BSP Pharma, a joint venture between leading specialty fats company Aarhus United and biopharma firm Astion, received regulatory approval from the FDA for the ingredient earlier this month.
Exhibiting at Natural Products Expo West in Anaheim next week, it is hoping to identify a North American partner to launch the patented BSP 201.
A clinical trial on the supplement suggests that it could help ease pain in joints and muscles affected by arthritis. Carried out last year, the study found that a daily supplement significantly reduced muscle soreness caused by repetitive exercise in human subjects. The cytokines released by the muscle strain (TNF-a and IL-6) play a key role in arthritis and a number of other systemic inflammatory conditions.
BSP 201 contains a high content of triterpene esters and is made from concentrated fractions of sheanut oil, which has GRAS status in the US. Shea butter, also derived from the sheanut, was introduced to the Western diet in the 1930s and is still used in foods. It has also been used for decades in cosmetics, valued for its emollient properties and ability to treat irritated skin.
FDA accepted a 'New Dietary Notification' on the active ingredient earlier this month, a significant boost for the company ahead of its launch on the US market at Natural Products Expo.
"Being able to launch and sell BSP 201 on the US market is a significant milestone for this product. The approval from FDA has certainly strengthened our situation tremendously," said Tonny Jorgensen, chief executive officer of BSP Pharma.
The company is looking for one or more leading supplement manufacturers to launch the product. Jorgensen said he expected to find the right partners for the launch this year with products ready for the market shortly after.
"BSP 201 has very strong positive attributes for the end user, as its relieving effect on joint and muscle soreness is faster and stronger than other products relevant for arthritis and muscle pain. Moreover it is well tolerated and extremely gentle to the body," he added.
In 2004 the global market for products treating arthritis is expected to reach $17.7 billion.
BSP 201 is said to be easy to formulate into soft-gel caps, into sports products or into a wide variety of foods as a functional ingredient.
Contact Tonny Jorgensen for further information on the product.