Celltrion is mass producing CT-P59 ahead of approvals
Celltrion is so confident that it will receive approval to run a Phase 3 trial on its Covid-19 treatment that it is manufacturing enough of the material ahead of time for the trial and for commercial distribution afterwards.
Its CT-P59 antibody candidate received the nod from the Ministry of Food and Drug Safety on Friday for Phase 1 clinical trials. The company will test the treatment on 32 healthy people for this stage of the approval process. Follow-up phases will require thousands of participants.
Confident that the results will be good, Celltrion Chairman and cofounder Seo Jung-jin said the company will start mass production at its Songdo, Incheon, factory in September, before all clinical trials are completed, so that treatments can be sold immediately if the government issues an emergency use authorization.
“A lot of countries issue permits for emergency use if necessary after Phase 2 clinical trials show efficacy and zero issues in terms of safety. Our goal is to fully cooperate with the government and reach commercialization in the shortest time possible,” said Seo during an online press conference held Monday.
The approval for Phase 1 tests came just a week after the company began the application process.
Starting mass production ahead of Phase 3 trials is also essential for authorization, which requires data that can validate Celltrion’s capacity to stably roll out the substance, he explained. Phase 3 clinical trials are planned for 3,000 patients in Korea and Europe.
“We’re expecting the production of the first batch and Phase 2 clinical trials will be completed at about the same time. If we can obtain an emergency permit at that point, the substance will be immediately available for use as a product to patients,” Seo added.
According to the chairman, 51 companies globally are in the race to find an antibody treatment against Covid-19. Antibodies can attach to viruses to neutralize their effect. This mechanism has been found effective and safe in treating other diseases, which is why Seo says side effects are unlikely.
“The real problem is price,” he said. “Fifty-one companies are on this. The key is which one can develop a treatment with the fewest side effects, maximum efficacy and a price tag that’s reasonable for everybody. That’s where the level of technology comes in. How much can we lower production costs? Do we have the capacity to make that possible?”
Price is key, not only for Celltrion but for all Covid-19 treatment developers, stressed Seo, because unless treatments can be distributed to all parts of the world, including developing countries, the pandemic will not disappear but continue to reappear.
To prevent supply shortages, the company is already in talks with contract manufacturing organizations (CMO) around the world. Combining its capacities in Songdo and the CMO capacity agreed upon so far, Seo said the company can make doses for 6 million people per year at the moment.
The ultimate goal is to complete all clinical trials and obtain a commercialization permits for CT-P59 by the first half of 2021.
The chairman and founder reaffirmed his January announcement to step down from leadership at the end of this year, even if it means walking away before CT-P59 is fully commercialized. He and a handful of colleagues started the company in 2002.
“I'll head the project myself until the year’s end. But after that point, my younger colleagues will take over. This company is not a weak organization; it’s not going to stumble because I leave, nor will it thrive just because I’m here.”
BY SONG KYOUNG-SON [firstname.lastname@example.org]
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