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NEW MERCK, REVIEWED

A "New Merck" Review. . .
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POWER ALLEY: MERCK CLOSES M&A DEAL; NOW OWNS HARPOON THERAPEUTICS, FOR
~$650 MILLION…

March 11, 2024 - Leave a Response

The Hart Scott Rodino waiting period had expired about a week ago (without an
added request from the Antitrust Division), and we mentioned the original inking
of the purchase contract, here two months ago. . . but it is now put to bed. The
assets are owned by Rahway, as of this morning, and the Harpoon stock symbol has
stopped trading — on the NASDAQ.

Good news — but even so, as a cogent commenter pointed out in January, there
have been some reports of off-target effects in the T-cell engager space (but
the patients often face dire circumstances, with SCLC — without therapy).

Here’s the latest:

> . . .[Rahway today completed] the acquisition of Harpoon Therapeutics, Inc.
> (Nasdaq: HARP). Harpoon is now a wholly-owned subsidiary of Merck, and
> Harpoon’s common stock will no longer be publicly traded or listed on the
> Nasdaq Stock Market.
> 
> “We continue to augment and diversify our oncology pipeline with innovative
> approaches to help people with cancer worldwide,” said Dr. Dean Y. Li,
> president, Merck Research Laboratories. “We are pleased to welcome our Harpoon
> colleagues to Merck and look forward to working together to advance a novel
> portfolio of T-cell engagers, including MK-6070.”
> 
> Harpoon’s lead candidate, MK-6070 (formerly known as HPN328), is a T-cell
> engager targeting delta-like ligand 3 (DLL3), an inhibitory canonical Notch
> ligand that is expressed at high levels in small cell lung cancer (SCLC) and
> neuroendocrine tumors. The safety, tolerability and pharmacokinetics of
> MK-6070 is currently being evaluated as monotherapy in a Phase 1/2 clinical
> trial (NCT04471727) in certain patients with advanced cancers associated with
> expression of DLL3. The study is also evaluating MK-6070 in combination with
> atezolizumab in certain patients with SCLC. In March 2022, the U.S. Food and
> Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the
> treatment of SCLC. . . .

Now you know — onward, grinning — sunny here! [With our second (smaller)
graphic, at left, we remind readers of an AI-powered diagnostics deal Merck has,
in the oncology space.]

नमस्ते



Categorized in Uncategorized
Tags: Harpoon Now Belongs To Merck Immuno Space $650 Million Q2 2024 January 8
2024


GERMAN MERCK SUFFERS SETBACK — IN POTENTIAL MS CANDIDATE, EVOBRUTINIB… SO
IT GOES.

March 10, 2024 - Leave a Response

Thus Sanofi’s Aubagio® (the current standard of care, in MS) remains the top of
the heap. Many pharmacos were looking at BTK inhibitors as the next generation —
for MS therapy. It is fair to say that the Germans’ misses have chilled the
entire space. But that — after all — is what science is about: trial and error;
and then a redirecting of efforts based on the shared learnings.

Are Biogen, Novartis and Roche each re-evaluating their MS / BTK development
programs? We shall soon see. In the mean time, here’s some of Fierce’s fine
reporting on it all:

> . . .It’s been a quick fall from grace for evobrutinib. Only months ago, Merck
> KGaA was outlining hopes for a major commer- cialization push for the BTK
> inhibitor — and now the German pharma has dropped the drug completely.
> 
> Merck told Fierce Biotech that the decision was made in response to the
> failure of evobrutinib to beat Sanofi’s Aubagio in two phase 3 multiple
> sclerosis (MS) clinical trials in December 2023. With Merck having pinned
> blockbuster hopes on the drug, the pair of failures sent shockwaves through
> the BTK inhibitor space at the time. . . .
> 
> Up to the phase 3 readouts, the company had maintained sky-high hopes for the
> drug. As recently as November, Merck had outlined plans to support evobrutinib
> with a major commercialization push, telling investors that launch
> preparations would drive up costs starting in the fourth quarter and mulling
> whether to use a voucher to accelerate the FDA review.
> 
> On a call with analysts to discuss the earnings results, Merck CEO Belén
> Garijo admitted the BTK inhibitor’s failure “was no doubt a disappointment. .
> . .”

Onward, smiling into the Sunday sunshine — for a brisk ride by the lake. . . .

नमस्ते



Categorized in Uncategorized
Tags: Darmstadt ESM Merck BTK Inhibitor Evobrutinib MS Candidate Flame Out
Adverse Liver Enzyme Readings Two Patients Germany DAX Price Down 6% April 12 13
2023 March 10 2024


SCAR JO — FLAWLESS, AS KATIE BRITT [CATCH THE “GET OUT!” REFERENCE]

March 10, 2024 - Leave a Response

Nothing more need be said — so, here is her comedic genius (scroll to about the
mid-point of the cold open):

For the perhaps 5% of all Americans who found Katie Britt compelling, this past
week. . . wake up. Please. . . wake up.

नमस्ते

Categorized in Uncategorized
Tags: Scarlett Johansson As Sen. Katie Britt R. AL Sen. Not For Long March 10
2024


TRIVIAL — BUT INTERESTING, TO ME, AT LEAST… AT THE MAIN LIFE SCIENCE BLOG SITE…

March 9, 2024 - Leave a Response

I guess I ought to invite my own. . . absence, more often. Heh.

Unlike at least the prior three years, this past one has seen my traffic spike
as I take more extended, off-grid trips. . . almost exclusively for. . .
pleasure.

But it truly is of no moment, since I never have — and never will — sell ads, or
try to monetize my traffic. It is more a tool for gauging reader interest, in my
case.

I gather (from my phone calendar) once in a great while, during one of the red
trips — I had a quick lunch or afternoon biz meeting there somewhere in the
middle, but mostly. . . I am out of pocket, and posting far less material during
the red arrow intervals, at right.

So. . . I’d guess the data in 2023. . . says I am a man who has much about which
to be. . . modest. Hah! Onward.

नमस्ते

Categorized in Uncategorized
Tags: My Traffic Spiked In 2023 When I STOPPED Posting For A Week Or More --
Hilarious! March 9 2024 March 22 2023 St. Paddy's '24 A-comin'


POWER ALLEY SATURDAY: WE HAVE SAID FOR QUITE A WHILE THAT WALL STREET HAS
UNDER-ESTIMATED KEYTRUDA®’S PATENT LIFE [EXTENDERS]…

March 9, 2024 - Leave a Response

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

Categorized in Uncategorized
Tags: Keytruda will be Subcutaneous by 2027 From Present IV Version And EXTEND
Patent Life Into 2040s Condor Sez March 9 2024


JOHN KEATS’ HEADSTONE READS “WRIT IN WATER…” — AND THE FORTHCOMING JPL EUROPA
CLIPPER MISSION WILL TAKE HIM LITERALLY AT HIS WORD…

March 8, 2024 - Leave a Response

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:

~~~~~~~~~~~~~~~~~~~~~~~

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.
नमस्ते

Categorized in Uncategorized
Tags: Europa Clipper Mission Tile Water Writ In Water Said John Keats 1820 Dead
At 25 March 8 2024 DMWH JPL JPF Birth Month


IN FRIDAY EBOLA RESEARCH NEWS… PROMISING IN VITRO RESULTS, FROM A STRAIN OF
PERHAPS THE PLANET’S OLDEST BACTERIUM…

March 8, 2024 - Leave a Response

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

Categorized in Uncategorized
Tags: Univ. of Nebraska Med Center microbial research scytovirin lectin
cyanobacteria as potential for Ebola therapeutic post symptoms physics.org
Frontiers in Microbiology March 8 2024


SKEWING INTO THE WHIMSICAL, ON A THURSDAY: “WHAT SHOULD THE ‘NEW’ LOGO(S) BE,
DEPENDING ON WHICH COMPANY LOSES THE LANHAM ACT SUIT?”

March 7, 2024 - Leave a Response

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

Categorized in Uncategorized
Tags: Whimsy 16-266 USDC NJDC Merck v. Merck Lanham Act Treaty of Versailles
1917 WWI End More Than A Century March 1 7 2024 22 2021 2022 DMWH


MERCK V. MERCK: LIKELY MULTI-BILLION DOLLAR NAME LITIGATION — GRINDING SLOWLY TO
A TRIAL DATE, IN THE NEW JERSEY FEDERAL COURTS.

March 7, 2024 - Leave a Response

As we most recently mentioned just a week ago, it seems the settlement talks in
this high stakes name fight have hit an impasse. So now this long running case
(with satellite cases dotting the globe — in Japan, the EU, Britain and various
South American geographies, to name just a few) is being served up, on a final
trial prep calendar.

The trial proper, is not likely to begin much before early 2025 — and, of course
— we may yet see settlement talks resume. Here’s the latest, though:

> . . .TEXT ORDER:
> 
> The protocol for in limine motions is as follows: At the outset, each side
> will be allowed to file a maximum of three in limine motions. Each in limine
> motion will be filed as its own application, and not as part of a larger
> omnibus motion.
> 
> The maximum page limits are as follows: moving brief-15 double-spaced pages;
> opposition brief-15 double-spaced pages; reply brief-7 double-spaced pages.
> However, any in limine motion challenging Philip Green and/or Dr. Dominique
> Hanssens shall be limited to moving brief-30 double-spaced pages,
> opposition-30 double-spaced pages, reply-15 double-spaced pages.
> 
> The parties will not file the motions until they are fully briefed, at which
> time the entire set of motion papers shall be filed. Accordingly, the movant
> shall serve, but not file, all moving papers on the adversary by May 3, 2024.
> The opposing party will serve, but not file, the opposition papers by June 3,
> 2024. On or before June 24, 2024, the movant will file all papers in support,
> opposition, and in reply, for the motion with the Clerk of Court.
> 
> No further in limine motions may be filed without leave of the Court, which
> application shall not be made before the Court has resolved the motions
> authorized by this Order.
> 
> So Ordered by Magistrate Judge Michael A. Hammer on 3/6/2024. . . .

I think the two experts — named, and linked — above, will testify on ongoing US
and global marketplace effects, and whether confusion is evident in the minds of
customers, suppliers, shareholders and providers; as well as whether
intellectual property laws are being bent (or broken) here — and whether they
(or the Lanham Act) fashion a workable remedy.

Now you know — and yes, I think Mr. Biden will win populist “hearts & minds”
tonight, by announcing an expanded push to use market incentives to reduce
average selling prices of life-saving meds, as well as a new “billionaires’
taxes” scheme. Onward then, into the Thursday morning sunshine. . . grin.

नमस्ते

Categorized in Uncategorized
Tags: 16-266 USDC NJDC Merck v. Merck Lanham Act Treaty of Versailles 1917 WWI
End More Than A Century March 1 7 2024 22 2021 2022 DMWH


MERCK + GILEAD: STILL ONLY PRELIM. RESULTS, IN AN OPEN LABEL HIV+ TWO THERAPY
COMBO (ONCE A WEEK)… BUT VERY ENCOURAGING.

March 6, 2024 - Leave a Response

As we mentioned exactly three years ago, here — these are early days, in an
entirely new way of approaching HIV+ patients. The loading is only once per
week, and it is all oral (thus higher compliance). A huge step forward, with
these two heavy-weights, cooperating since March 2021.

And now, the companies are showing very impressive real world sustained
reductions in viral loads. Here’s the latest, from Fierce (but not quite a
material development yet, for gargantuan Merck):

> . . .Early results show that a weekly combination of Merck & Co.’s islatravir
> and Gilead’s approved HIV med Sunlenca maintained a high rate of viral
> suppression in patients with HIV, and just one patient out of 100 missed on
> the primary endpoint that measured viral load.
> 
> The open-label phase 2 study is testing islatravir 2 mg and lenacapavir 300 mg
> once a week against Gilead’s oral Biktarvy daily in 104 virologically
> suppressed adults. . . .
> 
> [The dosing combo] maintained a high rate of viral suppression with 94% of the
> group reporting less than 50 copies/ML. This shows that patients who switched
> to the weekly combo, compared to Biktarvy’s daily dosing schedule, maintained
> comparable rates of HIV suppression, the companies explained.
> 
> No patients in the Biktarvy arm of the study had viral loads of more than 50
> copies/ML at week 24.

Now you know. From a certain death sentence — in the 1980s and early 1990s. . .
to long hospital stays and injections, in the late ’90s to early 2000s. . . to
now, a full and active — and long life, here over forty years later. Wow. . .
that’s. . . some seriously excellent life-science progress. Smile. . . .

नमस्ते

Categorized in Uncategorized
Tags: Gilead And Merck Cooperate In HIV Long Haul Therapies March 15 2021 End Of
Hep C Patent Wars Era March 6 2024

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