New breakthrough immunotherapy (pembrolizumab) launched in the UK for treatment of adults with advanced melanoma
London, UK, 11th March 2015: MRC Technology (MRCT), an independent life science research charity, is pleased to highlight that today the first drug to be approved through the Early Access to Medicine Scheme (EAMS) has been named as pembrolizumab, an immunotherapy treatment for advanced melanoma. The treatment has been developed by Merck (NYSE:MRK), known as MSD outside the United States and Canada, with early development work carried out using MRC Technology’s antibody humanization expertise.
Pembrolizumab is considered a next generation drug in cancer care, stimulating the body’s immune system to fight the disease. The therapeutic is one of a new generation of PD-1 (programmed cell death protein 1) therapies that block the biological pathways cancers use to disguise themselves from the immune system. It acts by making the cancer cell ‘visible’ to the immune system and the cell can thus be destroyed by the body’s natural defence mechanisms. UK based scientists at MRCT, with extensive expertise in antibody engineering techniques, first advanced the antibody-based treatment and carried out humanization, an essential step in the success of the therapeutic.
EAMS is a new NHS system enabling drugs to be fast-tracked to patients. The scheme has been set up to give severely ill patients rapid access to promising unlicensed medicines, meaning that this drug is available to be prescribed to patients much earlier than it would normally have been before EAMS was established.
Dave Tapolczay, Chief Executive Officer, MRC Technology said: “We are very proud of our role in bringing this new cancer treatment to patients with highly invasive tumours. Making pembrolizumab available under the Early Access to Medicines Scheme (EAMS) is another big step in getting healthcare innovation to patients sooner and underlines our commitment to improving lives through science.”
Dr Justin Bryans, Director of Drug Discovery, MRC Technology said: “Pembrolizumab is different from other cancer drugs, as it boosts the immune system to launch an attack on cancer cells, rather than destroying cancer cells directly. MRC Technology scientists humanised the antibody so it would not be recognised and hence destroyed by the immune system. The PD-1 pathway allows cancer cells to escape detection by the body’s immune response. The antibody blocks this pathway leaving cancer cells susceptible to attack and destruction by the immune system.”
MRC Technology has humanized over 55 antibodies to date, including four marketed products, Tysabri (natalizumab), Actemra (tocilizumab), Entyvio (vedolizumab) and Keytruda (pembrolizumab). A further five are in clinical trials and two more in preclinical studies.
Pembrolizumab received FDA (USA) approval in September 2014 and is commercially available in the United States as Keytruda. An application for European (EMA) approval was made in June 2014.
ENDS
Notes to Editors:
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About MRC Technology
MRC Technology (www.mrctechnology.org) is an independent life science medical research charity, offering professional services to organisations within the academic, charity, biotechnology and pharmaceutical sectors globally. Services include IP management and research and development for diagnostics, small molecules and therapeutic antibodies. MRC Technology bridges the gap between basic medical research and commercialisation, helping early discoveries progress to clinical application. Four of MRC Technology’s projects have led to approved drugs (Tysabri®, Actemra®, Entyvio®, Keytruda®) and the company has a strong pipeline in development.
Please note MRC Technology has been independent from the UK’s Medical Research Council (MRC) since 2000.
About EAMS (Early Access to Medicines Scheme)
Under the scheme, the UK’s Secretary of State for Health, acting through the Medicines and Healthcare products Regulatory Agency (MHRA), will issue a scientific opinion on the benefits and risks of a new medicine or indication, assessed as having a positive risk/benefit balance. The opinion will provide additional information for clinicians and patients to assist in treatment decisions in areas of unmet medical need. Further details of EAMS can be found here https://www.gov.uk/apply-for-the-early-access-to-medicines-scheme-eams
EAMS will see doctors working with patients to make innovative and promising drugs available as soon as the MHRA has signalled that the benefits outweigh the risks following an initial scientific assessment and the NHS has agreed to the supply. Medicines in EAMS will typically be commissioned by NHS England through its specialised commissioning arrangements, delivering a single national approach to commissioning.
Once drug manufacturers have received a scientific opinion from the MHRA, doctors will work with patients to prescribe the drugs when appropriate. As a result, the process of patient access will be speeded up and new drugs could be made available to patients months or sometimes years before the treatment is licensed.
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