Critical Pharmaceuticals to develop hGH nasal spray

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.”