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Tuesday, January 23, 2024

J&J Beats Q4 Expectations, Reports $21.4B in Revenue as Faces Patent Cliff

 Johnson & Johnson’s fourth-quarter 2023 earnings report Tuesday revealed the pharma giant exceeded Wall Street expectations. Revenue for the quarter came in at $21.4 billion, compared to consensus estimates of $21.01 billion, a 7% increase from the same quarter last year.  

J&J benefitted from a continued boost to its medical device business, which has been recovering steadily from its pandemic-induced dip as patients and doctors canceled elective surgeries. Fourth-quarter sales of medical devices were up 13.3% compared to the same quarter in 2022, bringing in $7.67 billion. J&J CFO Joseph Wolk attributed this to a further procedure increase in December 2023 and the company’s $16.6 billion acquisition of heart pump company Abiomed at the end of 2022. 

Full-year 2023 sales for the company rose 6.5% to $85.2 billion. J&J’s innovative medicine business represented 9.5% of fourth-quarter operational sales growth versus the prior year, excluding J&J’s COVID-19 vaccine.  

Weighing down J&J’s pharma business is a patent for one of its best sellers, Stelara, which expired last year. However, the company struck deals to delay the competition from launching their biosimilars. Amgen is first in line and has agreed to not launch until 2025, meaning Stelara can continue to add to J&J’s bottom line for 2024 and into 2025. Biosimilars are expected in Europe a bit earlier, mid-year 2024. Sales of the immunology drug were up 11.7% from 2022, bringing in $10.9 billion for the year. 

Also leading the company’s drug sales was J&J’s oncology portfolio. Immunotherapy multiple myeloma (MM) drug Darzalex grew over 22%, raking in $9.7 billion in full-year sales. Its CAR-T therapy for MM was under scrutiny by the FDA for the “serious risk” of secondary malignancies in patients treated with this type of immunotherapy. The agency has asked J&J as well as BMS, Gilead and Novartis to add boxed warnings to the labels of their respective CAR-T therapies, noting the potential risks. Sales of J&J’s CAR-T therapy Carvykti came in at $500 million for 2023.  

With the Stelara biosimilar entry in Europe this year, J&J is expecting “slightly stronger sales” in the first half of 2024 compared to the second half of the year due to continued uptake of recently launched products. The company has already announced its first acquisition of the year—Ambrx Biopharma for $2 billion—to add the next generation of antibody-drug conjugates to its oncology portfolio.  

J&J sales forecast for the full-year 2024 is set at $87.8 billion to $88.6 billion. Shares of the company were down around 3% in Tuesday morning trading. 

https://www.biospace.com/article/j-and-j-narrowly-beats-q4-expectations-reports-21-4b-in-revenue-as-faces-patent-cliff-/

Davos Admits Possibility Of Ukraine Defeat - Claims Putin Will Target EU Next

 In a move that would have been unthinkable a year ago, the WEF has formed a discussion panel at their annual Davos conference titled “What If Ukraine Loses?”  The panel represents, at the very least, an admission by the globalists that Ukraine could be defeated by Russia despite the deluge of money, armaments and intel assets that Ukraine has been given access to by western governments.

Since 2022, the narrative has shifted from talk of complete victory over Russia including the retaking of the Donbas and even Crimea, to merely holding the current front and keeping a steady supply of ammo and recruits.  

The realities on the ground cannot be denied.  The long vaunted “counter-offensive” that was supposed to crush Russian forces was a complete failure.  No significant ground was gained and no significant victories have been won.  It was a considerable propaganda error to hype up the counter-offensive the way Ukraine did, because when it turned out to be a dud all their other claims quickly came under suspicion.    

At the end of 2023, the average age of Ukrainian soldiers was older than 40 (compare this to the US where the average age is 27).  Rumors out of Ukraine abound that most younger soldiers are dead and that collection teams (government enforcers) now prowl the streets of cities like Kiev.  They search for and kidnap any fighting age men they find, only to send them to the front with little or no training. 

These are the kinds of stories that go mostly ignored by the wider western media.  When they are mentioned, it is usually in support of the Ukrainian government, chastising people who don't want to fight and die in a globalist proxy war as “draft dodgers.”  The level to which journalists have acted as a propaganda arm of NATO and Ukraine has been grotesque, but it does help to explain why so many Americans and Europeans were deluded about the war for so long.  All they have heard about for the past two years is that Ukraine is on the verge of imminent victory.

It's simply not true.

This is likely why the WEF is now forced to address the issue at Davos – The situation is becoming undeniable and the fact that the elites are allowing discussion about a Ukraine loss suggests that defeat might be closer than we know.

 

The panel itself is largely made up of Ukrainian representatives who are there to spin the facts, not have a frank discussion about the realities in the trenches.  Journalist Niall Ferguson seems to be the only member with a modicum of honesty on the panel, as he admits the situation in Ukraine has degraded dramatically.  He does, however, join with the Ukrainians in admonishing the American public's growing opposition to monetary and military support.

The underlying message?  If Ukraine loses, it will be your fault.     

Why should Americans be relied upon to dump hundreds of billions of dollars into a losing war against an opponent that has nothing to do with them?  The same question should be considered by Europeans, but their proximity is used as leverage against them.  The primary argument from political warhawks like Lindsay Graham and puppets like Zelensky is that when Ukraine falls, Putin intends to invade Europe next.  

It's the old Vietnam era “domino effect” narrative, repeated ad nauseum.  The problem is that warhawks along with Zelensky and his propagandists are caught in a Catch-22:  They have been promoting the idea that Russia's military is in shambles and that US and EU aid is bringing Ukraine to victory.  At the same time, they want to frighten Europeans and Americans with the prospect that Russia is strong enough to invade the EU.  They can't have it both ways – Either Russia's armies are crippled and ripe to be overrun, or, they are incredibly strong and capable of leaping into a series of invasions against Ukraine's neighbors.  

The notion that Vladimir Putin intends to blitz Eastern Europe and that Ukraine is the only thing stopping him has never been supported by any significant evidence.  Putin has never made this threat and there is no hard intel that confirms this is his strategy.  There was a multitude of reasons for Russia to invade Ukraine and take the Donbas region; there is no strategic reason for them to engage in conflict with any other nation.  

Rather than going into the ugly facts about Ukraine's chances, the Davos panel comes off more as a sales pitch for continued shipments of cash and weapons.  A disturbing cost/benefit analysis is offered up to the audience - For the cost of a couple hundred billion dollars and the lives of hundreds of thousands of Ukrainian citizens, here is what you get in return...

The speakers even refer to this dynamic as an “investment.”  Some of the more revealing comments include...

1)  Panel members demand that more needs to be done to give Ukraine the means to strike into the heart of Russia (meaning long range missiles), which would only open the door to total bombardment of Ukraine's civilian population centers (which Putin has so far kept to a minimum, especially when you compare operations by the US in places like Iraq).  Escalation could include nuclear strikes, which Putin has mentioned on multiple occasions.   

2)  The panel asserts that the "global community" needs to collectively approve the use of more aggressive strikes on Russia.  The nature of these strikes is not really discussed but this could include anything from bombardment of Russian cities, manufacturing, energy and agriculture to terror attacks on civilian populations.  One could say that all is fair in war, but this is not the point.  The point is that escalation is assured and many civilians (most of them Ukrainian) will die should Ukraine be armed with high tech weaponry or use tactics that risk much higher collateral damage.  This is not a scenario that the majority of Americans want to facilitate.

3)  Possibly the most interesting and disturbing comment of the panel came from politician Yehor Cherniev, who noted that the problem with America is that the government is forced to "listen to the people," which slows down decisions on Ukraine.  In other words, a dictatorship in the US would serve Ukrainian interests better.  Given that Ukraine is essentially a dictatorship right now, this sentiment is not surprising but still interesting to hear in a public forum.       

The clinical manner in which the war is being handled and sold suggests a sociopathy beyond reckoning, but it also lets us know that the war is intended to last.  So far, there has not been a single serious gesture from NATO leaders to engage in diplomatic negotiations or peace talks with the Kremlin.  And (if it hasn't happened already) eventually Ukraine will run out of soldiers to fight.  Under the circumstances, a devastating loss is assured, to the point that it appears to be the only outcome that is allowed to happen.     

https://www.zerohedge.com/geopolitical/davos-admits-possibility-ukraine-defeat-claims-putin-will-target-eu-next

What Are We Getting for All That Obamacare Spending?

 One reason the United States spends more on health care than other countries is that we are obsessive about health insurance instead of health care.

When the British National Health Service or the Canadian Medicare system spends additional money, they spend it employing doctors, building hospitals or buying medical equipment. When the U.S. government spends more money, we give it to insurance companies.

Take Obamacare. We are currently spending $214 billion a year insuring people through Medicaid (which is mostly contracted out to private insurers) and the Obamacare exchanges. At $1,731 for every household in America, that’s a great deal of money being transferred from taxpayers to insurance companies every year.

What are we getting for all that spending? Are people getting more health care? If they are, what difference is that making?

Apparently, few people find these questions interesting. In a Google search on “Obamacare,” every article I encountered discussed health insurance, but not health care. Even at the Obama Foundation website, the focus is entirely on insurance, not care.

Doctor Visits Have Fallen

Nonetheless, one scholarly study finds there has been no overall increase in health care in the US since the enactment of Obamacare. More on that below. The number of doctor visits per capita actually fell over the last decade. That’s surprising, because our population has been aging, and older people require more health care.

Unfortunately, there is nothing particularly new here. When Obamacare was enacted, it was expected to cost close to $1 trillion over the next ten years. But there was no serious discussion of what we were going to buy with all that spending – not in Congress, not in the mainstream media, or even in the health policy community.

Econ 101 teaches that all societies face a production possibility frontier. The typical textbook example is the choice between guns (military goods) and butter (consumer goods). In our case, it is health care versus other goods and services. To have more of one, you have to have less of the other.

To have more health care, we have to have more doctors, more nurses, more hospital beds, etc. Without any increase in supply, for one group of people to get more care, some other group has to get less.

We saw a vivid illustration of that during the Covid pandemic. In order to tend to the needs of a sudden surge in Covid patients, health care providers had to delay care for the non-Covid patients.

Throwing Money at the Problem

Our experience with Obamacare is similar to our experience with every major health program Congress has passed or even considered passing. We begin with a claim of unmet needs; we decide on a large sum of money to throw at the problem; but we never ask how the money can meet unmet needs if nothing is done on the supply side.

Medicare for the elderly and Medicaid for the poor were huge programs, even when they were started in 1965. In a short period of time the number of people who lacked health insurance dropped from nearly 25 percent to under 15 percent of the population.

As a result, physician visits by low-income people increased 6.2% and surgical procedures among the elderly increased 14.7%. But since there was no increase in the ability of the system to supply medical services, these increases were offset by a decrease in care delivered to the non-poor and the non-elderly. A study in the American Journal of Public Health found that “society-wide utilization of medical care remained unchanged.”

Even though there was an increase in health care services for seniors, MIT professor Amy Finkelstein discovered that the passage of Medicare had no effect on the health of the elderly—at least as measured by mortality. The additional spending set off a bout of health care inflation for all patients, however.

What lessons did Washington politicians learn as a result of this experience? Apparently, none at all.

During the first term of the Clinton Administration, Hillary Clinton proposed a plan to reform the private health care system and insure the remaining uninsured. But although that proposal consumed thousands of pages of analysis and discussion, almost no one asked what the nation would have less of in order to have more health care.

No Overall Increase in Health Care Utilization

Under Obamacare, the number of people without health insurance fell from 15.5 percent of the population in 2010 to 7.9 percent by 2022. Yet the study cited above found that health care utilization across all of society did not increase at all. There was some shifting, as low-income patients got more care, but that care was offset by reductions elsewhere in the system. In particular, “a 3.5-percentage-point increase in the proportion of persons earning less than or equal to 138% of the federal poverty level with at least 1 office visit was offset by small, nonsignificant reductions among the rest of the population.”

You might think that prescription drugs are different. If Congress liberalizes insurance for drugs, the drug companies can supply as much as patients demand. But even in the field of pharmaceuticals, there appears to be no limit to the ability of Congress to waste taxpayer money.

When Congress created Medicare Part D to pay for drugs in 2003, it created a $15.6 trillion unfunded liability for the federal government, looking indefinitely into the future. That was more than the unfunded liability in Social Security. Yet economist Andrew Rettenmaier discovered that only 7 percent of the benefits actually bought new drugs for seniors. The other 93 percent simply transferred to government (and therefore to taxpayers) the bill for drugs the elderly or their insurers were already buying. Only one in every thirteen dollars represented a new drug purchase.

Interestingly, the help given to the small number of people who were not otherwise getting medications actually reduced Medicare’s spending, as drugs were substituted for more expensive doctor and hospital therapies. But this profit on the truly needy was overwhelmed by the cost of giving the benefit to those who didn’t need it—a cost that has created an enormous obligation for current and future taxpayers.

https://www.goodmaninstitute.org/2024/01/19/what-are-we-getting-for-all-that-obamacare-spending/

Anixa: Japanese Patent on Ovarian Cancer Vaccine Tech

 Broad coverage extended to Japan and related regions

Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that its collaborator, Cleveland Clinic, has received a "Decision to Grant" notice from the Japan Patent Office (JPO) for the patent application titled "Ovarian Cancer Vaccines."

https://www.prnewswire.com/news-releases/anixa-biosciences-announces-japanese-patent-on-ovarian-cancer-vaccine-technology-302041596.html

4D: Rare Pediatric Disease Designation for Cystic Fibrosis Treatment

 

  • 4D-710 has demonstrated promising, reproducible, CFTR expression significantly above normal levels for seven patients across Cohorts 1 & 2 (1E15-2E15 vg) and durable improvement or stabilization of quality of life & pulmonary function for three patients through 12 months in Cohort 1
  • Given above normal CFTR transgene expression (~400% of normal lung levels), dose exploration continues with evaluation of lower doses (Cohort 3 dose 5E14 vg)
  • Interim data update from Phase 1/2 AEROW clinical trial expected in mid-2024, and pivotal trial planning update expected in Q1

'Trial raises hopes for simple Alzheimer’s blood test'

Testing a person’s blood for a protein called phosphorylated tau could provide a means of large-scale screening for Alzheimer’s disease (AD), according to a new study.

The immunoassay – which has been developed by California biotech ALZpath – focuses on a form of phosphorylated tau known as pTau217 and might be able to detect elevated risk of AD years before symptoms develop.

At the moment, AD is typically diagnosed with the help of time-consuming and expensive PET brain scans or invasive cerebrospinal fluid (CSF) analysis carried out by lumbar puncture, coupled with cognitive testing.

All of these tests can be hard to access for patients, which contributes to the current situation where almost four in 10 people with dementia do not have a diagnosis, according to the Alzheimer’s Society.

The pTau217 assay was found to be 96% accurate in identifying elevated levels of amyloid and up to 97% accurate in correctly identifying high levels of tau when compared with CSF testing, according to the study in almost 800 middle-aged and older people with and without cognitive impairment, which has been published in the journal JAMA Neurology.

The test was able to distinguish between people who were likely, intermediate, or unlikely to develop AD, according to the researchers, and was also able to detect changes in their risk profile over time.

“Expanding access to this highly accurate AD biomarker is crucial for wider evaluation and implementation of AD blood tests,” write the researchers in the paper.

Dr Richard Oakley, associate director of research and innovation at Alzheimer’s Society, said the study is “a hugely welcome step in the right direction, as it shows that blood tests can be just as accurate as more invasive and expensive tests at predicting if someone has features of Alzheimer’s disease in their brain.”

Results from the test could be clear enough to not require further follow-up investigations for some people living with AD, which potentially could speed up diagnosis pathways, according to Oakley, although, he said additional research is needed to make sure the results apply to real-world settings.

The researchers estimate that a blood test could help to reduce the demand for follow-up testing by around 80%, saving health systems money.

An effective blood test will be invaluable for selecting patients who may benefit from new AD therapies like Eisai and Biogen’s amyloid-targeting antibody Leqembi (lecanemab), which is now approved in the US, Japan, and China, and under regulatory review in Europe.

The Alzheimer’s Society recently launched a five-year Blood Biomarker Challenge project in the UK in partnership with Alzheimer’s Research UK and the National Institute of Health and Care Research (NIHCR) to gather the information needed to introduce a blood test for dementia into UK healthcare systems.

“Before these tests become widely used in the NHS, we will need further evidence to show that the blood test can accurately diagnose who is in the process of developing dementia, and that it can identify who is likely to benefit from treatments to slow down the disease,” commented Prof Charles Marshall, professor of clinical neurology at Queen Mary University of London.

“We will also need to ensure that the blood test performs equally well in more diverse populations, so that it does not worsen existing health inequalities in access to diagnosis and treatment for dementia.”

ALZpath said that the pTau217 assay will be available for clinical use as ALZpath Dx later this month in the US.

https://pharmaphorum.com/news/trial-raises-hopes-simple-alzheimers-blood-test

Roche ducks out of AC Immune Alzheimer's antibody alliance

 After almost 18 years of collaboration, Roche’s Genentech unit has ended a collaboration with AC Immune on Alzheimer’s disease therapies, handing back rights to two antibody-based drugs.

The end of the alliance doesn’t come as a huge surprise, given that both antibodies – anti-amyloid drug crenezumab and anti-tau candidate semorinemab – have both chalked up failed clinical trials as treatment for early-stage Alzheimer’s in the last few years.

Lausanne, Switzerland-based AC Immune said it would take a look at data from both programmes before deciding on the future of the drugs, including open-label extension results from the LAURIET trial of semorinemab, which showed an improvement in cognitive decline, but no effect on functional decline, in mild-to-moderate Alzheimer’s patients at its main readout in 2021.

Genentech licensed rights to crenezumab in 2006, and in 2012 broadened the partnership to include semorinemab, gaining drugs that target the two main histological hallmarks of Alzheimer’s disease – amyloid plaques and tau tangles. The two deals had a combined value of more than $700 million.

Crenezumab failed a pair of phase 3 studies in people with prodromal to mild sporadic Alzheimer’s in 2019, and Genentech continued to test the drug’s promise as a treatment for a rare, inherited form of the disease in the phase 2 API-ADAD trial, which was also a bust.

In 2022, AC Immune said it had found some positive efficacy signals after sifting through the API-ADAD data. However, that was clearly not enough to keep Genentech interested in the programme, particularly with one approved anti-amyloid drug on the market – Eisai/Biogen’s Leqembi (lecanemab) – and another from Eli Lilly (donanemab) under regulatory review.

Semorinemab, meanwhile, missed the mark in the phase 2 TAURIEL study in 2020, and the glimmers of efficacy in LAURIET were not enough to sway Genentech, which has had a bad run of luck with Alzheimer’s candidates in the last few years. In 2022, another of its amyloid-targeting drugs, gantenerumab, failed two phase 3 trials and was also abandoned.

AC Immune’s share price barely quivered upon the announcement, suggesting it was anticipated by investors, and the company said in a statement that it was focused on progressing its three active immunotherapy candidates through clinical testing.

That includes its wholly-owned amyloid vaccine ACI-24.060 and tau vaccine ACI-35.030, partnered with Johnson & Johnson, which are both in phase 2 studies that chief executive Dr Andrea Pfeifer said are “potentially registrational”.

It also has a Parkinson’s disease candidate, ACI-7104.056, which targets alpha-synuclein and is also in mid-stage testing.

Pfeifer said that regaining rights to crenezumab and semorinemab raises the prospect of combining them with its active immunotherapies. She also noted that the company remains well-financed after a $50 million fundraising round last month and a recent milestone payment from J&J that will extend its cash runway into 2026.

Roche remains committed to Alzheimer’s despite the return of the two antibodies, though its lead candidate now is bepranemab, an anti-tau candidate licensed from UCB that is in phase 2 testing.

Following directly after are trontinemab, a tweaked version of gantenerumab designed to improve its ability to penetrate the central nervous system, and a new-generation small-molecule gamma-secretase inhibitor RG6289 designed to block the formation of amyloid – both in phase 2.

https://pharmaphorum.com/news/roche-ducks-out-ac-immune-alzheimers-antibody-alliance