14th October 2009

Critical Pharmaceuticals, the speciality pharmaceuticals company, today announced that it had 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.

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.”

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.”

Editor’s notes:

Critical Pharmaceuticals is a Nottingham UK-based biotechnology company with proprietary drug delivery technologies for the sustained release and nasal delivery of proteins and peptides and labile or insoluble small molecules. 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
 

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