Critical Pharmaceuticals, the 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, based on supercritical fluid liquification of the encapsulating polymer and efficient distribution of the hGH in the dry state. 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 Office 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.”