Export of New Drug Technologies
Amid local bio pharmaceutical companies’ active development of new drug technologies, the Korean bio pharmaceutical industry shows mixed results in new technology exportation. The technology export of Kolon Life Science’s degenerative arthritis drug “Invossa” worth 440 billion won (US$407.11 million) to Japan is in peril, while HanAll Biopharma entered into a 550 billion won (US$508.79 million) deal to export the technology of new drug candidate.
HanAll Biopharma announced that it has signed an agreement with Switzerland-based Roivant Sciences to export the technology of its anti-FcRn monoclonal antibody HL161 for US$502.5 million (545.2 billion won). Under the agreement, Roivant will have the exclusive sales rights in Europe, North America, Latin America, Middle East and North Africa when HL161 is commercialized.
HanAll Biopharma, a biotechnology firm acquired by Daewoong Pharmaceutical for 104.6 billion won (US$96.85 million) in 2015, succeeded in exporting the technology of HL161, an antibody biomedicine for autoimmune diseases. Previously, Celltrion developed Remsima, a biosimilar for autoimmune diseases, for the first time in the world. However, HanAll Biopharma has become the first South Korean company that developed an original treatment for autoimmune diseases.
On the other hand, Kolon Life Science announced on the same day that it received a request from Japan’s Mitsubishi Tanabe Pharma to return 2.5 billion yen (US$22.06 million or 23.83 billion won) of contract money, along with the cancellation of the technology export deal of Invossa. Mitsubishi Tanabe said it would rescind the deal because Kolon Life Science did not explain that its subsidiary TissueGene, the developer of Invossa, considered changing the production site for the phase-3 clinical trial in the U.S. when the agreement was signed. The Japanese firm also argued that Kolon Life Science did not deliver the U.S. FDA’s clinical hold letter (CHL), which stated that a clinical trial should begin after receiving approval for the use of the investigational drug for the phase 3 clinical trial.
An official from Kolon Life Science said, “We shared information about it before signing the deal so Mitsubishi Tanabe’s claims do not seem to be sufficient for canceling the deal. When the two companies fail to reach an agreement, we are planning to file for arbitration at the Korean Commercial Arbitration Board.”
Kolon Life Science is in perplexity as Mitsubishi Tanabe notified that it would rescind the technology import deal. The company entered into the technology export deal of Invossa with Mitsubishi Tanabe in November last year. The deal is worth 45.7 billion yen (US$403.21 million or 44 billion won), including 2.5 billion yen (US$22.06 million or 23.8 billion won) of down payment and 43.2 billion yen (US$381.2 million or 416 billion won) of technical milestones. There are also concerns that the phase 3 clinical trial for Invossa in the U.S., which is scheduled in April next year, can be adversely affected when the contract is canceled.
Invossa, which was developed by Kolon Life Science with 18 years of its research and development, is the world’s first cell-mediated gene therapy for noninflammatory degenerative joint disease. Since Invossa has proved its efficacy in easing pain and improve the function for two years with just one injection in knee, it is considered a rising start that leads the global degenerative arthritis drug market worth 45 trillion won (US$41.69 billion) a year. Invossa has been releasing in South Korea from last month after receiving approval from the Ministry of Food and Drug Safety in July.