Tag Archives: Gilead

U.S. infectious disease group backs Gilead’s remdesivir for COVID-19 treatment

By Rebecca Spalding

(Reuters) – The top U.S. infectious disease medical association said on Monday that Gilead Sciences Inc’s antiviral drug remdesivir should be used for hospitalized COVID-19 patients despite a World Health Organization (WHO) recommendation last week against its use.

The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance.

“As hospitals around the United States fill up, the IDSA panel views the effect of remdesivir speeding up time to recovery to be an important benefit,” Dr. Rajesh Gandhi, co-chair of the society’s COVID-19 treatment and management guidelines expert panel, said on a call with reporters. “Better medicines that improve survival are clearly needed.”

Unlike the trial that led to its U.S. regulatory approval, the WHO’s study was not placebo-controlled. Studies with a placebo comparison are generally considered more scientifically rigorous than those without a control group.

The IDSA also has advised against the routine use of Eli Lilly and Co’s COVID-19 antibody treatment bamlanivimab, which received U.S. emergency use authorization. The IDSA panel said it recommended against its routine use for ambulatory patients, but that it may still be appropriate for patients with increased risks after a discussion with their doctor.

“Antibodies may end up having a role. I think we just need more definitive data,” Dr. Gandhi said. “I want to keep our eye on what benefit they may end up having as well as which patients are most likely to benefit.”

It said Roche Holdings Ag’s rheumatoid arthritis drug Actemra, known chemically as tocilizumab, is not recommended for routine use in hospitalized COVID-19 patients, saying there was still not enough evidence supporting its benefits.

(Reporting by Rebecca Spalding; Editing by Bill Berkrot)

EU urged to review remdesivir supply deal after COVID trial results

By Francesco Guarascio

BRUSSELS (Reuters) – The European Union should renegotiate a 1 billion euro ($1.17 billion) contract it sealed last week with Gilead for a six-month supply of the COVID-19 drug remdesivir after it showed poor results in a large trial, experts said on Friday.

In a blow to one of the few drugs being used to treat people with COVID-19, the Solidarity Trial conducted by the World Health Organization showed on Friday that remdesivir appeared to have little or no effect on mortality or length of hospital stays among patients with the respiratory disease.

The trial results were disclosed a week after the EU’s executive Commission announced its largest contract to date with Gilead for the supply of 500,000 courses of the antiviral drug at a price of 2,070 euro per treatment, which Gilead said was the standard for wealthy nations.

The Commission “needs to present the reasons behind the rush to conclude the latest contract with Gilead and move to review it in light of the Solidarity Trial findings,” said Yannis Natsis, who represents patients’ organizations on the board of the European Medicines Agency (EMA), the EU drug regulator.

The EU announced on Oct. 8 that it had signed the supply contract with the U.S. company on behalf of its 27 member states and 10 partner countries, including Britain.

Gilead had known about the results of Solidarity since Oct. 6, the WHO said, citing disclosure rules under the Solidarity Trial.

Gilead told Reuters it had received in late September an “heavily redacted manuscript” from the WHO which contained different information from the final document published on Friday.

“TIME IS OF THE ESSENCE”

The Commission’s decision was made after EU countries warned of shortages of remdesivir in their hospitals amid a new surge of COVID-19 infections across Europe.

The contract does not oblige countries to buy remdesivir, although it ties them to the agreed price.

Gilead did not comment on whether remdesivir’s price for wealthy countries could change after the WHO trial, and the company questioned its results.

“As time is of the essence – we are in a situation of a public health emergency – we have to not only invest up-front in vaccine development but also in access to therapeutics,” a spokesman for the European Commission said.

He added the EMA would look into the Solidarity results and data available from other studies on COVID treatments “to see if any changes are needed to the way these medicines are used”.

But the spokesman did not comment on whether the EU was aware of the Solidarity results before it signed the contract with Gilead. He also did not reply to questions on whether the price agreed with Gilead could be renegotiated.

“The EU should revisit the prices to be paid for Remdesivir. Why pay 1 billion euros for a drug with no effects on survival?” said Andrew Hill, a senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

He said generic versions of the drug manufactured in India were sold at 200 euros per course.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller; Editing by Gareth Jones)

Gilead bolsters cancer portfolio with $21 billion acquisition of Immunomedics

(Reuters) – Gilead Sciences Inc will acquire biotech company Immunomedics Inc for $21 billion, a move that will strengthen its cancer portfolio by gaining access to a promising drug, the two companies said in a joint statement on Sunday.

The deal will give Gilead access to Immunomedics’ breast cancer treatment drug Trodelvy, which was granted an accelerated FDA approval in April for an aggressive and tough to treat type of breast cancer.

Gilead said it would issue a tender offer to buy all the outstanding shares of Immunomedics for $88 per share, representing a premium of about 108% over their last closing price of $42.25 on Friday.

“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio,” Gilead Chief Executive Officer Daniel O’Day said in a statement. “Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer.”

Immunomedics is also on track to file for regulatory approval for Trodelvy in Europe in the first half of 2021, according to the statement.

The deal – and a separate transaction between Merck & Co and Seattle Genetics’s announced on Monday – was a sign of renewed confidence in an approach in oncology to pair antibodies with toxic agents to fight cancer.

Immunomedics’ Trodelvy is a so-called antibody-drug conjugates, or ADC, a class described by researchers as “guided missiles” that zero in on tumors to release cytotoxins that deliver up to 10,000 times the potency of standard chemotherapy, while minimizing damage to healthy tissue.

Merck, for its part, struck a deal with Seattle Genetics worth up to $4.2 billion, comprising stock purchases, an upfront payment and milestone rewards, to collaborate with the partner on two ADCs against breast cancer and other tumors.

In previous landmark deals for the field, AstraZeneca last year committed up to $7 billion for rights to Daiichi Sankyo’s Enhertu, another breast-cancer targeted ADC. It followed up in July with a deal worth up to $6 billion for DS-1062, another ADC developed by the Japanese drugmaker.

Trodelvy targets triple-negative breast cancer that has spread to other organs. Both aggressive and tough to treat, those tumor types account for 15-20% of breast cancers, lacking three genetic characteristics for which there are more treatment options.

Cancer immunotherapy Tecentriq by Gilead CEO O’Day’s former employer Roche has emerged as a new treatment option for this patient group.

Gilead’s offer will be funded with $15 billion in cash on hand, and through $6 billion in newly issued debt, according to the drugmaker.

The transaction is expected to close in the fourth quarter of 2020, the companies said.

The acquisition of Immunomedics is the latest of the several Gilead inked this year with the aim of expanding its oncology portfolio.

It bought a 49.9% stake in cancer drug developer Pionyr Immunotherapeutics in June for $275 million, just months after paying $4.9 billion for Forty Seven Inc, maker of an experimental treatment that targets blood cancer.

(Reporting by Ann Maria Shibu in Bengaluru and Ludwig Burger in Frankfurt; Editing by Peter Cooney, Diane Craft and Susan Fenton)

Gilead remdesivir study finds only marginal benefit for moderate COVID-19 patients

By Deena Beasley

(Reuters) – Moderately ill COVID-19 patients saw their condition improve after a 5-day course of Gilead Sciences Inc’s remdesivir, but the drug did not significantly shorten hospital stays and a 10-day course did not show a benefit, according to new data.

The drug, which was shown in a trial of severely ill COVID-19 patients to shorten their hospital recovery time, has been at the forefront of the battle against the pandemic.

The 600-patient analysis, published on Friday by the Journal of the American Medical Association, found that moderately ill patients treated with the antiviral drug for up to 5 days had significantly higher odds of improvement in certain areas, such as whether or not they needed supplemental oxygen, compared to patients given standard treatment.

Researchers said the clinical importance of the benefit for those patients was uncertain, however.

Remdesivir is currently sold under an emergency use authorization from the U.S. Food and Drug Administration for treating patients hospitalized with severe COVID-19, the disease caused by the new coronavirus. Gilead earlier this month filed an application seeking full FDA approval of the drug.

Differing trial results for remdesivir raise “the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” according to a JAMA editorial accompanying the study.

The new study in moderately ill COVID-19 patients showed that 11 days after starting treatment, 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients had left the hospital.

Side effects seen more frequently in the remdesivir groups included nausea, low blood potassium levels, and headache.

The JAMA editorial said important questions remain regarding the efficacy of remdesivir, including which patients are most likely to benefit from the drug, the optimal duration of therapy, the drug’s impact on clinical outcomes, and its relative effect if combined with generic steroid treatments.

(Reporting by Deena Beasley; Editing by Nick Tattersall and Sonya Hepinstall)

Drug costs for COVID-19 patients plunge at U.S. hospitals, but may rise

By Chad Terhune

(Reuters) – Medication costs for COVID-19 patients hospitalized in the United States have dropped sharply since May, reflecting advances in treatment, shorter stays and use of cheaper generic drugs.

But costs may rise again as hospitals start to pay for Gilead Sciences Inc’s remdesivir.

Research by the health data firm IllumiCare and exclusively shared with Reuters found that hospitals spent $1,090 per COVID-19 patient on medication in July. That was down from $3,011 in May among more than 50 hospitals in 10 states that were analyzed.

Several factors drove down the number. The average length of stay for COVID-19 patients declined by nearly 30%, from 9.6 days in April to 6.8 days in July, the hospital data show. And the number of medications used dropped by 22%, from nearly 20 individual drugs in April to 15.4 drugs in July.

Pharmacists say some of the decrease in medications may stem from reduced use of ventilators, which require painkillers for sedation.

“We were throwing the kitchen sink at these patients and now hospitals are getting better at treating these infections,” said G.T. LaBorde, chief executive of IllumiCare, a Birmingham, Alabama-based firm that works with hospitals and analyzes their electronic medical records.

Remdesivir, which helped speed up patients’ recovery in a U.S. trial, won emergency-use authorization in May from U.S. regulators. Gilead donated early doses but has begun charging. It has said the price for commercially insured patients is $3,120 per treatment course and $2,340 for patients on Medicare.

Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said many of the medications being used on COVID-19 patients are not “budget busters” and drug shortages have often been a bigger problem than cost.

But Ganio said pharmacy costs could increase significantly in the months ahead because of remdesivir.

Overall, many U.S. hospitals continue to face significant financial pressure from the pandemic as new infections remain high across much of the country, including in California, Florida and Texas. And health officials have warned that the upcoming flu season could further stress the healthcare system.

“As healthcare professionals, we are holding our breath for what fall will bring with flu season and COVID,” Ganio said.

In addition to remdesivir, hospital costs also may rise because of the increased use of tocilizumab, an anti-inflammatory drug widely used to treat arthritis. Hospital use jumped 29% among COVID-19 patients during July compared with the month earlier.

Tocilizumab costs more than $2,200 per patient, and is one of a class of drugs that includes Roche’s Actemra.

The most frequently prescribed drug for COVID-19 patients was the anticoagulant enoxaparin. It was given to 50% of inpatients last month at a cost of $322 per patient, the data show.

Another treatment recently found to reduce mortality for some COVID-19 patients, the steroid dexamethasone, costs $8.78 per patient, according to IllumiCare, and it was given to 35.1% of hospitalized COVID-19 patients reviewed in July.

Overall, IllumiCare said it looked at data from March through July at health systems in 10 states, including California, Texas and Alabama. It found more than 4,000 patients who were hospitalized and under treatment primarily for a coronavirus infection, drawing on medical billing codes for respiratory infection, sepsis and related conditions.

The firm excluded some COVID-positive patients, such as pregnant women, who were hospitalized for other reasons.

(Reporting by Chad Terhune. Editing by Peter Henderson and Gerry Doyle)

UK’s Hikma making Gilead’s COVID-19 drug remdesivir to increase supply

By Pushkala Aripaka

(Reuters) – Britain’s Hikma Pharmaceuticals said on Friday it has started manufacturing Gilead’s antiviral drug remdesivir under contract in Portugal, as the U.S. company outsources to increase availability of the COVID-19 treatment.

Remdesivir is one of only two medicines to have shown to help hospitalized COVID-19 patients in clinical trials, making it a front-runner treatment for the illness caused by the new coronavirus.

Hikma’s Chief Executive Siggi Olafsson said the company will start supplying batches of the drug “soon,” and Gilead is expected to distribute it.

“The terms of the deal are confidential, we are simply a contract manufacturer for Gilead – they order products from us as they expect the sales to be,” Olafsson told Reuters in a telephone interview.

Remdesivir, which is administered intravenously, has been conditionally approved or supported in many regions to treat COVID-19, which has killed more than 800,000 people globally.

A pledge by Gilead to send nearly all of its supplies to the United States between July and September stirred concerns about availability elsewhere.

This week, a bipartisan group of U.S. state attorney generals urged Washington to allow other companies to make the treatment to increase availability and lower the price.

On Friday, Pfizer said it had signed a multi-year deal with Gilead to manufacture and supply remdesivir.

Gilead said on Thursday that its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia.

The company had said in June that it was aiming to supply enough of the drug by the end of the year to treat more than 2 million COVID-19 patients, more than double its prior target of 1 million.

Gilead has signed several pacts with generic medicine makers in Egypt, India and Pakistan to distribute remdesivir in 127 countries. The deals include those with Cipla Jubilant and privately held Hetero.

Hikma’s announcement of the deal with Gilead helped its shares jump more than 10% on Friday as it also reported a jump in first-half operating profit and lifted its sales outlook.

Analysts said the deal highlights Hikma’s “growing importance as a trusted source of essential medicines.”

(Reporting by Pushkala Aripaka in Bengaluru; Editing by Arun Koyyur/Josephine Mason/Susan Fenton)

State attorneys general urge U.S. government to increase supply, lower price of remdesivir

(Reuters) – A bipartisan coalition of attorneys general on Tuesday urged the U.S. government to use its legal authority to increase the availability and lower the price of Gilead Sciences’ COVID-19 treatment, remdesivir.

Gilead has priced remdesivir, the antiviral drug at the forefront of the battle against the pandemic, at $2,340 per patient for wealthier nations and said will charge U.S. patients with commercial insurance, $3,120 per course, or $520 per vial.

The United States signed a deal with Gilead in June for more than 500,000 courses of the treatment, which shortened hospital recovery time in a U.S. trial, making up most of the company’s output through September.

In a letter sent to the U.S. health agencies, the coalition led by Louisiana Attorney General Jeff Landry and California Attorney General Xavier Becerra urged the federal government to ensure Americans can afford and have reasonable access to sufficient supply of remdesivir during this pandemic.

Under the Bayh-Dole Act, the National Institutes of Health and the U.S. Food and Drug Administration have the authority to license remdesivir to third-party manufacturers to scale up production and distribution and ensure its availability at a reasonable price, according to the letter.

Gilead was not immediately available for comment.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

Gilead says remdesivir reduced risk of death in COVID-19 patients, more studies needed

By Ankur Banerjee

(Reuters) – Gilead Sciences Inc. said on Friday additional data from a late-stage study showed its antiviral remdesivir reduced the risk of death and significantly improved the conditions of severely ill COVID-19 patients.

The company, which had initially released the data from the trial in April, said the finding requires confirmation in clinical trials.

Remdesivir has been at the forefront of the battle against COVID-19 after the intravenously administered medicine helped shorten hospital recovery times in a clinical trial.

Several countries have approved the use of the treatment in severe patients but there are concerns over supply of the drug, which is also being tested as an inhaled version.

Gilead said it analyzed data from 312 patients treated in a late-stage study and a separate real-world retrospective cohort of 818 patients with similar characteristics and disease severity as in the study.

Gilead’s late-stage study evaluated the safety and efficacy of five-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19, caused by the new coronavirus.

Dr. Susan Olender from Columbia University Irving Medical Center said in the Gilead statement that the analysis draws from a real-world setting and serves as an important adjunct to clinical trial data even as it is not as vigorous as a randomized controlled trial.

Findings from the analysis of its late-stage study showed that 74.4% of remdesivir-treated patients recovered by Day 14 versus 59.0% of patients receiving standard of care, the company said.

The mortality rate for patients treated with remdesivir in the analysis was 7.6% at Day 14, compared with 12.5% among patients not on remdesivir.

Gilead also said the rates and likelihood of recovery were lower in patients who received hydroxychloroquine as well as remdesivir compared with patients treated with remdesivir who did not receive hydroxychloroquine.

Gilead’s shares rose 2% to $76.21 in early trading.

(Reporting by Ankur Banerjee in Bengaluru; editing by Anil D’Silva and Maju Samuel)

Gilead study shows shorter five-day course of remdesivir works as well as 10-day one

By Deena Beasley

(Reuters) – Gilead Sciences Inc, which has suggested that a shorter treatment duration could extend limited supplies of its drug remdesivir, on Wednesday published results of a study showing no significant difference in outcomes between 5- and 10-day courses of the drug for patients with severe COVID-19.

Gilead announced “top-line” findings from the trial on April 29. The full results were published in the New England Journal of Medicine.

Gilead’s trial involved 397 patients hospitalized with severe COVID-19, most of whom were not on ventilators. The company said the study, which did not include a placebo comparison, showed that 14 days after treatment with the intravenous drug, 64% of patients treated for 5 days and 54% treated for 10 days showed some clinical improvement.

At the 14-day mark, 8% of patients in the 5-day group and 11% of patients in the 10-day group had died.

Gilead said the results should not be interpreted as indicating that the shorter duration worked better since evidence of improved outcomes occurred early on, leading investigators to attribute the difference to imbalances inpatient status at enrollment.

Adverse events included nausea and worsening respiratory failure. The company said 2.5% of patients in the 5-day group and 3.6% in the 10-day group discontinued treatment due to elevated liver enzymes.

The U.S. Food and Drug Administration granted emergency use authorization to remdesivir on May 1, citing results from a different study run by the National Institutes of Health showing that the drug reduced hospitalization stays by 31% compared to a placebo treatment.

Gilead has said it anticipates results from a company study of remdesivir in patients with more moderate COVID-19 around the end of this month.

Gilead has pledged to donate 1.5 million doses of remdesivir – or enough to treat at least 140,000 patients – to fight the global pandemic.

(Reporting By Deena Beasley; Editing by Sonya Hepinstall)