OPKO Health, Pfizer Ink Agreement For Long-Acting Human Growth Hormone HGH-CTP

(RTTNews) - OPKO Health, Inc. (OPK) and Pfizer Inc. (PFE) have reached a worldwide agreement for the development and commercialization of OPKO's long-acting hGH-CTP for the treatment of growth hormone deficiency or GHD in adults and children, as well as for the treatment of growth failure in children born small for gestational age or SGA who fail to show catch-up growth by 2 years of age.

hGH-CTP has the potential to lower the required dosing frequency of human growth hormone to a single weekly injection from the current standard of one injection per day. Presently, hGH-CTP is in a global phase 3 study in adults and a global phase 2 trial in children and has orphan drug designation in the U.S. and Europe for both adults and children with GHD.

As part of the agreement, OPKO would 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 would receive the exclusive license to commercialize hGH-CTP worldwide. Further, OPKO is eligible to receive initial royalty payments associated with the commercialization of hGH-CTP for Adult GHD which is subject to regulatory approval.

Following the introduction of hGH-CTP for Pediatric GHD, the royalties would transition to gross profit sharing for both hGH-CTP and Pfizer's Genotropin. The transaction is expected to close during the first quarter of 2015.