Archive for the ‘Uncategorized’ Category

In What Is Likely A First, CSPAN-TV Will Broadcast Ninth Circuit Hearing On “Ban 2.0” LIVE, On May 15, 2017
April 24, 2017

It is (I think) wise to allow the people of this great nation to see how their system of checks and balances functions, in their name.

But it is a rare thing, indeed, to see the inside of a federal appellate courtroom, LIVE, in real time, in session — on television. However, that is just exactly what’s on tap for May 15, in the Ninth Circuit, in Seattle. Excellent — per the court’s order, tonight:

. . . .C-Span applied to broadcast live, the case captioned above, scheduled to be heard at The William K. Nakamura Courthouse in Seattle, WA on Monday, May 15, 2017. C-Span’s request to broadcast live is GRANTED.

C-Span will serve as the pool-feed for all media organizations that submit an application. . . .

That is wonderful, truly — I am smiling ear to ear, here. But, in darker doings, do see the masthead — I couldn’t make this sort of Don-foolery up — if I tried. As of 10 PM EDT, the Trump Administration had removed the ad for his golf club from the Department of State website. Like many a person completely unaware of how others see them, I guess. . . but very nauseating — just the same. . . . G’night.


In What Might Be Thought Of As A “Nuisance Value” Patent Payment…
April 24, 2017

. . .over the weekend, Kenilworth apparently agreed to pay a waifish one time amount to a patent estate managing bio-science company with its HQ in Incline Village, Nevada. [That tells you something. Grin.]

The fact that it is less than $20 million, paid once only, and grants Merck perpetual freedom from nonsense value suits filed against pembrolizumab patents, tells us much about the context, here. Merck would spend that much, in all likelihood, should a trial and appeal occur — so all Merck has done here is avoid paying more legal fees, by simply and cheaply buying peace with the so-called Queen patent-holder (which PDL apparently itself acquired from a third party). From Yahoo! News:

. . . .Under the terms of the agreement, Merck will pay the Company a one time, lump-sum payment of $19.5 million, and the Company will grant Merck a fully paid-up, royalty free, non-exclusive license to certain of the Company’s Queen et al. patent rights for use in connection with Keytruda as well as a covenant not to sue Merck for any royalties regarding Keytruda. In addition, the parties agreed to dismiss all claims in the relevant legal proceedings. . . .

So Kenilworth made one payment of something well-shy of one half of one per cent of its likely 2017 sales of this product — to close PDL out. And with that, we are back at full-speed! Baby-Face grinning, on a sunny Monday. . . . Onward!

UPDATED: Signal acquired. Smile. Now you know — sunny and crisp here — still awaiting signal acquisition from Cassini, after her bend around Titan for the final time — yes, that lil’ “shepherd moon-lette” I’ve grown so fond of. Smile.


Update: The Ninth Circuit Is Once Again Back To A Three Judge Panel, On 45’s Muslim Ban 2.0
April 23, 2017

This order was entered while I was in the air on Friday.

It restores the Ninth Circuit’s clear timing advantage, in getting an opinion out first. And I for one believe the Ninth will preserve the nationwide injunction against the Ban 2.0. The order, then:

. . . .The full court was advised of the petition for initial hearing en banc. A judge requested a vote on whether to hear the matter en banc before the limited en banc court. Another judge requested a vote on whether to hear the matter en banc before the full court. The matter failed to receive a majority of the votes of the nonrecused active judges in favor of initial en banc consideration. Fed. R. App. P. 35. Therefore, initial en banc proceedings are concluded, and all remaining issues will be decided by the three-judge panel. . . .

Now you know. G’night to all of good will.


While I Was Away… News On Samsung/Merck; And J&J Remicade® Connections…
April 23, 2017

We have been following this specific arc of narrative for just over four years now (and the more general S-P Remicade® choke, for going on eight). Whilst we were off grid, our buddy John Carroll very-ably picked up the slack. Do go read all of his, from Friday, past. It is spot-on.

Even so, there is more history to be re-told here. As they say, one’s history is defined by the narrator, after the fact. [We hinted at some of this when we discussed J&J results, last week.]

In this case, the story (in our opinion) starts with less than careful lawyering by the then-GC at legacy Schering-Plough. And it devolves into a multi-billion dollar arbitration with J&J — in the settlement of which, Merck is required to surrender the US rights to Remicade®, to its opponent — J&J. So, when John closes below by saying that Merck will compete in the US against the branded version, while selling its new biosimilar with collaborator Samsung Bioepis — that leaves unsaid WHY that odd state of affairs now exists (with Merck still selling the branded version in Europe). It exists, in my opinion, due to a far too cute attempt to skirt a plainly enforceable contractual provision (which favored J&J/Centocor) — by the lawyers who (last-minute) tried to engineer a more-favorable sale — of legacy Schering Plough — to Merck, in late 2009/early 2010.

. . . .The FDA has approved a new knockoff of J&J’s top earning drug Remicade, which may finally start to shift the market dynamics toward greater competition with lower prices.

This new one is dubbed Renflexis and comes from Samsung Bioepis, one of the big players in the biosimilars field. And it arrives in the US market close to a year after the EMA approved it for Europe.

J&J’s Remicade earned close to $7 billion last year, making this by far its biggest drug in the portfolio. And as J&J noted a few days ago during its Q1 call with analysts, the pharma giant has yet to feel much of an impact from the first Remicade biosimilar from Pfizer, Inflectra (infliximab-dyyb), which was developed by Celltrion and then bagged by the pharma giant in its acquisition of Hospira. That was approved last fall.

Now Merck will pick up the commercialization work of this second knockoff as J&J enters a new stage in defending the huge franchise. Ironically, Merck will now market Remicade in Europe, while competing with it in the US. . . .

But if you’re a regular reader, here — you already well-knew that the irony mentioned above was born in the feverish opium den of drug and biologic non-discovery that was Fred Hassan’s version of Schering-Plough. . . smile.

And so, as we slip into the easy chair in our city-flat, on another languid, clear Sunday night — we will observe that this all unfolded, just as we had predicted — in 2010, 2013, 2014 and 2015. Grin-worthy. Onward. . . as we “wait for sleep to find us” — but tonight, we’ll not need to wait very long, at all [as sometimes it feels like we “write like we are running out of time,” indeed].


As I Head Off-Grid — For A Long Weekend, Of “Unwasted Grace”…
April 20, 2017

This evening, I will note the sublime synchronicity here — gossamer-like, and gracefully twisting, the dark-amber, almost cinnamon hued Cassini (at least as seen by these eyes, in the perpetual half-light that is Saturn, and her moons). . . will this weekend make her final close fly-by of the haze-shrouded big moon Titan.

[It seems I too will make a derivative-equations-laced version, of such a final fly-by, within hours of that time — but in our own southern states.] This has put me in mind of ways to best handle things that come naturally, but sweetly. . . to their ends. As all good things. . . do.

So as we often are wont, on such occasions, we will offer some poetry, welded to an image of that moment [click it to enlarge] — and a solid space science video, after the NASA pull-quote. Do enjoy, the wonder here offered:

. . . .NASA’s Cassini spacecraft will make its final close flyby of Saturn’s haze-enshrouded moon Titan this weekend. The flyby marks the mission’s final opportunity for up-close observations of the lakes and seas of liquid hydrocarbons that spread across the moon’s northern polar region, and the last chance to use its powerful radar to pierce the haze and make detailed images of the surface.

Closest approach to Titan is planned for 11:08 p.m. PDT on April 21 (2:08 a.m. EDT April 22). During the encounter, Cassini will pass as close as 608 miles (979 kilometers) above Titan’s surface at a speed of about 13,000 mph (21,000 kph).

The flyby is also the gateway to Cassini’s Grand Finale — a final set of 22 orbits that pass between the planet and its rings, ending with a plunge into Saturn on Sept. 15 that will end the mission. During the close pass on April 21, Titan’s gravity will bend Cassini’s orbit around Saturn, shrinking it slightly, so that instead of passing just outside the rings, the spacecraft will begin its finale dives which pass just inside the rings. . . .

So do treat each other well, whilst I’m twisting around Alabama — for if you do not, I will know of it, via astro-dynamics — and come visit, as a shipwreck — amongst those shepherded orbital ellipses — smile. . . .[Subsequently — oh my. My ‘Hawks looked awful last night. Congrats to the Preds. Next year. Always next year.]


Another Excellent Brief — By Amici — In The Ninth Circuit, Tonight…
April 20, 2017

This time, the amicus brief is authored by a coalition of the most esteemed Constitutional law professors our nation has to offer. So, I’d trust their views.

And this time, a great bit of scholarly attention is paid (in a 43 page PDF) to the Free Exercise and Establishment Clauses of the First Amendment — and long standing precedents there under. As you might imagine, Mr. Trump’s twin (but serial) Muslim banning orders flunk every imaginable test — and so, the Framers’ whose views are recounted here, and the language the amici use to convey the same is. . . towering, in its command of our system of ordered liberties (as this case is almost — but only almost — without precedent):

. . . .The bill against which James Madison famously remonstrated has been consigned to the dustbin of history. But the underlying evils against which Madison warned are still with us. This case does not present them in disguise. No, “this wolf comes. . . as a wolf.” Morrison v. Olson, 487 U.S. 654, 699 (1988) (Scalia, J., dissenting). President Trump repeatedly and ostentatiously expressed the animus that brought it forth in his calls, and subsequent acts, to ban persons of a single faith from entering the United States. For liberty to endure, the Order must be rejected. . . .

The Framers thus understood that their task was to design a “government for a pluralistic nation — a country in which people of different faiths had to live together.” Jon Meacham, American Gospel: God, the Founding Fathers, and the Making of a Nation 101 (2006). As George Washington wrote, “the government of the United States. . . gives to [religious] bigotry no sanction, to persecution no assistance.” Letter from George Washington to the Jews (Aug. 18, 1790). . . .

Thomas Jefferson, in turn, saw the Establishment Clause as “proof that [the people] meant to comprehend, within the mantle of [the law’s] protection, the Jew and the Gentile, the Christian and Mahometan, the Hindoo. . . [and] every denomination.” Thomas Jefferson, Writings 40 (Merrill D. Peterson ed., Library of Am. 1984). . . .

Even acknowledging the deference due to the President in matters of immigration and national security, it is hard to imagine a clearer case of governmental action motivated by animus toward a single religion. . . .

[A]s a matter of law, the Supreme Court has never suggested that statements in some fora — such as campaigns — are uniquely irrelevant to motive analysis. To the contrary, courts must consider “the historical background of the decision under challenge, the specific series of events leading to the enactment or official policy in question, and the legislative or administrative history, including contemporaneous statements made by members of the decisionmaking body.” Lukumi, 508 U.S. at 540 (opinion of Kennedy, J.) (citing Arlington Heights, 429 U.S. at 266). That reflects simple common sense: “[T]he world is not made brand new every morning.” McCreary, 545 U.S. at 866. . . .

[Now, as to that last bolded bit — in other contexts, I do so wish. . . that it were.] But so it goes — we try anew, tomorrow. And. . . a reckoning soon arrives — on swift and dark wings, indeed. That much is now a certainty — so I will smile — and smile widely, tonight. . . . Word.


Merck Adds Another $300,000 In Cash — To Neglected Disease Eradication — In Africa…
April 20, 2017

The total will rise to $600,000, as it is a matching grant — for anyone else who decides to chip in [that’s a hint, Mr. Reed. . . grin]. And the World Health Organization has set an aspirational goal of eradicating this scourge, and many others, throughout Africa — by 2020. Merck has already contributed over 2.5 billion doses of medicines, to the effort.

This underscores our post of Monday — and reminds the world of Kenilworth’s almost solitary original role (since the late 1980s — later picked up by GSK and others) in ending river blindness, in Africa. This is the highest and most noble calling — of stewardship, at a life science company blessed with the resources Merck enjoys. [In fact, in October of 2015, a former Merck scientist did win a Nobel for this work.] Kudos, Mr. Frazier — and a bit:

. . . .Merck announced today a $300,000 cash donation to support non-governmental organization (NGO) partners working to eliminate river blindness (onchocerciasis) and lymphatic filariasis (LF) in Africa. The donation will be offered to 10 NGOs beginning this year, and will be administered through the MECTIZAN® Donation Program (MDP), a public/private partnership established in 1987 following the announcement by Merck to donate MECTIZAN® to control and eliminate river blindness.

River blindness and LF are targeted for elimination in the World Health Organization’s (WHO) Roadmap on Neglected Tropical Diseases (NTDs), and NGOs have long played a critical role in the broad partnership focused on achieving those targets. Grants will be given to support activities focused on the elimination of river blindness or LF, and will be offered to our partner NGOs who are directly involved in the distribution of MECTIZAN®. Eligible NGOs will be able to request funds through an application process in which they will be required to secure a 50-50 matching grant, effectively doubling the resources to $600,000. . . .

Now you know. And now with feelings of a sweet reckoning abounding — and copper colored satellites once again twisting gracefully overhead — I cannot stop smiling. Word. . . .


Q1 2017 Forecasting: Will Merck’s Sales Lines Look Light, Again — As J&J’s Just Did?
April 19, 2017

As is often the case, we take a moderate amount of “Kentucky windage” — on Kenilworth’s prospects — by looking at other similar large cap multinational life science companies. One of those would be J&J. And J&J this past quarter saw the first truly pronounced full-quarter’s effect — of biosimilars to, and Pfizer’s branded alternative for, infliximab on market, post-launch. But sales were soft in several of its traditional pharma strongholds — including the diabetes space. And that might be worrisome for Merck.

[J&J is also in devices, while Merck is not — but that isn’t comforting for followers of Merck, since J&J’s growth in devices was reasonably robust — and Merck doesn’t offer any entrant, in any device segment.]

While we ought not get ahead of ourselves, I would expect only modest constant currency growth in most of Merck’s franchises — with Keytruda® as the stand out growth franchise — on both volume and price. J&J has no such flagship oncology product, so overall we remain sanguine for an in-line quarter at Merck. The company reports nearer month’s end.

It is also true that both J&J and Merck have now seen a full quarter’s effect of more aggressive price negotiating at US formularies by insurers (and similar toughness — by government payers in the UK and EU). In any event, here is Morningstar’s take on J&J latest results:

. . . .J&J reported first-quarter results largely in line with our expectations, and we don’t expect any major changes to our $108 fair value estimate. We continue to view the stock as slightly overvalued as the growth prospects for the company’s divisions don’t appear strong enough to support the current market price. . . .

Backgronders here, on infliximab going bio-similar (from October 2015), and the overall arbitration fight, from 2010 — triggered by poor deal lawyering, at legacy Schering-Plough. Now you know. Onward — toward the University of Alabama campus.


Meanwhile — Out West, In The Ninth Circuit — Another Muscular Amicus Brief Was Filed, This Afternoon…
April 18, 2017

This amicus brief was filed just today, by the MacArthur Justice Foundation. It — as much as any of the others — has buried 45’s chances, on appeal, in my estimation.

In my view, an unflinchingly accurate and impolite recitation of the facts — in this case, will all but compel the result (a complete loss for 45’s Ban 2.0), sua sponte. . . even at the Supremes.

Here is just a bit — but do go read all 33 pages:

. . . .This President of the United States, Donald Trump, selected an unpopular minority faith that makes up 1% of the nation’s population, ran a campaign that vilified and spread propaganda about that minority faith, and built an administration that has repeatedly equated the members of that faith with terrorists. He now expects the Court to turn a blind eye to that record of animus and, instead, accept the Government’s pretextual assertion of national security. . . .

That would be a serious abdication of the Court’s critical role in safeguarding discrete and insular minorities, and in preventing the use of Executive power to attack unpopular groups — the sort of abdication that has, in the past, left a permanent stain on American history [Ed. Note: the reference to Korematsu here is crystal clear — a U.S.S.Ct. case that belatedly stands for exactly the opposite of its original holding — against just these sorts of general and bigoted actions]. . . .

As early as April 11, 2011, Mr. Trump began advocating that a “Muslim problem” exists in the U.S., and suggesting that Islam teaches a “very negative vibe” and “tremendous hatred.” He recounted: “Bill O’Reilly asked me is there a Muslim problem? And I said absolutely, yes. In fact I went a step further. I said I didn’t see Swedish people knocking down the World Trade Center. . . . I mean I could have said, ‘Oh absolutely not Bill, there’s no Muslim problem, everything is wonderful, just forget about the World Trade Center.’ But you have to speak the truth. . . . The Koran is very interesting. . . . I’m certainly not an expert, to put it mildly. But there’s something there that teaches some very negative vibe. . . . there’s tremendous hatred out there that I’ve never seen anything like it. . . .” [Ed. Note: Except of course whenever 45 himself. . . speaks, on the topic.]

[And again — Mr. Trump, speaking in December 2015 about then-President Barack Obama, with a questioner]. . . .

“Questioner: “We have a problem in this country. It’s called Muslims.”

Mr. Trump: “Right.”

Questioner: “You know our current president [Mr. Obama] is one. You know he’s not even an American.”

Mr. Trump: “We need this question.”

The President has adhered to his view that people of the Muslim faith are a “problem” and vilified them on numerous other occasions. . . .

On November 22, 2015 [Mr. Trump] stated: “There were people that were cheering on the other side of New Jersey, where you have large Arab populations. They were cheering as the World Trade Center came down. . . there were people cheering as that building came down—as those buildings came down. And
that tells you something . . . . There were people over in New Jersey that were watching it, a heavy Arab population, that were cheering as the buildings came down. Not good. . . . [Ed. Note: this Trump assertion is universally known to be a complete lie.]

This man (along with others) must be brought to heel — like the unruly animal he clearly but vainly tries to be.

I’m taking a bit of time to enjoy a flawless afternoon in the sun, and express gratitude, to our founders for leaving us a very solid means to protect ourselves from animals like him. It is called judicial review — and I for one like the taste of it.

I no longer want to taste lies, spit into my own mouth. Out.


WHO: With Aid From GSK And Merck, Togo Becomes First Nation In Africa To End Lymphatic Filariasis as a Public Health Problem
April 18, 2017

After over 10 billion doses of a pair of medicines — essentially all donated by charitable arms affiliated with the two multinationals, over almost two decades — Togo has eliminated both elephantiasis and river blindness, as public health concerns, in the country.

The WHO has certified Togo as the first African nation to reach this milestone. Here’s a bit — and to be certain, Kenilworth should rightfully be lauded for this (as should GSK):

. . . .”We celebrate this important achievement with the people of Togo. Lymphatic filariasis is a debilitating, but preventable, disease that not only affects patients and their families but also communities and health care systems,” said Dr. Julie L. Gerberding, Merck’s chief patient officer. “Working with our partners for nearly two decades, we strive to eliminate LF in Africa and Yemen to help improve the lives of tens of millions of people.”

Phil Thomson, president of Global Affairs, GSK said “Achieving elimination of LF is a fantastic achievement for Togo and is testament to the commitment of the Togolese Government and the dedication of the health workers delivering treatments on the front line. We are committed to playing our part with the donation of albendazole for as long as it is needed to replicate this success throughout endemic countries, freeing communities from the burden of LF.”

The MDP’s director, Dr. Yao Sodahlon, is a Togolese national and expert in tropical diseases who worked closely over the years with the ministry of health and other partners to ensure Togo’s success. . . .

This is a story not told often enough, about the morally just contributions of many life sciences companies — to “the humbled, the lowly — the least able to pay — of our brothers and sisters. . .” (to refer to Luke 10:30-37, as Pentecost looms). . . But brothers and sisters. . . all of us, are — just the same. Now you know. Onward — with a fiercely independent smile.