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Saturday, July 1, 2023

Pfizer, European Pharmas Collaborate With EC For Future Health Emergency Preparedness

 The European Commission has reportedly made arrangements with Pfizer Inc 

 and various European pharmaceutical companies to secure the capacity to produce up to 325 million vaccines annually for potential future global health crises.

In May, the European Commission agreed with BioNTech SE 

 and Pfizer on adapting the existing contract on vaccines against Covid-19, including a reduction in the quantity of doses purchased by EU countries under the contract and pushing the delivery deadline to 2026.

Under the agreement, companies will maintain their facilities in a state of readiness, monitor supply chains, and stockpile as needed, to enable rapid production if a new public health crisis arises, Reuters reported.

However, vaccine equity activists caution that this plan could repeat the "vaccine apartheid" observed during the COVID-19 crisis.

Pfizer's plants in Ireland and Belgium have been chosen by the Commission to reserve mRNA vaccine production capacity; Spanish firms Reig Jofre and Laboratorios Hipra SA have been chosen for protein-based vaccine capacity and Bilthoven Biologicals B.V. of the Netherlands for vector-based vaccines.

Pfizer acknowledges the urgent need for improved pandemic preparedness and response planning and asserts that it has taken significant measures to prepare for potential future global disease outbreaks without specifying these measures.

Reig Jofre reveals that its deal with the EU reserves capacity for four years, with the option to extend up to a maximum of eight years, though financial details were undisclosed.

The World Health Organization has recommended that governments and manufacturers reserve up to 20% of any tests, vaccines, or treatments for distribution in poorer nations to avoid a recurrence of the "catastrophic failure" experienced during the COVID-19 pandemic. This suggestion is part of a draft global pandemic agreement currently under discussion.

https://www.benzinga.com/general/biotech/23/06/33080675/pfizer-european-pharma-firms-collaborate-with-european-commission-for-future-health-emergency-pre

Potential Upside For Eiger's Avexitide In Both PBH And CHI Indications: Baird

 Thursday, Eiger BioPharmaceuticals Inc 

 announced it would focus its development efforts on advancing avexitide in hyperinsulinemic hypoglycemia indications

Following a comprehensive review of programs, the company decided to allocate resources towards the potential of avexitide in treating metabolic diseases, with a primary focus on post-bariatric hypoglycemia (PBH), a condition with significant revenue potential. 

Baird raised the price target from $3 to $5 with an Outperform rating, citing prudent reprioritization away from virology.

It says that it is a bit surprising to see PBH shifted ahead of congenital hyperinsulinism (CHI) as the lead avexitide indication. The analyst also says that given its enthusiasm around CHI, it sees upside potential with both opportunities.

The analyst viewed the opportunity for avexitide in congenital hyperinsulinism as attractive for quite some time, and roughly a year ago, it hosted a KOL call with CHI pioneer Dr. Charles Stanley, which fortified the optimism around this indication.

In discussing the reasoning with management, Baird analyst noted that PBH presents a more significant commercial opportunity, even factoring in a potential priority review voucher with potential CHI approval, where rare pediatric disease designation has been granted.

Baird analyst also said the company's strategy to partner its virology programs for peginterferon lambda and lonafarnib is in line with what it noted would be a value-maximizing scenario of eliminating any further spend in HDV and to focus on avexitide.

https://www.benzinga.com/analyst-ratings/analyst-color/23/06/33082155/potential-upside-for-eigers-avexitide-in-both-pbh-and-chi-indications-analyst

Gilead, Teva Cleared of Pay-to-Delay HIV Drug Antitrust Claims

 A California jury found that Gilead Sciences Inc. and Teva Pharmaceutical Industries Ltd. didn’t engage in an anticompetitive conspiracy to delay generic versions of HIV treatment Truvada and other drugs.

The unanimous verdict Friday from the US District Court for the Northern District of California affirmed that a 2014 patent settlement between Foster City, Calif.-based Gilead and Israel-based Teva didn’t violate antitrust law.

Consumers and other direct purchasers, including the Blue Cross and Blue Shield Association, filed the antitrust lawsuit in 2019, alleging that Gilead maintained a monopoly in the HIV drug market by unlawfully extending patent protection for its drugs to delay generic competitors’ entry. Plaintiffs sought $3.6 billion in damages.

Gilead allegedly paid Teva, a generic drugmaker, a “reverse payment” worth $1 billion in a patent settlement to shelve Teva’s generic versions of Truvada and another similar drug, the lawsuit claimed. In reverse payments, a patent-owner company pays an alleged patent infringer, typically a generic drugmaker, to delay selling the generic version.

The companies’ agreement resulted in higher prices for the HIV drugs, plaintiffs claimed.

But the verdict affirmed that the companies’ settlement “was not a reverse payment,” Gilead said in a Friday statement.

Teva didn’t immediately respond to a request for comment.

The case is In re HIV Antitrust Litigation, N.D. Cal., No. 3:19-cv-02573, 6/30/23.

https://news.bloomberglaw.com/antitrust/gilead-teva-cleared-of-pay-to-delay-hiv-drug-antitrust-claims

US farmer warns ‘China is quietly taking over’ food security

 Despite lawmakers’ success in introducing legislation to address the issue, one U.S. farmer raised a red flag that China is still infiltrating "many, many acres" in rural America.

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"They're tapping into the American food structure and this country. And we should be looking at that as food security, people," National Black Farmers Association President John Boyd Jr. said on "Cavuto: Coast to Coast" Tuesday, "because they're tapping into American farms and tapping into the hog industry, all of these industries that China is quietly taking over here in the United States."

Farmers have voiced their concerns for more than two years over Chinese-owned companies purchasing large swaths of rural farmland in states like Oklahoma, Minnesota, North Carolina and Virginia.

U.S. Department of Agriculture (USDA) data from 2021 indicates that China controls an estimated 383,000 acres of U.S. farmland, with their investments reportedly generating $1.9 billion that year.

Chinese-backed companies with big bucks are also outbidding American farmers for new land, according to Boyd Jr.

John Boyd Jr on China farmland

National Black Farmers Association President John Boyd Jr. claimed Chinese companies are out-bidding American farmers for land on "Cavuto: Coast to Coast" Tuesday, June 27, 2023. (Fox News)

"Persons like myself who can maybe pay $4,000 or $5,000 an acre, some of these farms are being run up to $15,000 and $20,000 an acre," Boyd Jr. explained. "Now, how many American farmers that you know in the United States can afford $20,000 an acre for good farm ground? Because I can't."

The fourth-generation Black farmer criticized the Biden administration for being "asleep at the wheel" as China continues gaining land access adjacent to sensitive infrastructure and military bases.

"While we are losing farms, this administration hasn't done anything to stop farm foreclosures in this country. We have many of our members who are, right now, facing farm foreclosure, but we had $1 billion to help Chinese farmers and other entities in Russia," Boyd Jr. said.

"But they can come over here and purchase our farmland and purchase our infrastructure and tap into the American government here," he added. "Something is terribly wrong with this."

In May, Republicans and Democrats teamed up to introduce a bill that would block foreign adversaries like China from buying U.S. farmland, titled the "Protecting America’s Agricultural Land from Foreign Harm Act."

In addition to stopping people and companies linked to the Chinese Communist Party from buying U.S. farmland, the bill would block similar purchases out of Iran, North Korea and Russia and prohibit actors associated with the oppressive regimes from participating in certain programs directed by the USDA.

According to Congress’ legislative process tracker, a summary of the bill is still in progress and, thus, has not yet passed in either chamber to make its way onto the president's desk.

Boyd Jr. called out lawmakers for working "not aggressively" enough in order to pass and enact the law – and protect farmers, their land and businesses.

"U.S. senators and leaders in Congress, they need to put legislation in place to stop China from buying American farm ground and to stop them from buying American companies, and taking over the United States to quietly put a real strong foothold on the United States," the farmer said. "We’re not doing enough to stop this."

https://www.foxbusiness.com/economy/us-farmer-warns-china-quietly-taking-food-security

'Student loan repayments could slam big-name retailers this fall'

 The Supreme Court struck down President Biden's student loan forgiveness plan Friday, adding a layer of uncertainty to those straddled with payments. 

For more than three years, federal student loan borrowers have not had to make monthly payments. But that pandemic-era pause is coming to an end this fall, setting up a financial shock for millions of Americans and the big-name stores where they shop. 

About 44 million borrowers in the U.S. were affected by the payment pause, which initially began in March 2020 at the onset of the COVID-19 pandemic. The Biden administration extended the pause for the eighth time in November but will not do so again as part of the bipartisan debt ceiling deal approved by Congress. 

Payments, which will resume Aug. 30, can be substantial. The average monthly bill hovers between $200 and $299 per person, although it is even higher for some borrowers, according to most recent Federal Reserve data. 

Collectively, borrowers will resume paying about $10 billion a month, according to a recent analysis from JPMorgan. 

The resumption of these payments will likely force households to cut back on spending in other areas, particularly retail, according to a note from UBS analyst Jay Sole. 

"Inflation and the overall macro environment has caused U.S. consumers to defer many discretionary purchases over the past 18 months," Sole wrote in the note. "Apparel has proven to be the category consumers defer most often.

"Interestingly, market research of 1,392 U.S. consumers with student loans shows this trend is even more pronounced among this group. We believe this indicates student loan consumers will reduce spending on apparel in a big way when they have to start paying off their student loan debt." 

A number of brands and retailers could be negatively affected by the spending reduction, including American Eagle Outfitters, Carter's, Crocs, Foot Locker, Canada Goose, Gap, Nordstrom, Nike, Steve Madden, Under Armour and Victoria's Secret, according to UBS. 

UBS is not alone in its warning of trouble for retail. 

JPMorgan analyst Chris Horvers said Target sales could face a hit once student loan repayments begin in early September because Target caters to millennials, who carry a large share of student loan debt. 

"Target over-indexes to the millennial customer and, should student loan payments come back on, the company is more exposed than others in our coverage," Hovers wrote in the note. "Buy-side client expectations are in the $6-8 million per month consumer outflow range should this happen, per our conversations, which represents a potential 1-2 point [comparable] headwind to retail spending." 

Biden's broader student loan forgiveness plan, which SCOTUS blocked, had proposed the elimination of $10,000 in student loan debt for individual borrowers who earned less than $125,000 in either 2020 or 2021 or married couples who made less than $250,000 annually in those same years. If a qualifying borrower also received a Pell grant while enrolled in school, they would be eligible for up to $20,000 in debt forgiveness. 

"There are millions of Americans — millions of Americans in this country who feel disappointed and discouraged, or even a little bit angry, about the court’s decision today on student debt. And I must admit I do too," Biden said Friday afternoon. 

The White House plans to push forward a new plan to erase student loan debt. 

https://www.foxbusiness.com/economy/student-loan-repayments-slam-big-name-retailers-fall

Some Pfizer Vaccine Batches In The EU Were Placebos, Say Scientists

 by Robert Kogon via DailySceptic.org,

German scientists have uncovered startling evidence that a substantial portion of the batches of the Pfizer-BioNTech COVID-19 vaccine deployed in the European Union may in fact have consisted of placebos – and that the German regulator knew this and did not subject them to quality-control testing.

The scientists, Dr. Gerald Dyker, Professor of Organic Chemistry at the Ruhr University Bochum, and Dr. Jörg Matysik, Professor of Analytical Chemistry at the University of Leipzig, are part of a group of five German-speaking scientists who have been publicly raising questions about the quality and safety of the BioNTech vaccine (as it is known in Germany) for the last year and a half.

They recently appeared on the Punkt.Preradovic online programme of the German journalist Milena Preradovic to discuss batch variability. Their starting point was the recent Danish study showing enormous variation in the adverse events associated with different batches of the Pfizer-BioNTech vaccine, or BNT162b2 per its scientific codename. The below figure from the Danish study illustrates this variation.

It shows that the batches used in Denmark, which are represented by the points in the graph, essentially break down into three groups.

The ‘green batches’ clustered around the green line have a moderate or moderately-high level of adverse events associated with them. In the discussion with Preradovic, Gerald Dyker takes the example of the green point furthest to the right.

As he explains, it represents the batch that was the used the most in Denmark, with somewhat over 800,000 doses having been administered. These 800,000 doses are associated with around 2,000 suspected adverse events, which gives a reporting rate of one suspected adverse event per approximately 400 doses. As Dyker puts it, “That’s not a small amount if we compare to what we know otherwise from influenza vaccines.” According to Dyker’s calculation, the green batches account for more than 60% of the Danish sample.

There are then the ‘blue batches’ clustered around the blue line, which are obviously associated with an extraordinarily high level of adverse events. As Dyker notes, no more than 80,000 doses of any of the blue batches were administered in Denmark – suggesting that these especially bad batches may perhaps have been quietly pulled from the market by public health authorities.

Nonetheless, these batches had as many as 8,000 suspected adverse events associated with them. Eight thousand out of 80,000 doses would give a reporting rate of one suspected adverse event for every 10 doses – and Dyker notes that some of the blue batches are indeed associated with a reporting rate of as high as one suspected adverse event for every six doses!

On Dyker’s calculation, the blue batches represent less than 5% of the total number of doses included in the Danish study. Nonetheless, they are associated with nearly 50% of the 579 deaths recorded in the sample.

Finally, we have the ‘yellow batches’ clustered around the yellow line, which, as can be seen above, barely gets off the x-axis.

On Dyker’s calculation, the yellow batches represent around 30% of the total.

Dyker notes that they include batches comprising some 200,000 administered doses which are associated with literally zero suspected adverse events.

As Dyker puts it, “malicious” observers might note that “this is how placebos would look”.

And malicious observers might be right.

For Dyker and Matysik compared the batch numbers contained in the Danish study with publicly available information on the batches approved for release, and they made the startling discovery that almost none of the harmless batches, unlike the very-bad and not-so-bad batches, appear to have been subject to any quality-control testing at all.

Unbeknownst to most observers, it is precisely the German regulatory agency, the Paul Ehrlich Institute (PEI), which is, in principle, responsible for quality control of all the Pfizer-BioNTech vaccine supply in the EU. (The institute is named after the German immunologist and Nobel Prize winner Paul Ehrlich, not, of course, the Stanford biology professor of the same name.)

This reflects the fact that the actual legal manufacturer of the vaccine, as well as the marketing authorisation holder in the EU, is the German company BioNTech, not its more well-known American partner Pfizer.

Dyker and Matysik found that the PEI had tested and approved for release all the very bad ‘blue’ batches, the overwhelming majority of the not-so-bad ‘green’ batches, but almost none of the harmless ‘yellow’ batches – as if the PEI knew in advance that these batches were unproblematic.

This is shown in the below slide from Dyker’s presentation during the Punkt.Preradovic interview. The title reads: ‘Which batches from the Danish study did the Paul Ehrlich Institute test and approve for release?’

In the PEI column of each of the tables, “ja” means, of course, that the batch was tested, “nein” means that it was not. Note that only the first batch in the ‘yellow’ table was tested.

The caption under that table reads: “The PEI did not generally regard testing of the harmless ‘yellow batches’ as necessary.”

As Dyker put it, with notable restraint, “this would support the initial suspicion that they are maybe in fact something like placebos”.

Or, in short, to paraphrase the German scientists’ findings on the variability of the Pfizer-BioNTech batches, it would appear that the good was bad, the bad was very bad, and the very good was saline solution.

*  *  *

(The full Punkt.Preradovic interview with Gerald Dyker and Jörg Matysik is available here in German. The above translations are by your writer. A full, presumably machine-translated, English version of the interview is also available on the Punkt.Preradovic webpage.)

Robert Kogon is a pen name for a widely-published financial journalist, translator and researcher working in Europe. Subscribe to his Substack and follow him on Twitter.

https://www.zerohedge.com/covid-19/some-pfizer-vaccine-batches-eu-were-placebos-say-scientists