alemtuzumab $60,000 per annum
11 Sep 2011
“Based on its superior efficacy Alemtuzumab should command a premium price. However, the cost will affect its cost-effectiveness and its license in the UK under NICE. Ideally we would like to use Alemtuzumab in early MS; …

Alemtuzumab – risks of developing other autoimmune diseases
30 Jul 2011
“What is alemtuzumab? You may know the drug as Campath-1h. This is a powerful immuno-modulator that is given as a course of intravenous infusions. It depletes the immune system and allows it to recover. I refer to it as an …

Multiple Sclerosis Research: Alemtuzumab (Lemtrada) misses a …
11 Jul 2011
The second phase three study for alemtuzumab involves patients who have relapsed on Interferon i.e. more active so I wonder whether the results for that trial will be more encouraging. Monday, July 11, 2011 8:04:00 PM …

Research: Alemtuzumab treatment of Interferon-Unresponsive MS
09 Sep 2011
This is more of the same (good) news, with regard to Alemtuzumab. This un-controlled and unblinded study indicates that Alemtuzumab (an antibody that kills white blood cells) quells disease activity in MSers who have …

Multiple Sclerosis Research: More on the Alemtuzumab trial
12 Jul 2011
More on the Alemtuzumab trial. The previous post is simply the headline results; we need to wait for the full results that will be presented at the ECTRIMS/ACTRIMS meeting from the 19 – 22 October 2011, in Amsterdam, The …

Second successful phase III Results for Alemtuzumab in MS
14 Nov 2011
“Alemtuzumab is the most effective DMT in late stage development. The first MS’er was treated with the drug in 1991 by Prof. Alastair Compston in Cambridge; if or when Alemtuzumab becomes available in the UK it will have …

Research: White blood cell depletion and Alemtuzumab
10 Nov 2011
Background: Alemtuzumab is a lymphocyte depleting monoclonal antibody that has marked efficacy for relapsing-remitting multiple sclerosis (MS). One unresolved issue is the duration and significance of the lymphopenia …
http://multiple-sclerosis-research.blogspot.com/
Genzyme details market potential of Alemtuzumab for MS
17 Jan 2011
Genzyme details market potential of Alemtuzumab for MS. Wow! Let’s hope it is not too expensive for the NHS. Click here to read the press release! Posted by Gavin Giovannoni at 22:55 · Email ThisBlogThis!Share to …

Genzyme is bought by Sanofi: what will this mean for people with MS?
16 Feb 2011
Genzyme is the company that is developing Alemtuzumab (formerly known as Campath-1h) for MS. Alemtuzumab is clearly the most effective of the emerging drugs in clinical development. Sanofi on the other hand are …

Multiple Sclerosis Research: Meta-analysis of randomised …
28 Mar 2012
In comparing treatments with interferon beta-1b (250μg), the network analysis revealed that no therapy shows better response for all 3 efficacy outcomes and alemtuzumab, 12 and 24 mg, have better response for 2 of the …

Dr. Alasdair Coles: Guest Spot. Long-term follow up of CAMPATHers
14 Feb 2012
Without the persistance of Alasdair Coles and Alastair Compston, I doubt that CAMPATH-1H, (the worlds first humanised monoclonal antibody)/Alemtuzumab/Lemtrada would be on the MS agenda. This drug has told us a …

Multiple Sclerosis Research: Do the markets know more than we do?
12 Jul 2011
“Alemtuzumab is a very effective therapy with many advantages, but also some risks. Now that Cladribine is off the scene Alemtuzumab is the only induction therapy, or immune system rebooter, in late stage development.

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

11 comments

  • here is a comment from a cynical banker: Pharma is the new banking industry. It is as loosely regulated, as essential, as "big to fail" and a brain drain for the 3rd world.
    Yep, more MBA grads are now looking into pharma that Goldman Sachs. I am too!

    I agree with the above with the proviso that: The marketing expenditure far outweigh R&D spending making the case for a sustainable R&D pipeline less exhaustive than possible. Excess marketing is nothing but psychological bribing – certainly necessary for highly efficient products.

    That makes one wonder: the client is captive (this is no sports car, if you don't buy the product: you die) then why compete in a Machiavellian way in the market place for this customer? isn't it better spend on improving the product and let them choose?

    I don't buy into all the doctors' gifts, the adverts, the sponsoring, and the lousy supportive publication.

    Tight controls on marketing expenditure will make this industry better – much more that a simple re-branding of an existing product"

  • So MSers have lost a potentially valuable drug for at least 2 years until the EMA and NICE get through their paperwork, and even then NICE may refuse to use it until other less effective DMT's have been shown to have failed. So much for early aggressive treatment and patient choice.

  • Re: "MSers have lost a potentially valuable drug for at least 2 years until the EMA and NICE get through their paperwork…"

    I must remind you that alemtuzumab is not yet licensed for MS. In general the off-license use of drugs, when there are licensed drugs for the that indication, is frowned upon by the neurological community and even more so by the medico-legal community.

  • "Pharma is the new banking industry."

    I don't buy this analogy; Pharma is one of the most tightly regulated industries of all. I do like your proposal of limiting marketing budgets by ensuring that R&D budgets are higher. The problem is that some of R&D is marketing; i.e. lot of phase 4 trials are used to encourage drug use.

  • The tone of this post is highly questionable. Gavin Giovannoni, once again, whitewashes the unfair and merciless actions of big pharmaceutical companies and attempts to justify their greedy approaches to maximising profits at the peril of countless ill people. Please don’t ask us to celebrate the academic principals that led to the advent of alemtuzumab when the truth is that the very purpose why this drug was tested in MS has been squandered by Genzyme’s capitalist greed. The pharma companies are not working for the betterment of MSers, they merely want to find drugs that create lifelong revenue streams. Big pharmas are literally no different from street drug dealers, wanting to make money from misfortune.

    This blog, and its creators, are very much in bed with the pharmas. They will always try and rationalise their actions even when they are highly irrational. Even Shift.ms, an auxiliary of this blog, made some crappy short film thanks to hand outs from Novatris: the very company that is now suing the NHS for using cheaper and more efficacious versions of the drugs it peddles out.

    Wake up people and please don’t accept what is being said. Truth is that MS will never be cured as long as the emphasis is on trying to make money from it. Shame on the neurologists and the researchers. They are all despicable.

  • Anon: Big pharmas are literally no different from street drug dealers, wanting to make money from misfortune.

    What planet are you on? Are you an anti-capitalist? Without pharma there would be no DMTs for people with MS. If we didn't have Pharma's investment we would be in the dark ages with no hope! I think what Prof G is trying to tell us is that there are two sides to every story and we need to try and look at, and understand, the bigger picture. I doubt you will agree with me.

  • Re: "Gavin Giovannoni, once again, whitewashes the unfair and merciless actions of big pharmaceutical companies and attempts to justify their greedy approaches to maximising profits at the peril of countless ill people."

    Do you have an alternative system to develop drugs for MSers? If you do please share it with us.

    I have been spent a lot of time thinking about this problem and it is difficult nut to to crack. The only way we are going to be able to do things without Big Pharma, or in partnership with them, is for Governments' to increase their commitment to drug development and share the risk. Will this happen? I suspect yes, but not in relation to MS. The current R&D and development pipeline in MS is too healthy for government intervention.

    However, I suspect Governments' might be forced into taking on drug development costs sooner than expected in relation to Alzheimer’s disease. The Alzheimer’s problem is so large and expensive, and looming so fast, and the Pharma investment to date, using the classic model, is failing. No Pharma company may be big enough to take on the risk of a full-scale Alzheimer’s development programme on their own. This is scary stuff! So if you have a solution please share it with us. It is no use killing the golden goose without a suitable replacement.

  • Prof G,

    As a recipient of Alemtuzumab I have seen excellent results. Similar (no more relapses / stability) results have been seen by others I met who have had the treatment (some treated 6/7 years ago).

    It's a real shame that this treatment isn't available now. Hopefully, the drug will get a licence, but I guess NICE will manage to delay things (or worse).

    More importantly, are other seeking to develop similar drugs i.e. same target? Will Ocrelazumab offer similar efficacy (a competitor might push down the price which Genzyme may seek to get which could help with NICE).

    Even more importantly, what is Alemtuzumab telling us about the disease? In my experience, it is doingsomething remarkedly effective. Does it not, therefore, shine some light on what this disease actually is / the mechanisms involved?

  • Prof G, I marvel at you using the metaphor of a “golden goose” to describe the current composite of big pharmaceutical companies that are unforgivably penalising multiple sclerosis sufferers in order to generate greater profits. The current system is the antithesis of golden, nothing but rife with corruption, greed and abject chicanery. The ‘monumental’ prospects you prophesised at the start of the year in the world of MS treatments are turning truly bleak and finite. All that is left is atrocious DMTs that are marginally effective, if at all, and carry huge risks. To think that NASA has been able to send the Curiosity to Mars and MS researchers are not even able to slow down disease progression. In fact, none of you can even agree on what MS is and why it happens. All of those working in the field of MS should hang their heads in shame.

  • Re: "All of those working in the field of MS should hang their heads in shame."

    I suggest you have a conversation with some of the MSers, with highly-active MS, who have been treated with Alemtuzumab, Natalizumab, Fingolimod, Daclizumab or Rituximab/Ocrelizumab before making such sweeping statements. Their perspective may change your mind.

    Re: "the golden goose"

    The Pharma industry does not only exist to treat MS, but the whole range of human and animal diseases. As a neurologist I am relying on academia and pharma to come up with DMTs for Parkinson's disease, Alzheimer's disease, motor neurone disease and a whole lot of other conditions. The history of modern man is one of accelerating innovation; the advances in the field of MS are just one example of this. I sincerely hope medical innovation continues accelerating at the current rate. You don't have to look too far back in history to see how innovation can be stamped out or suppressed by short-sighted or blinkered attitudes. We don't need another dark age.

  • Re: "… what is Alemtuzumab telling us about the disease?"

    Alemtuzumab and other immune system rebooters is telling us a lot about the disease. What is interesting is that anti-CD20 or B-cell therapies (rituximab and ocrelizumab) seems to be as effective as alemtuzumab. The question for me is alemtuzumab working via targeting B cells? If this is the case then the answer lies in the B cell. Need I say more?

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