Pfizer is partially funding OPKO Health’s hGH-CTP development and commercialization initiatives in a deal that is potentially worth more than $570 million. hGH-CTP is a long-acting recombinant human growth hormone analog for the treatment of growth hormone deficiency (GHD) in adults and children. It is currently in a Phase III trial in adults and a Phase II study in children and has orphan drug designation in the U.S. and Europe.
Pfizer said it will pay OPKO an upfront payment of $295 million and up to an additional $275 million if certain regulatory milestones are achieved. The pharma giant will be given the exclusive license to commercialize hGH-CTP worldwide.
In addition, OPKO is eligible to receive initial royalty payments associated with the commercialization of hGH-CTP for adult GHD. Upon the launch of hGH-CTP for pediatric GHD, the royalties will transition to gross profit sharing for both hGH-CTP and Pfizer’s growth hormone treatment Genotropin.
According to the company, the agent could reduce the required dosing frequency of human growth hormone to a single weekly injection from the current standard of one injection per day. The company will lead the clinical activities and be responsible for funding the development programs for the key indications, which includes adult and pediatric GHD and children born small for gestational age. Pfizer is assuming responsibility of costs for all other indications.
OPKO picked up hGH-CTP from its $480 million acquisition of Prolor Biotech in April 2013.
“This agreement strengthens Pfizer’s commitment to rare diseases, and we are pleased to work with OPKO to help provide a potential next-generation therapy for patients with adult and pediatric growth hormone deficiency,” said Geno Germano, group president, Pfizer Global Innovative Pharma. “Long-acting growth hormone is the first innovation in the GHD space in 20 years. hGH-CTP would be complementary to our existing Genotropin franchise, and could potentially provide an option that could improve patients’ adherence to treatment with once weekly dosing.”