Pharming takes step towards lactoferrin commercialisation
companies in the US to bring its recombinant human lactoferrin to
the market, after submitting safety data to the Food and Drug
Administration.
The firm has been preceded by US-based Ventria Bioscience, which filed a notification for GRAS status - the route to acceptance in foods - last year. But with a base in Europe, and a production partner in Asia Pacific (New Zealand's AgResearch), the company is also looking ahead to marketing the ingredient in other regions like Asia, where the lactoferrin supplements are already well-established.
Pharming believes that its recombinant human lactoferrin will have nutritional advantages over the bovine version currently used in supplements.
The company's lactoferrin is produced in the mammary glands of transgenic cattle and then purified from the cows' milk. The protein has an identical structure to the lactoferrin produced by the body although there are some differences in the sugars that coat the protein.
Samir Singh, chief business officer at the firm, pointed to "a fair amount of studies in the literature" that reveal potential advantages, including some recent work done in Japan.
"The human receptors in the gut have the ability to bind and interact better with a human protein than a bovine one," he explained.
This would make the ingredient more effective in boosting gut health, he suggests.
The milk protein plays a role in binding iron in the gut and breaking open the cell membranes of microorganisms. It is thought to help fight infection and boost the immune system, as well as improving the intestinal microbial balance.
Singh said that more efficient binding of iron by the human protein than the bovine one may result in the lactoferrin remaining in the gut for longer, requiring less consumption and better health benefits.
The company has not yet tested the effects of its product in humans however, nor has it done a comparison trial with bovine lactoferrin.
"The first step will be to set up some non-exclusive relationships with key nutritional companies," Singh told NutraIngredients.com.
"We're talking to some manufacturers and nutritional companies in the US about the possibilities of using it as a standalone product or an ingredient in foods. A lot will depend on the partner, and relate to the end product. It may require additional end studies, for example if it is used in infant foods."
He added that there could also be partnerships with manufacturers of bovine lactoferrin who are interested in adding to their range.
The current market for bovine lactoferrin is thought to be worth around €100 million per year, with growth of about 20 per cent, suggests Singh. The majority of sales are in Asia where lactoferrin supplements are common and dairy companies fortify yoghurts with the protein.
This market is also likely to be more accepting of Pharming's technology. Recombinant proteins are made when the amino acid sequence is encoded by a cloned gene.The company may need to reassure future partners in Europe and the US about the safety of this technology although Singh is confident that attitudes are changing.
"We're interested in seeing how Europe develops. We appreciate that historically there have been concerns with some production technology but the environment is changing."
Pharming hopes to have a deal in place by the end of the year, "either distributing ourselves or in partnership with another company", said Singh.
"As we progress beyond the first stage, we'll probably do additional studies sponsored by our partners," he added.
FDA approval of the GRAS notification, expected by the end of the year, will make partnerships significantly more likely.
