Products and interventions
- Headline findings
- Details of new products/interventions arising from MRC supported research
- Monoclonal Antibodies
- New products/interventions in development
Headline findings
- Over 300 reports of new products or interventions were captured in MRC e-Val. These ranged from non-medical interventions and products (for example a new detector for electron microscopy), to drugs, new diagnostic tests or imaging techniques, or new public health advice.
- The products and interventions reported were at all stages of development from earliest proof of concept through to wide scale use. A third of reports were of new drugs in development.
- MRC research has led to at least 24 unique new products/interventions being launched onto the market over the last three years. These include 10 new drug therapies, of which nine were based on monoclonal antibody technology.
- A further 12 drugs are in Phase 2 trials and these include monoclonal antibodies for multiple sclerosis, type 1 diabetes, asthma, psoriasis, approaches for treatment of tuberculosis, amyloidosis, and to modify the immune response prior to organ transplantation.
More information
- Details of new products/interventions arising from MRC supported research
- Monoclonal antibody therapies approved for use
- New products/interventions in development
Details of new products/interventions arising from MRC supported research
New products/interventions launched into use since 2006
New Product/Intervention |
Impact |
More information |
Dr Nick Coleman (MRC Cancer Cell Unit) has developed a molecular test for early diagnosis of cervical cancer and pre-cancer in cytology and histology preparations. |
Antibody tests for MCM proteins have increasingly been cited in clinical reviews. ProExC is Beckton Dickinson’s licensed product and publications demonstrate increasing use in US and elsewhere, both for intended use and off label use. FDA approval trials are in progress. |
MRC achievements section on “Cancer Screening” |
Professor David Edwards (MRC Clinical Sciences Centre) has developed the first effective treatment for infants suffering birth asphyxia – hypothermic neural rescue therapy. |
Hypothermic neural rescue therapy reduces death and disability in infants suffering birth asphyxia and reduces cerebral palsy in survivors. This programme of work included a cost benefit analysis which showed that hypothermia is cost effective. Hypothermia has now been reviewed by NICE and preliminary advice is that it should be introduced into the NHS as a normal therapy. |
Written up and published as part of a showcase of successes from MRC experimental medicine research – “A New Therapy to Prevent Brain Injury at Birth” |
Dr Richard Henderson, former Director of the MRC LMB, reported the development of a new direct electron detector marketed by FEI |
The new detector allows researchers to see biologically significant detail that could not be seen before. |
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The use of Campath® (alemtuzumab) in treatment of multiple sclerosis |
Key contributions to bringing this treatment to the stage of a phase 3 trial were reported by Sir Greg Winter (MRC Laboratory of Molecular Biology), Professor Herman Waldmann (university of Oxford) and Professor Alistair Compston (University of Cambridge). |
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Dellbox is a novel computerised testing device for the detection of attention deficits in delirium |
Delbox has received further funding from the MRC to commercialise the device |
Written up and published as part of a showcase of successes from MRC experimental medicine research – “A New Diagnostic Tool for Delirium” |
Professor Ian McKeith demonstrated reduced activity of the dopamine transporter in post mortem human brain in patients with Lewy body dementia. |
The test has been developed in collaboration with GE Healthcare as a diagnostic brain imaging test usable in-vivo. |
Monoclonal Antibodies
The six therapeutic antibodies reported via MRC e-Val that all owe their discovery to technology discovered and developed at the MRC Laboratory of Molecular Biology. These therapies are used in eight conditions which range from rare (several cases per million) to common (between 1 and 2% of the population).
1. Humira® (adalimumab)
2. Actemra® (tocilizumab)
3. Cimzia® (certolizumab)
4. Soliris® (eculizumab)
5. Tysabri® (natalizumab)
6. Lucentis® (ranibizumab)
1. Humira® (adalimumab)
Humira® is an anti TNF antibody used to alleviate inflammation in autoimmune disease and is approved for treatment of patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis, and juvenile idiopathic arthritis.
Humira® was the first blockbuster monoclonal antibody therapy with $1bn in sales in 2005. By August 2009 Humira® was being used in 80 countries in the treatment of 370,000 patients, and it is now estimated to be the world’s top earning pharmaceutical product, expected to reach $10bn in sales by 2016 [1].
Humira® was created by Cambridge Antibody Technology (CAT) using phage display technology licensed from the MRC. The antibody selected using this process was marketed by Abbott laboratories.
Indication |
Impact |
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints, which can result in eventual destruction of the joints' interior and the surrounding bone, leading to disability. RA is a serious unmet clinical need – it is estimated that 1% of the world’s population suffer from RA, approximately 580,000 people in the UK [2]. |
Humira® was recommended by NICE as an option for the treatment of adults with RA in October 2007[3]. It is estimated that approximately 15,000 patients are eligible for anti-TNF therapy with an additional 950 cases arising each year [4]. |
Juvenile Idiopathic Arthritis (JIA) is the most common chronic rheumatic disease in children, with onset before age 16. The prevalence is about 1 per 1,000 children, with an estimated 10,000 children in the UK affected [5]. Typical symptoms include stiffness when awakening, limping, and joint swelling. Any joint can be affected and inflammation may limit the mobility of the affected joints. While it was once believed that most children eventually outgrow JIA, it is now known that between 25 and 70 percent of children with JIA will still have active disease into adulthood. |
In February 2008 Abbott was given approval by the US FDA to market Humira® for the treatment of JIA in children aged 4 years and older. The EMEA licensed Humira® for 13 – 17 year olds in 2009 [6]. The fixed 40-mg dose, which is the only dose of Humira currently available, was considered to be suitable only for patients aged 13 years or above. The proposed NICE appraisal of adalimumab for JIA was cancelled due to the restricted age-range in the European licence. |
Psoriasis is a noncontagious, recurrent autoimmune disease that affects around 1.2 million people in the UK, up to 240,000 of whom suffer from the severe form of the disease. |
NICE recommended Humira® as a treatment option for adults with severe chronic plaque psoriasis in June 2008 [7]. |
Ankylosing spondylitis (AS) is a form of chronic arthritis that mainly affects the spine. The condition may be treated with physiotherapy and medication. Annual incidence of AS is 6.9 per 100,000 of the population (prevalence 0.15%). 200,000 people are estimated as suffering from AS in the UK. |
Humira® is recommended by NICE (May 2008) as a treatment option for adults with severe active AS. |
Crohn’s disease is an inflammatory disease of the intestines and affects up to 60,000 people in the UK. Typically diagnosed before the age of 30, Crohn’s disease can have a devastating impact on the day-to-day life of patients, many of whom are young and active. |
NICE recommended Humira® as one of the treatment options for adults with severe and active Crohn’s disease in May 2010. Humira® is the first anti-TNF therapy approved by NICE for Crohn’s disease that can be self injected at home, after appropriate training. |
2. Actemra® (tocilizumab)
Actemra® inhibits human IL-6 (a key pro-inflammatory cytokine). Clinical studies have shown treatment of rheumatoid arthritis (RA) patients with Actemra® reduces joint inflammation and damage and also some of the systemic manifestations associated with RA.
Acetemra® was co-developed by Chugai Pharmaceutical Co (Japan) and Genentech, now both part of Roche. The mouse antibody was humanised by the MRC Collaborative Centre in London.
Based on the results of large randomised, controlled, Phase III clinical trials, Actemra® was approved by the European Medicines Agency (EMEA) in January 2009 and US Food and Drug Administration (FDA) in January 2010 [6] for treatment of adult patients with moderate to severe active RA, who have either responded inadequately to, or who were intolerant to, previous therapy. However at the end of 2009 NICE asked Roche to provide further information on the cost effectiveness of prescribing Acetmra®[7] before recommending it in the UK.
3. Cimzia® (certolizumab)
Cimzia® is a PEGylated, Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, manufactured by UCB Pharma Inc. PEGylation increases the half life of the drug in the body, reducing the dosing required. Removing the Fc portion of the antibody to leave just the antigen binding portion (Fab fragment) may also reduce unwanted reactions between the drug and the immune system.
NICE recommended Cimzia® as an option for the treatment of adults with severe active RA, in January 2010, on the condition that a Patient Access Scheme is implemented for the drug. UCB will offer the drug for free for the first 12 weeks of treatment. Clinical trials had shown that most patients responded to treatment within this time.
In 2010 UCB was awaiting approval for Cimzia® for the treatment of Crohn’s disease in Europe, it is approved by the FDA in the USA.
4. Soliris® (eculizumab)
Soliris® is a humanized monoclonal antibody that binds to the human C5 complement protein. The drug was developed by Alexion Pharmaceuticals Inc, licensees of MRC antibody technology, as a treatment for paroxysmal nocturnal hemoglobinuria (PNH).
PNH is a rare blood disorder (13 cases per million) however the condition has a high morbidity and mortality. The FDA and European Union approved the use of Soliris® in 2007.
5. Tysabri® (natalizumab)
Tysabri® is an antibody therapeutic against cellular adhesion molecule alpha 4 integrin, developed by Biogen Idec and Elan, licensees of MRC antibody technology. The drug was developed as a therapy for multiple sclerosis (MS).
Multiple sclerosis (MS) is a disorder of the brain and spinal cord. It can cause a variety of symptoms. In most cases, episodes of symptoms 'come and go' at first for several years. In time, some symptoms usually become permanent, and cause disability. There is no treatment that cures MS, but various medicines and therapies may reduce the number of 'flare-ups' and can help to ease symptoms and disability. Around 140 people per 100,000 in the UK have MS.
Tysabri® was recommended for patients with severe relapsing MS by NICE in 2007.
6. Lucentis® (ranibizumab)
Lucentis® is an antibody therapeutic against VEGF developed by Genentech/Roche, licensees of MRC antibody technology. Lucentis® is used in the treatment of age-related macular degeneration (AMD).
AMD is an eye condition that leads to a progressive loss of central vision. People retain some peripheral vision, but the ability to see well enough to recognise faces, drive and read is affected, and vision can deteriorate rapidly. AMD is the leading cause of blindness in the elderly, around 2 million have the condition in the USA. There are about 26,000 new cases of wet AMD in the UK each year and the condition affects more women than men.
NICE recommended Lucentis® as an option for the treatment of wet age-related macular degeneration under certain criteria in August 2008.
[1] Humira set to steal Avastin’s crown (EvaluatePharma report, 2010)
[2] The National Audit Office. Services for people with rheumatoid arthritis: Report by the comptroller and auditor General. HC 823 Session 2008-2009. 15 July 2009.
[4] National Horizon Scanning Centre, Birmingham New and Emerging Technology Briefing.
[6] EMEA European Public Assessment Report summary (2009)
[9] UK's NICE seeks more data on Roche arthritis drug (Reuters News Story December 2009)
New products/interventions in development
Modality assessment
Professor Steven Bloom (Imperial College) has shown that Kisspeptin may have the potential to treat reproductive disorders in humans. |
Written up and published as part of a showcase of successes from MRC experimental medicine research |
Dr Dario Alessi has patented a new optimised assay to assess the activity of the Leucine Rich Repeat protein Kinase-2 (LRKK2). Mutations in LRKK2 have been found to predispose humans to develop late-onset Parkinson’s disease (PD). Companies are using the assay to develop LRRK2 inhibitors as potential treatments for PD. |
Early clinical assessment
Dr Graham P Taylor (Imperial College) has demonstrated proof of concept that ciclosporin is effective for the treatment of HTLV-1 associated myelopathy (HAM) |
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A proportion of neural tube defects (which lead to spina bifida) are resistant to folic acid supplementation. MRC funded animal model research, at the Institute of Child Health indicated a preventive action of inositol in cases where folic acid is ineffective. |
The PONTI phase 2 clinical trial is now ongoing, having been started with funding from an MRC Trial Platform Grant (more information). The PONTI study seeks to determine whether inositol treatment, in conjunction with folic acid, may lead to a reduction in the frequency of neural tube defects compared with use of folic acid alone. |
Late clinical assessment
Benlysta for the treatment of Lupus MRC LMB combinatorial library/phage display technology used by Cambridge Antibody Technology and Human Genome Sciences to develop Benlysta® (Belimumab) with GSK. Benlysta® is the first new promising treatment of systemic lupus erythematosis (SLE) for fifty years. |
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Cryptococcal disease prophylaxis trial An MRC/UVRI trial in Uganda showed the most common disease of the central nervous system in HIV infected African people could be prevented with a pill. Around 10 per cent of HIV positive people in Africa are affected by cryptococcal disease and about half of those people die from it. An MRC trial helped to show that HIV positive people are far less likely to get the deadly disease if they take a regular dose of the medicine Fluconazole, an inexpensive drug which is safe to take. |