In an exclusive global license agreement with Medigene, Dr. Falk Pharma is taking over both responsibility for and all the costs pertaining to the marketing and clinical development of Medigene's RhuDex® for indications in hepatology and gastroenterology. Medigene will be retaining those same rights for rheumatoid arthritis, psoriasis, and other autoimmune disease indications.
Per the agreement, Falk Pharma will be giving Medigene an upfront payment and future milestone payments, as well as double-digit RhuDex royalties. Falk Pharma is initially planning to concentrate on development of RhuDex for primary biliary cirrhosis, an autoimmune disease that affects the bile ducts.
Medigene is developing RhuDex as a modifying agent for the oral treatment of autoimmune diseases. According to the firm, RhuDex can bind to the CD80 protein, preventing interaction with the CD28 protein receptor on the surface of T cells and thus blocking a signaling pathway of T-cell activation. The company also says it successfully concluded a Phase IIa pilot trial for the indication rheumatoid arthritis.
"Falk Pharma has already successfully developed and launched several drugs to treat diseases of the liver and biliary tract," Medigene CEO Frank Mathias, Ph.D., said in a statement. "After the transforming acquisition of Trianta Immunotherapies, this partnership for RhuDex represents another major step in the implementation of our strategy for sustainable growth."