Lilly and Amgen announce manufacturing collaboration for antibody therapies

Pharma News: Eli Lilly and Amgen announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies. 

Lilly is currently studying several potential neutralising antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies will have the ability to quickly scale up production and serve many more patients around the world should one or more of Lilly’s antibody therapies prove successful in clinical testing and receive regulatory approval.

“Based on our initial clinical studies, we believe that virus neutralising antibodies, including LY-CoV-555, could play an important role in the fight against COVID-19,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

“Increasing the manufacturing capacity for our neutralising antibodies through this collaboration with Amgen is a crucial next step, and together we hope to be able to produce many millions of doses even next year,” he said.

“We are impressed with Lilly’s data, in particular the reduction in hospitalizations, and are enthusiastic about the potential for these neutralizing antibodies as a therapeutic for COVID-19,” said David M. Reese, M.D., executive vice president of research and development at Amgen.

“These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce COVID-related hospitalizations,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. “The results reinforce our conviction that neutralizing antibodies can help in the fight against COVID-19.”

Lilly intends to publish the results of this interim analysis in a peer-reviewed journal and discuss appropriate next steps with global regulators. The BLAZE-1 clinical trial remains ongoing, testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds a different epitope in the SARS-CoV-2 spike region. The trial is currently enrolling a larger, confirmatory cohort of higher risk patients, testing the ability of the antibody combination to reduce the number of patients with persistently high viral load and reduce COVID-related hospitalizations.

Esteban Santos, executive vice president of Operations at Amgen, added “We are proud to partner with Lilly and leverage our deep technical expertise in antibody development and, in particular, our strong capabilities in the scale up and manufacturing of complex biologics. This is yet another example of the ways our industry is closely collaborating to combat this devastating disease and help patients around the world access new therapies.”