Human growth hormone, molecular graphic (National Center for Biotechnology Information)
16 December 2014. The pharmaceutical company Pfizer is licensing an engineered compound to treat human growth hormone deficiency in adults and children from Opko Health Inc., a provider of therapeutics and diagnostics. The deal has a potential value to Opko of $570 million, plus royalties from sales.
Opko Health, based in Miami, offers drugs and diagnostic tests, that it commercializes from investments in and acquisition of intellectual property developed by other enterprises. In April 2013, Opko acquired the Israeli biotechnology company Prolor that designed a synthetic human growth hormone analog code-named hGH-CTP for both adults and children with growth hormone deficiencies.
Prolor’s CTP platform, based on research at Washington University in St. Louis, binds the natural peptide C-terminal peptide or CTP to therapeutic proteins and extends their activity time in the body. Clinical trials of hGH-CTP show it can reduce the dosing frequency for human growth hormone from the standard daily injections to one injection per week. The compound received orphan drug status in Europe and the U.S., and is currently in a late-stage clinical trial for adults and intermediate-stage trial with children.
Under the deal Pfizer gains an exclusive worldwide license to hGH-CTP. Opko will continue clinical development of hGH-CTP for growth hormone deficiencies in adults and children, as well as for growth failures in children born small for gestational age. Pfizer will be responsible for further applications of hGH-CTP, as well as all commercialization and manufacturing of the drug.
The agreement provides Opko with an initial payment from Pfizer of $295 million and up to another $275 million in regulatory milestone payments. Opko will also be eligible for royalties on sales of adult growth hormone products developed in the collaboration. Once a pediatric growth hormone product receives approval, royalties will shift to gross profit sharing on both hGH-CTP propducts and Genotropin, a drug currently offered by Pfizer for pediatric growth hormone deficiency.
In a company statement, Phillip Frost, Opko’s CEO, estimates the global human growth hormone market at $3 billion.
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Hat tip: FirstWord Pharma
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