These companies are demonstrating that it is not just the probiotic giants that are willing invest large percentages of their revenues in research and development, even in a European environment where academics and industry warn of the research damage being wrought by the so-far 100% rejection of probiotic health claim submissions by the European Food Safety Authority (EFSA).
€13m UK firm Probiotics International is most active in the animal nutrition area – 55% of its revenues come there – but its human arm accounts for 30% and is growing fast and helping feed overall growth forecasts of 20% in 2011 as its operations spread into 50 countries.
Its current human nutrition portfolio sits at three digestive and gut health-marketed products, but it wants to add more, so it has commissioned three product-specific studies in the areas of Irritable Bowl Syndrome (IBS), hospital superbugs and thrush, with EFSA’s take on probiotic science very much in mind.
What has gone before is redundant
"These studies are in reaction to the EU nutrition and health claims regulation (NHCR),” commercial director Jonathan Sowler told NutraIngredients. “We are trying to find a way through that.We have been waiting on the sidelines watching what has been going on and while not crystal clear we think these trials can meet EFSA’s requirements.”
The IBS trial is the first due for completion in two years time, a timeframe that may mean the current gut and immune health claims may have to be pulled if the 200+ probiotic rejections enter EU law books at the beginning of 2012 if time frames are met.
“We expect that we may have 18 months where we may not be able to make any claims,” Sowler conveyed. “We think this regulation is harsh, and you can see that is not just a commercial point of view when you look at the academic reaction to some of the rulings, but in a way it has been good for smaller companies because we have been able to catch up because even the well-documented strains of Danone or Yakult have not won EFSA support.”
“Much of the science that has gone before is completely redundant now.”
But like most in the claims game, he called on pre-submission meetings with the agency to guide trials design.
“These trials are expensive but we have no guidance on them. The thing is industry would be willing to pay for pre-submission meetings but EFSA says it doesn’t have the resources so we have to hope for the best.”
Spain
Spanish biotech company AB-Biotics is another small company investing big in research. The company emerged in 2004 from the University Autònoma of Barcelona and has developed a number of branded probiotic offerings selected from a bank of 550 “wild type” strains.
It is proposing health conditions ranging from cholesterol reduction to gut health.
One of its strains, AB-I3.1, targets IBS and communications officer, Nuria Peláez, said early clincical research had thrown up positive results.
“It inhibits common intestinal pathogens while allowing the growth of normal commensal bacteria, reduces the levels of inflammatory cytokines IL-6 and IFN-g , produces SCFAs that stimulate serotonin release and induces regenerative processes in inflamed gut mucosa,” he said. More studies were underway.
Probiotech, Milan, June 23-24
For the latest developments with real market relevance in pre- and probiotic science, formulation, markets and marketing places are still available at Probiotech in Milan, Italy, on June 23-24.
Leading academics, analysts, regulatory and industry experts will share their know-how in areas like probiotic films, animal feed, genonomics, pharma formulations.
Click here for more information about the two-day programme.