First UK ‘Promising Innovative Medicine’ Designation Awarded [UK Dept of Health PR]

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The following is a press release from the UK Department of Health and Life Sciences Minister George Freeman. The original press release may be found here: https://www.gov.uk/government/news/first-uk-promising-innovative-medicine-designation-awarded

An innovative cell therapy for cancer has become the first designated ‘promising’ as part of a scheme to get medicines to patients quicker.

The medicine, named DCVax-L, has been developed by US-based pharmaceutical company Northwest Biotherapeutics Inc (NW Bio) and is the first drug to be awarded the UK’s new ‘Promising Innovative Medicine’ (PIM) designation. The designation is the initial step in the Early Access to Medicines Scheme (EAMS) which aims to increase patient access to medicines where there is an unmet medical need.

Life Sciences Minister George Freeman welcomed the company’s announcement that it had received the first PIM, saying that the scheme is an important step for the UK to remain a world leader in the field of life sciences.

The Government is determined to strengthen Britain’s science, research and development industry as part of its long term economic plan, and become one of the best countries in the world for capitalising on breakthroughs in medical care.

The Early Access to Medicines Scheme, launched in April 2014, offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally reach them. A drug like Kalydeco which is used to treat cystic fibrosis would have been an appropriate candidate for the Early Access Scheme had it existed when the drug was developed, meaning it may have been made available to patients sooner.

The PIM, which is awarded following an assessment of early clinical data by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been created as an early signal to companies that its development plan is on the right track, indicating that a product could be a candidate for the Early Access to Medicines Scheme, when further development work has been conducted. This early boost to a drug’s potential is expected to be beneficial to companies, especially small and medium-sized enterprises, who can struggle to attract capital during drug development from investors.

NW Bio will now continue to develop the medicine and, if proven in trials, it will be eligible to apply for step II of the UK Early Access to Medicines Scheme, meaning that patients could benefit and the company will be able to generate further data to improve the understanding of the way the drug works. It will then go through formal medicines licensing.

Life Sciences Minister George Freeman said:

Making Britain the best place in the world for science, research and development is a central part of our long term economic plan. We want to make Britain the best place in the world to design and deliver 21st Century healthcare technologies which is central to our life science strategy. This Promising Innovative Medicine designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families.

This scheme is helping to secure a better future for people and proves that our country is leading the world in Life Sciences. I hope more companies – big and small – and medical charities, will nominate products to be part of this scheme.

Linda Powers, CEO of Northwest Biotherapeutics Inc, said:

We are most grateful to the MHRA and Minister Freeman for spearheading this new Early Access to Medicines Scheme (EAMS). It strikes a very practical balance between clinical benefits and risks, through careful scientific evaluations, and will be of great help to doctors and patients in opening up new treatment options.

We are very excited to have DCVax-L receive the first designation under the EAMS, and believe that DCVax-L embodies the combination of innovation and beneficial balance of clinical benefits and risks that the EAMS is designed to accelerate.

Background information

For more information contact the Department of Health press office on 0207 210 5477 / 5738.

The MHRA Press office can be contacted on 020 3080 7651

For more information on NW Bio and their products, please contact Les Goldman on +1 202-841-7909

About DCVax-L

DCVax-L is the first product to receive formal designation as a “Promising Innovative Medicine” (PIM) under the new Early Access to Medicines Scheme. The PIM designation for DCVax-L covers all malignant gliomas, which would include both Glioblastoma multiforme (the most severe grade) as well as less malignant grades, and would include both newly diagnosed and recurrent gliomas.

The product works by retraining an individual’s immune system to recognize and attack cancer cells with the potential to treat many solid tumour cancers.

About the Government’s Strategy for Life Sciences

The Government’s Strategy for UK Life Sciences (2011) set out an ambitious long-term programme of action to improve the wider environment for health life sciences companies and included a commitment to consulting on proposals for an early access to medicines scheme. A successful, competitive UK Life Sciences sector can improve the lives of UK patients, increase efficiency in the NHS, and benefit the UK economy contributing to long-term sustainable growth.

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