Development and commercialization deal


Our attorneys advised long-time client Pfizer on its worldwide agreement with OPKO Health Inc. to develop and commercialize OPKO’s long-acting human growth hormone (hGH-CTP) for the treatment of growth hormone deficiency (GHD) in adults and children. hGH-CTP has the potential to reduce the dosing frequency of human growth hormone from the current daily injection standard to just a single weekly injection.

Under terms of the agreement, which was announced December 15, 2014 and is expected to close 1Q 2015 subject to customary Hart-Scott-Rodino approval, Pfizer will receive the exclusive license to commercialize hGH-CTP worldwide. OPKO will receive an upfront payment of $295 million and be eligible to receive up to an additional $275 million upon the achievement of certain regulatory milestones. Further, OPKO will receive 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 global growth hormone market is currently valued at more than $3 billion and hGH-CTP is believed to have the potential to be the best in class long-acting growth hormone product. Pfizer says the agreement strengthens its commitment to rare diseases, complements its existing Genotropin franchise and will help provide a potential next-generation therapy for patients with adult and pediatric GHD.

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