Still Rolling… 5,000 “Martian Days” — Or Sols: NASA/JPL Opportunity Rover Style!

February 18, 2018 - Leave a Response

I must mark this stunningly audacious milestone, if only in brief:

Overnight, NASA/JPL’s Opportunity Mars rover logged its 5,000th “Sol”, on Mars (each “Sol” on Mars is about two-thirds of an hour longer than an Earth day, due to the distance Mars is from the sun — and the differing speeds of rotation — compared to Earth’s rate of rotation, from the moment of one sunrise, to the next sunrise).

It was expected by JPL and NASA to survive 90 Martian “days” — or sols. That would have been a success — but it is well past fifty-five times that in service duration record, now. Opportunity has driven over 28 miles away from its landing site — and is about one-third of the way down “Perseverance Valley,” a shallow channel incised from a crater’s rim. The rover has returned about 225,000 images, all promptly made public online.

That’s a well-engineered rig.

And I am beaming, ear to ear, about it.

Now, with a clip of some poetry by Mr. Atkinson (in the image). . . here’s to the future, what Sweet Will called. . . the “undiscovered country“. . . . it too, calls forever to me. Sweetly haunts me, in fact. Grin.

नमस्ते

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As I Long Predicted — Gilead Was Never Likely To Pay Any $2.54 Billion Patent Infringement Verdict

February 17, 2018 - 2 Responses

mrk-alt-gil-verdict-hep-c-12-15-16 The single largest patent verdict in the history of the US court system. . . was just struck down, overnight. [My now prescient 2016 prediction on that; and a September 2017 one as well, here.]

To be fair, Merck’s NYSE trading price never reflected an expectation that $2.54 billion would be paid to it, by Gilead. So its stock should be unaffected on next week’s NYSE open — but Gilead’s may rise modestly, with this news, as most of the uncertainty — over levels of profitability on Gilead’s largest single franchise, Sovaldi®/Harvoni®. . . is clearing.

And now, the central question is whether and when Merck will have to pay the $15 million in legal fees it has been ordered — at the trial level — to pay to Gilead, in California, on these same patents.

The able judge back in Delaware has ruled that the prior in time Merck patent (via the Idenix acquisition) is invalid essentially for being too vague to teach a skilled scientist how to make the specific compound that became Gilead’s (via the acquisition of Pharmasset). . . Harvoni®/Sovaldi®. Here is a pertinent bit — but do go read it all (some 52 pages, if you are so inclined!):

. . . .Only in March 2005 — two months after the publication of U.S. Patent Application No. 2005/0009737 (DX371), issued to Pharmasset[/Gilead’s] Jeremy Clark (more on him below), had been distributed at Idenix[/Merck] — did Idenix[/Merck] first succeed in making and testing 2′-methyl up 2′-fl-µoro down. (DX359; DX0274.0119, 0122; Wang Tr. at 1196, 1198-1200 (stating that in March 2005 Idenix[/Merck] first successfully synthesized “an unprotected 2′-methyl-2′-fluoro nucleoside” and recognized it had done so); Standring Tr. at 1831-33)In short, the undisputed record shows that, between 2002 and 2005, Idenix[/Merck] tried and failed to make and test a 2′-methyl up 2′-fluoro down nucleoside, and only succeeded when [Idenix/Merck’s] Dr. Griffon “us[ed] information from a published Pharmasset[/Gilead] patent application. . . .”

The only reasonable finding, based on the trial record, is that Gilead met its burden to prove non-enablement by clear and convincing evidence. The trial revealed that there are no genuinely disputed material facts with respect to enablement. Accordingly, Gilead is entitled to judgment as a matter of law that the asserted claims of the ‘597 patent are invalid due to lack of enablement. . . .

While Merck will appeal this loss to be certain, I think the most likely final outcome is that Merck pays Gilead’s legal bills in California, and does not win any royalty on Gilead sales.

We shall see — but likely so ends the largest patent infringement award in US history. Back to championship basketball, in the gym. . . .

नमस्ते

155 Years Ago This Morning In Genevé — What Became The International Red Cross Was Founded…

February 17, 2018 - Leave a Response

This morning, we resolve anew, to bend the arc of history — once again, toward. . . progress.

And so, in Genevé, Switzerland, 155 years ago this day — a Swiss businessman named Henry Dunant founded the “Committee of the Five” — with members of five other prominent Swiss business families. He was moved to do so after witnessing first hand the horrific aftermath of the battle of Soferino on June 24, 1859 — a battle in the Second Italian War of Independence — in which as many as 40,000 men in a single day of fighting were left dead or dying on the battlefield, with essentially no triage or treatment.

Within a few days of forming the Committee of the Five, the Swiss business leaders renamed it the “International Committee for Relief to the Wounded“, which in turn grew in time to become the International Red Cross movement. By 1864, the first use of the Red Cross icon, as a protective banner for medical personnel, occurred — in an armed conflict during the Battle of Dybbøl, in Denmark.

In parts of the world where the cross might be a misinterpreted iconography (or misunderstood as a purely religious allegiance, and thus less welcome), it now also operates in appropriate geographies as the Red Crescent.

. . . .Directly following the establishment of the Genevé Convention, the first national [Red Cross] societies were founded in Belgium, Denmark, France, Oldenburg, Prussia, Spain, and Württemberg. Also in 1864, Louis Appia and Charles van de Velde, a captain of the Dutch Army, became the first independent and neutral delegates to work under the symbol of the Red Cross in an armed conflict. Three years later in 1867, the first International Conference of National Aid Societies for the Nursing of the War Wounded was convened. . . .

And so it began on February 17, so so long ago. Though the American Red Cross has seen its share of administrative and fundraising controversies, the overall international organization does invaluable humanitarian work.

So let us each remember this weekend, today in particular, to celebrate the birthdays. . . of the good. I am off to the 50th annual local charity middle-school championship basketball game, and pancake breakfast benefit, in just a bit — and here’s to 50 more, for this particular support organization, focused on at-risk youth. Smile.

नमस्ते

Donald Trump’s Loony Friday Afternoon “Russia Denial” Tweet — After 15 People/Companies Indicted; And Three Felony Guilty Pleas, Just To Date.

February 16, 2018 - Leave a Response

Well, Mr. Mueller has added 14 more scalps this afternoon, to his previous totals.

Almost in passing, I simply must point out that 45 cannot possibly have any rational basis — for the bolded statement in his most recent tweet, below.

He simply cannot. No one will ever know — so we may safely (once again!) call him. . . a liar.

. . . .Russia started their anti-US campaign in 2014, long before I announced that I would run for President. The results of the election were not impacted. The Trump campaign did nothing wrong – no collusion!. . . .

Unless 45 has Marty McFly’s DeLorean (and a working flux capacitor, built by Doc Emmett Brown) — and then actually does go back to “Alternate 2014 to 2016” — we may safely call him. . . a bold faced liar. Because he. . . is.

Now off, for a sublimely great weekend! Do be excellent to one another. . . .

नमस्ते

Impertinent Friday Questions Dept.: Is Gates Likely Entering A Plea Deal Tonight, Or Next Week?

February 16, 2018 - Leave a Response

Several major outlets (including CNN, which first broke the story) have now reported — citing anonymous sources — this bit of salacious but fascinating speculation. So. . . I too, will oblige, and add my take on it all.

The D.C. federal District Court’s latest docket entries likely confirm that reporting (see below).

Specifically, Mr. Gates is presently arguing pro se (without much success), to keep secret his problems surrounding the recent motion for withdrawal — by his defense counsel.

And the court has suspended the current deadlines in the cases of Manafort and Gates, pending “further order“. This almost certainly means Mr. Gates will plead guilty to crimes, and agree to cooperate with Mr. Mueller — and the announcement of this development could come as early as late today:

. . . .MINUTE ORDER as to PAUL J. MANAFORT, JR. (1), RICHARD W. GATES, III (2).

The Current Briefing and Hearing schedules that were established at the Status Conference held on 1/16/2018, and in the Minute Order issued on 1/17/2018 are suspended pending further Order of the Court. The government’s [155] Motion to Modify the Court’s Schedule for Rule 404(b) Notice and Briefing remains under advisement. SO ORDERED. By Judge Amy Berman Jackson on 2/14/2018. . . .

Now you know — Bobby Three Sticks is certainly tightening the ropes here. My prediction? Manafort will be crushingly pressed by this development — and will have to rat out 45, to avoid a potential 30 year sentence (essentially life, given his age and health), on his own. There will be no slack for 45, in the end.

And in closing, in a Merck-related footnote/bit of marginalia, British intelligence is confirming that the “Not Petya” hack of the spring of 2017 was in fact sponsored by Russian state actors. Of course, under Trump’s thumb, we may confidently predict only this very bland US assessment will see the light of day, until Herr Trump is deposed — but Mr. Frazier should be encouraged to know that most cogent analyses suggest his company was largely collateral damage in yet another Russian sponsored cyber-terror plot. As such, there is little he could have done to avert it — especially with a President reticent to call Putin out, for his high-price tag cyber chicanery.

Onward.

नमस्ते

I Will Reserve Judgment — But This Seems “A Bridge Too Far”: Rofecoxib, Which Cost Merck Over $4.85 Billion, In Settlements…

February 15, 2018 - Leave a Response

I’ve felt ambivalence, all day, about even mentioning this development, here (as I genuinely do not want to hurt the mentioned company’s chances). But I do feel it needs to be said, at least to keep a complete record, on rofecoxib. [So I’ll say it at night — late — where Poe’s immortal words still profoundly echo, off carmel-colored marble hallways. . . smile.]

It seems that in the last few days, a smallish privately-held Cambridge drug firm raised $5 million. It raised the money, with an express plan to bring the drug that Merck called Vioxx® (rofecoxib). . . back to market.

This time, though — to be fair to the people at Tremeau — the drug will be prescribed (if and when it clears FDA) for an exceedingly small number of patients — people with otherwise untreatable pain from hemophilic arthropathy. [The buzz is also a bit about non-opioid pain relief.] Here is a bit of the presser — do go read it all:

. . . .About TRM-201

TRM-201 (rofecoxib) is a highly potent cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile and is the first and only product granted orphan designation status for the treatment for hemophilic arthropathy. Rofecoxib is a non-narcotic analgesic, has no effect on bleeding time relative to placebo, and is the only COX-2 selective NSAID ever approved in the U.S. to demonstrate a reduced risk of gastrointestinal bleeding versus a traditional NSAID in a controlled trial. . . .

Yes, Merck did license this out. And yes, if it gives a small base of rare disease patients some relief — even at some increased cardiac event risk — I suppose that is a discussion best had between each patient, and his/her treating doctor. . . not the regulator, per se. Vioxx always did provide good pain relief, but in ordinary cases, with other alternatives, Merck itself decided to pull it from the market voluntarily, fourteen years ago. Now you know.

And I do fully-understand the counter-argument. Be excellent to one another. . . as I am out — completely out, as Mr. Trump has refused to release the photo from January of 2017, of his signing a law that made it easier for the mentally ill to get weapons (repealing an Obama measure) — weapons including those like the ones used yesterday in Parkland, Florida. What a coward — 45 won’t even own his public, and entirely notorious prior (and recent) supplications to the NRA, and its lobbyists. Ugh.

G’night.

नमस्ते

As Expected, The Fourth Circuit Joins The Ninth, And Rules 9 to 4 That The Muslim Ban 3.0 Injunction Out Of Maryland Should Continue…

February 15, 2018 - Leave a Response

No surprise — and (of course, as we’ve always said) all of this will ultimately be decided by the Supremes, come late summer, or early fall of 2018 (and my January 2018 backgrounder).

But 45 has yet to win a single matter on the merits, in any federal court. In fact he is now like 0-17, on procedural matters, related to his three would-be Muslim Bans. And make no mistake, folks — he has openly said that is what he intends them to be. Here’s a bit — of the once again towering language of the opinion, just released by the Fourth Circuit (285 pages of PDF goodness!), this morning:

. . . .. . . .“The First Amendment mandates governmental neutrality between religion and religion, and between religion and nonreligion.” Epperson v. Arkansas, 393 U.S. 97, 104 (1968); accord Larson v. Valente, 456 U.S. 228, 244 (1982) (holding that Establishment Clause prohibits “one religious denomination [from being] officially preferred over another.”).

“When the government acts with the ostensible and predominant purpose of advancing religion, it violates that central Establishment Clause value of official religious neutrality, there being no neutrality when the government’s ostensible object is to take sides.” McCreary Cty. v. ACLU, 545 U.S. 844, 860 (2005). “[T]he Establishment Clause forbids subtle departures from neutrality, ‘religious gerrymanders,’ as well as obvious abuses.” Gillette v. United States, 401 U.S. 437, 452 (1971) (quoting Walz v. Tax Comm’n, 397 U.S. 664, 696 (1970)). Similarly, “any covert suppression of particular religious beliefs” is unconstitutional. See Bowen v. Roy, 476 U.S. 693, 703 (1986) (plurality opinion). . . .

Plaintiffs here do not just plausibly allege with particularity that the Proclamation’s purpose is driven by anti-Muslim bias, they offer undisputed evidence of such bias: the words of the President. This evidence includes President Trump’s disparaging comments and tweets regarding Muslims. . . .

The Government does not — and, indeed, cannot — dispute that the President made these statements. Instead, it argues that the “statements that occurred after the issuance of [Muslim Ban 2.0] do not reflect any religious animus” but reflect “the compelling secular goal of protecting national security from an amply-documented present threat.” We cannot agree.

Rather, an objective observer could conclude that the President’s repeated statements convey the primary purpose of the Proclamation — to exclude Muslims from the United States. In fact, it is hard to imagine how an objective observer could come to any other conclusion when the President’s own deputy press secretary made this connection express: he explained that President Trump tweets extremist anti-Muslim videos as part of his broader concerns about “security,” which he has “addressed. . . with. . . the proclamation. . . .”

Onward — to the Supremes, with a smile. Trump loses — again. And. . . I am debating whether to add the latest Florida 17 (school kids, for God’s sake) to the grim totals I’ve been tracking — just since 45 took office. We are nearing 700 dead and injured, now (almost all these shooters are white males, with automatic weaponry). When is it going to be enough, for the Big Cheeto?

नमस्ते

Courtesy The Oh-So-Kind Anon: Nice Reversal, At Swords, Ireland, Since November 2013…

February 14, 2018 - Leave a Response

As we somberly reported back in November of 2013, this entire Merck Ireland facility was slated to close forever.

Between the ongoing, and dragged out Brexit shifts, and improving bioscience (immuno-oncology) pipeline deliveries, Merck’s MSD subsidiaries are now expanding in and near London, as well as in Dublin — one of my favorite places on the green Earth. Smile. Here’s the bit, from Irish Times:

. . . .MSD’s US parent, the drug giant Merck, is looking to ramp up global manufacturing capacity for its blockbuster cancer therapy Keytruda. At present the group has only one immuno-oncology manufacturing base, with the rest of its supplies delivered by contract manufacturing partners.

Ger Brennan, managing director of MSD Human Health, said the company expected “significant growth” in immuno-oncology over the coming years.

“We need to have confidence in supply,” he said.

MSD expects the new facility to be operational in 2021 and fully certified by 2022. “It’s a bold statement by MSD,” said Mr Brennan, “but that’s our target.”

The Swords investment will be a “significant component” of the €4 billion capital expenditure plan outlined by the US group earlier this month, Mr Brennan said, although MSD did not disclose the amount of its investment. . . .

Now you know — smiling, as quite leprechaun-like. . . I vanish.

नमस्ते

Four Stories I Missed — While Looking For Something… That (Apparently) Never Existed.

February 14, 2018 - Leave a Response

Here is the Verubecestat story — from Bloomberg. This outcome was widely telegraphed to the NYSE by this and other outlets, back in February of 2017 (while I was still looking — into April and May of that year) and again in January of 2018, as we noted here. So it goes. More than five years. . . wasted.

Heh. Next, a tiny (by capitalization) sub of Merck called StayWell has acquired a small start up called Provata Health — in Portland, Oregon — to do digital health. No needle mover there, either.

Third, as of year end 2017, and as expected — Merck has completely sold off its stake in BeiGene, since it had gone public, and made that orderly liquidation process. . . easy. At one point in 2016 (continuing into 2017), Merck related entities owned more than 10 per cent of this rising bioscience star.

And the final “missed” story, with nearly no chance to harm Merck’s NYSE trading price, is simply. . . bizarre. A long time chemist for Merck was apparently interested in killing rodents in his alley, and inexplicably stole an entire industrial size bottle of cyanide from an area of Merck’s labs he was not authorized to be in — and was observed by other employees removing the cyanide. Crazy. Here’s a local PhillyVoice.com story, on it all:

. . . .Richard O’Rourke, 60, of Warrington, Bucks County, told authorities that he dumped 219.79 grams of potassium cyanide into a stormwater inlet in Bucks County in December after his employer at the time, Merck & Co., became suspicious that he had taken it and an investigation was launched. The lethal dose for potassium cyanide is 200-300 mg.

The alleged incident sparked a two-week period of testing and monitoring stormwater systems, outfalls, retention, waterways and their tributaries in the Philadelphia area earlier this winter, according to an affidavit from the Upper Gwynedd Township Police Department.

But officials said the significant rainfall that fell several days after O’Rourke allegedly dumped the chemical should have been able to flush it out of any stormwater inlet. . . .

No large employer can reliably prevent any employee — especially a quiet one, who clearly had a screw loose — from (without warning) doing this sort of irrational nonsense. Now you know — and. . . sometimes it is better to “freeze nearby, than to burn at a distance,” it seems.

नमस्ते

Also While Off Grid Dept: Four Years Running — Vanguard Group AGAIN Upped Its Merck Holdings In 2017

February 12, 2018 - Leave a Response

Playing more catch up here, tonight. . .

It is a strong vote of confidence — in Merck’s management and business acumen — that for the last four years in a row, Vanguard has bumped up its stake on a percentage basis of the company’s shares. Here’s the SEC filed Schedule 13G, from from late last week — and a bit:

. . . .197,466,971 shares — 7.24%. . . .

Pretty solid stuff. Now you know — and my golden dog and I are smiling at the southern view(s). . . . as the Winter Games roll by our screens. . . .

नमस्ते