South Korean biopharma Celltrion says it is on the path to come up with the first antibody therapy to treat the flu as CT-P27 moves through Phase II clinical trials. Expectations are such that a successful outcome could bring a U.S. FDA breakthrough therapy designation.
The Korea Herald, citing the CEO and founder Seo Jung-jin, said preparations for the second part of Phase II trials are underway, though a location remains undetermined after the first part of the trial took place in London earlier this year.
“Given the possibility that the drug may receive ‘breakthrough therapy’ designation, we are looking at potential countries in which we can conditionally commercialize the drug without conducting phase-III trials (as protocol dictates),” Celltrion spokesman Lee Kun-hyuk told the Korea Herald.
The Celltrion candidate faces competition from the Genentech unit of Roche ($RHBBY), which is also at work on two antibody therapies along the same lines. But Celltrion, citing success in its development of biosimilars, said it is confident.
“As we have been a ‘first-mover’ in biosimilars, we hope that we can reap similar success in the new drug development arena as well,” Lee told the Korea Herald.
Celltrion hopes that its biosimilar of Remicade makes it on sales in the U.S. this year, despite a legal challenge Johnson & Johnson ($JNJ). Pfizer ($PFE) owns the U.S. rights to the copycat biologic by virtue of its purchase of Hospira last year--which in turn has a marketing pact with South Korea's Celltrion. The biosimilar dubbed Inflectra (infliximab-dyyb), has been sold in Europe since 2015.
- here's the story from the Korea Herald