US-based drug maker Pfizer has signed a worldwide agreement with OPKO Health to develop and commercialise hGH-CTP to treat growth hormone deficiency (GHD) in adults and children.
The agreement includes the development of OPKO’s hGH-CTP to treat growth failure in children, who are born small for gestational age (SGA) and fail to show catch-up growth by two years of age.
The hGH-CTP is a long-acting recombinant human growth hormone analogue being developed by OPKO to treat 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.
Pfizer Global Innovative Pharma group president Geno Germano said: "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."
OPKO will receive an upfront payment of $295m and was provided with an option to receive up to an additional $275m upon the achievement of certain regulatory milestones.
The deal allows Pfizer to receive the exclusive license to commercialise hGH-CTP worldwide.
Pfizer noted that OPKO is also eligible to receive initial royalty payments associated with the commercialisation of hGH-CTP for adult GHD, which is subject to regulatory approval.
Currently, hGH-CTP is in a global Phase III trial for adults and a global Phase II trial for children. It has orphan drug designation in the US and Europe for both adults and children with GHD.
OPKO will be involved in clinical activities of hGH-CTP and is responsible for funding development programmes for key indications, including adult and paediatric GHD, as well as paediatric SGA.
Pfizer will take responsibility for all development costs for additional indications, as well as post-marketing studies. The company will also fund commercialisation activities for all indications and lead the manufacturing activities covered by the global development plan.
Subject to customary Hart-Scott-Rodino approval, the transaction is expected to be completed in the first-quarter of 2015.
Image: Pfizer World Headquarters. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.