辉瑞与OPKO联手开发长效人体生长激素hGH-CTP
1.长效人体生长激素（hGH-CTP）可以治疗儿童和成人生长激素缺乏症
2.hGH-CTP可以降低用药频率，由以往的每天注射一次降低为每周注射一次。
3.OPKO将因此获得2.95亿美元的预付款，并将视项目进展获得额外不超过2.75亿美元的资金。
4.按照辉瑞对hGH-CTP的商业化安排，OPKO可以获得相应的利润分成，辉瑞也将独占hGH-CTP在全球商业化的特许权。
OPKO与辉瑞今天宣布，他们联手开发治疗儿童和成人生长激素缺乏症的长效人体生长激素（hGH-CTP）全球商业化协议。hGH-CTP目前正处于成人方面全球性3期临床试验阶段和儿童方面全球性Ⅱ期临床试验阶段，是在美国和欧洲成人和儿童GHD的孤儿药。
此外，OPKO有资格获得受监管部门批准、成人GHD的商业化hGH-CTP的相关初次特权费用。儿童GHD的hGH-CTP受监管部门批准的特权费用将转变为hGH-CTP和辉瑞Genotropin毛利共享。
辉瑞将负责额外适应症以及所有上市后研究的所有开发成本。此外，辉瑞将投资所有适应症的商业化活动，并领导包括全球发展计划的生产活动。
“我们相信这一合作将有助于推动我们关于治疗患有生长激素缺乏症的成人和儿童患者承诺，我们相信辉瑞公司的优势、专业知识和人类生长荷尔蒙空间的存在，使他们是我们hGH-CTP项目的理想合作伙伴。 我们的合作使辉瑞和OPKO之间能充分调整优化发展，潜在为患者带来创新治疗。我们认为，全球生长激素市场目前的价值超过30亿美元，并相信hGH-CTP绝对是一流潜在长效生长激素产品。我们的长效人生长激素是使用CTP技术延长了治疗肽和蛋白质半衰期的最先进候选产品。通过减少注射次数可以提高患者的依从性。”OPKO的首席执行官Phillip Frost, M.D.说道。
OPKO and Pfizer Enter into Global Agreement for OPKO’s Long-Acting Human Growth Hormone (hGH-CTP)
hGH-CTP in global clinical development for the treatment of pediatric and adult growth hormone deficiency (GHD)
hGH-CTP has potential to reduce dosing frequency of human growth hormone to single weekly injection from current standard of daily injection
OPKO to receive upfront payment of $295 million and eligible to receive up to an additional $275 million upon achievement of regulatory milestones
Upon Pfizer’s commercialization of hGH-CTP, OPKO is eligible to receive royalty and/or profit sharing payments
Pfizer to obtain exclusive license to commercialize hGH-CTP globally
OPKO Health, Inc. (OPK) and Pfizer Inc. (PFE) announced today 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.
OPKO will lead the clinical activities and will be responsible for funding the development programs for the key indications, which includes Adult and Pediatric GHD and Pediatric SGA. Pfizer will be responsible for all development costs for additional indications as well as all post-marketing studies. In addition, Pfizer will fund the commercialization activities for all indications and lead the manufacturing activities covered by the global development plan.
"We believe this collaboration will help advance our commitments to patients with Adult and Pediatric Growth Hormone Deficiency as we believe Pfizer’s strengths, expertise and presence in the human growth hormone space makes them the ideal partner for our hGH-CTP program. Our collaboration enables full alignment between Pfizer and OPKO to optimize development and potentially bring an innovative treatment to patients. We believe that the global growth hormone market is currently valued at more than $3 billion, and believe that hGH-CTP has the potential to be the best in class long-acting growth hormone product. Our long acting human growth hormone is our most advanced product candidate utilizing our CTP technology to extend the half-life of a broad range of therapeutic peptides and
proteins. By reducing the number of injections, our technology can improve patient compliance,” said OPKO's CEO,Phillip Frost, M.D.
“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,” said Geno Germano, group president, Pfizer Global Innovative Pharma (GIP). “Long-acting growth hormone is the first innovation in the GHD space in 20 years. hGH-CTP would be complementary to our existing Genotropin franchise, and could potentially provide an option that could improve patients’ adherence to treatment with once weekly dosing.”
The transaction is subject to customary Hart-Scott-Rodino approval and is expected to close during the first-quarter of 2015.
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