Pharming balances expenses while awaiting FDA lactoferrin review
with its finances in first half 2006, with both costs and expenses
and losses totalling €8.1mm as awaits the US FDA's review of its
GRAS filing for its human lactoferrin for functional foods.
The core activities of Pharming, which reported a cash position of €41.6m for the six month period, revolve around developing innovative protein products. While it puts much of its resources into treatments for disorders and surgical indications, its human lactoferrin is one of the two products in late stage development.
The other is recombinant human inhibitor for hereditary angioedema (rhC1INH) - and while Pharming has awaited the FDA's response, most of the developments over the past six months have centered around this - including the fast-tracking of its Marketing Authorisation Application with the European Medicines Agency.
The human lactoferrin GRAS filing, made at the tail end of 2005, is expected to make commercialisation considerably easier in the US, but the company is also looking to market the ingredients in other regions such as Europe and Asia. Since it has a base in Europe, and a production partner in Asia in the form of New Zealand's AgResearch, it already has an advantage in these markets.
"The company will provide an update on the progress being made with [this product] when specific milestones have been met," it said.
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.
The company believes human lactoferrin will have nutritional advantages over the bovine version currently used in supplements.
Samir Singh, chief business officer at the firm, pointed earlier this year 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, and suggested that this would make the ingredient more effective in boosting gut health.
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.
Other key financial developments during Pharming's first half including raising €17.1m in equity to develop rhC1INH for new indications and for corporate purposes; US$15m in cash and $5m in equity from affiliates of the Paul Royalty Fund; an increase in inventories from €3.9m to €7.7m in preparation for the rhC1INH launch.
"In the first half of 2006, Pharming attained a solid cash position through key transactions and well controlled costs and expenses," said CEO Dr Francis Pinto.
The company is also awaiting a decision from the Enterprise Section as to its planned acquisition of Rotterdam-based biopharmaceutical company DNage, which develops products for medical and health problems associated with ageing.
