It’s important to stay on top of the latest services, companies and innovations. EPM’s Chemical Reaction highlights a technology, service or business we think would be worth keeping an eye on. . .
Nigel Theobald, N4 Pharma offers an insight into the company’s latest offerings to the pharma sector.
Nigel Theobold, N4 Pharma
EPM: Who are you and what do you do?
NT: N4 Pharma is a drug reformulation company focused on developing and out licensing new versions of existing high value drugs with an unmet commercial or medical need.
N4’s commercial strategy is to advance a pipeline of products through clinical proof of concept and then partner to take the products through bio-equivalence studies to regulatory approval. This simplified regulatory pathway reduces development risk and results in faster market access. We also offers our Cocrys service (which uses hot melt extrusion to manufacture co-crystals) to pharmaceutical companies with their own molecules that have issues with solubility and need a commercially robust process to help take them into clinical trials and beyond to a commercially scalable formulation.
EPM: What have you focussed on recently?
NT: Our initial focus has been on developing Cocrys. The co-crystals can be used to improve a drug’s solubility either to improve onset of action or increase bioavailability and can also be used to control the solubility to enable a sustained release effect. Crucially the process uses standard twin screw extruders and is therefore capable of large volume efficient commercial production of the co-crystals.
We have also developed Nuvac a nano-carrier delivery system for antigens that improves both humoral and cell mediation effects for vaccines. It can be used to reduce vaccine dose or improve vaccine or antibody drug conjugate performance and our first program with Nuvac is a single dose version of the hepatitis B vaccine using the antigen HBsAg.
EPM: What is you latest service/ innovation?
NT: Our latest product we are developing is a new improved version of Sildenafil (Viagra). Sildenafil base API is highly insoluble and has been formulated and marketed as Sildenafil Citrate, a salt to improve its solubility. Despite this improvement on the base product Sildenafil citrate still takes around an hour to take effect. This can lead to clinical problems for patients who are concerned that having taken the drug it has not worked and who subsequently ‘double dose’. It is also a problem and an opportunity for the drug as it becomes more widely available to consumers, assuming the current attempts to switch to OTC status are widely successful.
N4 is developing a patented co-crystal of Sildenafil that will have a faster onset of action (target 15 minutes) and improved bio-availability. Cocrys enables new co-crystals to be developed and manufactured that will meet the FDA requirements for this new version of the drug to be classed as a drug product intermediate so therefore it will only require 505(b)(2) approval in the USA and Article 10 in Europe.
EPM: How can you benefit the pharmaceutical sector?
NT: As well as developing our own products we offer our Cocrys system to pharma companies under license to develop more soluble versions of either generic molecules or their own molecules.
For companies wishing to investigate the potential of Cocrys we initially offer a simple screening service to identify the most appropriate co-crystal to use, produce a small quantity of this co-crystal using a 16mm hot melt extruder and test its dissolution profile. Once we have approved the preferred co-crystal we then optimise the co-crystal to 100% purity and produce GMP quantities for small-scale clinical trials.
Cocrys is set to revolutionise the approach to manufacturing co-crystals that can then be easily commercially scaled to large volume market requirements.
EPM: Future plans?
NT: After optimising the Sildenafil co-crystal we intend to undertake a small patient study to determine the faster acting pharmacokinetic profile and bioavailability of the new co-crystal. At this point we will be looking to partner with a pharmaceutical company to take the product through larger scale clinical work to get the required regulatory approval for launch.
In addition we are looking to develop improved versions of itraconazole (much lower cost of goods) and Alendronate with improved bioavailability to reduce associated gastric issues.
We are also strengthening our own internal hot melt capability to cope with the increased demand we expect for the use of our Cocrys system. All in all a very exciting and high growth time for N4 Pharma.