Russian Firm Seeks to Produce COVID-19 Drug Remdesivir Without Patent | Top News

MOSCOW (Reuters) – Russian drugmaker Pharmasyntez has asked the Kremlin to allow it to produce a generic version of U.S. COVID-19 drug remdesivir, used to treat U.S. President Donald Trump, despite lacking a patent to do so, the firm’s director said on Monday.

Remdesivir is not available in Russia, Pharmasyntez’s director Vikram Punia said, but a generic version cannot be produced and distributed without the consent of the patent-holder, U.S. firm Gilead Sciences

.

Pharmasyntez wrote to the U.S. firm in July requesting its consent in the form of a voluntary licence, but did not hear back, Punia said.

The Siberian-based drugmaker is now asking the Kremlin to activate a compulsory licensing process on the basis of national security, granting it the right to produce the generic – labelled Remdeform – without Gilead’s consent.

“Many people’s lives could be saved using this drug. The longer this drug is inaccessible, the more people we will lose,” Punia said.

The law has not been used on behalf of a pharmaceutical product in Russia before, Punia said after the Vedomosti newspaper reported on his company’s letter to the Kremlin earlier on Monday.

Gilead could not immediately be reached for comment outside normal business hours on Monday. It has already granted voluntary licences to producers in 127 countries, predominantly low-income countries or those with other significant obstacles to healthcare access.

Russia registered a record high daily tally of 18,665 new coronavirus cases on Sunday, bringing the total number since the pandemic began to 1,655,038.

Remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration in May after it was shown to shorten hospital stays for COVID-19 patients in a government-run clinical trial. It was one of the treatments given to Trump during his recent bout of the disease.

The FDA formally approved the drug this month, despite recent results from a World Health Organization-sponsored trial showing remdesivir did not improve patient outcomes.

Pharmasyntez has completed a clinical trial of the generic drug on 300 COVID-19 patients across 23 Russian hospitals, according to a register entry.

Punia said the company could market its drug at a significantly lower cost of around $540 for a 6-vial course. A five-day course of Gilead’s remdesivir, marketed under the brand name Veklury, has been pricaed at $3,120.

(Reporting by Polina Ivanova; Editing by Edmund Blair, Kirsten Donovan)

Copyright 2020 Thomson Reuters.

Source Article

Read more

Egyptian NHS doctor stricken by Covid seeks visa reassurances from Home Office



a man holding a fish: Dr Basem Enany has thanked the more than 4,000 people who donated to a crowdfunder to pay for his legal and medical bills.


© Photograph: GoFundMe/PA
Dr Basem Enany has thanked the more than 4,000 people who donated to a crowdfunder to pay for his legal and medical bills.

An Egyptian NHS doctor who became critically ill after complications from contracting Covid-19, has spoken for the first time about his fears of being removed from the UK by the Home Office while he lay in his hospital bed on a ventilator.

Dr Basem Enany, a locum consultant cardiologist at York teaching hospital, had treated many coronavirus patients. He was placed on a ventilator after developing Guillain-Barré syndrome, a rare complication of Covid-19 and other viruses, which has left him partially paralysed. He can now breathe unaided but believes he has a long rehabilitation journey ahead of him.

“At first I had the usual symptoms of Covid – cough, fever, loss of taste and smell – but then I began to develop a weakness throughout my body. Then I was no longer able to move and couldn’t breathe properly.” he said. “I had never seen this happen in any of the Covid patients I had treated and had to research my symptoms as they were so unusual.”

He has a work visa that is due to expire next month. He and his wife, Marwa Mohamed, believe they and their four young daughters could face removal from the UK as he is unlikely to be well enough by December to renew the visa.

While Enany has regained partial use of his hands, his legs remain paralysed and he is waiting to be moved from Leeds general infirmary to a specialist neuro-rehabilitation facility. “I was not sedated on the ventilator and was lying awake in my hospital bed thinking: ‘Oh my God, my visa is about to finish,’” he said.

Enany thanked the dedicated NHS workers who have been looking after him and the more than 4,000 people who have made donations to a crowdfund that will pay for his legal and medical bills. Any remaining funds will be donated to research into Covid-19 and into Guillain-Barré syndrome.

While the Home Office has said it had no plans to deport the family, Enany does not know what kind of replacement visa he will receive, how long it will be for and whether it will allow work.

While Enany thanked the Home Office for its reassurances, he said: “We still don’t have any solid documents in our hands and my visa will expire soon.”

A Home Office spokesperson said: “We’ve spoken to Dr Enany’s family to reassure them that their immigration status is not in jeopardy and they are not facing enforcement action. They are here entirely legally and have every right to remain the UK. We will continue to work with them to find a way forward. Our thoughts remain with Dr Enany and his family at this difficult time.”

On Friday there will be the second reading of a private member’s bill from Liberal Democrat MP Christine Jardine calling for indefinite leave to remain to

Read more

As Cases Rise, RivCo Still Seeks Escape To Coronavirus Tiering

RIVERSIDE COUNTY, CA — The number of new coronavirus cases jumped in Riverside County over the weekend, as did the death toll and the number of people admitted into intensive care units, according to figures released Monday by Riverside University Health System.

The uptick comes as Riverside County Supervisor Karen Spiegel will ask her colleagues Tuesday to support a proposal for the Executive Office to coordinate with neighboring counties in presenting a unified request to the governor to revise or drop the state’s current color-coded coronavirus tier system.

The total number of COVID-19 infections recorded in Riverside County since the public health documentation period began in early March stands at 66,732 Monday, an increase of 975 people since Friday’s reporting, according to RUHS.

The number of deaths linked to COVID-19 was reported at 1,295 Monday, and increase of 16 people since Friday, the data showed.

The number of COVID-positive hospitalizations totaled 164 Monday, compared to 161 on Friday. Monday’s figure includes 60 ICU patients — 21 more than Friday, according to RUHS.

As numbers continue rising, Spiegel’s proposal amounts to a directive for retiring CEO George Johnson, or incoming Interim CEO Juan Perez, and Executive Office staff to “engage” Imperial, Orange, San Bernardino, San Diego and possibly other Southern California counties in forming a partnership focused on addressing defects in the state’s coronavirus tier structure.

Riverside County was bumped back to the purple tier Tuesday due an increased coronavirus case rate and not meeting state thresholds for testing.

“Riverside County has created or expanded 22 programs to mitigate direct and indirect impacts (of COVID-19),” Spiegel said in documents posted to the Board of Supervisors’ agenda for Tuesday. “Yet there is no number of programs that can replace someone’s livelihood or business … Entire industries are at a standstill, and public assistance is limited.”

Gov. Gavin Newsom announced the color-coded system in August to replace the multi-phase public health de-regulation strategy originally established at the end of April.

The tier plan has four color bands — purple, red, orange and yellow — that reflect how a county is managing coronavirus impacts. Riverside County had moved into the “red” tier in the third week of September, removing barriers for some businesses and houses of worship to resume indoor operations with capacity limitations.

With Riverside County now back in the state’s most restrictive “purple” tier, many indoor services and functions are prohibited.

“Riverside County continues to make great strides in improving testing, as well as outreach within hard-to-reach groups and high spread workplaces,” Spiegel said. “Hospital capacity also remains very stable and has been for months.”

The supervisor was the foremost critic of the CDPH’s reclassification, remarking immediately after the board was informed of the change that “enough is enough. We’ve got to find a way to step forward without hurting people. My frustration has turned to anger. We are way too far beyond this.”

In her call for a united front to challenge the color-coded categorizations, Spiegel said “our residents

Read more

Texas seeks to shore up hospital capacity in El Paso as coronavirus cases surge nationwide

New reported infections nationwide surpassed 80,000 for the first time this Friday and again Saturday, as hospitalizations push past 40,000 and daily death tolls begin to climb. Officials are already trying to shore up overwhelmed facilities: In Texas, Gov. Greg Abbott (R) on Sunday announced that state authorities are creating a new site for medical care and deploying extra resources to hospitals in El Paso, where covid-19 hospitalizations have nearly quadrupled to almost 800 in less than three weeks.

The United States’ latest case spike, expected to intensify as winter draws closer, is geographically broader than the spring surge that devastated East Coast states and the summer wave that hit the South and Southwest. And it comes as leaders are leery of renewed shutdowns, as Americans grow wearier of restrictions and as the Thanksgiving travel season looms.

In previous waves, “our governments reacted,” said Megan Ranney, an emergency medicine professor at Brown University. “We closed bars. We closed restaurants. We enforced mask mandates. And I’m not seeing a lot of that nationally right now.”

“We are set up for just a perfect storm — a conflagration,” she said. “Right now, you can talk about there being lots of little burning fires across the country. And then Thanksgiving will be the wind that will whip this fire up into an absolutely human disaster for our country.”

In El Paso, authorities are urging people to stay home as efforts to add hospital beds kick in. The new facility announced by Abbott, set to open this week at the El Paso Convention and Performing Arts Center, will start at 50 beds but can expand to 100 if necessary, the governor’s office said, while “auxiliary medical units” sent to hospitals can boost capacity by 100 beds.

In a Sunday call, Abbott also asked the U.S. Department of Health and Human Services to ease the pressure with a Department of Defense medical center in El Paso. Abbott asked to house non-coronavirus patients in William Beaumont Army Medical Center so that hospitals in the El Paso area could give more beds to those with covid-19, the disease the novel coronavirus causes.

Health and Human Services did not immediately provide a comment.

New daily infections in El Paso have rocketed from fewer than 25,000 at the beginning of the month to more than 38,500 this weekend, according to The Washington Post’s tracking. New deaths have yet to surpass a peak in August, but deaths lag behind spikes in cases and hospitalizations.

The mayor of El Paso, Dee Margo, said he learned on a recent ride-along with fire officials that most of their calls are related to the coronavirus. If moves to address hospitals’ strain do not work, he said, he will ask the governor for more action. He pleaded with residents to mind their behavior to avoid “drastic measures.”

Some public health experts say they are not optimistic about the chances of ramping up coronavirus restrictions again across the country.

“I don’t see forceful policy intervention happening

Read more

EU medicine regulator seeks full results of WHO’s remdesivir trial

The EU’s medicines regulator has requested the complete results of the World Health Organization’s remdesivir trial, the European Commission said, after the study found the Covid-19 treatment to have no substantial effect on rates of survival.

The European Commission announced last week that it had signed a deal with the developer, Gilead Sciences, to supply 500,000 treatment courses of the drug, worth more than €1bn. Trial data had shown the treatment cut the time to recover from Covid-19 by as much five days, while Gilead had said the drug may also reduce the likelihood of death.

But the results from the WHO’s highly anticipated Solidarity trial, first reported by the Financial Times, found that remdesivir and other three other potential drug regimens “appeared to have little or no effect on 28-day mortality or the in-hospital course of Covid-19 among hospitalised patients”.

According to WHO officials, the organisation told Gilead of the findings of the Solidarity trial in September, as long as two weeks before the European Commission announced its deal to procure the drug.

“[The WHO] made a presentation to Gilead and other companies [on the results of the trial] on September 23,” Ana Maria Henao-Restrepo, a medical officer at the WHO, said at a briefing on Friday. “On the following Monday, September 28, [the WHO] forwarded [to Gilead] not only the graph, figures and tables, but the first draft of the manuscript”.

Ms Henao-Restrepo said the manuscript was “not exactly” the same as the one published late on Thursday, but that it contained the same numbers and conclusions.

Richard Peto, emeritus professor of medical statistics and epidemiology at Oxford university and chief statistician on the Solidarity trial, said the preliminary results “came to the same conclusions that you now see”.

In response to a request for comment, Gilead said the initial manuscript it had received from the WHO in September had been “heavily redacted”.

“As of today, Gilead has still not received the underlying data sets or statistical analysis plan necessary to validate the results,” it said. “We received the full manuscript, which included materially different information than what was included in the initial draft, only hours before it was published yesterday.”

The European Commission told the FT it had not made any payments under the October 8 Gilead agreement, which gives 36 European countries, including the UK, the option to buy future remdesivir supplies.

“[European Medicines Agency] will look at the Solidarity data . . . to see if any changes are needed to the way these medicines are used,” it said.

Gilead has priced remdesivir at $2,340 per five-day course on the basis that it cuts the cost of care by reducing the length of hospital stays, though the Solidarity results may have damaged that thesis.

Yannis Natsis, a policy manager at the European Public Health Alliance and a board member at the EMA, said the situation with remdesivir felt like “déjà-vu”, citing the large sums of money spent on past antivirals, such as Tamiflu, only

Read more