Pfizer, OPKO Partner for Human Growth Hormone Product
Pfizer Inc. and OPKO Health, Inc., a biopharmaceutical company, have entered into a worldwide agreement for the development and commercialization of OPKO's long-acting human growth hormone (hGH) therapy, 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. Under the agreement, 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.
As part of the agreement, 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, the company human growth hormone product.
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 is currently in a global Phase III trial in adults and a global Phase II trial in children and has orphan drug designation in the US and Europe for both adults and children with GHD. hGH-CTP is a novel, long-acting recombinant human growth hormone analog being developed by OPKO for the treatment of children with growth failure due to inadequate endogenous growth hormone secretion, and adults with growth hormone deficiency (GHD) of either childhood or adult-onset etiology. OPKO's proprietary technology allows the company to extend the hormone's half-life without the use of polymers, encapsulation techniques, or nanoparticles. This technology is based on a natural peptide, the C-terminal peptide (CTP) of the beta chain of human chorionic gonadotropin.
Under the agreement, 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. The transaction is subject to customary Hart-Scott-Rodino approval and is expected to close during the first-quarter of 2015.