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Critical Pharmaceuticals Enter Sustained Release hGH Arena
Date:10/1/2008

Preclinical Results of New Somatropin Formulation Demonstrate Advantages

Over Existing Once-Daily Product

NOTTINGHAM, England, October 1 /PRNewswire/ -- Critical Pharmaceuticals, the Nottingham, UK-based speciality pharmaceuticals company, today announced that the successful completion of preclinical trials of a sustained release formulation of the synthetic human growth hormone (hGH) somatropin. Trials demonstrated therapeutic plasma concentrations were achieved over an extended period of time supporting the development of the product as a once every two weekly injection. In addition, the efficacy profile using biomarkers was comparable to current daily formulations.

The new formulation was produced using Critical's patented CriticalMix delivery technology, which is based on world leading supercritical fluid expertise. This enables the optimal encapsulation of drugs into injectable microparticles with superior drug release properties. hGH delivery is a natural application for this technology, and the company now intends to take this product forward into Phase 1 clinical trials. This decision coincides with a recent report by Frost & Sullivan valuing the European market at $846.4m in 2007, with a compound annual growth rate (CAGR) of 2.4 per cent from 2007 to 2014. The report also highlighted new delivery methods together with approval for new indications as keys to success.

According to Chief Business Officer Gareth King, these preclinical results mark an important milestone for the company: "Over the past few years, we have concentrated on optimizing our delivery technologies and ensuring they are transferable from the lab into an industrial setting. Sustained release hGH is one of three projects we are now developing in areas of unmet need. There is no doubt that a sustained release version of hGH would be preferred by patients, particularly paediatric, but there are naturally concerns over safety and efficacy. We are confident the highly controlled release rates achieved with our technology will overcome these concerns. The plan is now to take this product into clinic either by ourselves or in partnership. We are also in preclinical development with sustained release Risperidone and, demonstrating the versatility of our technology platform, a once-daily nasal formulation of hGH."

About Critical Pharmaceuticals

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 http://www.criticalpharmaceuticals.com

Corporate Inquiries

Gareth King, Chief Business Officer

Critical Pharmaceuticals,

BioCity Nottingham NG1 1GF UK

Tel +44-115-8820100; +44-7720-051988

Email: gareth.king@criticalpharmaceuticals.com


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SOURCE Critical Pharmaceuticals
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