Lilly to supply 300,000 vials of COVID-19 monoclonal antibody to the U.S.

Eli Lilly and Company officially announced on Oct. 28, an initial deal with the U.S. government to supply 300,000 vials of the COVID-19 monoclonal antibody bamlanivimab (LY-CoV555) 700 mg in a deal worth $375 million.

Deal worth $375 million sees U.S. government secure promising COVID-19 monoclonal antibody

The $375 million supply agreement, comes just as the U.S. has reported a huge rise in COVID-19 cases in recent weeks. The world superpower has set a new all-time high for confirmed coronavirus cases over a 24-hour period today, reporting just over 100,000 new infections to beat the record of 91,000 recorded the previous day, according to a Reuters tally.

The investigational neutralizing monoclonal antibody Bamlanivimab vials may be accepted by the U.S. government if an Emergency Use Authorization (EUA) is issued by the U.S. Food and Drug Administration (FDA). In early October, Lilly submitted a request for a EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA.

U.S Government may purchase 650,000 additional vials of Lilly’s COVID-19 monoclonal antibody

The initial official deal is for the supply over a two month period following a EUA. Moreover, it provides the option for the U.S. government to purchase up to an additional 650,000 vials through to June 30, 2021, under the same terms as the base contract and subject to agreement from Lilly, product availability and the medical need in the U.S.

Lilly’s chairman and CEO, David A. Ricks stated:

“Lilly has leveraged our deep scientific capability to fight this pandemic and we are proud of our efforts to develop potential medicines to combat COVID-19. Supply agreements with governments – such as this one with the U.S. government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy. The U.S. is experiencing a surge in COVID-19 cases and associated hospitalizations, and we believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”

The U.S. government has decided, once an EUA is awarded, that patients will have no extra expenses for the drug, although healthcare centers may charge a fee for the administration of the medication, a government allocation programme for bamlanivimab, which has been implemented by the federal government in collaboration with state health departments. Lilly is working in partnership with Operation Warp Speed and a nationwide distributor as part of this government initiative to finalize delivery schedules and shipment arrangements.

The intravenous application of therapeutics to patients with confirmed mild to severe COVID-19 confronts the healthcare system with challenging problems. Therefore, Lilly also partners closely with Operation Warp Speed to help U.S. federal and state departments to define and establish alternatives for facilities where patients can receive this therapy safely and reduce the spread of infections.

Lilly to manufacture up to 1 million doses of bamlanivimab by the end of 2020

By the end of 2020, Lilly plans to manufacture up to 1 million doses of bamlanivimab 700 mg, with 100,000 doses eligible for shipping within days of approval, for use around the world. Starting in Q1 2021, the availability of Lilly’s antibody therapy is projected to expand dramatically as supplementary production capacity comes online during the year. Lilly has a stable global supply chain in place to manufacture bamlanivimab, with the manufacturing of five active pharmaceutical ingredients (APIs).

Dedicated to ensuring rapid access to this life-saving drug to patients globally, Lilly engaged in large-scale production of bamlanivimab taking on significant risk, as this bold move long preceded the data revealing that the investigational drug is a potentially safe and effective treatment option for COVID-19.

Discussions with global regulatory bodies are currently ongoing. Global allocation will be made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet need, no matter where they live.

David A. Ricks added:

“We are also partnering with governments and philanthropic organizations around the world to ensure a fair and transparent allocation of the limited supply of our antibody therapies to those who need it most, based on a global methodology using data from trusted research centers”.

About Lilly’s COVID-19 monoclonal antibody Bamlanivimab (LY-CoV555)

Bamlanivimab is an effective, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is developed to inhibit and prevent viral penetration and attachment into human cells, blocking the virus, potentially preventing and treating COVID-19. Bamlanivimab has been developed in partnership between Lilly and AbCellera devoted to creating antibody therapies to combat and eradicate COVID-19.

Initially, the antibody has been analysed after being isolated in a blood sample taken from one of the first U.S. patients who recovered from COVID-19. In less than three months after being discovered by AbCellera and the researchers of the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center, Lilly’s scientists quickly developed the antibody.

A Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628) has already been successfully completed by Lilly. A Phase 2 trial in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. 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 currently ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study of ambulatory COVID-19 patients.

Bamlanivimab results from the BLAZE-1 study indicate that this investigational therapeutic may be effective in treating the viral infection by significantly minimizing viral load, symptoms and the risk of hospitalization in individuals newly diagnosed with mild to moderate COVID-19.

The levels and forms of adverse effects between bamlanivimab and placebo were comparable, with the majority being mild to moderate in severity and with no significant adverse drug-related events reported to date. Other trials of the neutralizing monoclonal antibody bamlanivimab have reported, generally mild to moderate, drug-related infusion reactions or hypersensitivity (two reported as severe infusion reactions, both participants recovered).

About Lilly’s COVID-19 Efforts

Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19.

About Eli Lilly and Company 

Lilly is a worldwide pioneer in healthcare that blends science with innovation to develop drugs that change people’s lives for the better around the globe. More than a century ago, the company was founded by a man dedicated to developing high-quality drugs that met real needs, and today, in all its work, Lilly remains true to that purpose. Lilly’s employees around the world are striving to develop and introduce life-changing drugs to people who need them, enhance the knowledge and treatment of various illnesses, and payback to societies, through philanthropic endeavours and volunteerism.

For more information please visit: www.lilly.com and www.lilly.com/news. 


Original Source: https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-us-government-supply-300000-vials


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