Nutra launch for future pharmaceuticals helps build market
nutraceuticals, with a view to pharmaceutical launch at a later
date, is helping expand supplement-makers' toolkit - as well as
providing biotechs with a revenue stream earlier.
Some technologies, particularly those from natural sources may have applications in supplements and foods intended to promote health and reduce the risk of disease, as well as in pharmaceuticals for treatment or cure.
But whether they are classified as nutra or pharma depends on the level of research completed, and regulatory approval they have obtained.
The relative simplicity of nutraceutical regulatory requirements means that some companies launch a nutraceutical on the market with the aim of ticking all the classification boxes to be a pharmaceutical at a later stage.
Moreover, there is a trend towards biotechs drawing on revenues from their nutraceutical portfolios to help fund pharmaceutical development, and if an ingredient may have applications in both - and can meet the regulatory requirements for both - there is no reason why the market strategy cannot be two-pronged.
Although the European regulatory landscape is becoming more stringent (and costly to comply with) with the 2002 Food Supplements Directive requiring the compilation of dossiers containing evidence of safety and efficacy, it still does not require the full spectrum of phase I to III clinical trials.
For instance, Alltracel expects that its cellulose fibre bioactive will be available for use in functional foods before pharmaceuticals - even though it has been investigating the cholesterol-lowering effects of the bioactive in synergy with statin drugs in tandem with research using plant sterols and omega-3.
"It is not illogical to have the technology present in both drugs and non-drugs," said chief marketing officer Noel Toolan. "Pharmaceutical companies are looking for better and safer cures, and the food drive fits in with the shift towards healthy eating."
Likewise Australian biotech Phosphagenics has said that the phosphorylation technology behind its GTP-0805 drug candidate could also have a use in foods.
While it is designed to enhance the bioavailability of drugs and improve absorption through the gastrointestinal tract or skin, the company has said that the phosphorylated variant of gamma-tocopherol could also be added to lycopene-rich foods like tomato sauce to boost the carotenoid's anti-cancer activity.
But whether or not they are planning to go the full pharmaceutical hog or not, companies do not generally call a halt to scientific study once a nutraceutical ingredient has come to market.
Indeed, there is an industry push towards more science to help build trust in products amongst both consumers and health care practitioners, particularly in the US where individual ingredients and the supplements industry as a whole have come under fire from those that would like to see them lumped under the same regulations as pharmaceuticals.
For Canada's Advitech, a desire to build credibility for a nutraceutical with health care professions (thus building sales potential through recommendations) led to a postponement of the launch of Dermylex, an oral product from sweet whey that has been shown to benefit sufferers of mild to moderate psoriasis.
Although Dermylex is expected to debut in France, Canada, US and Taiwan this year (three years after it was originally due) Advitech is also looking to back up treatment claims with further research into its use for other chronic inflammatory diseases such as Crohn's disease, ulcerative colitis and arthritis.
Canadian government is contributing C$610,000 - half the total budget - towards a three-year research project at Université Laval aimed at identifying new applications, and potential alternative sources besides sweet whey (such as bovine colostrum) that would increase the quantities available to the market.
