Biomira and Merck KGaA amended their collaboration and supply agreements related to Stimuvax®. This vaccine candidate is designed to induce an immune response to cancer cells that express MUC1, a protein antigen expressed in common cancers. Merck currently is conducting a global Phase III trial in patients with unresectable Stage III non-small-cell lung cancer.
Biomira will receive a payment of $2.5 million upon clearance of the transaction with the U.S. antitrust authorities.
Under the terms of the restated deals, Merck will have worldwide marketing rights to and will be entirely responsible for the further clinical development of Stimuvax. Biomira is entitled to development- and sales-based milestone payments and a royalty on net sales.
Biomira retains responsibility for the manufacture of Stimuvax, including process development and scale-up for commercial manufacturing. Merck will exclusively purchase the drug from Biomira. With respect to purchases for commercial sales, the price will be subtracted from Biomira's royalty. The new transactions provide Biomira with revised payments based on manufacturing scale-up and process transfer milestones.
Merck KGaA and its U.S. affiliate EMD Serono expect to enroll more than 1,300 patients in approximately 30 countries for the Phase III study. The trial is designed to assess survival in patients receiving best supportive care and Stimuvax, compared with patients receiving best supportive care alone.