Press review


Merck & Co adopts 'error catastrophe' coronavirus drug

LONDON, 29 May (APM) - Merck & Co is launching its hunt for a coronavirus treatment with a pill developed by U.S. academics that is designed to force an "error catastrophe" on viruses, the Financial Times reported on Thursday.
The compound, which is known as EIDD-2801, works by planting molecules in a virus' RNA genetic material that then trigger a cascade of mutations, which ultimately kill it.
The drug completed its first safety trial in about 100 human volunteers in the UK and is set to begin extensive clinical testing in the U.S. and UK early in June, the FT said.
Merck said this week that it would develop the drug in collaboration with Ridgeback Biotherapeutics, a small Florida company that had licensed rights to the drug from its discoverers at Emory University in Atlanta.
EIDD-2801 resembles the chemicals with which replicating viruses build their genes. "When the virus incorporates molecules from the drug into its RNA, there is a lethal accumulation of mistakes — an error catastrophe," said professor Ralph Baric, a coronavirus expert at the University of North Carolina who has been working for several years with colleagues at Emory to develop EIDD-2801.
It is in the same class of drug as Gilead's remdesivir, the antiviral that has so far shown most promise for treating Covid-19 patients in trials, but they work in a different way, said Roger Perlmutter, Merck's head of research.
"Remdesivir blocks an enzyme that the virus needs to replicate," he said. "EIDD-2801 causes the enzyme to make mistakes and these errors lead to a catastrophic mutational burden."

U.S. relaxes rules for opioid substitutes during lockdowns

Coronavirus lockdowns have prompted the Trump administration to relax rules governing addiction treatments such as methadone, in what campaigners say has been a policy revolution in dealing with the U.S. opioid crisis, the FT said on Thursday.
In the past few months, U.S. agencies have temporarily eased restrictions governing how doctors can prescribe drugs meant to help addicts wean themselves off heroin and other opioids. Addicts can now begin treatment online instead of in person, receive home deliveries of drugs used as treatments and keep weeks’ worth of supplies at home.
While lockdowns have made life harder for addicts in many ways, those working in addiction therapy say the new rules for the crisis could encourage more people to seek treatment.
"We are seeing changes for which people had been advocating for decades," said Matthew Stefanko, a director at Shatterproof, which campaigns for addiction treatment. "The short-term changes we have seen are a really positive sign — the hope is now that they will last for longer than the lockdowns."

Stanford University investigates own researchers over Covid-19 antibody study

Researchers at Stanford University are being accused of 'tipping the scale' on their antibody study and implying coronavirus is more widespread - but less fatal - than previously thought, the Mail Online reported on Tuesday.
Last month, their analysis found that between 2.5 and 5.2% of Santa Clara County residents tested positive for antibodies. That meant the number of infected Americans in the county was 50 to 80 times higher than officials had reported.
But it was not peer-reviewed, many noticed the way calculations were made was not explained, and several found mistakes in the methodology.
In Version 2, the team walked back its earlier estimates and said only 2.8 percent of Santa Clara residents contracted the virus but didn't know they were ill.
That's 54 times more than the 956 confirmed cases that had been counted in the area as of 1 April, the Mail said.
The university is now investigating the research to see if the analysts was, in fact, politically motivated, inaccurate and misleading.
The findings, published by Drs Jayanta Bhattacharya, John Ioannidis and Eran Bendavid, were astounding because it meant the virus was much more widespread and that the death toll was much lower than believed.
However, not long after version one came out, criticism started pouring in, the Mail added.
Some experts critiqued the antibody test the researchers used, which was not approved by the US Food and Drug Administration.
Others said that, because volunteers were recruited via Facebook, the participants were not random nor representative of the county.
Additionally, the raw percentage of people who tested positive for antibodies was 1.5 percent, which would mean the true number of infections is only 30 times higher than reported.
A few weeks later, the revision was published saying that the estimated rate of infection was on the low end of their initial predictions.

NHS patients set to receive remdesivir

NHS patients are to benefit from remdesivir, hailed as the "biggest step forward" in treating coronavirus, The Times reported on Wednesday.
Remdesivir, an antiviral originally designed to fight ebola, is the only drug shown to have any effect in combating Covid-19. It will soon be available to some of those in greatest need, Matt Hancock, the health secretary, announced on Tuesday. (APMHE 67492)
"This is probably the biggest step forward in the treatment of coronavirus since the crisis began," The Times quoted him as saying.
The drug interferes with the life cycle of the virus and in a large trial in the U.S. was shown to shorten the time patients took to recover by about four days. It is undergoing other trials but has not been shown to cut mortality rates.
The fact that it has any effect was described by Anthony Fauci, a leading member of the US coronavirus task force, as "a very important proof of concept".
The development came as the World Health Organization said that a second wave of coronavirus was unlikely to be as bad as the first one because countries were better prepared.

WHO suspends hydroxychloroquine trials

The World Health Organisation has temporarily suspended clinical trials of hydroxychloroquine as a potential treatment for coronavirus, The Telegraph reported on Tuesday.
The decision came after a study published in The Lancet medical journal last week suggested the drug could increase the risk of death among Covid-19 patients, WHO chief Tedros Adhanom Ghebreyesus told a virtual press conference.
Tedros said the executive group of the so-called Solidarity Trial, in which hundreds of hospitals across the world have enrolled patients to test several possible treatments for the novel coronavirus, had suspended trials using that drug as a precaution.
"The executive group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the data safety monitoring board," Tedros said.
"The other arms of the trial are continuing."

Soriot puts Astrazeneca's star into the ascendancy

Saturday's Times carried a lengthy profile of AstraZeneca's chief executive Pascal Soriot and how he has turned the pharma into the UK's highest valued company.
Six years after resisting Pfizer's takeover bid, the company has also gone on to build a new, albeit delayed and over-budget, £1 billion headquarters and research and development centre in Cambridge and to play a pivotal role in the partnership with government and the Oxbridge universities to combat coronavirus through the development of a vaccine and diagnostic tests.
The remarkable revival has been built on Soriot's strategy, sharpened during Pfizer's contentious approach, of focusing resources on replenishing AstraZeneca's depleted drugs pipeline. "The result is, in the words of one top shareholder, a 'fairytale investment case'."
The FT on Wednesday carried a similar piece, examining how AstraZeneca overtook GlaxoSmithKline to become the UK's biggest pharma and how AstraZeneca's turnaround under Soriot's leadership has boosted the industry in the UK.

Succession challenges at AstraZeneca

Astrazeneca is facing the challenge of managing succession across the top of the company with corporate governance rules limiting the chairman's tenure, Saturday's Times reported
Leif Johansson, 68, has been on the board of the company since April 2012 and has been its chairman since June that year, but the corporate governance code, published in July 2018, states that chairmen should not remain in their post beyond nine years.
Pascal Soriot, 61, has been chief executive since October 2012 and Marc Dunoyer, 67, the group's chief financial officer, has held that job since November 2013.
Last year Soriot dispelled speculation, circulating towards the end of 2018, that he was nearing the end of his tenure. He told The Times that he aimed to stay in charge for "two big milestones", the opening of its new Cambridge headquarters and research centre and the 2023 sales targets, issued at the time of its defence of Pfizer's takeover approach in 2014. He said this year that flexibility was needed over the tenure of FTSE chairmen.
Louise Kernohan, investment director at Aberdeen Standard Investments, a leading investor, said that she expected Soriot to stay until 2023, but added that the "day he leaves won't be a good day for the shares". She said that she expected Dunoyer to go before then.

Oxford/AstraZeneca's Covid-19 vaccine has 50% chance of success

Professor Hill, director of Oxford University's Jenner Institute, in partnership with AstraZeneca to develop a Covid-19 vaccine by September, revealed that his team now faces a major problem, throwing the September deadline into doubt.
He said that of 10,000 people recruited to test the vaccine in the coming weeks - some of whom will be given a placebo - he expected fewer than 50 people to catch the virus. If fewer than 20 test positive, then the results may be useless, he warned.
"It is a race, yes. But it's not a race against the other guys. It's a race against the virus disappearing, and against time," Hill told the Telegraph, published at the weekend, from his university laboratory, long emptied by the lockdown.
"We said earlier in the year that there was an 80% chance of developing an effective vaccine by September. But at the moment, there's a 50% chance that we get no result at all.
"We're in the bizarre position of wanting Covid to stay, at least for a little while. But cases are declining."
The UK government has agreed to pay for up to 100 million doses, adding that 30 million may be ready for UK citizens by September.

Profile of Moderna's CEO Stéphane Bancel

The FT on Monday carried a profile of Stéphane Bancel, Moderna's chief executive. In January, when the 47-year-old Frenchman told staff that they would make a vaccine for Covid-19, he said they could get it done in a record 60 days.
"They created the first vial ready to test in humans in just 42 — and Mr Bancel thinks they could be quicker next time," the paper said.
It quoted Moderna's second-in-command Stephen Hoge, who has worked with Bancel since the Boston-based biotech was a small start-up, as saying: "He's a driver, he's intense, he's expansive in his thinking." 

Scientists dampen 'warp speed' vaccine enthusiasm

The recent announcement of the U.S. government's 'Operation Warp Speed' to find a Covid-19 vaccine is being tempered by scientists, the FT said at the weekend.
Many scientists feel a duty to damp the enthusiasm. They say a vaccine could take much longer because little is known about the disease and how bodies will react to attempts at immunisation. In fact, some warn we may never create a vaccine for Covid-19.
Soumya Swaminathan, chief scientist for the World Health Organization, believes an optimistic scenario is a vaccine produced in the "tens of millions" next year, which would be mainly distributed to healthcare workers, and far larger volumes in 2022. To inoculate the world and defeat Covid-19 could take four to five years, she says.
We have no "crystal ball" to tell the future, she told the FT. "It depends how the virus behaves: whether it mutates, whether it becomes more or less virulent, more or less transmittable."

Sanofi to slash $12 billion stake in Regeneron

Sanofi plans to sell down most of its 20.6% stake in U.S. biotech Regeneron as part of chief executive Paul Hudson's promised overhaul of the French pharma, the Financial Times reported on Monday (APMHE 67484).
The two companies have had a research and marketing partnership since 2003, which led Sanofi to build up an equity stake worth $12.1 billion as of the market's close on Friday.
They will continue to work together after the divestment and jointly own fast-growing eczema drug Dupixent, as well as Kevzara, a rheumatoid arthritis drug that is being tested for treating Covid-19.
Sanofi said it intends to sell approximately 12.8 million Regeneron shares out of a total of 23.2 million and may also sell an additional 10% of the offering, or 1.28 million shares, in the next 30 days if there is sufficient demand.
If the proposed public offering is completed, Regeneron said it would repurchase $5 billion of its stock from Sanofi using $3.5 billion of its own cash and a loan from Goldman Sachs. According to Dealogic data, it would be the largest public equity offering in the healthcare industry on record, the FT added.

Moderna volunteer 'suffered severe reaction'

A coronavirus vaccine trial participant says he suffered a serious adverse reaction after a dose, but still wants people to get the jab when it becomes available, the Mail online reported on Tuesday.
Ian Haydon, 29, from Seattle, Washington, is one of several people who was given an immunisation developed by Moderna Therapeutics at Kaiser Permanente.
He told STAT News that his temperature shot up to 103F just 12 hours after his second dose was administered, the Mail said.
Then, after being released from an urgent care clinic, he fainted in his own home, but recovered within 24 hours.

Sanofi sells majority of Regeneron stake

Sanofi's sale of most of its stake in U.S. biotech Regeneron was covered in the FT on Wednesday.
The share sale will be used to develop new drugs and to fuel acquisitions, it added.

Millicent Pharma buys women's health drug to treat dyspareunia

Millicent Pharma, the Irish pharma group headed by former Galen boss Dr John King, is paying $125 million (€112 million) to acquire the rights to a drug to treat dyspareunia, a common complaint of menopausal women, The Sunday Times reported.
Headquartered in Ireland, Millicent was formed by King, and former Galen colleagues Roger Boissonneault and Geoffrey Elliott, to develop a global pharmaceutical company focused on women’s health.
The company has signed a definitive agreement to acquire the U.S. commercial rights to Intrarosa from Amag Pharmaceuticals, a U.S. company The deal was jointly funded by Millicent management and the Carlyle funds.

GSK to make one billion doses of vaccine booster

The FT on Thursday reported GlaxoSmithKline as saying it will produce one billion doses of a vaccine booster as it steps up its preparations for an eventual immunisation for coronavirus. (APME 67524)
GSK, one of the world’s largest vaccine makers, said its adjuvant could make "a significant contribution against Covid-19".



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