Celltrion completes Phase 2 tests of Covid treatment
According to the company Wednesday, a total of 327 coronavirus patients with light and moderate symptoms took part in the Phase 2 tests in Korea, the United States, Romania and Spain.
In Phase 1 trials, the CT-P59 antibody treatment completely neutralized the virus in four to five days from the point of administration to patients with light-symptoms, Celltrion said.
Another month is needed for data analysis of the Phase 2 clinical trials. Then Celltrion will apply for a “conditional” emergency use authorization from the Ministry of Food and Drug Safety — “conditional” in that the company promises to conduct Phase 3 clinical trials.
Obtaining a sales permit for drugs is a rigorous process that conventionally takes years. With the urgency of this pandemic, governments have been fast forwarding the procedures.
Eli Lilly and Regeneron’s antibody treatments for Covid-19, for example, obtained emergency use authorization from the U.S. Food and Drug Administration this month in the middle of Phase 3 trials.
Celltrion’s Chairman Seo Jung-jin has expressed confidence that the company will be able to complete necessary procedures and approvals for a market release by early 2021. Kim Kang-lip, head of the Ministry of Food and Drug Safety, promised fast authorization during a visit to Celltrion’s factory in Incheon, Wednesday.
“To ensure that it can be distributed to local hospitals as soon as the permit arrives, we started producing CT-P59 at our Songdo plant in September and stockpiled doses that could treat around 100,000 patients,” Celltrion said in a Wednesday statement.
According to the company, 100,000 doses is more than enough to treat patients in Korea, even with wider outbreaks. As of Wednesday, some 31,000 people came down with the disease in Korea since the pandemic started, among which 26,000 have recovered. Some 513 died and the rest are in hospitals or quarantine.
CT-P59’s Phase 3 clinical trials will test efficacy and safety on a larger scale. Phase 3 tests will be conducted in 10 countries or more.
Celltrion’s goal is to produce enough CT-P59 to treat 1.5 to 2 million patients a year.
As for the price, Chairman Seo has said in interviews with local media that CT-P59 will be sold to Korean patients with zero profit for Celltrion.
“The price that Eli Lilly or Regeneron offered to the U.S. government as they obtained the authorization — to my knowledge that’s around 4 million won [$3,600] to 4.5 million won per patient,” Seo said in a Tuesday interview with TBS Radio.
“I already made a promise to sell our treatment at cost in Korea,” he said, later admitting that would make it around one-tenth of what the U.S. pharmaceutical companies are charging for Covid-19 treatments.
Seo made it clear that Celltrion would put on a higher price on overseas sales — but still “slightly lower” compared to other global competitors.
A Celltrion spokesman said there is no company policy on CT-P59’s price yet.
BY SONG KYOUNG-SON [firstname.lastname@example.org]
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