Tag Archives: Eli Lilly

U.S. has a plan to start Pfizer vaccine shots in December: Health Secretary Azar

By Doina Chiacu and Deena Beasley

WASHINGTON (Reuters) – If Pfizer Inc. submits the positive initial data from its COVID-19 vaccine trial to health regulators as quickly as expected, the U.S. government plans to begin vaccinating Americans in December, Health Secretary Alex Azar said on Tuesday.

Pfizer on Monday said the vaccine it has been developing with German partner BioNTech SE was 90% effective against COVID-19, based on an early look at results from its large, late-stage trial.

The U.S. drugmaker said it expects to have safety data as soon as next week that it needs to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration.

Upon FDA authorization, the United States would receive about 20 million doses of the Pfizer vaccine per month, Azar said on a call with reporters, noting that HHS could being procuring supplies at the end of this month.

The United States has a $1.95 billion contract for 100 million doses of the Pfizer vaccine – enough to inoculate 50 million people – with an option to acquire 500 million more.

Earlier on Tuesday, Azar said on CNBC that final decisions are subject to a close look at the vaccine efficacy data.

Based on recommendations to the government, it will likely start with inoculations of the elderly in nursing homes and assisted living facilities, healthcare workers and first responders, with a goal to complete those shots by the end of January.

Top U.S. infectious disease expert Anthony Fauci also said in an interview with MSNBC that he expects the doses of the vaccine to be available for certain high priority groups in December.

Azar said he anticipates there will soon be more vaccines to protect against COVID-19 from other companies, including Moderna Inc <MRNA.O>, which is expected to announce interim results of a large trial of its experimental vaccine at the end of the month.

“By the end of March, early April, we expect to have enough for every American who would like to be vaccinated,” Azar told CBNC.

ANTIBODY DRUG DISTRIBUTION

Azar also said the U.S. government would begin distribution of Eli Lilly and Co’s antibody treatment this week, starting first in areas with the highest numbers of hospitalized COVID-19 patients and overall cases.

The treatment, which is administered by infusion, received an EUA on Monday.

“We’ll ensure equitable distribution, and we’ll work tightly with our governors,” Azar said. He said the government will use the same process employed to distribute remdesivir, an antiviral drug from Gilead Sciences Inc used to treat people hospitalized with COVID-19.

According to the Health and Human Services website, the agency will ship more than 79,000 doses of the antibody therapy this week, with the largest number going to Wisconsin, Texas, California, and Illinois.

The United States has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.

Azar said health officials and Eli Lilly were exploring ways to provide the treatment outside of hospitals, including through outpatient infusion centers.

Fauci described the Lilly treatment as “an important first step in the development and distribution of interventions that are given early in the course of disease.”

(Reporting by Doina Chiacu in Washington, Caroline Humer and Carl O’Donnell in New York, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; Editing by Andrew Heavens, Alexandra Hudson and Bill Berkrot)

Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

Eli Lilly backs U.S. proposal on drug rebates to lower costs

The logo and ticker for Eli Lilly and Co. are displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 18, 2018. REUTERS/Brendan McDermid

By Tamara Mathias

(Reuters) – Eli Lilly and Co on Wednesday embraced a U.S. government proposal to end a decades-old system of rebates drugmakers make to industry middlemen, saying it could lower the cost of insulin and other prescription drugs for patients.

Lilly, along with other major insulin makers, Sanofi SA and Novo Nordisk, has been under mounting pressure from patients and politicians over the rising cost of the life-sustaining diabetes treatment.

“While it’s still a proposal, we see this as … a win for patients, lowering their out-of-pocket costs at the pharmacy counter with the greatest benefit realized by patients taking more highly-rebated products such as insulin,” Chief Executive David Ricks said on a call with analysts.

Drugmakers argue they have to keep prices high because of the rebates they must pay to pharmacy benefit managers and health insurers to get products on their lists of covered drugs. In January, the administration of U.S. President Donald Trump proposed a rule that would end the rebate system or pass along the savings to patients.

“We’ll adapt to whatever rules come out and how they get finalized,&rdquo; Ricks said.

Lilly on Wednesday also cut its 2019 profit and revenue forecasts to account for disappearing sales of its cancer drug Lartruvo, which won conditional U.S. approval in 2016 based on early data but last month failed to extend patient survival a confirmatory trial. Costs related to Lilly’s pending $8 billion acquisition of Loxo Oncology also contributed to the revised forecast.

Lilly has said it is suspending promotion of Lartruvo and it will no longer be prescribed to new U.S. patients.

The Indianapolis-based drugmaker’s research and development spending is also expected to rise as it develops Loxo’s pipeline of targeted drugs for cancers driven by rare genetic mutations.

The company said it now expects 2019 adjusted earnings of $5.55 to $5.65 per share, down from its prior forecast of $5.90 to $6.00. It expects revenue of $25.1 billion to $25.6 billion versus its prior view of $25.3 billion to $25.8 billion.

“The forecast cut was generally expected, given the Loxo acquisition and the Lartruvo failure were known events,” Edward Jones analyst Ashtyn Evans said.

“Diabetes will always be an area where we’ll see pricing pressure. Lilly fully takes that into consideration when giving guidance,” she added.

Excluding items, Lilly earned $1.33 per share, a penny shy of analysts’ average estimate, according to IBES data from Refinitiv.

Eli Lilly shares fell 1.3 percent to $118.82.

(Reporting by Manogna Maddipatla, Tamara Mathias in Bengaluru and Julie Steenhuysen in Chicago; Editing by Saumyadeb Chakrabarty and Bill Berkrot)

U.S. lawmakers request info from insulin makers on rising prices

FILE PHOTO: Insulin supplies are pictured in the Manhattan borough of New York City, New York, U.S., January 18, 2019. REUTERS/Carlo Allegri

By Yasmeen Abutaleb

WASHINGTON (Reuters) – Two powerful U.S. lawmakers sent letters to the three leading insulin manufacturers on Wednesday requesting information on why its cost has skyrocketed in recent years and how much the companies profit from the life-sustaining diabetes treatment.

Democratic Representatives Frank Pallone and Diana DeGette, the chairman and a top-ranking member of the House Energy and Commerce Committee, respectively, wrote to the heads of Eli Lilly and Co, Novo Nordisk and Sanofi, the long-time leading manufacturers of insulin. The drugmakers have all raised the price of insulin at similar rates over the last several years.

“Despite the fact that it has been available for decades, prices for insulin have skyrocketed in recent years, putting it out of reach for many patients,” the lawmakers wrote.

“As one of the few manufacturers of insulin in the United States, your company is well-suited to shed light on these issues and offer potential solutions,” the letter to the three companies said.

The committee has not set a date for a hearing, a spokesman for DeGette said. It has the power to subpoena the drugmakers if they do not answer the committee’s request.

The annual cost of insulin for treating a type 1 diabetes patient in the United States nearly doubled from 2012 to 2016 to $5,705 from $2,864, according to a recent study.

The lawmakers’ letters come amid intensifying scrutiny from Congress over the high cost of prescription drugs for U.S. consumers. Both the House Oversight Committee and Senate Finance Committee held hearings on prescription drug prices on Tuesday, with a focus on insulin.

Sanofi confirmed receipt of the letter and said it would work with the committee on its request. Neither Novo nor Lilly immediately responded to requests for comment.

High prescription drug costs have consistently polled as a top voter concern and have been a top priority of the administration of U.S. President Donald Trump, a Republican.

U.S. prescription drug prices are far higher than in other developed nations that either directly or indirectly control medicine costs.

Democratic Representative Elijah Cummings earlier this month wrote to 12 pharmaceutical companies asking for detailed information on their pricing practices, including the makers of insulin.

About 1.2 million Americans have type 1 diabetes, requiring daily insulin. Type 2 diabetes, which affects nearly 30 million Americans, according to the American Diabetes Association, is treated with a variety of other medicines. But those patients may also eventually become dependent on insulin.

(Reporting By Yasmeen Abutaleb; Editing by Bill Berkrot)