J&J to contribute up to $5 billion to potential U.S. opioid settlement

(Reuters) – Johnson & Johnson on Tuesday said it will contribute up to $1 billion more to a potential settlement of lawsuits alleging it and other companies fueled the U.S. opioid epidemic, bringing the total amount it would pay to $5 billion.

The New Brunswick, New Jersey-based drugmaker said the additional money represented an increase to a proposed $4 billion settlement framework it negotiated with a group of state attorneys general that was announced last year.

That October 2019 proposal also called for the drug distributors McKesson Corp, Cardinal Health and AmerisourceBergen to pay a combined $18 billion, but the framework met resistance from some states and local governments.

Negotiations have been ongoing since then, and the dollar amounts have been shifting. J&J in a statement said the additional $1 billion it would pay reflected continued negotiations and said additional terms are being finalized.

Lawyers for the plaintiffs in the opioid litigation and representatives for several state attorneys general did not immediately respond to requests for comment.

More than 3,000 lawsuits have been filed nationally largely by states, counties and municipalities seeking to hold drug companies responsible for the U.S. opioid addiction epidemic.

The lawsuits generally accuse drugmakers including J&J of deceptively marketing opioids and distributors of ignoring red flags indicating the painkillers were being diverted for improper uses.

The companies including J&J deny wrongdoing. J&J is separately appealing a $465 million judgment the state of Oklahoma won against it in the first case to go to trial in the litigation.

(Reporting by Nate Raymond in Boston; Editing by Chris Reese)

GSK, partner Vir join race to find COVID-19 antibody treatment

(Reuters) – GlaxoSmithKline and partner Vir Biotechnology have started testing their experimental antibody on early-stage COVID-19 patients, entering the race to find a winner in a promising class of antiviral drugs to combat the pandemic.

The British drugmaker said on Monday the long-acting single injection will be tested on recently diagnosed high-risk cases for its ability to prevent hospitalization, typically a life threatening disease stage.

GSK, which in April moved to invest $250 million in Vir and agreed to collaborate on the antibody, is behind some peers in developing the class.

Regeneron, which is working on antibody manufacturing with Roche, expects initial data from ongoing trials of its COVID-19 two-antibody combination in September.

Eli Lilly, working with biotech firm AbCellera, early this month started testing whether their antibody can prevent the infections in nursing homes. A separate trial testing the compound on recently diagnosed COVID patients may yield initial data in September or shortly after.

“We’re coming into the clinic a little bit later and part of that is because we spent some time selecting what we believe will be a best-in-class antibody,” Vir Chief Executive George Scangos told Reuters.

The antibody is designed to not only block the virus from invading cells but also to recruit immune cells to kill already infected cells, which would otherwise replicate the virus.

It also has been altered to stay effective for several months on a single shot and to cling to a part of the virus’s outer spike protein that has shown no tendency to mutate.

After testing the drug on an initial 20 U.S. participants over two weeks for safety, the trial will expand to 1,300 patients globally.

GSK said initial results could be available by the end of the year, complete results during the first quarter of 2021, and early access to patients could be on the cards before June.

GSK’s more prominent role so far in combating the pandemic has been in providing adjuvants, efficacy boosters that play a vital role in many vaccines.

The global effort to develop a vaccine against the virus, which has so far claimed more than 800,000 lives globally, has seen recent launches of late-stage trials, but work on treatments has also gone into overdrive.

While one approach has been to quell a dangerous overreaction of the immune system, known as cytokine storm, another has been to block the virus from invading cells with antibodies.

Antibodies, part of the body’s adaptive immune system, are normally made by white blood cells in response to a foreign substance in the body.

But pharma companies, also including AstraZeneca and Molecular Partners, are working on manufactured monoclonal antibodies, made in bioreactors from living cells, for a more targeted attack on the virus.

Using plasma from recovered COVID-19 patients, which contains a range of antibodies, is a similar approach but it may be fraught with more complex logistics and less consistent quality than manufactured antibodies.

In future studies, GSK and Vir plan to run more trials on their antibody’s ability to prevent the infection and treat patients that are already in hospital care. Later this year, they plan to start a trial of a second antibody from the collaboration.

(Reporting by Ludwig Burger; editing by David Evans)

J&J to start mid-stage coronavirus vaccine trials in three European countries

By Nathan Allen

MADRID (Reuters) – Johnson & Johnson’s Janssen unit will begin mid-stage trials for its coronavirus vaccine in Spain, the Netherlands and Germany next week, Spain’s health minister said on Friday, as the U.S. drugmaker expands testing for its experimental shot.

The Phase II trial will last two months and include 550 participants across the three countries, including 190 people in Spain, Salvador Illa told a news conference in Madrid.

“It’s a vote of confidence in our health system,” Illa said, adding it was the first human trial for a coronavirus vaccine to be approved in Spain.

The study will focus on healthy people between the ages of 18 and 55 as well as people over 65.

Johnson & Johnson said the study will evaluate the safety and the ability to induce an immune response from single dose and two-dose regimens of the vaccine candidate, the company said in a statement.

Spain, which has western Europe’s highest tally of coronavirus cases, is also working with AstraZeneca via the European Union’s vaccine procurement program to secure sufficient doses.

J&J’s website says if the latest trials are successful, it will begin final Phase III studies, in which even more volunteers will receive the experimental vaccine.

More than 150 potential vaccines are being developed and tested globally to combat the COVID-19 pandemic, with 30 in human trials.

There is so far no approved vaccine, except one authorized in Russia before large-scale trials.

J&J is carrying out tests in the United States and Belgium, and this week added Chile, Argentina and Peru to the list of Latin American nations where it plans to conduct Phase III trials on 60,000 volunteers, in a study that will also cover Brazil, Colombia and Mexico.

The company’s potential vaccine uses “viral vectors” to generate immune responses, similar to the approach taken by the University of Oxford and AstraZeneca in their experimental vaccine, as well as China’s CanSino.

(Reporting by Nathan Allen and Jose Elías Rodríguez; editing by Mark Potter and Jason Neely)