Zosano, Eli Lilly Partner On Parathyroid Hormone Patch For Osteoporosis
By Cyndi Root
Zosano Pharma and Eli Lilly have partnered to develop Zosano's parathyroid hormone 1-34 (PTH). The companies announced the deal in a press release, stating that the proprietary formulation is a microneedle patch system for osteoporosis patients. A Phase 2 study of the agent is complete, and Zosano intends to advance to Phase 3 development.
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."
Zosano and Eli Lilly Agreement
Under the terms of the agreement between Zosano and Eli Lilly, the license is an exclusive and worldwide marketing agreement. If the agent proves viable in clinical trials, and regulatory submissions are successful, Lilly agrees to commercialize ZP-PTH. Zosano agrees to fund the development and conduct the clinical, regulatory, and manufacturing scale-up. Zosano also agrees to manufacture the product. Eli Lilly will invest $15 million in Zosano during Zosano's initial public offering. Eli Lilly will also make milestone payments up to $425 million. The manufacturing costs will be reimbursed, and Zosano will receive royalties on sales.
Parathyroid Hormone Patch
Zosano’s parathyroid hormone is engineered for delivery using a microneedle patch system that delivers the agent through the skin via titanium microneedles that penetrate 200 microns or less. The formulation allows for rapid delivery without injection needles and the accompanying pain. Zosano has tested 30,000 patches in preclinical and clinical studies and demonstrated that 30 compounds may be loaded onto the patch. The parathyroid hormone patch contains PTH 1-34, teriparatide (PTH), which stimulates bone formation and reduces bone fractures. The product does not need refrigeration and has a 36-month shelf life.
About Zosano Pharma
Zosano Pharma focuses on transdermal drug delivery. The company is working on loading various compounds with known safety and efficacy on its patch and is actively seeking partners to develop products. Zosano’s lead product candidates include ZP-PTH for severe osteoporosis, ZP-Glucagon for severe hypoglycemia, and ZP-Triptan for migraines. Zosano is also working on GLP-1, a diabetes treatment, with Novo Nordisk. The companies completed a feasibility study on GLP-1 in Q3 2014.