In 2006 the European Medicine Agency (EMEA) approved Sandoz’s follow-on biologic human growth hormone (hGH) and Frost & Sullivan believes this generic competition will drive innovation in the drug delivery sector.
The Frost & Sullivan report stated that, given it is predominately children who need to receive daily hGH injections, alternative drug delivery techniques could increase the market size and improve compliance.
Gareth King, chief business officer at Critical, told in-PharmaTechnologist that the company recognised this growth opportunity, adding that some “traditional drug delivery methods have failed using hGH”.
King believes its CriticalSorb technology has the potential to succeed in the sector. CriticalSorb is an adsorption promoter that in preclinical delivered biologics “with exceptional bioavailabilities”.
The technology can be applied to many biologics and is already being used by companies in their preclinical programmes. In addition to opening up new delivery routes CriticalSorb should face few regulatory hurdles as it uses generally regarded as safe (GRAS) materials.
Entering Phase I
An hGH nasal spray using CriticalSorb will enter Phase I in the middle to end of 2010, according to King, using £1.5m funding Critical received from the Wellcome Trust.
King added that moving the project quickly into clinical trials is just one of the benefits of the funding. He explained that the Wellcome trust is a well respected scientific organisation and consequently the award gives Critical “lots of credibility”.
To receive funding from the Wellcome Trust a proposal goes through a multi-stage review process, being viewed by internal and external experts, and consequently King believes the award reflects well on CriticalSorb.
King added that once Phase I is completed Critical hopes to license or sell its hGH product, at which point the credibility gained from the Wellcome trust may be valuable.