Discontinuation of licensed supplies of alemtuzumab or campath

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"A major reason why Genzyme has withdrawn the off-label use of alemtuzumab in MS is safety.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 ...
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.