Collaboration will exploit Zosano’s delivery system to develop weekly patch for treating osteoporosis patients at high risk of fracture.
Zosano Pharma received a $7.5 million up-front payment from Japanese firm Asahi Kasei Pharma as part of a collaboration to develop a weekly transdermal patch formulation of the latter’s injectable parathyroid hormone (human PTH 1-34) Teribone™ (teriparatide acetate) for the treatment of osteoporosis patients at high risk of fracture. The subcutaneous injection Teribone was approved in Japan in September. The new weekly transdermal patch formulation will be based on Zosano’s ZP Patch Technology to administer human PTH (1-34) through the skin.
The deal was actually signed in February 2011, but has been kept under wraps by the two firms until Teribone achieved approval in Japan. Under terms of the deal AKP retains exclusive rights to develop and commercialize the transdermal a patch in Japan, Korea, China, and Taiwan, and will be responsible for all clinical and regulatory development and commercialization activities: clinical trials are expected to start in Japan in 2012.
Zosano could receive over $25 million in development, regulatory, and commercial milestones, plus royalties on AKP’s sales in its designated territories. The firms say they will also investigate potential joint development of the patch in other territories. “We believe this relationship will provide a superior fracture reduction and enhanced patient compliance compared to the currently available PTH injectabes,” comments Gail Schulze, Zosano CEO.
Zosano’s ZP Patch platform is a needle-free transdermal delivery system comprising a patch and reusable applicator, for the delivery of peptides, proteins, small molecules, and vaccines. The technology painlessly delivers therapeutic compounds via microprojections that permeate the skin’s outer layer, to provide rapid and efficient systemic delivery, the firm claims.