Power Alley Saturday: We Have Said For Quite A While That Wall Street Has Under-Estimated Keytruda®’s Patent Life [Extenders]…

Much of the current analysts’ writing — at Wall and Broad — operates from the assumption that when Merck’s first patent on pembrolizumab (branded as Keytruda®) expires, a generic / biosimilar “gold rush” will take place. The bulk of them put that as a 2027 event (and harm Merck’s present, and future cash flow juggernaut).

As I’ve said for over four years, here — that misunderstands the way the patent law in the US favors… extensions, and new formulations. To be sure, at over $25 billion a year in revenue, there will be many competitors hoping to enter, with bio-similar versions… but Merck is presently conducting several Phase 2 and Phase 3 studies showing that a much more convenient “shot version” (subcutaneous) — as opposed to an hours long IV drip version, as presently patented — will do the job just as well.

Candidly, that effort (based on already-well-known, “generally recognized as safe” processes) is nearly certain to deliver, in demonstrating comparable efficacy — i.e., succeed, and thus support an entirely new FDA approval (and new US issued patents, to boot!) — for this far more convenient formulation.

By my lights, this would extend the highest margin markets’ patent protection to the mid-2040s. And there may well be other reformulations, or combos-, that make the old IV patented version… less attractive in the high-end oncology suites.

Sure, the generic manufacturers will come with various bio-similars, but those — relegated to the IV formulation — will be seen mostly in China and Russia, and India… and eventually parts of Sub-Saharan Africa, and South America. But that will be, net-net, only about five to ten percent of the overall revenue — and less than one to two percent of the profits, that Keytruda will be racking up, as a subcutaneous injection… in the EU, UK, Australia and Japan — and of course, the vast US and Canadian markets.

That is my candid assessment. So, in general — this is in no manner akin to the situation in 2008-09 that legacy Schering-Plough faced when one franchise was over 65 percent of the company profits, and over 40 percent of the company revenue… and was then determined to be an expensive placebo. Do trade with this in mind, as you look at Merck around $123 a share on the NYSE.

It has quite a bit of blue sky ahead, in a series of wildly profitable, and vitally life saving markets, around the globe. Smile.

नमस्ते

Bill Otis Wrote A Thing BEFORE The SOTU. I Doubt He Believes It, Now.

Read it solely for its comical appeal — if you do decide to read it, at all.

But to be fair — he wrote it about 20 hours before Mr. Biden delivered his SOTU.

Yes we are still eight months away from voting.

But Bill is correct that there is a probable scenario where Cheeto-lini is a convicted felon by then. And in this new world, that well may be lethal. And that is after the public will have seen headlines for days that he’s had to post over $600 million in bonds, in the courts, due to his losses on fraud charges — and on libel and defamation. Libel and defamation related to his lies about forcibly sexually assaulting a woman in a dressing room in a Manhattan department store.

So Bill’s headline gets it… exactly bass-ackwards. It is Cheeto who is DOA.

Out.

John Keats’ Headstone Reads “Writ in Water…” — And The Forthcoming JPL Europa Clipper Mission Will Take Him Literally At His Word…

John Keats1 had once penned a few lines… and then asked that one part in particular, be inscribed on his tombstone — as he lay dying at 25, in 1820. So it reads “here lies one whose name is… writ, in water…” — so true. All of our lives, it seems, are writ in water — ethereal, beautiful, fragile and fleeting.

And the mission to search for water, on Europa, called Clipper — will carry a tile with the wave form of human voices, in over 100 languages… saying the word “water”.

We need not explain why the finding of that silvery liquid on out-worlds means… everything, in our search for life, like ours. Just know that Mr. Keats is… smiling, this evening… somewhere, out there. Here’s the story, for a rain-soaked Friday:

…Made of the metal tantalum and about 7 by 11 inches (18 by 28 centimeters), the plate features graphic elements on both sides. The outward-facing panel features art that highlights Earth’s connection to Europa. Linguists collected recordings of the word “water” spoken in 103 languages, from families of languages around the world. The audio files were converted into waveforms (visual representations of sound waves) and etched into the plate. The waveforms radiate out from a symbol representing the American Sign Language sign for “water.”

To hear audio of the spoken languages and see the sign, go to: go.nasa.gov/MakeWaves.

In the spirit of the Voyager spacecraft’s Golden Record, which carries sounds and images to convey the richness and diversity of life on Earth, the layered message on Europa Clipper aims to spark the imagination and offer a unifying vision….

Ada Limon’s sublime poem appears on the reverse of this tile. Onward, smiling here in the steel and glass canyons… ever, smiling:

नमस्ते

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1. An earlier version of this post had mis-attributed the quote to William Butler Yeats. In was, in fact, John Keats, nearly a century earlier. The mistake was the author’s alone. So it goes.

Just The Tip Of The Iceberg — $93 Million Bond, Signed By Cheeto-lini, In Carroll Libel Judgment Case.

Well… this ABSOLUTELY has to be a first: the presumptive GOP nominee in ’24 has just posted a $93 million — insurer backed — bond, in the Southern District of New York, and it will shortly be followed by a perhaps nearly $500 million bond, in state court in New York (on the fraud judgment)…

The GOP is backing a guy who owes, under judgments of competent courts — nearly $600 million for fraud — and Libel. Libel involving a forcible sexual assault.

This is the best guy they could find.

But — if it means the Democratic Party retains the West Wing of 1600 Penn, for another four years…. I concur.

Let Tangerine lose… and lose… and… lose.

Onward.

In Friday Ebola Research News… Promising In Vitro Results, From A Strain Of Perhaps The Planet’s Oldest Bacterium…

To be clear, this would be a therapeutic, not a vaccine. For use in humans who’ve already presented with symptoms of Ebola.

Of the potentially greatest significance, it can be safely stored at room temperature, rather than the deep sub zero temps needed (and in scarce supply, in much of rural Africa) for the current and effective vaccine stocks.

The team at the University of Nebraska is beginning mouse models this year. We will keep our fingers crossed, but here is the story, from Phys.org:

…Nebraska’s Shi-Hua Xiang, Joshua Wiggins and colleagues took a special interest in scytovirin, a type of lectin produced by cyanobacteria, likely the Earth’s first oxygen-producing organisms. Because scytovirin had shown some early success in inhibiting Ebola, the Husker team went about engineering two strains of lactic acid bacteria, which can safely colonize the human body, to display scytovirin on their own surfaces. The study is published in the journal Frontiers in Microbiology.

After constructing research-safe shells of Ebola particles, the virologists introduced them to the two bacterial strains. Their experiments revealed that one of the engineered strains, Lactococcus lactis, could neutralize roughly 54% of the Ebola particles—more than twice the rate of scytovirin-free L. lactis.

Xiang, Wiggins and the team are now testing their bacteria-delivered antiviral in mice, where the virologists are determining whether the engineered L. lactis can neutralize Ebola the way it did in cell cultures. Passing that test could eventually lead to human trials.

If it does continue to perform, L. lactis — which is already used to make cheese and buttermilk — could become a relatively simple, inexpensive, long-term way to protect vulnerable populations against the devastating virus, the team said….

Now you know — a hopeful time, for advances in human disease management sciences. Onward.

नमस्ते

What On Earth Is He… Smoking?! Hinderaker Calls Joe Out — For Being “Mean-Spirited”?!

Well… that’s hilarious.

Hinderaker — as poisonous as a rattler… (at least before he went mostly senile) thinks Mr. Biden is… mean.

And all the while, John’s guy says “grab her by the pussy”… and calls gentle older women “nasty skanks”.

His attacks on Congressmen’s wives were… jaw-slacking in their depravity. We (after 2019) can add “horseface” to the list of insults 45 has hurled at women publicly, which also includes “fat pigs,” “slobs,” and “dogs,” just to name a few.

But Joe Biden is… mean?

This is sheer desperation, after all the agist lies from GOP — before the live SOTU… failed to resonate. We all saw a seasoned, mature (true), balanced leader with our own eyes this evening.

Tangerine looks like a sideshow barker by comparison.

In short, the GOP now well-knows it is DOA — with Cheeto-lini 2.0.

Perfect!

Amazon Update, For March ’24: A Lil’ Late In Posting This, But After ~70 Years, And Over 1.2 Million Employees — Amazon Claims The NLRB Is… Unconstitutional.

Unsurprisingly, Amazon has simply cribbed from a recent Elon Musk / SpaceX filing, to claim — in its JFK8 amended answer before the NLRB — that a federal agency, created by Congress to deal with rampant labor abuses nearly 90 years ago, and never once found to be an unconstitutional use of executive or legislative authority, in hundreds of thousands of cases… is unconstitutionally unfair to the behemoth’s rights to force individuals of extremely limited means to either bring suit all alone, or be relegated to one-sided arbitration clauses. [In short, Amazon would read the First Amendment’s “right to freely associate” out of the First Amendment. Who are these lawyers? That last link is background, from last year.]

This “I am the victim, here” claim by Amazon.,. is, of course… poppycock.

I debated about not quoting the specious nonsense from Amazon’s lawyers, but decided the world ought to see how the billionaires Bezos [and Musk!] abuse families making less than $40,000 a year in his warehouses and trucks. He claims (as a multi-billion corporation) that his rights are more important than those of actual “We the people” human citizens, thus:

…Some or all of the relief requested in the Second Amended Consolidated Complaint, including but not limited to paragraphs 51(c), 51(d), 51(e), and 51(f), would violate the First Amendment to the United States Constitution. . . . [Ed. note: But the people’s free association rights here are at least equal to Amazon’s.]

The Second Amended Consolidated Complaint should be dismissed because the General Counsel’s interpretation of the Act and requests to the National Labor Relations Board in this case implicate the Major Questions Doctrine and associated principles of non-delegation and therefore violate Article I of the United States Constitution. [Ed. note: But the Congress had long ago (in the 1930s) decided this supposed “major question”, by passing the National Labor Relations Act. Sheesh.]

The structure of the NLRB violates the separation of powers because its Administrative Law Judges are insulated from presidential oversight by at least two layers of “for case” removal protection, thus impeding the executive power provided for in Article II of the United States Constitution. [Ed. note: But all federal judges are never removable — at least as bad as Amazon’s purported whining.]

The structure of the NLRB violates the separation of powers because its Board Members, who are principal officers of the United States, are insulated from removal by the President except for inefficiency, neglect of duty, or malfeasance of office, thus impeding the executive power provided for in Article II of the United States Constitution [Ed. note: See immediately prior bracketed material]….

These guys’ hubris knows no bounds. [Yeesh. When is $250 billion (in net worth) ever going to be enough, for each of them? Do lay a new tax on this billionaires’ club tonight, Mr. Biden.]

We can only hope that, in time, justice will be visited on him (and Elon and Trader Joe’s), in favor of all the members of the ALU and all other union brothers and sisters, nationwide.

Onward.

नमस्ते

No Surprise. Scott Johnson Seeks… Genocide In Gaza.

Again this midday — he says “gag me with a spoon” to the President’s executive order, coming tonight — contemplating the UN and US establishment of a temporary port, right on the water in Gaza, to more effectively prevent children and women from… starving.

Or dying from thirst — and lack of essential medications.

Of course, Scott churlishly mislabels it as aid to Hamas. Feckless A-hole.

At least he isn’t shying away from admitting it now… he simply wants the Israelis to commit genocide.

Charming, ole’ Scottie.

Out.

Skewing Into The Whimsical, On A Thursday: “What Should The ‘New’ Logo(s) Be, Depending On Which Company Loses The Lanham Act Suit?”

Our ever-erstwhile Anon. commenter has put in mind of this — once again.

We’ve repeatedly speculated on a whimsical name for the US entity, should it lose the Lanham Act suit — though as I’ve long said, I don’t think an outright loss of name is likely for the US-based entity.

But we’ve never deeply explored what might be the new name or logo, for the Darmstadt entity, should it turn up as the loser.

So — without any ado — see at right.

For the sake of a complete record, here below is our prior take, on the US rebrand (should it be forced to do so, by a court loss).


Onward, grinning.

नमस्ते