Cephalon will assume all expenses for Phase III studies, regulatory filings and subsequent commercialization of the product.
ImmuPharma has received a $15 million upfront fee at the initiation of the deal in 2008. In exercising its option, Cephalon will pay ImmuPharma a one-time license fee of $30 million. ImmuPharma could receive future cash milestone payments upon the achievement of certain regulatory and sales milestones, as well as royalties on commercial sales of Lupuzor. The various cash milestone payments may total up to approximately $500 million.
Lupuzor has shown that it modulates, through a unique mechanism, a specific subset of CD4 T cells which play a critical role in the physiopathology of Lupus. This investigational medication has the potential to halt the progression of the disease in a substantial proportion of patients. Patents for Lupuzor have been approved in Japan and Australia, and the US Patent Office recently issued a notice of allowance, the company said.
Lesley Russell, executive vice president and chief medical officer of Cephalon, said: We are pleased that this Phase IIb study shows a favorable efficacy and safety profile for Lupuzor. We will initiate plans to implement pivotal Phase III clinical trials in 2009.