BASF Corporation (Florham Park, NJ) and DIEM Labs, LLC (Buffalo, WY) have entered into a distribution agreement to commercialize BASF’s first U.S. medical food product for the dietary management of patients with non-alcoholic fatty liver disease (NAFLD).
As part of this agreement, BASF will use its scientific expertise and state-of-the-art manufacturing capabilities to provide a first-to-the-market medical food product to patients with NAFLD. DIEM Labs will market the product to health care professionals in the U.S. and sell it through an online hub. The product will be available to U.S. patients, who are under the supervision of a physician for NAFLD management.
NAFLD is defined as fat accumulated in the liver, representing more than 5 percent of its weight. This condition has an estimated prevalence of 20 to 30 percent in the western population, and is closely linked to obesity and metabolic syndrome. Diagnosis often starts with abnormal liver function test results or detection of hepatic steatosis during incidental imaging. If the condition is not managed, it can progress to more severe liver damage such as fibrosis and cirrhosis. By managing the condition at an early stage, called “simple steatosis,” the disease can be controlled. Currently, there is no dedicated product available on the market specifically targeting patients with NAFLD, and patients are left with no solution to improve their condition other than undergo extensive lifestyle changes.
BASF acknowledged the significant unmet need and developed a new medical food product for the dietary management of patients with NAFLD. A product-specific human intervention trial including more than 170 patients has been conducted by BASF to show that the product is effective and safe in the dietary management of patients with NAFLD. The to-be-launched product will therefore add to the current standard of care for NAFLD. It is anticipated that it will be commercially available throughout the U.S. in the first half of 2018.
Specially formulated foods are increasingly used as part of the overall management regimen for certain diseases or associated conditions and play a vital role in supporting a patient’s nutrient requirements.
“With this step, BASF is entering an attractive new market segment in the space between human nutrition and pharma,” said François Scheffler, head of BASF’s Global Human Nutrition and Pharma Solutions Businesses. “This further supports our mission to enable people to live a healthy and fulfilling life.”
“We are delighted to work together with such a renowned company as BASF in the medical foods market,” added Cai Berg, CEO of DIEM labs. “The new product will offer a solution to patients who currently have no other alternative than lifestyle modifications to turn their NAFLD around.”