After more than a decade in development, XP-828L has recently come to market in France (with Cothera) and Canada (Jamieson Laboratories) aimed at sufferers of mild to moderate psoriasis, under the Dermylex brand.
However Renaud Beauchesne, president and CEO, told NutraIngredients-USA.com that the company has had to be careful how much it can offer because of limited availability.
"We had an initial plan for this year, but demand has been much higher," he said. "The capacity will be there next year."
Beyond psoriasis, the Canadian company's long-term plan has been to look at how it may help alleviate the symptoms of other immunity-related health conditions too, and to this end it conducted preliminary studies on its use for atopic dermatitis and irritable bowel disease (IBD) like Crohn's disease.
The positive IBD results were publicized last October, and the company said today that the early results for atopic dermatitis indicate it could be useful for this condition too.
Atopic dermatitis, also known as eczema, is characterized by dry skin that may appear anywhere on the body in small patches or covering large portions of skin. It is generally recognized to be an immune-mediated skin disease, characterized by a predominance of IL-4, which leads to IgE production and, as a consequence, inflammation.
Advitech's orally administered sweet-whey extract is said to have demonstrated "significant results in reducing in vitro and in vivo IL-4 production by immune cells", but Beauchesne said that the company is not releasing the full results of the latest research just yet, as it will take another two to three months to perform additional analysis.
He expects that it will be 18 months before Advitech is ready to introduce a nutraceutical for the condition to market. When it is, it could be well received by around 6 percent of the population of Western countries estimated to suffer from the disorder.
Because of the relative complexity and expense associated with clinical trials for IBD, a product for this condition is thought to be two years off.
Beauchesne said that even though the XP-828L platform is being researched for its benefits for particular health conditions, Advitech is still considering it as a nutraceutical rather than a pharmaceutical.
How it complies with regulatory requirements with this positioning varies from market to market. Beauchesne said that the claim for mild to moderate psoriasis is possible for a nutraceutical in some European markets, and in Canada it is working with Health Canada.
In the US, he expects the company will have to seek a structure/function claim from the FDA, which could take some time. The other alternative would be to enter the market without a claim.
"That way is also possible, but it will depend on what the marketing partner wants."
Advitech has a preliminary agreement in the US with PhotoMedex, and in Taiwan with Enbio-Life Biotechnology & Medical Co.