26 Apr BIOTHERAPY SERVICES AWARDED INNOVATION PASSPORT
BIOTHERAPY SERVICES AWARDED INNOVATION PASSPORT FOR GROUNDBREAKING TREATMENT FOR DIABETIC FOOT ULCERS.
WINDSOR, April 8, 2021 – Biotherapy Services Ltd (BTS), a clinical stage pharmaceutical biotechnology company developing novel autologous therapies for complex and chronic wounds, has been awarded the innovative medicine designation – the Innovation Passport – for RAPIDTM Biodynamic Haematogel in the treatment of chronic ulceration of the diabetic foot. The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP), a new UK approval process designed to reduce time to market and accelerate access to innovative medicines. RAPIDTM Gel is a wound care treatment that uses a patient’s own blood to accelerate the healing of otherwise unhealable atrophic wounds. It is the first therapy of its type to be classified as a medicine – and has the potential to transform the treatment landscape for diabetic foot ulcers (DFUs). The designation for RAPIDTM Gel – awarded by the ILAP Steering Group following consideration by MHRA, NICE and the SMC – will see BTS work with experts from the ILAP partner network to define a target development profile (TDP) and co-create a roadmap for early patient access. Among the criteria for Innovation Passport designation, products must address a ‘significant patient or public health need’. This is certainly the case with DFUs, which have a substantial and growing global prevalence.
The impact on quality of life for patients is significant. Non-healing foot ulcers can lead to toe, foot or leg amputation in diabetic patients, with ulceration and amputation associated with high mortality. Currently, only two thirds of DFUs eventually heal without surgery. Globally, there is one diabetic amputation every 30 seconds. The clinical and economic burden of DFUs is similarly significant. In the UK, where £1 in every £140 of NHS spend goes on care for the diabetic foot, there were around 7 million prevalent DFU cases in 2020. In total, DFUs cost the UK taxpayer more than £1 billion each year. BTS is currently expanding the clinical applications of RAPIDTM Biodynamic Haematogel treatments in other complex wound areas including pressure ulcers, cardio-thoracic sternal wounds and venous ulcers. Significantly, the Innovation Passport designation acknowledges the potential to broaden the indication to other forms of skin ulceration.
Janet Hadfield, Co-Founder & CBDO, Biotherapy Services Ltd, said:
“The award of Innovation Passport designation is a landmark moment in the growth of Biotherapy Services and the treatment of diabetic foot ulcers. For our technology to be recognised by MHRA, NICE and the SMC – not only for use with DFUs but also in other complex wound areas – is a huge achievement. The potential to accelerate approval and access through the ILAP process gives real hope to patients with debilitating DFUs, providing an opportunity to reduce the number of avoidable amputations caused by non-healing foot ulcers. RAPIDTM Gel could bring about a step change in clinical practice for DFUs. The first-in-class medicine, which uses a patient’s own blood, is manufactured at the patient bedside by BTS staff, reducing the burden on over-stretched hospital teams. Our novel technology and patented processes unlock the body’s ability to heal itself through autologous biological therapies, activating the healing pathway through the release of growth factors. In the era of person-centred healthcare, RAPIDTM Gel is the very definition of a personalised medicine: the patient is the solution. We look forward to harnessing the ILAP to accelerate marketing authorisation and bring this innovative treatment to patients.”
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MORE INFORMATION ABOUT BTS:
Biotherapy Services Ltd. is a clinical stage, pharmaceutical biotechnology company developing and delivering novel autologous therapies for complex and chronic wounds. The company has developed proprietary expertise and a unique GMP standard operational model to provide the proprietary RAPIDTMBiodynamic Haematogel autologous wound care treatment, targeting complex and chronic wounds.
ABOUT RAPID™ BIODYNAMIC HAEMATOGEL
RAPIDTM Biodynamic Haematogel is a first-in-class medicine. It is manufactured and administered at the patient bedside using the patient’s own blood components to work at a cellular level to stimulate the patient’s own healing process.
The technology has a wide range of potential applications across regenerative medicine both in the prevention and treatment of chronic/complex wounds.
The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.
The ILAP is open to both commercial and non-commercial developers of medicines (UK based and or global). It comprises of an Innovation Passport designation, a Target Development Profile (TDP) and provides applicants with access to a toolkit to support all stages of the design, development and approvals process.
The ILAP provides opportunities for enhanced regulatory and other stakeholder input. Permanent partners in the ILAP are MHRA, NICE and SMC. Supporting partners include NHS England, NHS Improvement, Health Research Authority (HRA), National Institute for Health Research (NIHR)
For more information, visit www.gov.uk/guidance/innovative-licensing-and-access-pathway#TDP
Janet Hadfield, MBA (Hons) – Co-founder and Chief Business Development Officer
James Rickard, MPharm – Chief Scientific & Regulatory Officer
+44 (0) 207 788 7828