I don't think CNC is a public company.
The recent PR is probably to capitalise on the funding tranche achieved. It has marketing value in many ways, as long as it does not conflict with the licensing process.
I think the message to take away from this is that licensing is close, and there are no significant obstructions. For example if the primary deliverable required for a UK NRT is cessation of smoking, then NRTs do not need to deliver nicotine cessation
per se.
Since the Snus safety data was used as the main proof of safety for extended NRT use in the UK, it follows that nicotine use is not seen as harmful, at least in comparison to smoking. Smoking kills a measurable proportion of users, whereas Snus (in Sweden, and when using Swedish-made products) is proven to have no significant elevated risk of mortality, i.e. a Snus user has the same risk as a non-smoker. Therefore long-term nicotine use in and of itself poses no significant risk of mortality. The risk, if any, compared to smoking, is at least one million times less. There may be undetected (or unmeasured) risk of low-level morbidity at population level, but taken against the risk from smoking, it is not significant. If it is safe to prescribe Chantix for smokers, when balancing the risk, then it must be safe to consume nicotine
ad lib. Unrestricted nicotine use is provably thousands of times safer than Chantix, after all.
I believe that Intellicig has been working on various types of trials for about two years. Some may be applicable to pharma licensing, and some not. There is not exactly an over-abundance of lab or clinical data in this field, so it may well be that much of it is useful. Some very interesting information has resulted from this work, some of which has been published, some not. For example, some of the research appears to show that nicotine delivery from an e-cig, into the bloodstream of the user, is much faster than previously observed.
Some other research seems to show unusual implications for the nicotine strength of refill liquid and we may be making an announcement about this soon.
In general, Intellicig are spending money on clinical research, are probably unique in this respect, and as a result we can probably expect data useful to the entire industry from it.
In the UK, previous relevant documentation may be used in an application for the MA (market authorisation). This means that a company does not have to duplicate work that has already been done, such as for therapeutic supply of nicotine. You can see that this will reduce costs and time considerably. In addition, should such documentation pre-exist, then clinical trials can be small-scale, for example with 24 participants instead of the much larger numbers usually required.
The reasons why an e-cigarette licensed as an NRT will be highly profitable in the UK are:
- The NRT e-cig will be placed in front of tens of thousands of doctors and clinicians in surgeries, health centres, hospitals, and nursing-led treatment centres.
- It will appear in the MIMS book and the pharmacopeia.
- It will make a massive splash in the medical magazines. Sales will be monumental when word gets out.
- Many doctors are aware their current prescriptions have around a 95% failure rate in the long term.
- It will legitimise the concept of harm reduction because although current NRTs are often marketed as some form of of THR, their failure rates in this mode are abysmal.
- All medications are state-funded so there is no problem there. Patients can pay £7.50 per prescription (~$12), or get a yearly ticket for about £100 (~$160). Medication is free thereafter (except for some ultra-expensive categories where there is argument about who pays the cost).
- Depending on the initial classification, there are more possible sales options. It depends on whether the product is prescription-only, OTC or deregulated (supermarket shelf, like patches etc).
- Chemists (pharmacies) will market the product strongly, once 'approved'. Private sales of the licensed product will be substantial.
- Mail-order sales to overseas destinations is another route: a unique, UK-licensed pharma product will have status elsewhere.
Unless the product is time-limited for prescription use, the Sate will actually be be funding e-smokers, so they will have to do some thinking about that. Long-term / repeat prescriptions would turn out to be a losing option...
So there are good reasons why the product will do well. We didn't include any of the multiple reasons that an approved pharma product will boost Intellicig's other sales. Their standard e-cig product is currently considerably under-marketed, and this would likely change. In addition, they own a Quit Smoking mentoring service which contracts to the NHS, and you can guess which product will be featured strongly after licensing is achieved.
However the situation in the US may well be different. I would think that, eventually, pressure on the FDA from well-funded sources will remove any obstacles. Time will tell. The MHRA were far more conservative in their obstruction to e-cigarettes, so they have less damage to undo. Profit is the ultimate motive and will fix anything in the end.
