Zosano Pharma, based in Fremont, Calif., and Eli Lilly have entered into an exclusive agreement to develop ZP-PTH, Zosano's proprietary formulation of parathyroid hormone 1-34 (PTH) using Zosano's microneedle patch system for treating osteoporosis patients, globally. Zosano has completed a phase II study of ZP-PTH for the treatment of severe osteoporosis and plans to conduct phase III development.
Zosano has granted Lilly an exclusive worldwide license to commercialize ZP-PTH. Lilly will make an equity investment of up to $15 million in Zosano concurrent with the consummation of Zosano's initial public offering of equity securities, and additionally make payments upon achievement of certain regulatory and sales milestones totaling up to $300 million for regulatory approvals and up to $125 million for sales milestones. Zosano also is eligible to receive double-digit royalties on sales of products in major markets and will receive reimbursement of all manufacturing costs.
Pending successful clinical testing outcomes and regulatory approval of ZP-PTH, Lilly will be responsible for commercialization of the product. Zosano will be responsible for funding and developing the product, including clinical, regulatory and manufacturing scale-up activities. Zosano also will manufacture the product and provide commercial product supply to Lilly.
"The treatment of osteoporosis has advanced significantly in recent years, and, if approved, Zosano's microneedle patch system could offer a potentially innovative way to deliver this important medicine," said David A. Ricks, president, Lilly Bio-Medicines and Lilly senior vice president. "Zosano shares our commitment to making life better for the tens of millions of people with osteoporosis around the world, and we look forward to helping advance this potential innovation to improve the patient's experience."
Vikram Lamba, CEO of Zosano, said, "The product, if approved, could help patients suffering from osteoporosis to get a room temperature stable PTH patch for self-administration, without the need for a subcutaneous injection."