Lilly In Deal To Supply 300,000 Vials Of COVID-19 Drug Bamlanivimab To U.S. Govt For $375 Mln

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.

For comments and feedback contact: editorial@rttnews.com

Article written by an RTT News Staff Writer, and posted on the RTT News.com website.

Article reposted on Markethive by Jeffrey Sloe

Pfizer To Apply For Emergency Use Of COVID-19 Vaccine By Late Nov.

By RTTNews Staff Writer | Published: 10/16/2020 9:48 AM ET

Pfizer Inc (PFE) said Friday that it will apply for emergency authorization use of its COVID-19 vaccine in the U.S. in the third week of November, once safety milestone is achieved.

The U.S. Food and Drug Administration wants at least two months of safety data before authorizing emergency use of any experimental coronavirus vaccine.

Pfizer, which is developing vaccine candidate BNT162b2 with German BioNTech SE (BNTX), said it will continue running its trial through its final analysis point, even if it is declared effective at an earlier stage. The company expects to reach safety milestone in the third week of November.

"As I've said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," CEO Albert Bourla wrote in an open letter.

BNT162b2 vaccine candidate is based on BioNTech's mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in a global Phase 3 study.

Earlier this month, Pfizer and BioNTech said that they have initiated a rolling submission to the European Medicines Agency for the COVID-19 vaccine.

Last month, the companies said they are on track to seek regulatory review for BNT162b2 as early as October 2020. If regulatory authorization or approval is obtained, the companies plan to supply up to 100 million doses worldwide by the end of 2020, and about 1.3 billion doses by the end of 2021.

For comments and feedback contact: editorial@rttnews.com

Article written by an RTT News Staff Writer, and posted on the RTT News.com website.

Article reposted on Markethive by Jeffrey Sloe

Tag Archives: COVID19

Lilly In Deal To Supply 300000 Vials Of COVID-19 Drug Bamlanivimab To US Govt For 375 Mln

Lilly In Deal To Supply 300,000 Vials Of COVID-19 Drug Bamlanivimab To U.S. Govt For $375 Mln

Pfizer To Apply For Emergency Use Of COVID-19 Vaccine By Late Nov

Pfizer To Apply For Emergency Use Of COVID-19 Vaccine By Late Nov.