Critical Pharma gets Wellcome funding for biologic spray technology
pharmafile | October 26, 2009 | News story | Research and Development |Â Â critical pharmaÂ
A nasal spray technology which promises an alternative drug delivery method for biologic drugs has been given a funding boost.
Critical Pharmaceuticals, a spin-out company from The University of Nottingham, has secured a £1.5 million translation award from the Wellcome Trust to develop the nasal spray to deliver Human Growth Hormone (hGH).
Large molecule biological drugs are playing an increasingly important role in medicine, but usually require an injection to administer them, which are disliked and inconvenient for patients.
The company is focusing on hGH as the first drug to be delivered using the system. Human Growth Hormone is a leading biologic treatment for growth disorders, with global sales reaching $2.8bn in 2007.
Professor Steven Howdle, from the University's School of Chemistry and founder of the company, developed the CriticalSorb technology as an alternative to injection. He says Critical Pharmaceuticals will use the new funding to conduct phase I studies of the technology.
"The Wellcome Trust translational award is a tremendous step forward for the company," said Prof Howdle. "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 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.
"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."
The company has a number of proprietary drug delivery technologies for injectable sustained release and nasal delivery of challenging drugs including proteins and peptides.
CriticalSorb is an absorption promoter that has been shown to enable the delivery of biological drugs in pre-clinical 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 I proof of concept study in human volunteers and determine the long term nasal tolerability of CriticalSorb.
Critical Pharmaceuticals was founded by Prof Steve Howdle in 2002 based on his world leading research into supercritical fluids. He noticed that supercritical carbon dioxide was able to liquify certain polymers, and realised 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 pharma and biotech companies, the company is now developing its own in-house pipeline of reformulated drug candidates for areas of unmet needs, including human growth hormone.
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