OPKO Health, a multinational biopharmaceutical and diagnostics company, and Pfizer have entered into a worldwide agreement for the development and commercialization of OPKO's long-acting hGH-CTP for the treatment of growth hormone deficiency (GHD) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (SGA) who fail to show catch-up growth by two years of age.
hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone to a single weekly injection from the current standard of one injection per day. hGH-CTP currently is in a global phase III trial in adults and a global phase II trial in children and has Orphan Drug designation in the U.S. and Europe for both adults and children with GHD.
OPKO will receive an upfront payment of $295 million and is eligible to receive up to an additional $275 million upon the achievement of certain regulatory milestones. Pfizer will receive 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, which is subject to regulatory approval. Upon the launch of hGH-CTP for pediatric GHD, which is subject to regulatory approval, the royalties will transition to gross profit sharing for both hGH-CTP and Pfizer's Genotropin.
OPKO will lead the clinical activities and will be responsible for funding the development programs for the key indications, which includes adult and pediatric GHD and pediatric SGA. Pfizer will be responsible for all development costs for additional indications as well as all post-marketing studies. In addition, Pfizer will fund the commercialization activities for all indications and lead the manufacturing activities covered by the global development plan.
"We believe that the global growth hormone market currently is valued at more than $3 billion, and believe that hGH-CTP has the potential to be the best in class long-acting growth hormone product,” said Phillip Frost, M.D., OPKO's CEO. “Our long acting human growth hormone is our most advanced product candidate utilizing our CTP technology to extend the half-life of a broad range of therapeutic peptides and proteins. By reducing the number of injections, our technology can improve patient compliance."