Novacea is currently conducting a large international phase III trial evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC). Asentar is a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor.
Under the terms of the agreement, Novacea will receive an upfront payment of $60 million, including $35 million as reimbursement for past research and development expenses, a license fee of $25 million, and a commitment by Schering-Plough to purchase $12 million of Novacea common stock at a predetermined price within ten days of the closing.
Additionally, the agreement provides Novacea with potential pre-commercial milestone payments of up to $380 million, and tiered royalties on worldwide sales of Asentar. Closing of the transaction is subject to regulatory clearance.
Schering-Plough will be responsible for all forward development costs in exploring indications for earlier stages of prostate cancer, such as androgen-dependent prostate cancer and adjuvant therapy and will lead all global commercialization efforts for Asentar.
Novacea will provide medical support to Schering-Plough’s commercial operations for Asentar in the United States, including deployment of their Medical Science Liaisons, which will be funded by Schering-Plough.
“This agreement with Novacea allows us the potential opportunity to extend our oncology pipeline into a tumor with significant unmet need,” said Thomas Koestler, executive vice president and president of Schering-Plough Research Institute.