Insulin long-acting(Hanmi Pharmaceutical)

September 29, 2016 By Mark Terry , BioSpace.com Breaking News Staff Genentech , a member of the Roche Group (RHO) , licensed HM95573 from Seoul, South Korea-based Hanmi Pharmaceutical Co. for a deal that could hit $910 million. HM95573 is a pan-RAF inhibitor currently in Phase I clinical development. The Phase I trial is being underwritten by the South Korean Ministry of Health and Welfare for $545,843 (US). RAF kinases have three subtypes, A, B and C, and are associated with several different types of cancers. RAF stands for rapidly accelerated fibrosarcoma, and they are retroviral oncogenes that are overexpressed in cancer. Genentech is paying an upfront fee of $80 million and up to $830 million in various milestone payments. Hanmi will also be eligible for tiered double-digit royalties on any commercial products. “We are pleased to collaborate with Genentech, which has significant expertise in the field of oncology,” said Gwan Sun Lee , Hanmi’s chief executive officer and president, in a statement. “We are excited about the potential this license agreement with Genentech will bring to the development of HM95573 and the potential benefit this may offer to cancer patients worldwide.” Hanmi has had a string of licensing deals valued at $6.42 million recently, and indicated that it is increasing its research-and-development operations. In a March press conference, Son Jee-woong , the company’s chief medical officer, said, “Nearly 15 percent of the company’s total sales revenue is reinvested in the company’s research and development for the past 15 years. Such a ratio is unseen in any other pharmaceutical company in the world. Despite last year’s immense success, the company is still quite small compared to other global drug companies. In order to compete in the global market, Hanmi should further develop core technologies in specialized categories.” The two areas it plans to focus on are novel long-acting biologics based on its Lapscovery platform and combination therapies in diabetes and obesity dubbed the Quantum Project , and on targeted agents against cancer and autoimmune disorders. Currently the company has 28 research projects underway. The Lapscovery platform allows a drug’s effects to last up to a month longer. The Quantum Project itself involves three diabetes drugs, Efpeglenatide, LAPSInsulin115 and LAPSInsulin combo. Hanmi has an exclusive licensing deal with Paris-based Sanofi to develop and commercialize the Quantum Project. It is worth 3.9 billion euros. Under that deal, Sanofi has exclusive global rights to develop and commercialize the Quantum Project, except in Korea and China. It also has a deal with Johnson & Johnson ’s Janssen Pharmaceuticals to develop and commercialize oxyntomodulin-based drugs that improve metabolism, insulin secretion and suppress appetite. Under that deal, Janssen has global rights to develop and commercialize HM12525A except in Korea and China. J&J paid an upfront fee of $105 million, and Hanmi could receive up to $810 million in various milestone payments, as well as tiered double-digit royalties. Of the new deal, James Sabry , senior vice president and global head of Genentech Partnering said in a statement, “This collaboration demonstrates our commitment to bring the best science in the world to Genentech with the ultimate goal of developing life-changing therapies for people with cancer. We are excited to partner with Hanmi and leverage their scientific insights to develop novel therapies that target the MAPK pathway.”