Arnold & Porter Advises OPKO Health on Global Agreement to Develop Long-Acting Growth Hormone
NEW YORK, December 18, 2014 -- Arnold & Porter LLP client OPKO Health, Inc. announced on December 15 that they have entered into a worldwide agreement for the development and commercialization of OPKO's long-acting 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 2 years of age. 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 3 trial 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.
Under the terms of 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. 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.
Arnold & Porter's cross-practice legal team advising OPKO Health included attorneys from its New York, London and Washington, DC offices. The transaction team consisted of Blaine Templeman, Kristen Riemenschneider, Rachel Baylis, Tara Williamson and Steve Parker. The firm's regulatory team included Daniel Kracov, Lincoln Tsang and Abeba Habtemariam, while Scott Lent and Barbara Wootton served as antitrust counsel. Tax aspects of the deal were handled by Cynthia Mann.
Arnold & Porter has a cross-office and cross-departmental focus on advising a wide-range of clients in the life sciences sector, and an extensive track record of licensing, merger and acquisition and other transactions for pharmaceutical companies, biotechs, medical device companies and others in the life sciences.