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European Biopharmaceutical Review
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Advanced therapy medicinal products (ATMPs) represent one of the fastest-growing areas of clinical research due to their potential to cure severe chronic conditions. Despite the important health benefits that ATMPs are expected to bring, relatively few have reached the market, and several have been subsequently withdrawn. Oncology indications remain the largest sector in the UK, and, while Phase 3 trials have increased, most are still in early phase development. Therefore, it is likely to be several years before the full potential for ATMPs is translated into meaningful patient benefit and will be dependent upon researchers overcoming numerous challenges, including recruitment, operational, and safety considerations. Overcoming these challenges requires innovation, collaboration, and sound strategic development to ensure ATMPs are brought to market efficiently and without a prohibitive impact on drug budgets. This article will discuss how researchers in the UK are at the forefront of this scientific endeavour, with several exciting collaborations, backed by Innovate UK, generating optimism for future success.
The ATMP Market
ATMPs are a new generation of treatments that use gene therapy, cell therapy, and tissue engineering. They offer unprecedented promise for the treatment of diseases or injuries that currently have a high, unmet medical need, such as Alzheimer’s disease, cancer, muscular dystrophy, ophthalmology, and skin in burns victims. Given their curative potential in severe chronic conditions, ATMPs are, unsurprisingly, one of the fastest-growing areas of research, with an estimated global market opportunity of up to £14 billion by 2025, with predicted additional year-on-year growth potential of 25% to 2030.
While optimism may be justified for the future of ATMPs, the situation today is that this technology remains extremely complex and expensive and is only available to a small number of patients. Results from clinical studies have shown promise, but few products have yet to reach the market – only 10 have been approved in Europe, most recently being Alofisel (to treat anal fistulas in Crohn’s Disease) from TiGenix/Takeda. Of these, four have since been withdrawn. This is slow progress considering that the first ATMP, chondrocelect (to repair damage to the cartilage in the knee), was approved nine years ago, especially given the level of interest and investment in the field.
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Dr Fiona Thistlethwaite is a Medical Oncology Consultant within the experimental cancer medicine team at The Christie Hospital, UK, and Honorary Senior Lecturer at the Division of Cancer Sciences, Faculty of Biology Medicine & Health, at The University of Manchester, UK. Fiona is also the Director for iMATCH.
Dr Ian Thomas is a drug development expert with several decades of early and late phase oncology experience. In his role as Clinical Delivery Director for Aptus Clinical, a specialist CRO, Ian leads the company’s advanced therapy clinical development activities and is extensively involved in supporting iMATCH.
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Humanigen Enters into Agreement with PCI Pharma Services as Part of Preparations for Commercialization in the United Kingdom
SHORT HILLS, NJ. June 16, 2022--(BUSINESS WIRE)-- Humanigen, Inc.
(Nasdaq: HGEN) (“Humanigen”), a late-stage clinical biopharmaceutical
company focused on preventing and treating an immune hyper-response
called ‘cytokine storm,’ today announced it entered into an agreement
with PCI Pharma Services (PCI), a leading integrated global contract
development manufacturing organization (CDMO), to provide importation,
release and commercialization services in the United Kingdom (UK) for
lenzilumab. Under the agreement, PCI will purchase lenzilumab for resale
and distribution in the event a Conditional Marketing Authorization is
received in the UK for use in patients hospitalized with COVID-19.
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