Takeda group begins manufacturing COVID-19 plasma treatment ahead of approval
NEW YORK (Reuters) - The Takeda Pharmaceutical Co-led group that is developing a blood plasma treatment for COVID-19 has started manufacturing while the late-stage trial to determine whether it works is ongoing, Takeda 4502.T Chief Executive Christophe Weber said on Monday.
The group, known as the CoVIg Plasma Alliance, enrolled its first patient in the Phase III trial on Friday after months of delays. It aims to enroll 500 adult patients from the United States, Mexico and 16 other countries and hope to have results by the end of the year.
“The likelihood it works is very high,” Weber said in an interview. “And that’s why we have launched a campaign in order to accelerate the donation of convalescent plasma to manufacture and produce this product.”
The alliance, which includes CSL Behring, Germany's Biotest AG BIOG.DE and other companies, is testing a hyperimmune globulin therapy, which is derived from blood plasma of people who have recovered from COVID-19. Hyperimmune globulin therapy offers a standardized dose of antibodies and does not need to be limited to patients with matching blood types.
That makes it more advanced and convenient than treatment with convalescent plasma drawn from recovered patients.
The manufacturing process is expensive.
Weber said the treatment could be slightly more costly to make than monoclonal antibody treatments like the ones Regeneron Pharmaceuticals Inc REGN.O and Eli Lilly and Co LLY.N have developed. The alliance does not intend to profit from the treatment, Weber said.
The Takeda CEO said he does not know how many doses of the treatment the group will be able to produce by the end of the year. That will depend on donations as well as the dosage size they decide to test in the clinical trial.
The trial will test the hyperimmune globulin therapy in combination with Gilead Sciences Inc's GILD.O antiviral drug remdesivir compared with patients who get remdesivir alone, he said.
OCTOBER 13, 2020