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Power Alley: Fierce Quotes Leerink — Merck Expected To See Stronger Ramp In Winrevair™ — In 2025, Multi-Blockbuster Status Coming…

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We long ago predicted that Winrevair™ — for PAH — would be a multi-billion dollar franchise for Rahway. I was a little puzzled in the second half of 2024, when it seemed to initially be slow going.

The treatment should be a breakthrough, and as more real world post approval data flows in, it seems that maybe some side-effects are not quite as prevalent as the initial, smaller clinical trials suggest they might be. So all of that is very good news, for Merck. Here’s just a bit from FiercePharma — do go read it all, from Friday past:

…Based on a survey of cardiologist and pulmonologists treating patients for pulmonary arterial hypertension (PAH), analysts at Leerink Partners believe that Merck’s Winrevair “should have strong uptake growth” in 2025.

The treatment, which was the primary target in Merck’s $11.5 billion acquisition of Acceleron in 2021, logged $149 million in sales in the third quarter. It was a solid but underwhelming performance for the long-awaited drug that Merck has projected will reach $3 billion in peak sales….

[T]he Leerink survey indicates that the risk of patients bleeding as a side effect of Winrevair is lower than that portrayed in a registrational trial that set the drug up for its FDA nod in March 2024.

“The real-world safety is better than expected,” Leerink wrote while acknowledging that the data need to mature.

“In 2024 we believe sentiment regarding bleeding risk and early market access challenges likely contributed to a slower Winrevair ramp, as many respondents expressed caution given the high bleed rate reported in clinical trials and were quick to discontinue or pause therapy,” Leerink wrote….

So — we will reiterate our belief that a year from now, Merck ought to be trading closer to $130 on the NYSE, than the high $90s of today. Onward, smiling… be excellent to one another.

नमस्ते

Hayward Doesn’t Know That Many INDICTED — And Disbarred — Attorneys Lose Banking Privileges?!

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That lame dolt Steve Hayward speciously says it is “his politics” that got his checking accounts closed.

No. It is that he used his law license to commit felonies (helping in falsifying the 2020 election outcome — by deceit — including forgeries), according to a speaking indictment in Arizona.

It is a sensible (and common) practice, at big money center banks, to close such lawyers’ checking accounts — due to the extreme dangers their deceitful conduct represents.

Lawyers willing to tell sophisticated felonious lies… may easily get even a large bank in very deep trouble with regulators — and be PR nightmares. May injure hundreds. May engender… insurrections.

So, Hayward is knowingly full of crap, in suggesting that his political views got him “debarked”.

No, it was the conduct (the same conduct that got him disbarred, you putz.

Out.

UPDATE On That Stupid Fitton Strike Suit, Against Reparations, Here In My Home Town…

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Yesterday, whilst we were busy doing other things, the City added to the weight of authority that holds Tom Fitton and his goofy solicited “plaintiffs” should be bounced for lack of having any concrete injury — called “lack of standing“.

The City pointed the able USDC Judge in Chicago to a decision in the Fourth Circuit, earlier in the month called Hierholzer, and here is what the City offered about that decision:

…In Hierholzer, the Fourth Circuit affirmed the district court’s dismissal for lack of standing a claim that the Small Business Administration’s Section 8(a) Business Development Program unlawfully discriminated against the plaintiffs on the basis of race.

The district court’s dismissal was based, in part, on the plaintiffs’ inability to plead facts sufficient to show that they were “able and ready” to participate in the program but for the program’s racial consideration because they could not meet the program’s race neutral requirements. Id. at *8. The Fourth Circuit affirmed.

Noting that because “‘the party invoking federal jurisdiction[]bears the burden of establishing’ standing… [plaintiffs] were required to plead facts to support that they would be eligible for the program” by meeting both its requirements that considered race and those that were race neutral. Id. “Because [plaintiffs] failed to do so, [plaintiffs] have not demonstrated that they suffered an injury in fact….”

The chuckleheads who brought this silly claim will (despite Tangerine’s endlessly hateful burping) be dumped out on their ears. Onward, grinning. . . [people who don’t own property, pay taxes locally, or… live here, cannot dictate how we choose, via our own city council decisions, to spend our own real estate tax money — in repair for wrongs previously done. Full stop.]

Now, enjoy “He Lives In You”:

नमस्ते

Okay, Hinderaker — You Own His Coming Screw Ups, Or Worse. He’s Your Drinking (Drunk) Buddy.

~ condor ~ 2 Comments

So never in our history has the Veep had to break a tie, with 50 voting “no” (including three Senators from Tangerine 2.0’s own GOP party!) — on any Defense Sec’y. nominee.

Never. Until tonight.

When he implodes (and he will… implode) — Hinderaker, his malfeasance is on your account.

Full stop. Let us just hope his incompetence (or drunkenness, or lewd public behavior or forcible assaults) don’t somehow provoke another hot war — one that gets US troops killed.

Let’s hope he won’t try to run Defense at all. Let’s hope he just crawls inside a bottle at the office by noon every day, and sleeps it off all afternoon — 52 weeks a year. [Until Tangerine fires him — for some likely imaginary slight, that is. You know that’s how this will end, if you’re honest.]

I mean c’mon man — he bankrupted the small charity he ran — with 100 staffers. He’s now the head of 2.8 million employees, including over 1.29 million active servicemen and women… and must administer the largest single component of the federal deficit. Damn.

Out.

Courtesy My Erstwhile Anon(s).: Here Is At Least One Take On Tangerine 2.0’s “Anti-Science” Bias — In His Executive Order Passels, This Week.

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It has taken us a moment here, to find free time to put this and an all-new graphic together — but it is courtesy of my long reading / suffering Anon.(s)… thanks go to them for showing me it. I likely never would have seen it, in the blizzard of Sharpie scribbles this week alone.

So it is, that Trump/Vance (and Musk, clearly!) want to prevent real life sciences researchers and policy experts from sharing what they’ve learned — with one another. And, to stymie the award of a very large number of already green-lit, and pending federal life science research grants. [To the extent that Tangerine 2.0 wishes to emphasize differing research goals, that is within his ambit, at 1600 Penn.]

But the wholesale mothballing of ALL science efforts, for disease mitigation, for example — or new mRNA vaccines work, in particular — should be beyond his remit. This agency at right — and other related agencies — were created, and specifically funded by long-ago Congressional Acts. So the argument runs that only the US House, by legislation (as keeper of the purse strings) can authorize what amounts to a near-shut-down. Here’s the latest story on what’s happening:

…Confusion and anxiety is rippling through the US health-research community this week following Donald Trump taking office as the 47th US president. His administration has abruptly cancelled research-grant reviews, travel and trainings for scientists inside and outside the National Institutes of Health (NIH), the world’s largest public biomedical funder. Adding to the worry: the Trump team appears to have deleted entire webpages about diversity programmes and diversity-related grants from the agency’s site….

Researchers who spoke to Nature say that although a short, daylong pause in communications at US agencies has occurred in the past when new administrations have started, to reorient strategy, the reach and length of the Trump team’s — it is set to last until at least 1 February — is unprecedented. Without advisory-committee meetings, the NIH cannot issue research grants, temporarily freezing 80% of the agency’s US$47-billion budget that funds research across the country and beyond.

“I’ve never seen anything like this before,” says Carole LaBonne, a developmental biologist at Northwestern University in Evanston, Illinois, who has received funding from the agency for more than 20 years….

As we’ve previously said — to the extent he targets DEI programs (or people), there exists strong precedent for challenging him in the courts, but this portends nothing near the slam dunk thumping that his preposterous “end birthright citizenship” Sharpie saw. The law here is in fact… murkier. So the focus has to be… on getting the word out, over the din/chaos/lies of what he always serves up.

Unfortunately, that is going to be a tall order, well into February / March. Damn.

Onward, just the same.

नमस्ते

Interesting — Parts Of This Brooks Opinion Are Worth Reading — And Pondering…

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From time to time, I read the NYT opinion page. And to be sure — I rarely agree wholeheartedly with what I see there. But that is the beauty of a free America: I can think (and more importantly, decide) for myself.

I am more than a little worried that many of my fellow Americans, those cheering Tangerine 2.0… lack the critical thinking skills to evaluate what they hear, and decide whether it rings true. Just see this, as one poignant example (these people believe he keeps promises?!).

Well… I cannot help them. And while I disagree about Brooks’ closing advice to Democrats (it is largely a troll operation / subterfuge — to build an imagined “glide path”, for a future Vance run/win — if he’s the nominee in 2028. This, as Brooks purports to say… a more competent authoritarian is what America needs. Not). I will reprint some of what he wrote, in spite of this.

Here’s what David Brooks had to say — and I will confess that at least half of it rings… pretty true.

…Over the past few months, and especially in his second Inaugural Address, Trump has gone all 19th century on us. He seems to find in this period everything he likes: tariffs, Manifest Destiny, seizing land from weaker nations, mercantilism, railroads, manufacturing and populism. Many presidents mention George Washington or Abraham Lincoln in their inaugurals. Who was the immortal Trump cited? William McKinley….

The problem with populism and the whole 19th-century governmental framework is that it didn’t work. Between 1825 and 1901 we had 20 presidencies. We had a bunch of one-term presidents; voters kept throwing the incumbents out because they were not happy with the way government was performing. The last three decades of that century saw a string of brutalizing recessions and depressions that profoundly shook the country….

“Populist thought showed an unusually strong tendency to account for relatively impersonal events in highly personal terms.” In other words, they thought they could solve the disruptions of industrialization if only they could find the evil conspirators who were responsible for every ill. Their diagnoses were simple-minded, their rhetoric over the top; their proposals, Hofstadter noted, wandered “over the border between reality and impossibility.” Sound familiar?….

Here’s how America recovered: Populist indignation finally got professionalized. In the 20th century, members of the progressive movement took the problems the populists were rightly angry about and built the institutions that were required to address them effectively — like the Food and Drug Administration, the Federal Trade Commission and the Federal Reserve. Populists had trouble thinking institutionally; the progressives, who were well trained, morally upright, self-disciplined, disgusted by corruption, intellectually rigorous (and sometimes priggish and arrogant) did not have that problem….

I would tell the American people that Donald Trump is right about a lot of things. He’s accurately identified problems on issues like inflation, the border and the fallout from cultural condescension that members of the educated class have been too insular to anticipate. But when it comes to building structures to address those problems — well, the man is just hapless and incompetent….

Thanks David. But that last bit… looks a lot like laying the groundwork for a Vance nomination in 2028. Hard pass.

We Democrats are not in the hurt you imagine us to be — or the one you spin to your MAGA masses. We are coming for your boy — peaceably and rationally. He will have imploded by 2026 (if not much sooner). We will then hold the Congress.

And Vance will be as relevant to the conversation… as Mike Pence or Dan Quayle is, now.

Y A W N.

Out.

Lilly “Fell Off A Cliff” In Q4 2024 — On Lobby Spend — And This, With Difficult Govt. Payor Negotiations On Its Weight Loss Franchises, Ahead… Odd.

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Yes, it is an election year. Yes, Tangerine 2.0’s influence is most chaotic in the days BEFORE he assumes office — as once in, the courts (as we’ve seen) may pretty promptly rein in the worst of him. But still… only spending under $200,000 in Q4 seemed. . . odd, for Lilly (see second chart — below right).

Thus, the list of what it bent Congressional ears on… is correlatively shorter than that seen in Q3 2024, to be certain. Anyway, here it is, for the $190,000 in spending, all in:

…▲ Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil….

▲ Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value, access and quality; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care….

▲ Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement, coverage and value; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; The INSULIN Act….

▲ Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value, access and quality….

▲ Pharmaceutical intellectual property issues….

▲ Implementation of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax; Pension and retirement benefit issues; round-tripping [Ed. Note: what exactly is meant by this? A “donut hole” derivative?!]….

▲ Hospital discounts; 340B program; Prescription drug value, access, quality and compliance with Drug Quality and Safety Act….

Now you know — onward grinning — and scratching my head — as to what Lilly’s lobbying team means by “round tripping” [also, at the vast bump in traffic, out of Lilly’s HQ in the last forty-eight hours]. Here you go, folks! Smile.

Updated: if “round tripping” does not refer to US pricing of pharmaceuticals, but instead refers to the questionable tax minimization strategy of multi-nationals, generally — in moving IP to low tax jurisdictions, reporting vast income there, but then deploying the accumulated capital back into the US, to pay dividends on the Holdco (or to lend money to it) thus effectively repatriating the earnings, to build new factories, etc. (effectively tax nearly-free), while avoiding formal repatriation taxes… well, the company should be MUCH more transparent about it being a tax strategy that some it Congress may seek to curtail or end, entirely. So far, Tangerine 2.0 is completely mum on that topic (he very likely won’t understand it, when it is explained to him in small words, pictures and short sentences, some months from now, anyway!). Trump seems content to let PhRMA do as it pleases, at the moment. I guess that’s good news for Lilly — and the pharma majors.

नमस्ते

Most Savvy Analysts Believe Some US Controlled Entity, Or Group Of High Net Worth Individuals, Will Get Control Of TikTok US…

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This is a minor update, to our coverage of last week.

It is clear that Apple (and its market leading App Store) will NOT return the TikTok download to the App Store’s shelves until this is sorted out. It has formally said it is simply following the law the Supremes upheld last week. And we are beyond the grace period for a divestiture of the US operations that the Congress thoughtfully-baked-into the law, proper.

Perhaps the most surprising part of this delay is that (if MSM reports are to be believed) China’s Xi is now open to letting US investor(s) gain control of the US operations of TikTok. That, coupled to the likelihood that ByteDance has been talking to various suitors for months now. . . should signal a quick deal closing.

But I suppose with Tangerine 2.0 now muddying the waters — by saying maybe the US government must get a 50% stake in the US operations (a proposal with manifold Constitutional infirmities) — the calmer, more rational businesspeople at the negotiating table are seeking ways to blunt the orange tinged chaos (should they announce an M&A deal that doesn’t make the US government at least a part owner).

In any event, Condor thinks the proper lens on all of this is that it will take longer… precisely BECAUSE Trump infuses chaos everywhere he drops in. In time, though — the private parties’ deal (Amazon? Oracle? or another) will get done. [As we said before, Musk hisself has Hart-Scott problems here. since he personally controls X-itter (formerly Twitter, a competitor).] Here’s some representative coverage in the MSM:

…[T]he big question is now about who or what will buy TikTok and not whether ByteDance will sell it, some experts say. Still, it will be complicated. People have also expressed concerns over how a sale might affect TikTok’s unique algorithm, which is known for its ability to curate highly personalized feeds and may be hard to replicate by a new owner.

“What happens to the algorithm? Will this be an outright sale or a JV/partnership structure?” Dan Ives, an analyst for the financial services firm Wedbush Securities, wrote in an analyst note Wednesday. “Our view is ByteDance is willing to play ball and look for a legitimate deal/JV partner to keep TikTok up and running while protecting its algorithm. From the beginning we have only seen a few core potential bidders for the TikTok asset that would be ‘approved’ by Beijing…”

Trump has proposed the idea of a joint venture that produces a 50-50 ownership split between ByteDance and the United States, although it’s unclear whether he means ownership by the U.S. government [Ed. Note: Seriously, WTH, Tangerine?!] or a U.S. company….

As I’ve said before, I don’t use the stuff — but I am a balanced supporter of both… free expression privileges — and our own US national security concerns. We will keep an eye on it — so, do stay tuned. Onward, into a chilly, but sunny Friday here… with bright white stuff covering most open ground, still. [I’ll do a Lilly-focused Q4 2024 lobby piece next, based on high traffic out of Lilly’s HQ down in Indy. Grin….]

नमस्ते

As I Pointed Out To John Hinderaker, Last Night — That Argument Was D.O.A. — Idiotic, In Fact.

~ condor ~ 1 Comment

Or, “That Was… Swift. “The 14th Amendment Means Just What It Says”. Tangerine 2.0 Cannot Repeal It, With A Sharpie…”

These guys — geez — they are… preposterous.

Arguing that people without papers “are not subject” to US jurisdiction… is patently… silly. And self-defeating for these idiots. So the executive order is dead — before the Sharpie’s ink even had a chance to fully-dry.

Here’s the completely unsurprising account, from the AP:

…A federal judge on Thursday temporarily blocked President Donald Trump’s executive order redefining birthright citizenship, calling it “blatantly unconstitutional” during the first hearing in a multi-state effort challenging the order.

“This is a blatantly unconstitutional order,” USDC Judge Coughenour (a Ronald Reagan appointee) told Shumate. The judge said he’s been on the bench for more than four decades, and he couldn’t remember seeing another case where the action challenged so clearly violated the constitution.

[Tangerine attorney] Brett Shumate said he… disagreed and asked the judge for an opportunity to have a full briefing on the merits of the case, rather than have a 14-day restraining order issued blocking its implementation.

Arguing for the states, Washington assistant attorney general Lane Polozola labeled as “absurd” the government’s argument that the children of parents living in the country illegally are not “subject to the jurisdiction” of the United States….

Yep. Just as I said — when I gave you some “Lion King” to smile over. Here’s some more:

नमस्ते

Full Year ’24 Results: Amgen Lobby Spending; Year Over Year Trends, Against Three Other Majors…

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We have covered both Merck and Pfizer, in the Q4 ’24 lobby spends, of each — do see below, yesterday. Now it is time to look at the run-away full year 2024 leader: Amgen. This year’s spending was truly outsized — for the Thousand Oaks company — and doubly so — for an election year.

In any event, here is the (very hefty!) list of what all the bioscience major, Amgen spent on — just looking at Q4 ’24. But as I’ve said, I would expect Pfizer to once again be the overall spend leader in the full year 2025 — if for no other reason than that it is about double the size of most of the others, on market cap and global revenue:

…▲ Issues related to drug pricing reform; Changes to Public law 117-1769 Inflation Reduction Act; Awareness of implications to patients and research and development of Public law 117-1769; Inflation Reduction Act; S. 113 Prescription Pricing for the People Act of 2023; S.127 Pharmacy Benefit Manager Transparency Act; HR 830/ S 1375 HELP Copays Act; HR 485 Protecting Health Care for All Patients Act; HR 5378 Lower Costs, More Transparency Act; R 2534 PROTECT 340B Act of 2023; HR 3561 the PATIENT Act; S. 1542 DRUG Act; S. 1967 PBM Act; HR 3503 The NIH Clinical Trials Diversity Act; Issues related to cardiovascular disease awareness and treatment; Issues related to Federal Trade Commission; FDA issues; Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters; Biosimilars reimbursement issues, no specific bill; Supply Chain Issues, no specific bill; Issues related to 340B; Issues related to pharmacy benefit managers; Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program; HR 4818/ S. 2407 Treat and Reduce Obesity Act; S. 2305 Biosimilar Red Tape Elimination Act; S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act; Issues related to PAHPA reauthorization; Modernizing and Ensuring PBM Accountability Act (Finance Committee); S. 652/ HR2630 SAFE Step Act; S 2474/ HR 5376 Share the Savings with Seniors Act; S 2456 Protecting Seniors from High Drug Costs Act; HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; HR 3281 Protecting Patients Against PBM Abuses Act; HR 4822 Health Care Price Transparency Act of 2023; S 1339 Pharmacy Benefit Manager Reform Act; HR 2679 Pharmacy Benefits Manager Accountability Act; HR 4507 Transparency in Coverage Act of 2023; HR 1352 Increasing Access to Biosimilars Act of 2023; HR 2880 Protecting Patients Against PBM Abuses Act; Issues pertaining to the implementation of PL 97-414 “Orphan Drug Act,” all provisions; HR 5539 Orphan Cures Act; HR 5547 Maintaining Investments in New Innovation Act; S 3558 BIOSECURE Act; HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act); S Res 566 Cholesterol Education Month 2024; HR 7635 340B PATIENTS Act of 2024; H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act; H.R.8574 – 340B Affording Care for Communities and Ensuring a Strong Safety-net Act; HR 5376 Share the Savings With Seniors Act; S 3430 Mental Health, Lower Cost Drugs and Extenders Package; BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities; HR 8412 Clinical Trial Modernization Act; S 5573 Skinny Labels, Big Savings Act; HR 10515 American Relief Act….

▲ Issues related to corporate and international tax, including regarding Public Law 115-97, Tax Cuts and Jobs Act; Issues related to Puerto Rico; Issues related to OECD negotiations on the taxation of global income; HR 3938 Build it in America Act….

▲ S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023; S. 113 Prescription Pricing for the People Act of 2023; S. 1250 Drug-price Transparency for Consumers Act; S.127 Pharmacy Benefit Transparency Act; S. 150 Affordable Prescriptions for Patients Act of 2023; S. 148 Stop STALLING Act; S. 142 Preserve Access to Affordable Generics and Biosimilars; Federal Trade Commission related issues, no specific bill; Issues related to the Patent Act, no specific bill; Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill; Issues related to patent thickets/product hopping;
Issues related to obviousness/double patenting; S.2140 Patent Eligibility Restoration Act of 2023; S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act; S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents; H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress; H.R. 3535 Advancing Americas Interests Act; H.R. 5475 Prohibiting Adversarial Patents Act of 2023; S.3385/HR 8333– BIOSECURE Act; BIOCOMPETE (no bill number) — Issues related to prohibiting the export of biotechnology to certain foreign entities; Issues related to FDA/PTO coordination; S.2780 Medication Affordability and Patent Integrity Act; Issues related to skinny labeling; S. 3583/HR 6986 To Address Patent Thickets; S. 1956 Invent It Here, Make It Here Act; S 5573 Skinny Labels, Big Savings Act [Ed. Note: Seriously?!]….

Now you know — and depending on other commitments, we may not separately cover Lilly this quarter, since it only spent $190,000 all in. Indeed, starting next week, postings may diminish overall here — as I spend more of my free daylight hours, in pro bono / street law / ACLU-directed and filed-federal litigation practice, against the largely comically inept Tangerine 2.0 “initiatives”. Onward, resolutely. Ever, onward.

नमस्ते