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Critical Pharmaceuticals, a spin-out company from The University of Nottingham, has secured a £1.5m translation award from the Wellcome Trust to develop a nasal spray of Human Growth Hormone (hGH) using its proprietary CriticalSorb technology as an alternative to injection. hGH, a leading biological drug for the treatment of growth disorders had global sales of $2.8bn in 2007.
Professor Steven Howdle, from the School of Chemistry and founder of the company said: “The Wellcome Trust translational award is a tremendous step forward for the company — not only does it provide very important funds to develop our new nasal technology, but also it provides very strong validation that the company will produce innovative new products that will, in the near future, be of significant benefit for a wide range of patients in the UK and beyond.”
Lisbeth Illum, Chief Executive Officer of Critical Pharmaceuticals said the hGH market represented a major opportunity for Critical: “This project addresses a large unmet medical need. Biologics continue to grow in importance, representing 30% of new drugs. However, 98% of these are administered by frequent injection, which can cause problems with patient compliance. Human growth hormone is a prime example. Current therapies require daily injections and are strongly disliked by patients and their carers. We believe Critical Pharmaceuticals’ CriticalSorb™ technology has the potential to enable the non-invasive delivery of not just human growth hormone but many other biological drugs with at least equivalent efficacy.”
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Critical Pharmaceuticals is a biotechnology company with proprietary drug delivery technologies for injectable sustained release and nasal delivery of challenging drugs including proteins and peptides. They are developing a number of ground breaking products to treat various diverse diseases.
CriticalSorb™ is an absorption promoter that has been shown to enable the delivery of biological drugs in preclinical studies with exceptional bioavailabilities. It is a 'GRAS' (generally regarded as safe) material that is already marketed in various drug products for intravenous and oral administration.
The Wellcome Trust funding will support the development of a nasal human growth hormone product through a phase 1 proof of concept study in human volunteers and determine the long term nasal tolerability of CriticalSorb™. Richard Seabrook, Head of Business Development, Technology Transfer Division, at the Wellcome Trust added: “Technologies for non-injectable administration of complex drugs like human growth hormone are desperately needed. We are very pleased to be funding this application of CriticalSorb™ which may avoid patient discomfort and improve eventual outcomes for this patient population. We look forward to Critical’s results.”
Critical Pharmaceuticals was founded by Professor Steve Howdle in 2002 based on his world leading research into supercritical fluids. Professor Howdle noticed that supercritical carbon dioxide was able to liquify certain polymers, and in a moment of inspiration realised that this could be used to encapsulate thermally labile or solvent sensitive drugs to create injectable sustained release products. As well as working in partnership with other pharmaceutical and biotechnology companies, the company is now developing a pipeline of reformulated drug candidates for areas of unmet needs including human growth hormone. For more information visit www.criticalpharmaceuticals.com
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Notes to editors: The University of Nottingham is ranked in the UK's Top 10 and the World's Top 100 universities by the Shanghai Jiao Tong (SJTU) and Times Higher (THE) World University Rankings.
More than 90 per cent of research at The University of Nottingham is of international quality, according to RAE 2008, with almost 60 per cent of all research defined as ‘world-leading’ or ‘internationally excellent’. Research Fortnight analysis of RAE 2008 ranks the University 7th in the UK by research power. In 27 subject areas, the University features in the UK Top Ten, with 14 of those in the Top Five.
The University provides innovative and top quality teaching, undertakes world-changing research, and attracts talented staff and students from 150 nations. Described by The Times as Britain's "only truly global university", it has invested continuously in award-winning campuses in the United Kingdom, China and Malaysia. Twice since 2003 its research and teaching academics have won Nobel Prizes. The University has won the Queen's Award for Enterprise in both 2006 (International Trade) and 2007 (Innovation — School of Pharmacy), and was named ‘Entrepreneurial University of the Year’ at the Times Higher Education Awards 2008.
Nottingham was designated as a Science City in 2005 in recognition of its rich scientific heritage, industrial base and role as a leading research centre. Nottingham has since embarked on a wide range of business, property, knowledge transfer and educational initiatives (www.science-city.co.uk) in order to build on its growing reputation as an international centre of scientific excellence. The University of Nottingham is a partner in Nottingham: the Science City.
The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending over £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. For more information visit www.wellcome.ac.uk