Monday, April 23, 2018

Jami Rubin, At Goldman Sachs, Bumps Merck Equity Up Two Notches -- To $73...


I still think Goldman (firm wide, given its vast debt underwriting desks) has some inherent conflicts here -- but I do think the move (given the immuno-oncology outcomes data in Chicago last week) makes sense, as to Merck's 12 to 24 month future per share NYSE values.

The link -- and a bit:

. . . .Goldman Analyst Jami Rubin upgrades Merck (NYSE: MRK) from Neutral to Conviction Buy with a price target of $73.00 (from $63.00). . . .


Now you know -- onward, on a stellar day. . . even as more senseless AR-15 automatic rifle mayhem afflicts Antioch, anew. When will it be enough, Mr. Trump? When? But I will resolve to remain focused on all the good that ordinary Americans are doing -- in spite of 45’s dysfunction. . . .

नमस्ते

Sunday, April 22, 2018

Pfizer Spent $5.44 Million On Lobbyists, While Merck Spent $3.86 Million In Q1 2018...


On the heels of a STATnews report that the trade group PhRMA (detailing an all-time record high for a single quarter) spent over $10 million in Q1. . . I thought it was high time to compare such spending at Merck, Amgen and Pfizer (again). You'll note that like last year at this time, Pfizer is more focused on financial engineering measures (changes in law), here -- than basic drug discovery policy. That sets it apart from both Amgen and Merck.

As was true with the industry generally, lobby spending was way up, over prior periods, in early 2018 -- at all three companies. Amgen came in at $4.46 million -- but Pfizer was well beyond both of them, at over half what the whole trade group spent in Q1. For its part, here is a bit of what Pfizer lobbied about:

. . . .Drug Pricing, Biosimilars Reimbursement, Antibiotic Resistance/ Incentives, Drug Shortages, Reimbursement for products treating Sickle Cell Disease. . . .

Trans Pacific Partnership Negotiations, Miscellaneous Tariff Bill, Trans-Atlantic trade & Investment Partnership, Canada, IP/Trade Issues, South Africa IP Issues, China IP, Indonesia IP, Thailand IP, Korea Pricing Issues, United Nations Health Panel, G7/G20, APEC, OECD, Australia Market -- Size Damages, WTO "Zero for Zero" Pharmaceutical Agreement, NAFTA. . . .

Medicare Part D, Coverage Gap, Biosimilar pass-through. . . .

Comprehensive Corporate Tax Reform. . . .


Now you know -- I think it likely that there is some fear of a Trump administration move to directly regulate drug prices (a la Nixon's wage/price freezes), driving this upsurge in spending. Indeed, on to the north woods, for a few hours' drive, and a sweet Sunday brunch with my youngest.

नमस्ते

Saturday, April 21, 2018

[U] In The... "What are THOSE?!" Department: Marine Biology Mystery Edition


From almost 2,800 feet under the Sea of Cortez, off the coast of Mexico. . . this is a lovely NOAA.gov mystery.

What is that? It is demon red -- complete with "horns". . . and it is likely folded up, to shield its eye from the blazingly bright undersea camera lights -- the video is jaw slacking; do watch it:

". . .The strange squid was captured on April 17 by the crew of NOAA ship Okeanos Explorer during a scientific voyage studying an ocean area never explored before. The mission has been conducting both scientific research and capturing images of deep-sea habitats in the western Gulf of Mexico that likely found nowhere else. . . ."



Yes I do love me some. . . life science. Onward, to a water workout now, myself. . . smile.

UPDATED Sunday @ 8 AM EDT, Courtesy Google: Earth Day 2018:



नमस्ते

Friday, April 20, 2018

And No "Sanctuary" Surprise: Trump Lost -- In Chicago's Seventh Circuit This Week.


Just as we said he would, he lost -- at trial. and now on appeal. Chucklehead.

I note the 7th Circuit's opinion for the very severe language used -- language unseen in several decades (since Nixon was in that office, at least). Three able federal appellate judges, both republicans and democrats, have penned a 47 page opinion that characterizes Mr. Trump's administration as evincing "a disturbing disregard for the separation of powers. . ." Not a good look, here 45:

. . . .In considering on appeal the likelihood of success on the merits, it is necessary to focus narrowly on the dispositive question and to avoid the invitation of the parties to weigh in on broader policy considerations. For instance, the Attorney General repeatedly characterizes the issue as whether localities can be allowed to thwart federal law enforcement.

That is a red herring. First, nothing in this case involves any affirmative interference with federal law enforcement at all, nor is there any interference whatsoever with federal immigration authorities. The only conduct at issue here is the refusal of the local law enforcement to aid in civil immigration enforcement through informing the federal authorities when persons are in their custody and providing access to those persons at the local law enforcement facility. Some localities might choose to cooperate with federal immigration efforts, and others may see such cooperation as impeding the community relationships necessary to identify and solve crimes.

The choice as to how to devote law enforcement resources -- including whether or not to use such resources to aid in federal immigration efforts—would traditionally be one left to state and local authorities. . . .

In fact, throughout the briefs in this case, the Attorney General is incredulous that localities receiving federal funds can complain about conditions attached to the distribution of those funds. But that repeated mantra evinces a disturbing disregard for the separation of powers. The power of the purse does not belong to the Executive Branch. It rests in the Legislative Branch. . . .

As the Supreme Court has repeatedly held, “’Congress. . . does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions -- it does not, one might say, hide elephants in mouseholes.’” Gonzales, 546 U.S. at 267, quoting Whitman v. American Trucking Assns., Inc., 531 U.S. 457, 468 (2001). . . .


Indeed. 45 is -- as I said he would be, repeatedly -- a loser, again. Sleep well, all you of good will, and good cheer. . . .

नमस्ते

Thursday, April 19, 2018

Thanks, Anon. -- I Was Remiss, In Not Getting To This: Merck/NewLink Ebola Vaccine, Now With TWO Years' Durability Data...


I admit that I've had quite a bit "in the real world" on my plate -- of late. Even so, that is no excuse: I am decidedly tardy in mentioning Merck's very nice first line lung cancer data, and in mentioning the below -- also very good news.

Thanks go to the faithful Anon. commenter who reminded me of the Lancet release having cleared embargo. More broadly, it is very encouraging to know that the Merck vaccine is showing a durable sero-positivity, in the wild (so to speak).

Let us hope that we see similar data three and five years on, as well. In any event, here is FierceVaccines on it all -- and a bit:

. . . .The new study, published in Lancet Infectious Diseases, shows antibodies persist for two years after a single shot of Merck’s rVSV-ZEBOV vaccine.

Researchers examined participants from a previous phase 1 study who returned for follow-up research. All 44 of those patients who had received a high dose of the vaccine remained seropositive at two years, and 33 of 37 who got a lower dose were still seropositive. . . .


Now you know. With my eldest in Paris and Provence for ten days, and launching a new travel magazine, I am sorely tempted (coldest April here, in over 130 years!) to hop a plane -- and go missing for a few, as early next week. We shall see -- as I could catch No. 2 in London, same trip, for Indian food!

Today is chilly, but quite clear, so I may just stay put. Dunno. . . . Onward, now to lunch -- with Riot Blockchain swooning (again, the former BiOptix) -- it's good for my personal predictive portfolio, anew. . . . grin.

नमस्ते

Wednesday, April 18, 2018

A Bit "Helter-Skelter", At The Shop, Today -- But Back To Comment On This -- Later Tonight...


The able AUSAs in Manhattan have let the court and Mr. Cohen know that Messrs. Cohen and Trump should expect rolling production of the searched materials, later next week.

Here is the full two page PDF letter, and a bit -- but I concur that no special master is warranted -- nor should Trump be shown favoritism, especially if it slows the felony (and grand jury) criminal investigation -- of his attorney.

. . . .[T]he Government expects to begin a rolling production by Friday, April 27, 2018, and to complete the production by on or about May 11, 2018, with the possible exception of the content of certain telephones. . . .


I am now. . . just. flat. out. of. time. Will be back late tonight, with analysis -- and some grins, about Sean "Hide-A-Hoe" Hannity. Keep it spinning in good karma, as we watch carefully -- to be sure the City of Memphis is not ultimately punished, financially, by the Tennessee legislature -- for pulling down Klan-related Civil War statues, in that fine blues infused (like mine, here, up north!) city.

Similarly, we smiled overnight, upon seeing the statue of James Marion Sims stricken from Central Park, in Manhattan. And we are now full-circle. Onward.

नमस्ते

Monday, April 16, 2018

Given Today's Surreal Manhattan Courtroom Events, Before USDC Judge Kimba Wood -- This 75 Year Anniversary Seems... Apt.


I will put together a quick graphic, but as the evening is slipping away -- I'll get this out without a graphic at first.

Michael Cohen's (court-ordered) reveal of Sean Hannity as a "client" -- followed within an hour by Mr. Hannity's "I am no client" declaration -- was entirely surreal. And it leaves me wondering whether, since Mr. Cohen is likely going to be charged with felonies anyway, if he's decided to cook up a cover (about Hannity) -- to hide his (purely speculative legal work) for. . . Donnie Jr., and what has now been coined as Mr. Cohen's specialty in the practice of law. . . negotiating what we have heard called. . . "Hide-A-Ho" arrangements. Hilarious. And almost Twilight Zone episode worthy.

And so. . . in an ironic echo -- 75 years ago this evening, at a Sandoz lab, the psycho-tropic LSD was first ingested, by Dr. Albert Hofmann:

. . . .In Basel, Switzerland, Albert Hofmann, a Swiss chemist working at the Sandoz pharmaceutical research laboratory, accidentally consumes LSD-25, a synthetic drug he had created in 1938 as part of his research into the medicinal value of lysergic acid compounds. . . .

After taking the drug, formally known as lysergic acid diethylamide, Dr. Hofmann was disturbed by unusual sensations and hallucinations. . . .


Indeed. And today was. . . one of those days. Now you know -- sleep well -- but don't dream of electric. . . Hannities or Cohens. . . I couldn't make this junk up, if I tried.

नमस्ते

Saturday, April 14, 2018

[U, X3] On A Quiet, Lightly-Snowy Saturday Morning: Trump's Lawyers To File Papers By THIS Sunday Night -- In Cohen Search Warrant Matter


And oh. Yeah, this: It turns out Cohen said that Sean Hannity is “mystery client no. 3” — which Hannity just promptly denied; saying he never retained Cohen — because Hannity never disclosed (to/on Fox) that he has the same lawyer as Trump — one who is now under criminal investigation, all as Mr. Hannity decried the whole matter as a witch hunt. . . . (Conflicted, much?!). . . This just entered. . . The Orwellian ZoneTM!

UPDATED @ 9 PM EDT on 04.15.2018 & 10 AM EDT on 04.16: The Cohen version is available now as well. Still no client list. Shocking. Not. And from last night:

Here is 45's new lawyer letter (that's an eight page PDF file). I am still reading the cases cited. . . but I am decidedly underwhelmed. I expect the able Judge Kimba Wood will be, as well. Now we wait for Cohen's 10 AM filing, and the 2 PM EDT appearance tomorrow, as ordered -- and Stormy Daniels will be in gallery, inside the courtroom in Manhattan. Could be a Stormy Monday, indeed. [End, updated portion.]

At the outset, I think dealing directly with Assad promptly -- and forcefully -- is the right answer. We and Britain and France need to be sure we don't create a[nother] quagmire, in the Middle East -- in the process. And in this regard, we need to tread lightly around the Russians in Syria, now long-present there. But what Assad did to his own people is. . . monstrous. I'll remain hopeful that this will be one of only a few surgical strikes.

Next, I want to link to [former US Attorney] Patrick Fitzgerald's full retort, on Scooter Libby's abrupt pardon (elegant, and spare, in his take-down of 45's clueless non-rationale for the same) -- and Marcy Wheeler's NYT editorial -- on the preposterously obvious implications of it. Do read both, and do so -- rather than fall for the nonsense 45 is peddling on Faux News.

Finally, then -- 45 has moved (and has been allowed, by USDC Judge Kimba Wood, sitting in Manhattan) to intervene in the high-stakes fight over the propriety of the DoJ no-knock search warrants executed on Monday past -- against Mr. Trump's 20-plus year personal lawyer. [It turns out Michael Cohen, that lawyer, has been under (a largely separate FBI/DoJ) investigation -- for a host of felonies for many months now. Classy company 45 keeps, no? If we were able to say nothing else, that speaks volumes. . . about 45.]

More to the point, though: Mr. Cohen (based just on what has been unsealed, thus far) is very likely headed to prison for a host of felonies. Chief among them (at least as to the chances of 45 continuing in office), and aside from "garden variety" frauds -- is the documentary proof that Mr. Mueller has obtained, showing Mr. Cohen was in Prague in 2016. Which likely means Mr. Mueller can prove he was at least one of the bag-men, for the Russian drops, in the collusion/obstruction line of cases he will pursue.

Here is the order from last night, setting a due date, on Sunday night, for Trump's intervention -- in these sordid matters:

. . . .Minute Entry for proceedings held before Judge Kimba M. Wood:

Show Cause Hearing as to In the Matter of Search Warrants Executed on April 9, 2018 held on April 13, 2018. Movant Michael D. Cohen not present but attorneys Todd Harrison, Michael Huttenlocher, and Joseph B. Evans present. AUSAs Thomas A. McKay, Rachel Maimin, and Nicholas Roos present. Counsel for Intervenor President Donald J. Trump, Joanna C. Hendon present. Counsel for intervenor President Donald J. Trump shall file a letter on or before Sunday, April 15, 2018 by 9:00 pm.

Counsel for movant Michael D. Cohen shall file a letter substantiating factual claims in support of his position on unsealing by 10:00 am on Monday, April 16, 2018.

Today's hearing on the movant's motion for an order to show cause and a temporary restraining order shall be continued on Monday, April 16, 2018 in courtroom 21B at which Movant Michael D. Cohen is ordered to be present in person.

(Court Reporter Carol Ganley) Modified on 4/13/2018 (Mohan, Andrew). . . .


It seems the noose is getting. . . rather snug, around 45's neck. His crooked lawyer will be his undoing -- as now it is a race between Cohen and Manafort as to which first flips. But it is certain one or both of them. . . will.

These remain dangerous and somber times, to be sure -- in which it is still possible that the 242 uninterrupted years of this glowingly-American notion -- of ordered liberty -- under a careful constitutional framework -- fails. But increasingly, it is looking to be inevitable -- that Mr. Trump will leave office peaceably -- well before the end of his term. So I will be smiling, on a chilly mountain bike ride, shortly. Onward.



नमस्ते

Friday, April 13, 2018

Friday Trivia: Merck Vs. Merck Discovery Schedule Delayed By Yet Another Month...


Under the newly agreed proposal (not yet signed by the able judge), all discovery will be concluded by November 15, 2018 -- instead of mid-October 2018. [Earlier backgrounder on the agreed delays, here.]

As I've repeatedly said, I suspect that there are on and off discussions of a global settlement, and master cross license of some sort, underway. And having a stretched discovery schedule is nice cover for that -- while not letting go of the trial dates, should negotiations fail. Here's a bit, and the full two page PDF letter -- with a complete set of revised deadlines:

. . . .The parties submit this joint letter to request a one month extension of the current discovery schedule. The parties have been working diligently to narrow and resolve their discovery disputes and have made significant progress.

However, unresolved disputes remain and are the subject of ongoing meet-and-confer discussions. Postponing the current April 12 deadline for raising fact discovery disputes is likely to reduce the need for judicial resolution of those issues. The parties are also in the process of conducting depositions, but witness availability has pushed certain deposition dates into June. Extending the current discovery deadlines by a month should give the parties sufficient time to complete outstanding depositions. . . .


Now you know -- onward, on a cooler but hopeful Friday, assuming that Bobby Three Sticks got some audio tapes from Mr. Cohen. If so, game. . . essentially over, for 45's presidency, erh crime spree.

नमस्ते

Thursday, April 12, 2018

The Vaccine Wars: Glaxo's Shingrix® Is Besting Merck's Older Zostavax® In The US Market -- On Efficacy, Primarily...


Some pretty respectable sell-side analysts believed that the need for a second jab, in the case of GSK's new shingles vaccine -- called Shingrix® -- would mitigate its advantage over Kenilworth's Zostavax®. That however, has not turned out to be the case in the US sales data, thus far.

It seems the GSK rollout was exceeding well-stocked and staged, making it easy to both source the new vaccine stock, and secure reimbursement, at the pharmacies. So -- as Fierce Pharma reported later yesterday, the lead now firmly belongs to GSK. Merck's $600 million a year (in the past) from Zostavax is likely to whither to below $300 million this full year. And in an encouraging note for science -- differential efficacy explains the story:

. . . .The GSK shot is believed to be more effective, though no head-to-head studies have pitted the two vaccines against each other. In phase 3, the two-dose Shingrix showed that it is 97.2% efficacious in those age 50 and older. The CDC says the one-dose Zostavax can reduce shingles risk by 51%.

If there's one problem with those numbers, it's dosing. Deutsche Bank analysts cautioned that Shingrix's two-dose schedule might ultimately hamper sales.

Signs of Shingrix’s rise — and hence Zostavax’s fall — were already showing up late last year. For the fourth quarter, GSK reeled in about $30 million in Shingrix sales, while Merck's Zostavax revenue dropped 45% to $121 million. . . .


Now you know. Onward -- on a simply glorious spring morning, here. . . [But snow is expected (again!) by the weekend. . . Ah, Chicago. . . you fickle-fated friend -- so I'll embrace it and go north -- to the Marquette territory. . . .]

नमस्ते

Wednesday, April 11, 2018

[U] At $4.2 Million, We May Never See The Full Propecia Settlement Agreement. But It Doesn't Really Matter.


Updated -- 04.14.18 @ 10 AM EDT: Here is the order, as signed by the able Judge Bryan Cogan. End update.

Here is the latest Merck lawyers' letter, as filed with Judge Cogan tonight. It is self-explanatory, and barely a page long (as a PDF).

I will also attach the claim census form (as a PDF file), for plaintiffs and claimants who might be reading this -- as even people who haven't yet filed suit (but have talked to a lawyer about filing suit) -- are in fact eligible to participate in the settlement.

. . . .[T]he Merck Defendants have agreed that the Plaintiffs' Executive Committee may disclose the Gross Settlement Amount for purposes of consideration of the Allocation Plan. . . .

Finally, because the parties did not intend to submit the Master Settlement Agreement as a publicly filed document, as it is a private agreement between the parties, the parties will not be submitting the Master Settlement Agreement jointly. If the Court requires any additional information, the parties stand ready to accommodate the Court. . . .


This concluding language, from the above letter -- essentially dares Judge Cogan to order the disclosure of it. We shall see.

Onward -- with a flawless 70 degree day ahead tomorrow -- grinning ear to ear, essentially incessantly -- as my daughter's literary travel magazine, by women, for women -- is due to launch next week. I am just so incredibly proud of her.

नमस्ते

[U] Live Argument: "Sanctuary Cities" Case, In The Ninth Circuit...


LIVE BLOGGING UNDERWAY: Chad A. Readler (Acting US AG) barely gets started, when the panel jumps in to pepper him with questions. The lawyers for 45 admit that if Congress did not expressly allow "strings" on grants to cities from the feds, then Donald Trump has no authority to "graft" them on later, by executive order. . . .

L O S E R.

Having now listened to the entire argument session, I will say quite confidently that the injunctions will be upheld by the Ninth Circuit, and ultimately then sent on to the Supremes, when 45 appeals to that court. The County of Santa Clara and the City of San Francisco appellate counsel handled the arguments quite deftly, and never faced a single hostile question -- because I surmise it is plain they are in the right, on the settled black letter law, here. . . .


Nothing new from Kenilworth on the putative Propecia/Proscar settlement papers this morning, so we will jump right on, to the West Coast, live:

. . . .Executive Order 13,678 (hereafter, the “Executive Order” or “Order”) represents an impermissible bid by the president to exceed his constitutional powers and punish communities whose local governments choose -- consistent with their rightful role in our federal system -- to decline conscription into a scheme of immigration law enforcement that threatens to undermine public safety and up-end community stability. [Technology and life sciences companies] and the communities in which they are embedded have benefited from the open values, the diverse and inclusive culture, the lawful and welcoming immigration practices, and the supportive local governments that were jeopardized by a hastily imposed and unconstitutional Executive Order. . . .




Starting in about one hour and fifteen minutes, now -- expect 45's lawyers to lose -- and lose handily, here. Love to all -- malice toward no one of genuine good will, on this perfectly sunny, warm spring morning. . . . in the greatest place on Earth.

नमस्ते

Tuesday, April 10, 2018

Nightly(?) Propecia Updates: We Expect More From Merck By Tomorrow, Wednesday... But It's A $4.3 Million Proposed Fund...


I will attach the motion for settlement, and the proposed plan of allocation, as filed tonight.

It is in that latter document that we learn that the total settlement fund amounts to $4.3 million, give or take. Significantly, plaintiffs' attorney fees are proposed to be paid outside of (and not deducted from) that figure, as I understand it, as of tonight.

And that amount is plainly immaterial to Merck -- so it need not disclose it under SEC rules. However, Judge Cogan is likely to be persuaded (by news organizations, if no one else) that there are public policy reasons (related to drug safety and side effect profiles) which militate toward disclosure of the basis for settlement.

Now we wait to see what Kenilworth files tomorrow. But this one has rather suddenly turned into a quite-interesting back and forth -- it may make some new law, here. G'night all. . . sleep soundly, like little round river rocks!

नमस्ते

UPDATED & Exclusive: USDC SDNY Judge Brian M. Cogan Says “Not So Fast!” — With That Sealing Order...

I had wondered last night, after posting this one -- whether the press might make a filing, saying the public has “a right to know”. Now (as the case the able judge cites would suggest), the issues will be vetted -- in open court.

Here is the full text order — just entered; more soon:
. . . .All litigation in the bellweather cases is stayed until August 15, 2018. As to filing the MSA and associated Exhibits under seal, the parties will need to make a showing beyond their mere agreement that what appear to be judicial documents should be filed under seal.

See City of Hartford v. Chase, 942 F.2d 130, 136 (2d Cir. 1991). Ordered by Judge Brian M. Cogan on 4/10/2018. . . .

UPDATED @ 2 PM EDT: As the Second Circuit observed, in City of Hartford (cited above), there is "a strong presumption against sealing any document that is filed with the court. Our courts do not operate in secrecy. Except on rare occasions and for compelling reasons, everything that courts do is subject to direct public scrutiny. To hide from the public eye entire proceedings, or even particular documents or testimony forming a basis for judicial action that may directly and significantly affect public interests, would be contrary to the premises underlying a free, democratic society. . . .

This is highly unusual -- and I doubt this is a plaintiffs' request. And so, I might expect that Kenilworth will not be able to articulate such a "compelling interest" -- given that most of its own other class settlements have been widely published. I am thinking of the Vioxx litigation, the Fosamax litigation, the Nuvaring litigation and the Vytorin litigation, just to name the most recent three four.

In any event, it is a near certainty that each settling plaintiff will know what their particular payment will be; we just may not know the grand total, less attorneys’ fees — of all 652 added up. That is, if Merck's lawyers can demonstrate a compelling interest in secrecy.

 More as I have free time — smile!

नमस्ते

Monday, April 9, 2018

[U] BREAKING: It Would Appear Merck Has Agreed To Settle 562 State MCL AND Federal MDL Propecia®/Proscar® Cases...


UPDATED @ 10 AM EDT on 04.10.2018: Unrelated, but Mr. Frazier was paid quite a lot of money last year -- about 215 times what an average Merck employee makes. I unequivocally believe he is very near the top, among the most competent CEOs in multinational public companies in the pharmaceuticals and life sciences spaces. It is impossible to say whether he is "worth" the money he is paid (as all these numbers seem so wildly-inflated, compared to an the median worker's $85,000 annual salary and bonus at Merck) -- but it is true that he is being paid about what he'd earn at other similar companies, were he to jump ship -- and that would be very bad for Kenilworth. So while I might be tempted to say that I think $17.6 million is a lot of money for a year's work -- it probably makes sense, at a $42 billion company. [End updated portion.]

This will be splashed all over the papers tomorrow.

But you -- dear faithful, loyal and abiding readers -- you. . . may see it right here tonight (as a two page PDF file), exclusively. Just hot off the PACER wire:

. . . .The undersigned counsel for the Plaintiffs’ Executive Committee (“PEC”) and Merck & Co., Inc. and Merck Sharp & Dohme, Inc. (“Merck”) (collectively, the Parties) write to advise the Court that a Master Settlement Agreement (“MSA”) was executed earlier today that establishes a settlement program seeking to resolve the claims of 562 cases pending in this MDL and the Consolidated State Court Action in New Jersey. Because the terms and conditions of the MSA and the Proposed Plan for Allocation of Settlement Funds (“Allocation Plan”) are confidential, the Parties submit this letter to the Court directly. Specifically, the purpose of this letter is to apprise the Court of the MSA and to outline the Parties’ plan to submit settlement materials to the Court [under seal, tomorrow, April 10, 2018]. . . .

Finally, because the Parties have executed the MSA, they jointly request a stay of the litigation, including but not limited to Reply briefing in the four bellwether cases under Practice and Procedure Order No. 15, as amended, until August 15, 2018 to evaluate which claims will participate in the Settlement Program. . . .


Now you know. Good for Merck to have resolved these claims. . . though we wait to see what the price tag is, in the next SEC Form 10-Q (assuming the amount is presently immaterial, at least on probabilities). It may be that it is immaterial overall -- though SEC rules do not allow the company to count insurance recoveries, in assessing whether the settlement is material.

That said, we may never know what the actually-agreed total. . . was. If it is not material, there is no rule which requires disclosure. Now, sleep well all you little ones -- pancakes for dinner, with my baby-girl (down with a fever) -- and they were a hit, tonight!

नमस्त

Webb Space Telescope Update: New Oversight Board -- NASA Now Getting It Back On Track...


I do believe the Webb Space Telescope will launch in 2020, and will be a huge scientific success -- lasting decades.

I just think we are going to need to be patient -- and (via a close review, by the below-expert panel) be sure that Northrop Grumman isn't engaging in wasteful spending, on an admittedly vast, and very complex. . . government contract. [This post updates this one.]

Here is a bit from last Friday's NASA press announcement:

. . . .The Independent Review Board review process will take approximately eight weeks. . . . NASA will review those findings and then provide its assessment in a report to Congress at the end of June 2018. . . . Members of the board:

Mr. Thomas Young, NASA/Lockheed Martin in Bethesda, Maryland – Retired (Chair)

Dr. William Ballhaus, Aerospace Corporation in El Segundo, California- Retired

Mr. Steve Battel, Battel Engineering, Inc. in Scottsdale, Arizona

Mr. Orlando Figueroa, NASA Headquarters and Goddard Space Flight Center in Greenbelt, Maryland – Retired

Dr. Fiona Harrison, Caltech University in Pasadena, California

Ms. Michele King, NASA Office of Chief Financial Officer/Strategic Investments Division in Washington, DC

Mr. Paul McConnaughey, NASA/Marshall Space Flight Center/Webb Standing Review Board (Chair) in Huntsville, Alabama

Ms. Dorothy Perkins, NASA Goddard Space Flight Center in Greenbelt, Maryland - Retired

Mr. Pete Theisinger, Jet Propulsion Laboratory in Pasadena, California

Dr. Maria Zuber, Massachusetts Institute of Technology in Cambridge, Massachusetts. . . .


Indeed -- that's a top flight review roster.

It is. . . surreal -- here at the noon hour, as a hard pelting hail is now falling on top of about an inch of earlier soft snow. [After the carnage in Syria, over the weekend, and 45's bellicose rhetoric, blaming 44, I thought this. . . apropos.] I'd mournfully ask. . . "Where have all the flowers gone. . ." long time passing. . . long time, ago(?)







नमस्ते

Friday Past: While It Was Bad News For Incyte, The Merck Downdraft On The NYSE Seemed An Overreaction...


Regular readers will recall that we specifically discussed this collaborative immuno oncology Phase III melanoma study almost a year ago. [And that one was updating a broader overall backgrounder -- from February 2014, or four years ago.]

As is becoming increasingly clear, Kenilworth's pembrolizumab seems most potent against cancers that express a specific set of proteins -- in significant amounts. Immuno-oncology it seems, will be largely about tailoring the cocktail, to the specific patient. Here is a bit -- from the Incyte Friday presser:

. . . .Merck. . . today announced that an external Data Monitoring Committee (eDMC) review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with Merck’s KEYTRUDA® in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy. The study’s second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA. . . .


Even so, it seems to me at least that the selling pressure seen in Merck's shares, on the NYSE on Friday was a bit over-baked. The thesis generally remains solid, and the evidence continues to mount that Keytruda® improves progression free survival in a wide array of solid organ tumors, and in patients with certain protein expression profiles. So sayeth the Condor. . . grin.

Onward then -- on a cloudy April Monday morning, with pristinely shimmering white snows, once again on my greening lawn. . . crazy!

नमस्ते

Sunday, April 8, 2018

Looking Forward -- To May 2018 -- When Insight Mars Launch Window Opens...


. . .When the launch window opens for the Mars Insight mission, I'll (almost certainly) be on the rail, at Churchill Downs -- but I doubt the launch will take place on that first weekend of window opening. . . . Or at least I'm hoping it won't.

This is a mission to plumb beneath the surface of Mars, with 15 feet deep drilling — and seismometer imaging -- to hopefully get answers about how these "rocky" planets form -- at least in our local neighborhood.



Here's the backgrounder, from JPL/NASA:

. . . .InSight -- short for Interior Exploration using Seismic Investigations, Geodesy and Heat Transport -- is a stationary lander scheduled to launch as early as May 5. It will be the first mission ever dedicated to Mars' deep interior, and the first NASA mission since the Apollo moon landings to place a seismometer on the soil of another planet. . . .


Now you know -- onward, as a soft Sunday evening snow begins wheeling silently to Earth, here out my sliding glass doors. . . onward -- to the morrow -- with a wide grin. . . . We will be watching, on "may the fourth be with you" day, in any event.

नमस्ते

Thursday, April 5, 2018

Merck, Up... Pfizer, Down -- According to Barclays, This Morning...


Merck was last an "Overweight" at Barclays in December of 2015 -- and was also a $66 target, then. This morning's move is predicated on strong prospects for Kenilworth's pembrolizumab, in lung cancers. [Much of the eight years' prior backstory, here. . . .]

Unlike December of 2015, though -- the bank has also dropped the hammer, on Mr. Ian Read, and Pfizer -- making it an "Equal Weight", with a new $3 haircut -- on the price target (as detailed at right). Barclay's says it is less likely now that Pfizer will undergo a "transformative" mega-deal. So it is clipping the stock's wings (even though that $38. . . is above current NYSE trading prices).

Here is a bit from CNBC on it all:

. . . .Analyst Geoff Meacham and his team also raised their price target on Merck by $2 to $64, a more than 17 percent increase from Wednesday's close.

"In our view, there is perhaps 15 to 20 percent of first-line lung market share 'up for grabs' in the U.S.," the analysts said in a note to investors Thursday. Meacham also noted a better outlook versus key competitors, namely Bristol-Myers Squibb.

Merck shares rose 1.1 percent Thursday above $55 a share. The stock has fallen 3 percent this year. . . .


Now you know. Great news, for Merckies! And do get out and breathe that emerging spring air -- I am off to do so -- and find a food truck with lobster rolls (or gumbo), right now! Smiling widely, at "Miss Calypso". . . . (of one year ago).



नमस्ते

Wednesday, April 4, 2018

In A Decade-Old Battle, Merck Seeks To Arbitrate Zetia® Antitrust Claims: USDC ED VA Filing, Overnight...


This particular post takes the blog back to its origins -- some 6,400 posts, and. . . a decade ago.

Back then, legacy Schering-Plough was making billions off of an expensive placebo -- without any clinical proof of efficacy. To be fair, so too was Merck. And pharmacy distributors collectively sued, saying they were being unfairly overcharged -- for a drug that was no better than a generic statin. [One of those was styled as an antitrust suit in Virginia federal court. We didn't separately cover it in real time, as it was largely cumulative, of all the others.]

Okay. Along about 2010, Glenmark and Mylan and others filed with FDA to bring a generic version to market, while the IMPOROVE-IT study was still pending. [In the end, that study showed that we would spend an additional almost $750,000, over seven years in 50 patients, to prevent one additional MI event. Not a great win.]

Fast-forward eight long years. . . . and we now see Merck (as the legacy bag-holder for Fast Fred Hassan) seeking to invoke an arbitration clause in the distribution agreements, and send the pharmacy-distributor antitrust claims to binding private arbitration.

Here is the full 33 page PDF memo of law, just filed overnight -- but it is partially-redacted (for trade secrets).

And it is Dr. Maya Angelou's 90th. . . so I will toss my head back, and smile widely, and speak mellifluously (in but a pale imitation of her voice), about all of that (". . .and still, I rise") -- even as we reflect on what is now a half-century of. . . lost wisdom (had he lived, to ripen into old age, and his golden years) -- all due to an assassin's rifle shot, in Memphis -- at 6 PM local, this evening. . . .

Onward. Just the same. . . travel well; travel light -- one and all.



नमस्ते