nasal device

Wellcome Trust Funds Developoment of CP024 hGH Nasal Spray

Critical Pharmaceuticals Secures £1.5m From Wellcome Trust To Develop hGH Nasal Spray 14/10/2009 09:00

Critical Pharmaceuticals Secures £1.5m From Wellcome Trust 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.”

CP024 Nasal hGH

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CP024 has completed two Phase 1 clinical trials where our intranasal growth hormone has shown comparable activity to injection.

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CriticalSorb Technology

nasal device

CriticalSorb enables the non-invasive nasal delivery delivery of high-value biologic products and challenging small molecule drugs.

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Richard Seabrook, Wellcome Trust
“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.”