This approval triggers the final milestone payment of $4 million to Upsher-Smith Laboratories under Unigene’s exclusive US licensing agreement.
Fortical will be manufactured at Unigene’s production facility in Boonton, New Jersey. The final product will be packaged, marketed and sold in the US by Upsher-Smith. Unigene will sell the filled product to Upsher-Smith and receive royalties on Upsher-Smith’s sales.
“We are thrilled that the FDA has approved Unigene’s Fortical as an important therapy for the osteoporosis market, which in 2004 grew nearly 18% to reach $4 billion,” said Mark Evenstad, Upsher-Smith president and vice chair. “We look forward to engaging our marketing and distribution expertise to help make this important calcitonin product available to the millions of Americans affected by osteoporosis.”