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Merck’s Bridion® Generated ~$1.84 Billion In Sales In 2023 — Now Hikma And Five Others Seek Early Generic Copy Authority Under Hatch-Waxman…

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We have followed the chemical known generically as sugammadex, since about 2008, when it was a nascent Schering-Plough candidate, then one of Fred Hassan’s “five stars”. It is sold in the OR to help awaken patients, post surgery. [Except that it was seven years late in arriving, it is/was a success.] Indeed, it has slowly grown over the years — to be a nice blockbuster for Rahway.

The molecule is fairly easy to synthesize. . . and thus makes a rather promising “at risk” launch project, under Hatch-Waxman (even prior to 2026, in the US). And so it is not surprising that it has attracted the attention of at least five US generic manufacturers, since 2023 — seeking to compete with it. It went off patent in the EU as of 2023, and will soon be so, in Japan here early in 2024.

Apparently, last week a sixth generic entrant emerged — Hikma Pharmaceuticals’ generics arm. Merck’s Form 10-K discloses it is still deciding whether it might allow one or more versions of an “authorized” generic, to blunt Hikma and the others — possibly with some other purveyor. Here is that bit — but overall, this is not likely to be material, since Bridion is only about Merck’s sixth largest franchise (see page 106):

. . .As previously disclosed, in June 2023, the U.S. District Court for the District of New Jersey ruled in Merck’s favor. The court held that Merck’s calculation of PTE for the sugammadex patent covering the compound is not invalid and that the U.S. Patent & Trademark Office correctly granted a full five-year extension. This ruling affirms and validates Merck’s U.S. patent protection for Bridion through at least January 2026. On June 29, 2023, the U.S. District Court for the District of New Jersey issued a final judgment prohibiting the FDA from approving any of the pending or tentatively approved generic applications until January 27, 2026, except for any subsequent agreements between defendants and Merck or further order by the court.

In July 2023, defendants filed a notice of appeal with the United States Court of Appeals for the Federal Circuit. The appeal is currently pending.

On February 5, 2024, the Company received another Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Hikma Pharmaceuticals USA Inc. has filed an application to the FDA seeking pre-patent expiry approval to sell a generic version of Bridion Injection. The Company is currently considering its options. . . .

Now you know — with just one of my older backgrounders, here. Search “sugammadex” in the box at upper left — for over 45 other entries.

Be excellent ot one another. Smile. . . .

नमस्ते

What The Smirnov Indictment… Really Reveals: Do Read EmptyWheel, On It All.

~ condor ~ 1 Comment

First, the caveats: if you’ve not closely followed the actual court filings, you are likely operating from a convoluted series of false narratives, and premises — largely created by hard-right media outlets. [Cough; Power-liners.]

But if you’ve been reading the actual filings and motions, then you know. EmptyWheel is by far the most reliable narrator you’ll ever find, on matters Hunter Biden.

And so, today — please do read all of hers, here — she offers a “kill-shot” of sorts, on the whole Cotton / GOP / MAGA bullcrap mischaracterization of / about the 51 former intelligence agents’ letter.

She also makes plain that more than a few career AUSAs were simply trying to apply the law, as written. Nothing more.

And that the then AG (Bill Barr) was trying his level best to “muddy the waters” with various forms of stupid agit-prop distractions. These have caught up to… Smirnov.

See EW’s concluding bit here — but do read it all:

…It seems clear that Lesley Wolf left the Smirnov allegation well enough alone, knowing that the project generally was producing garbage that could only endanger the case.

Leo Wise seemingly used the Smirnov allegation as an excuse to reopen the case against the President’s son, only to discover it opened a nasty can of worms. It gave Abbe Lowell the evidence to prove that the prosecution of Hunter Biden was infected by an effort by the Attorney General to accommodate the dirt that Trump’s lawyers picked up from Russian spies. And it gave Wise a real headache of a prosecution to deal with.

Lesley Wolf probably didn’t decline all the garbage from Scott Brady for noble reasons. She was just protecting her case. But having made the opposite decision, Wise may end up blowing that case.

You know who is vindicated by the Alexander Smirnov indictment? Lesley Wolf….

Yep. That’s… flawless (do take heed, Scott Johnson and John Hinderaker). Out.

Just As We Said — The DoJ/FTC (and State AGs) Are Clearing Their Throats — On US Antitrust Enforcement. Do Take Heed, Pharma…

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As we mentioned a lil’ more than a week ago, the US antitrust authorities have once again… found their collective voice. And now, as we predicted, the FTC has sued, to either enjoin or reform the Albertsons / Kroger merger.

This will, at a minimum, involve the parties divesting outlets each controls in certain markets (to an independent competitor), to preserve real competition in grocery prices. And it would behoove the people circling the Sanofi consumer health businesses to take into account that — in certain mature therapies the proposed deal may unlawfully harm natural price competition, for say shoe inserts and OTC allergy meds. This is going to change the way parties bid for, or at least set “hold backs” — in the mature life sciences brands as well. In any event, here’s the latest:

…The Federal Trade Commission sued to block a proposed merger between grocery giants Kroger and Albertsons, saying the $24.6 billion deal would eliminate competition and lead to higher prices for millions of Americans.

The FTC filed an administrative complaint against the companies Monday, which will be considered by an administrative law judge at the agency. It also filed a lawsuit with the U.S. District Court in Oregon requesting a temporary injunction blocking the merger. That lawsuit was joined by the attorneys general of eight states and the District of Columbia.

Kroger and Albertsons, two of the nation’s largest grocers, agreed to merge in October 2022. The companies said a merger would help them better compete with Walmart, Amazon, Costco and other big rivals. Together, Kroger and Albertsons would control around 13% of the U.S. grocery market; Walmart controls 22%, according to J.P. Morgan analyst Ken Goldman….

Now you know… onward — grinning in the sunshine — for a cool afternoon bike ride.

नमस्ते

[U] Has Hinderaker’s Silly Trivia Re Thomas’s Law Clerk — Dead To Rights.

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Updated: Friday, March 1, 2024 — This morning, The New Yorker points out how utterly… unbelievable this whole “I was the victim” saga cum lately has become. Do read it all. End of updated portion.

Courtesy erstwhile commenter Rigby — nailing Hinderaker’s churlish lilly-gilding:

John’s other post yesterday, about law clerk Crystal Clanton, was equally hilarious (and dishonest). I have no idea if the accusations against Ms. Clanton are accurate, but even John would have to admit that her denial is less that emphatic:

I have no recollection of these messages and they do not reflect what I believe or who I am, and the same was true when I was a teenager.

“I have no recollection” is often lawyer-speak for “there’s enough evidence out there that I can’t come right out and deny it.” Again, I have no insight into the truthfullness of these accusations, but that non-denial gives me pause. If it were I, I would have said that those messages were unequivocally not mine. Notably, Clanton didn’t say that.

John also leaves out the rest of the racist message attributed to Ms. Clanton (“Like f—them all . . . I hate blacks. End of story!”), as well as the fact that this wasn’t the only racist language attributed to her.

John concludes:

The moral of the story, I suppose, is that the Left never forgets. No matter that she was cleared by an investigation by one of the nation’s courts of appeals; once the Left gets its hands on a smear it never lets go. It will never stop trying to destroy your life.

Riiiiight.

Anita Hill would like a word. So would Hillary Clinton (Vince Foster, anyone?). So would Ray Epps. So would Wandrea “Shaye” Moss and Ruby Freeman. So would John Kerry. So would Peter Strzok and Lisa Page. And on and on and on….

And Condor adds, as his own take on it:

I would also note that i find it extremely odd, that she “lived with” Ginny Thomas for over a year, in the Justice’s home… while “recovering” from being outed as a racist.

I hate to say it, but it makes me wonder… even more, about Justice Clarence Thomas himself. WTAH?

Anyway… it is all largely trivial, except that it speaks to some sort of dysfunction there. Wow. Onward.

WHO Reports Out Improved Standards For Protecting Health Workers, In Ebola And Marburg Outbreaks…

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The new WHO-generated advice is the result of deep experience in the last decade, during prior flare ups.

The central message is to ease back on the spraying of aerosolized higher concentration chlorine solutions creates more problems and risks than it ameliorates. Here’s the latest — and a bit, from MedPage Today:

…Excessive or inappropriate use of PPE is associated with adverse effects for healthcare workers and negative impacts on the environment, they noted. Spraying workers and the environment with chlorine during Ebola and Marburg virus outbreaks remains a common practice, but causes adverse ocular, respiratory, and skin reactions. Instead, the WHO recommends wiping potentially contaminated surfaces with disinfectant.

One example of confusion surrounding PPE use is that some facilities rely on double gloving with variable approaches to changing gloves between patients and glove disinfection, Willet and colleagues pointed out. The new guidelines, which were published last August, clarify when double or single gloving should be used, how to disinfect gloves, and when to change gloves between patients….

We all know there will be another outbreak, the question is simply… when — and how best to minimize the number of deaths, when it comes… as “the fire, next time“. Onward… smiling into the sunshine just the same.

नमस्ते

Hinderaker: Fear-Mongering Energy… Idiot.

~ condor ~ 2 Comments

Tonight (again!), he offers ignorant, wild-eyed fear mongering… on energy rationing (which he considers “socialism”) — across the pond.

But here at home, he ignores that Texas provides corporate welfare, in the form of transfer payments to large businesses, that drive sky-rocketing prices per kWh that residential consumers (most of limited means) must pay.

In many cases, during increasingly frequent cold snaps, the price reaches over $3,000 in a month, to heat a home. So, GOP Texas (and MAGA Gov. Abbott) gets to the same socialist state of affairs as the UK — but gives the gravy to energy hogging Bitcoin miners.

In sum — John has met his boogeyman: it’s his own political party, and parasitic capitalism on energy — right here (in Texas).

Sheesh.

CHMP Favorable On Merck’s Pembrolizumab In Resectable NSCLC at High Risk of Recurrence — With Chemo…

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Again, not material, but still good EU news for US Merck, this past week.

The approvals continue to pile up — for the juggernaut. Here’s the latest:

…Merck today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults….

“The CHMP’s positive opinion puts us another step closer to helping certain patients in Europe with earlier stages of non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We look forward to the European Commission’s decision, as we continue to build on the legacy of KEYTRUDA in certain types of lung cancer and pursue meaningful advances that may help extend the lives of patients….”

Now you know — onward, to catch a matinee of “Origin“, this afternoon — smiling.

नमस्ते

And… Fox News Wants The 46th President To Be “Responsible” For The Death Of A Georgia Nursing Student?! WHY?

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This seems to be the new pet jingoists’ talking point:

Fox is bleating like Hinderacket and Billingspuss. Funny — they never asked Tangerine to explain the grandson / mass murders in Colo. Springs, at left.

Seems it has more to do with skin color, than any actual concern for any individual human life.

Fox, Dylan Roof would like an interview — from his life without parole cell.

Please swing into action — to help him out. It’s totally on brand for you jamokes.

Out.

When John And Lloyd Need To Vent, On Crime… At Best, Senility Is Seen.

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Any crime of sexual violence is tragic. That is clear.

But overnight, both Hinderaker and Billingsley speak of the same one — doubling up.

From one crime, the pair commits an age old logical blunder — intentionally.

They want us to infer that “what is true of one, is true of most or all…”

But in reality, they offer only racists’ fear mongering.

Tellingly, they’ll never mention whyte sexual predators in positions of trust, whyte domestic terrorists trying to start race wars, or the whyte suburban (Gilgo Beach) architect / serial killer of women in sex work.

And they’d never mention the whyte Colorado Springs mass murderer — whose family runs a large MAGA operation in San Diego, California.

We’ve never read those stories… on their pages.

I’ll let the readership figure out… why.

Out.

Gangs That Can’t Shoot Straight: Texas Anti-Immigrant Entities Edition.

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So, some knuckleheads wanted to oppose the DHS and CBP in the en banc rehearing of the floating razor wire case, in the Fifth Circuit.

But they filed their purported amicus brief in the one on appeal from Alia Moses’ orders. That is, they filed in the wrong case. Here’s the operative bit of their admission:

…Counsel for CRA mistakenly filed CRA’s brief yesterday, February 23, 2024, in related case, Texas v. U.S. Dept. of Homeland Security, Case No. 23-50869, because of a typographical error on the cover page of its brief. See Exhibit A attached hereto. Counsel for CRA is correcting that mistake now, filing CRA’s brief in this case today, and therefore humbly seeks leave for CRA’s brief to be filed….

All this grand-standing… is just silly. The State of Texas (and Gov. Abbott) is a clear loser in both cases.

Out.