Thermo-Qiagen saga comes to an end

Qiagen is one of the few medtechs to do well out of the Covid-19 pandemic. From Thermo Fisher’s point of view it has done too well.

Up for sale, not up for sale, selling to the obvious buyer, demanding more money, getting it, then then pulling out of the deal anyway – you can’t fault Qiagen for entertainment. The drama’s latest twist, in which the diagnostics group told its putative buyer Thermo Fisher Scientific thanks but no thanks, comes as a result of Covid-19. 

This will not be the only deal stymied by the pandemic. But in this case it is not because a company has been badly affected, but because it has done too well. Qiagen’s Covid-19 tests have been leaping off the shelves, and consequently a majority of its shareholders no longer believe that the $12.5bn Thermo Fisher has agreed to pay represents fair value. 

The deal was initially arranged in early March, before the Covid-19 outbreak had become a pandemic and no lockdowns had yet occurred outside Asia, and valued Qiagen at $11.5bn. At the time the Dutch group was in trouble, having haemorrhaged sales, canned its outdated sequencing technology and seen its chief executive of 27 years walk away (Storm-tossed Qiagen plots a course to higher growth, October 8, 2019). 

Its fortunes reversed spectacularly with Covid-19. Qiagen’s molecular test for the virus was authorised by the US FDA at the end of March, and the group also makes the RNA extraction kits and other reagents used in Covid-19 assays sold by many other organisations – so many, in fact, that there was a shortage in March because Qiagen could not ramp up production fast enough.

The group’s first-quarter revenue climbed 9%, much higher than guidance. By the second quarter sales were up 18% higher. Naturally Qiagen insisted that Thermo Fisher’s €39 ($46)-per-share offer was inadequate, and in mid-July Thermo duly raised this to €43, adding nearly $1bn to the purchase price.

Not good enough was the verdict of the hedge fund Davidson Kempner, which has an 8% stake in Qiagen. This argument clearly resonated with the wider shareholder base: only 47% of them tendered their shares, falling short of the two-thirds threshold needed to get the deal done. 

A neu deal

So what now? In the immediate future Qiagen will make a $95m payment to Thermo Fisher; this was part of the revised deal’s terms, along with a lowering of the minimum number shareholders whose consent was required from 75% to 66.7%. 

Beyond that, Qiagen has definite ideas about growth, and is acquiring the 80% of the private group Neumodx it does not already own for $234m. Neumodx specialises in molecular tests for infectious diseases; its Covid-19 assay received US authorisation on the same day as Qiagen’s. 

Qiagen is also moving forward with other kinds of coronavirus tests; an antibody and an antigen assay are both in development and expected to be launched by the year end. 

Longer term, Qiagen’s leadership will have to consider its future. The board continued to recommend the deal even as major investors railed against it, and that stance has now been shown to be out of step with most shareholders. 

As for the other party in the case, Thermo Fisher might well start looking for a different company to buy – ideally one with more tractable shareholders. 

https://www.evaluate.com/vantage/articles/news/deals/thermo-qiagen-saga-comes-end

Johnson & Johnson closing in on COVID-19 vaccine supply deal in Europe

August 13, 2020

The European Commission (EC) has finished exploratory talks with Johnson & Johnson (JNJ -0.8%) about a potential contract to supply up to 200M doses of its COVID-19 vaccine, if approved, to member states. The agreement, if consummated, may include an option to buy up to 200M additional doses.

The EU has allocated €2B ($2.3B) to procure vaccines from up to six producers.

The EC concluded exploratory discussions with representatives of Sanofi (SNY -0.7%) and adjuvant supplier GlaxoSmithKline (GSK -1.1%) in late July.

https://seekingalpha.com/news/3605269-johnson-johnson-closing-in-on-covidminus-19-vaccine-supply-deal-in-europe

Production of AstraZeneca COVID-19 vaccine in Latin America to launch early 2021

Under a COVID-19 vaccine supply contract with the governments of Mexico and Argentina, AstraZeneca (AZN -0.8%) may start production in Q1 2021. It plans to initially produce 150M doses for distribution in Latin America with an upside to 400M doses. The cost, though not final, should be no more than $4 per dose.

The initial supply, funded in part by the foundation of Mexican billionaire Carlos Slim, is aimed at all of Latin America except Brazil.

AstraZeneca plans to transfer the relevant manufacturing technology to Mexico’s Laboratorios Liomont and Argentina’s INSUD Group by year-end.

Phase 3 trials should wind up by mid-to-late Q4.

https://seekingalpha.com/news/3605288-production-of-astrazeneca-covidminus-19-vaccine-in-latin-america-to-launch-early-2021

Convalescent plasma likely can help treat Covid-19, but experts have doubts

Infusing hospitalized Covid-19 patients with blood plasma from people who recovered from the disease appeared to show a benefit in a nationwide study, but the study’s lack of a placebo group left several experts struggling to interpret the data.

The study, which enrolled more than 35,000 patients, found that quickly administering so-called convalescent plasma had a marked effect on mortality for patients with severe cases of Covid-19. Those who received transfusions within three days of diagnosis had a seven-day death rate of 8.7%, while patients who got plasma after four or more days had a mortality rate of 11.9%. The difference met the standard for statistical significance.

But without a placebo group for comparison, it’s unclear just how valuable the treatment might be. The study, run by the Mayo Clinic and sponsored by the National Institutes of Health, was meant to broaden access to convalescent plasma. It was part of what is known as an “expanded access program,” not designed to definitively test how well the treatment works but to get it to patients while collecting data.

In a statement, the Mayo Clinic said that the Food and Drug Administration has advised it that the expanded access program will continue “while planning is under way to transition smoothly to Emergency Use Authorization of convalescent plasma.”

Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, said there’s no way to be sure about the ultimate benefit of convalescent plasma, but the study “checks a few boxes.” For one, it supports the overall theory that convalescent plasma might help some patients, he said. He noted that researchers also found that the quality of the plasma infusion had an effect on patient outcomes, as those who got infusions that were particularly rich with antibodies fared better overall. 

“If we had just done the randomized controlled trials, we would know the answers we are still guessing at,” Bach said, noting the authors of the study were “appropriately cautious.”

The results of the study were published Thursday on a preprint server, meaning they have not yet been peer-reviewed. 

The study enrolled a high proportion of critically ill patients, with about 52% in intensive care units and 28% requiring mechanical help to breathe. About 60% of the study participants were male. Roughly half the patients were white, while 38% were Hispanic, 19% were Black, and 4% were Asian. The study classified more than a quarter of patients as “other or unknown.”

The concept behind convalescent plasma, which dates back more than a century, is that blood from patients who have recovered from an infection will be rich with antibodies against it, making their plasma an effective treatment. A host of pharmaceutical companies are developing lab-grown Covid-19 antibodies that would work much the same way, and the many vaccines in development are meant to spur the production of similar antibodies that would prevent infection in the first place.

As doctors around the world scramble to find effective therapies for Covid-19, studies like this one present enticing data but do little to address the clinical guesswork physicians face when treating the disease.

“It raises the question of what strength of evidence is necessary to treat during a pandemic,” said Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital. “The problem is we have yet to resolve what is sufficient evidence to change the treatment paradigm.”

Steven Nissen, a noted clinical trialist at the Cleveland Clinic, agreed: “The lack of high-quality trials in making clinical decisions about how to treat patients with coronavirus infection is a national embarrassment. Here we have another non-randomized study, NIH-funded, and uninterpretable.”

Randomized, placebo-control studies of convalescent plasma are ongoing.

Large study suggests convalescent plasma can help treat Covid-19, but experts have doubts

Instead of lockdowns, teach people how to socialize safely

In response to the rising Covid-19 death toll and case counts in the U.S., calls for a national lockdown have been escalating. In an open letter to America’s decision-makers, more than 150 medical professionals urge them to “shut it down now, and start over.” In the letter, they argue that people should “stay home, going out only to get food and medicine or to exercise and get fresh air.”

I empathize with the urgency in their plea for people to stay home. I felt helpless watching patient after patient die from Covid-19 while working in a New York hospital in April. In the Northern California Covid-19 clinic I work in, I continue to see patients infected with and harmed by the virus. I, too, am desperate for this pandemic to end.

But I believe that telling people to stay home and avoid all nonessential social interactions is the wrong way forward. We should instead focus on educating people and helping them socialize safely. Lessons from sex education indicate that this will be a more effective approach.

A national lockdown is politically impossible today given widespread unemployment and the deepening recession, not to mention the federal government’s failure to coordinate a national response and the extreme politicization of the pandemic.

Telling people to stay home will worsen the mental health epidemic brought on by Covid-19. Michelle Obama recently admitted that “there have been periods throughout this quarantine, where I just have felt too low.” She is not alone. Since the pandemic started, loneliness has increased by 20% to 30%, and emotional distress has more than tripled. This is not surprising: Numerous studies have demonstrated deleterious effects of social isolation on physical and mental health.

Without widespread understanding of how to socialize safely, the cooped-up need for social connection will lead to surges of long-awaited get-togethers and new infections when lockdowns end. We have already seen this phenomenon in Florida and Arizona. It is happening across Europe. In the urgent care clinic where I work, I have seen an increasing number of people who developed Covid-19 symptoms after attending an indoor get-together following months of judicious social distancing.

If telling people to stay home isn’t the answer, then how do we slow this pandemic? By helping them socialize safely.

Several months into the pandemic, we know more about SARS-CoV-2, the virus that causes Covid-19, how it spreads, and how to reduce its transmission from person to person. We know that infection via surfaces is uncommon, and that outdoor transmission is even rarer. We know that face coverings and physical distancing significantly reduce the virus’s spread. At a hair salon in Missouri, for example, two stylists with Covid-19 interacted with more than 100 clients and infected none of them, thanks to the salon’s policy of having stylists and clients wear face coverings.

Instead of insisting that people stay home and indefinitely postpone seeing their loved ones and friends, we should be helping people socialize in ways that minimize the risk of spreading Covid-19.

At an individual level, socializing safely means taking into consideration various factors that determine the risk of coming in contact with SARS-CoV-2: wearing a face covering; frequently washing your hands; being aware of how close you are to others, and for how long; the number of nonhousehold contacts you are with; and ventilation.

Putting that into practice looks like this: Hang out outdoors with a few people instead of indoors with many. Wear a face covering when physical distancing is not possible. Stay home at the smallest hint of fever, fatigue, or cough. Don’t share food or drinks. Limit your social circle and consider creating a “Covid-19 bubble” with one or two close households. These relatively simple steps can help us meaningfully connect with one another without significantly increasing the risk of developing Covid-19.

At a community level, people should be educated about the Covid-19 risks associated with various social activities. Going to the grocery store or playing a noncontact sport like tennis are low-risk activities, while going to a bar or attending a crowded indoor religious service are high-risk activities. Such information, though available, is far from being commonplace knowledge.

It is also essential to enable safe socialization by both making it easy and enforcing it. Closing off streets to cars and painting reminders for physical distancing in public parks and stores are a start, but we can do more. Just as lifeguards at a beach or pool monitor swimmers and discourage them from behaving unsafely, public officials should be deployed in crowded places to remind people to socialize safely and make face coverings freely available to those who need them.

And until the pandemic is under control, the highest-risk activities, such as indoor dining or large concerts, should be discouraged, if not banned.

Some may argue that this “socialize safely” message will backfire and lead to more risky social interactions. There are a few reasons that likely won’t be the case.

One comes from another field of public health: sexual health. Proponents of “abstinence only” education worry that comprehensive sexual education, which covers sexually transmitted diseases, condom use, and safe sexual practices — along with abstinence — leads to increased sexual activity among teens. Yet studies have repeatedly shown that the safe-sex curriculum actually reduces rates of unprotected sex, sexually transmitted diseases, and unwanted pregnancies.

In the context of this pandemic, the “safe socialization” approach has proven successful in other countries. In Japan, people are asked to avoid the 3 C’s — closed spaces, crowded places, and close contact. Instead of self-isolating at home, Canadians are encouraged to exclusively hang out with another household in a “double bubble.”

Telling people to stay home backfired early in the pandemic, resulting in protests, premature reopenings, risky social activities, and the worst Covid-19 pandemic in the world. We can avoid making the same mistake if we choose to accept our social and political realities, heed the latest scientific evidence, and help people socialize safely.

Instead of lockdowns, teach people how to socialize safely in the time of coronavirus

Nasal spray could offer protection against COVID-19

Researchers at the University of California, San Francisco, have devised a nasal spray to administer synthetic antibodies, which they believe will help stop the spread of the coronavirus.

A team led by graduate student Michael Schoof engineered the synthetic molecule that “straitjackets the crucial SARS-CoV-2 machinery that allows the virus to infect our cells,” according to a report on the university’s website.

A paper posted on the preprint server bioRxiv says experiments using the live virus show the molecule is among the most powerful COVID-19 antivirals yet discovered.

While it’s not a traditional vaccine, the researchers believe one spray a day of the synthetic antibodies, dubbed “AeroNabs,” from a nasal spray or inhaler could offer protection from the deadly bug until a vaccine becomes available, according to ABC 7 News.

“Because it’s so stable, we can essentially put in one of these, this is a little nebulizer,” said Dr. Aashish Manglik, an assistant professor of pharmaceutical chemistry at UCSF, who added that the aerosolized agents trace back to a minuscule molecule first discovered in camels and similar animals, called a nanobody.

https://nypost.com/2020/08/13/nasal-spray-could-offer-protection-against-covid-19-scientists/

FDA accepts TG Therapeutics application, action date February 2021

Under Priority Review status, the FDA accepts TG Therapeutics’ (TGTX +4.9%) marketing application for umbralisib for the treatment of patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies.

The agency’s action date is February 15, 2021.

https://seekingalpha.com/news/3605251-fda-accepts-tg-therapeutics-umbralisib-application-action-date-february-2021