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By RTTNews Staff Writer | Published: Published: 10/28/2020 7:14 AM ET
Eli Lilly and Co. (LLY) announced Wednesday an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg for $375 million in an effort to fight COVID-19.
Bamlanivimab is a potent, neutralizing IgG1 monoclonal antibody or mAb directed against the spike protein of SARS-CoV-2. Lilly in early October submitted a request for an Emergency Use Authorization or EUA for bamlanivimab to the FDA for the treatment of mild to moderate COVID-19 in high-risk patients.
If FDA grants an EUA, the U.S. government will accept the vials of bamlanivimab, which will be delivered over the two months following an EUA. The agreement also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021, under the same terms.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.
Further, a Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. Bamlanivimab is also is being tested in the National Institutes of Health-led ACTIV-2 study of ambulatory COVID-19 patients.
The company's discussions with global regulators are ongoing.
The U.S. government has further committed that patients will have no out-of-pocket costs for the medicine, if granted EUA, although healthcare facilities may charge a fee for the product's administration.
The company noted that the federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab. As part of this government program, Lilly is partnering with Operation Warp Speed and a national distributor to finalize distribution plans and shipping preparations, should an EUA be granted.
Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, with 100,000 doses ready to ship within days of authorization.
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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.
Article reposted on Markethive by Jeffrey Sloe
