The start-up pharma company which span out from the University of Nottingham, UK presented its two innovative biologics drug delivery– the CriticalSorb nasal and the CriticalMix long acting injectable – technologies at the GPCM Event (Global Pharmaceutical Contract Manufacturing) in London.
Faron Jordan, Head of Preclinical and Clinical Development at Critical, said the company was able to get funding due to being focused on peptide and protein delivery – an area that has certain patient compliance issues.
“30 percent of new drug application are biological drugs,” with a market value of $100bn (€76bn) he said, “but the problem is that 98 percent of them have to be given as injection.”
Whilst compliance with a critical drug such as insulin will be high, products such as growth hormones which are not life-threatening if not taken fall short in patient administration, especially as they are often given to children. Such drugs may cost up to $5000 per gram to manufacture and is therefore a huge waste of money if thrown out each month.
Therefore, after having received a $2.3m grant from the Wellcome Trust and with backing of Big Pharma – though which company exactly was not divulged – behind it, Critical moved forward with its two technologies.
At present, the firm has one candidate (the CP024 growth hormone) in Phase I clinical trials, using the CriticalSorb nasal drug delivery technology.
Jordan said the nasal route was attractive due to a number of reasons, especially for biologics, including: the large surface area, an excellent blood supply, a rapid onset, the avoidance of first pass metabolism, ease of use and a potential for delivery direct to the brain.
This drug delivery technology is a long acting injectable which, though it is in an early clinical trial stage, could offer patients a monthly administration in place of a weekly or even a daily injection.
According to Jordan this technology would be a challenge to the PEGylation technique – the addition of polyethylene glycol (PEG) in order to permit targeted release and offer better pharmacokinetics – but without the need to modify the molecule.
The process involves high temperatures and pressure in order to form Supercritical carbon dioxide (scCO2) that has the ability to plasticize polymers. This is mixed with the biologic resulting in a liquefied mixture that can produce microparticles, implants or fibres for delivery.
As a start-up biopharma company, Critical has been outsourcing work as and when required, approaching CMOs in order to manufacture clinical batches.
Such work cannot be done in-house, Jordan explained, as it would need a large amount of capital investment, a bigger team, equipment and documentation.
He said with the nasal technology the sourcing of a CMO is not a problem as the product is manufactured via spray drying which is a fairly established technique. However, with the CriticalMix high pressure technology selecting the right CMO is more difficult and Critical had “been burnt in the past.”
However, if the technology makes it to the marketing stage or is licensed to a Big Pharma company, Jordan said the CMO would be retained as a safe provider and thus such a contract now could be lucrative in the future.