Wednesday, November 22, 2017

Another Thanksgiving, Another Old Legacy Merck Property For Sale...


At Thanksgiving 2016, we were discussing the fact that the Whitehouse Station former Merck HQ sale had fallen through.

Here at Thanksgiving 2017, Merck has relisted a nearby (or a part of the same?) property -- 154 acres, in all -- with Jones Lang LaSalle. The full article is behind a registration wall, so if any readers out there want to chime in with more detail, that would be great. I've used a Google Maps image of the corner where the parking entrance is, as my graphic, at right. But is this the other half/parcel of the since-divided old Merck HQ lots? The one million or so square foot building that was HQ is still listed (I believe) with Cushman -- is/was this part of that?

Hmmm. . . is this the "rest" of that tract -- the more prosaic, and industrial complex part of it? It seems so (unless my memory is faulty, here two decades on), by the iconic sandwich shoppe, down the street, on the corner -- from those "bad old days", flying in and out, to meet with Merck. [I used to snag lunch there, when I flew in and out for the day, to do licensing and M&A deals (on behalf of another life science company) with various factions of Merck. . . gosh, how time flies. . . . In any event, do let me know. . . what you know, dear readers.] It should be quiet around here for a bit.

And do have a safe and happy turkey feast, one and all. I'm out until Monday night, barring an unforeseen event in the land of the crazy that is 45. Which is to say -- I am sure he will do something. . . nutty. Sheesh. Smile -- just the same.

नमस्ते

Tuesday, November 21, 2017

[U] A "Tumbling, Reddish Brown, Mount Blanc Pen" -- Blazing By @ 196,000 MPH -- Just Flew In, And Out, Of Our Solar System...


UPDATED -- Dawn in Italy, on Tuesday 11.21.2017: I bumped this back up to the top. We could all use some happier-science infused ju ju, here. [End, updated portion.]

Let's just have the sublime ESO video do the 'splainin', shall we? [She's been named "Oumuamua", by her discoverers -- which translates from the native Hawaiian as "first arriving messenger, from afar".] Yes. . . let's. See below.

It is highly unlikely that this object will ever see her arc bend backward, and twist, toward our sun again -- she is passing through our lives but once. Like so many odd, yet preciously graceful, things. . . indeed.

. . . .Astronomers have recently studied an asteroid that has entered the Solar System from interstellar space. Observations from ESO’s Very Large Telescope in Chile (and other observatories around the world) prove that this unique object was travelling through interstellar space for millions of years before its chance encounter with our star system. It appears to be a darkly reddish (red-bone!), highly-elongated, high-metal-content object. . . .




As ever -- the idea of a dusky metallic visitor -- from near the "time, before time". . . at least relative to our own local group. . . fires my imagination. No doubt (being a man of science, after all!), under this graceful, roughly Mount Blanc pen-shaped metal, are the vestiges of one or more timeless raindrops -- and under those raindrops, are the words -- and some of those words, are mine to you. Travel well -- and do travel light.

नमस्ते

Monday, November 20, 2017

UPDATED, X3: Trump's Lawyers Are REALLY Behind The Eight Ball, Once Again -- CA DACA Developments This Afternoon


Moving swiftly, the plaintiffs in the California DACA litigation have correctly noted, in a brief filed a few minutes ago -- that Trump's lawyers don't even understand the posture of their case -- which is (politely) to say nothing of the merits, here.

But in a show of equanimity, coupled to a thoughtful expediency, the lawyers for the kids are willing (but only in the federal trial level court in San Francisco) to allow the Trump Administration to wait until Christmas week 2017 to deliver the full discovery materials it owes them -- because it is likely (they rightly surmise) that one court or another will enjoin Trump on the merits by or before then. Lovely. Here's a bit, from the 11 page PDF, just filed:

. . . .As it happens, the plaintiffs here agree that it would be sensible at this particular juncture for the district court to temporarily stay its orders requiring completion and filing of the administrative record by November 22, although not in exactly the manner sought by defendants. Plaintiffs’ motion for a preliminary injunction and defendants’ motion to dismiss are now pending in the district court, and will be fully briefed and argued by December 20. A temporary stay until after the district court rules on those motions would allow the parties to focus on the most immediate issue of whether defendants’ decision to rescind DACA should be enjoined from taking effect while this litigation proceeds. The district court’s ruling on those motions could also either moot or clarify some of the arguments proffered by defendants in support of the extraordinary interlocutory relief that defendants sought from this Court and have now indicated they otherwise intend to pursue immediately in the Supreme Court. A temporary stay would perhaps also obviate any perceived need for defendants to further multiply proceedings in this case.

For all these reasons, on November 19 (Saturday) plaintiffs themselves (the kids!) filed a motion in the district court seeking a stay tailored to the circumstances of this case. See D.Ct. Dkt. No. 190. This morning, the district court issued a tentative order that would delay defendants’ obligation to file the augmented administrative record and stay discovery until December 22, two days after the scheduled hearing on plaintiffs’ motion for preliminary injunction and defendants’ motion to dismiss. . . .


Gentle readers: this is what it looks like -- when one side is so far ahead on the merits, in important litigation: they (the kids) turn their cards all face up -- and offer to be. . . kind. It clearly illuminates just how preposterous Trump's lawyers are being. And I love this style -- both economical, and devastating, all in one. Well-done!

[45's lawyers will have their say, later this evening -- such as it is. I'll post it late tonight -- here it is. YAWN. That's some weak sauce, indeed. Smile.] 11.21.2017 -- 8 PM EST: Told ya'. Here is the Court's order.

नमस्ते

नमस्ते

I Still Think There Will Be No Tax Package In 2017 -- Or 2018 -- Until After The Mid-Terms...


. . .But on the small chance that 45 signs some ill-starred, and mean spirited piece of legislation that takes from the middle class, in order to increase tax breaks on private jets, and repeals the estate tax for the wealthiest one-one-hundredth of one per cent of all Americans, as well as vastly benefits his real estate driven empire. . . I will commend this piece in The Atlantic to the readership.

Do go read it all -- it correctly argues that even if a bill is signed into law, most sensible corporations will not change their longer term plans, on a measure they well-know may be repealed or greatly scaled back -- come midterms in late 2018. That is only one year away. Corporate strategists at the tax line think in longer terms. Frum is right -- do go read it all, but here is the concluding bit:

. . . .A rationally conservative party of business and enterprise could, and should, have written a corporate tax reform compelling on the merits. The slowdown of U.S. productivity growth would be the country’s leading problem if U.S. constitutional democracy were not being attacked from the White House at the same time. The GOP submitted to Trump in 2016 very largely to reach this moment. The ironic outcome is that his success that year doomed the very prize for which his party sold its soul. . . .


Indeed -- succinctly, and perfectly put. [After the holiday, in a look across the pond, as it were -- I plan to update the thinking here, on the likely now increasing delays, looming over any Brexit. As I long said, it may end up being almost. . . nothing. The weekend walkout -- on Merkel's latest, coupled to May's troubles -- may mean 2020 or later for any soft Brexit.]

Now. . . as more and more of my usually-geographically-scattered family arrives, I will grow increasingly silent here -- until mid next week, in all likelihood. Be excellent to those you love -- so much to give thanks for, here. Smile.

नमस्ते

Sunday, November 19, 2017

[U] The Trump DACA Defendants In Northern California May Seek USSCt Review Of Thursday's Order...


UPDATED: Monday Morning -- I should have mentioned late last night how unusual the ending of the below order, in blue is. I laughed out loud when I read it (but then promptly forgot to mention it!), for you see, it takes the extraordinary step of pointing the US Solicitor General. . . to the existing law (for it seems he is unaware of it). In the case the court mentions by name -- the Ellis case, the appellate court held that a stay of a denial of mandamus is properly to be addressed in the court in which it was entered, or the trial court -- in this case. Or, as the court points out -- by application for a writ of cert., to the Supremes, directly. Hilarious. The Ninth Circuit is teaching what amounts to rudimentary, basic federal procedural law to Trump's Solicitor General (which tells you something about the calibre of his Administration). These are fascinating -- if sort of sad -- times. [End, updated portion.]

Should Trump's lawyers do so, it will likely be a vain act. Here is our coverage -- from Friday, of last Thursday's order.

The standard of review at the Supremes would be "was the District Court's order (asking for production of more than 14 documents -- 11 of them published court opinions -- to explain a major change in policy) clearly erroneous?"

Unless it was clearly erroneous, the Supremes will let the Ninth Circuit order stand, and the trial level court in San Francisco will order Trump to provide documents from the dozens of other officials who -- in press interviews -- indicated that they too had a role in making these decisions -- including Trump himself. He personally turned over zero documents, yet he took credit for making the change. We must hold people in power to the standards of the law as it exists -- otherwise we are. . . Russia.

Here is the Saturday afternoon order -- with briefs due by Monday afternoon, Eastern time.

. . . .The court has received the government’s November 17, 2017 emergency stay motion. The response to the motion is due Monday, November 20, 2017, at 12:00 p.m. PST, and the optional reply is due Monday, November 20, 2017, at 5:00 p.m. PST. . . .

In addition to all other issues the parties wish to raise in the response and reply, the parties shall address whether this court has jurisdiction to grant a stay of proceedings, or whether the motion for a stay should instead be filed in the district court. See Ellis v. U.S. Dist. Court, 360 F.3d 1022 (9th Cir. 2004) (en banc). . . .


Now you know. I hope the new week brings. . . a newly joyful "magic carpet ride's" attitude -- to all those who travel in good will, toward this holiday of gratitude. Smile.

नमस्ते

Friday, November 17, 2017

Ninth Circuit: Trump Administration Simply MUST "Comply With The Law" -- In California DACA Case


At the head -- I've been watching this piece of litigation, since it quite closely tracks one I'm involved in here in the federal courts in Chicago. But I've not reported on it until today. Out west, it has reached the Ninth Circuit on appeal, and has now articulated anew the unsurprising principle that Mr. Trump must comply with existing law.

Mr. Trump has claimed the right to end DACA without showing all the documents his administration relied upon to make a change in policy that impacts 800,000 Americans directly. He offered only 14 documents, totaling 256 pages of previously public materials. All but about 60 of those pages were court opinions. That sort of opacity is most usually seen in. . . tyranical oligarchies (Cough. Russia).

By way of contrast, here we are a government "of the people, for the people, and by the people. . . ." So the Judicial Branch has effectively told him to obey the law, on transparency, and separation of powers doctrines -- and thus to explain the real basis (as opposed to his odious political subterfuge) for his decision.

That an appellate level federal court must spend 18 pages and much research, crafting a formal written and published opinion of law, and has wasted oral argument time, as well as the plaintiffs' (and the taxpayers' money and time) on legal fees. . . all to reiterate what has been clear law for nearly 75 years, is -- well. . . astonishing. But that is Trump -- and here is a bit of the decision:

. . .At the initial case management conference before the district court, the government agreed to produce the complete administrative record on October 6, 2017. On that date, the government submitted as “the” administrative record fourteen documents comprising a mere 256 pages, all of which are publicly available on the internet. Indeed, all of the documents in the government’s proffered record had previously been included in filings in the district court in this case, and 192 of its 256 pages consist of the Supreme Court, Fifth Circuit, and district court opinions in the Texas v. United States litigation. . . .

Faced with this sparse record, and on the plaintiffs’ motion (opposed by the government), the district court ordered the government to complete the record to include, among other things, all DACA-related materials considered by subordinates or other government personnel who then provided written or verbal input directly to Acting Secretary Duke. The district court excluded from the record documents that it determined in camera are protected by privilege. . . .

Put bluntly, the notion that the head of a United States agency would decide to terminate a program giving legal protections to roughly 800,000 people based solely on 256 pages of publicly available documents is not credible, as the district court concluded. . . .

The district court identified several specific categories of materials that were likely considered by the Acting Secretary or those advising her, but which were not included in the government’s proffered record. For example, the record contains no materials from the Department of Justice or the White House—other than a one-page letter from Attorney General Jefferson B. Sessions—despite evidence that both bodies were involved in the decision to end DACA, including the President’s own press release taking credit for the decision. . . . Nor does the proffered record include any documents from Acting Secretary Duke’s subordinates; we agree with the district court that “it strains credulity” to suggest that the Acting Secretary decided to terminate DACA “without consulting one advisor or subordinate within DHS. . . .”  And the proffered record contains no materials addressing the change of position between February 2017—when then-Secretary John Kelly affirmatively decided not to end DACA—and Acting Secretary Duke’s September 2017 decision to do the exact opposite, despite the principle that reasoned agency decision-making “ordinarily demand[s] that [the agency] display awareness that it is changing position” and “show that there are good reasons for the new policy.” FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009).

At oral argument, the government took the position that because the Acting Secretary’s stated justification for her decision was litigation risk, materials unrelated to litigation risk need not be included in the administrative record. Simply put, this is not what the law dictates. The administrative record consists of all materials “considered by agency decision-makers,” Thompson, 885 F.2d at 555 (emphasis added), not just those which support or form the basis for the agency’s ultimate decision. See also, e.g., Amfac Resorts, LLC v. U.S. Dep’t of Interior, 143 F. Supp. 2d 7, 12 (D.D.C. 2001) (“[A] complete administrative record should include all materials that ‘might have influenced the agency’s decision,’ and not merely those on which the agency relied in its final decision.”) (quoting Bethlehem Steel v. EPA, 638 F.2d 994, 1000 (7th Cir. 1980)). . . . 

The district court’s decision to require a privilege log and evaluate claims of privilege on an individual basis before including documents in the record was not clearly erroneous as a matter of law. . . .


Now you know. Onward, in the district court in San Francisco, for discovery, and then back to the Ninth Circuit -- to a likely 45 loss, on the merits on its revocation, in the DACA decision. Sunny and crisp and cool here -- a great Friday shaping up, overall -- with my baby girl due in this weekend. Smile.

नमस्ते

Thursday, November 16, 2017

In Which Merck Pays A T-Cell R&D Upfront Fee: To Tiny Cue Biopharma; Full Financial Terms Not Disclosed


It seems today was a day for announced dealmaking, in the longer term developmental space, for Kenilworth.

Of course, Merck itself would never announce something this small -- but it has given permission to Cue to do so. The vote of confidence is immensely helpful to smaller outfits like Cue -- in future collaboration and fund-raising efforts.

[Like this morning's Spero announcement, Cue is headquartered in Cambridge Massachusetts, as well.] This pull quote below is from the presser -- and I'd personally bet that the upfront was less than $10 million. To get to a third of a billion dollars in payments from Kenilworth, Cue will have to deliver on all research milestones -- but that is the way all smart deals of this kind are now done:

. . . .Cue Biopharma, an immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer and autoimmune diseases, today announced a strategic research collaboration and license agreement with Merck, known as MSD outside of the United States and Canada. Under the terms of the deal, the CUE Biologics™ platform will be leveraged to develop biologics engineered to selectively modulate disease-relevant T cell subsets for the treatment of autoimmune disease. The multi-year collaboration will encompass multiple disease targets across certain primary disease indication areas. . . .

While specific financial arrangements are not being disclosed, Cue Biopharma will receive an up-front payment. Cue Biopharma is also eligible to earn up to $374 million in research, development, regulatory and commercial milestone payments in addition to tiered royalties on sales, if all pre-specified milestones associated with multiple products across the primary disease indication areas are achieved. . . .


Now you know -- with some more, of a "look back" set of tunes -- on the repeat button. . . smile. Onward. Ever, onward. Never buckle; never fall. . . onward.

नमस्ते

Spero Therapeutics Sports Some Heavy-Hitters -- As Major Shareholders: IPO Follow-Up


Obviously, Merck's research arm has invested through a fund because the burgeoning pipeline of Spero dovetails with its much earlier acquisition of Cubicin, and the Gram negative antibacterial products previously developed by the former Cubist Pharmaceuticals.

It is also true that Cubicin is under pressure due to generic manufacturers seizing on prior patent maneuvers, to bring a copycat to market.

So this "informational" 5 per centers' pipeline is likely a toe-hold to picking up additional anti-infectives, for Kenilworth -- and keeps it even with GSK and Google's Alphabet in the "pipeline info" wars. Do go see the whole run-down here -- but you'll need to read the footnotes, to that table on page 162, to figure out that the holders listed there are actually investment vehicles/funds controlled by Glaxo, Merck and Google's Alphabet, respectively.

Quite an array of the "Masters of the (Anti-Bacterials) Universe", that. I'll close by listing just a bit of what the able team at Spero is chasing:

. . . .We are a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant bacterial infections. Our most advanced product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat multi-drug resistant, or MDR, Gram-negative infections. Treatment with effective orally administrable antibiotics may prevent hospitalizations for serious infections and enable earlier, more convenient and cost-effective treatment of patients after hospitalization.

We also have a platform technology known as our Potentiator Platform that we believe will enable us to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Our lead product candidates generated from our Potentiator Platform are two intravenous, or IV,-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting. In addition, we are developing SPR720, an oral antibiotic designed for the treatment of pulmonary non-tuberculous mycobacterial infections. We believe that our novel product candidates, if successfully developed and approved, would have a meaningful patient impact and significant commercial applications for the treatment of MDR infections in both the community and hospital settings. . . .


The IPO priced on November 1, and Merck filed an SEC Form 13G last night. Now you know -- for my part, I grow excited to have my goofy, vibrant, successful adult children home for the holidays, starting this weekend. Smile -- ever Macy Gray "I Try". . . onward.

नमस्ते

UPDATING 11.16.17: Most Direct Marburg Viral Contacts Will Clear The 21 Day Observation Period At Midnight, Local -- In Kenya And Uganda


We will hold our breath until after midnight in New York -- in the hope that all of Kenya and Uganda reach an "all-clear" (the expiration of a 21 day observation period) -- as to the recent Marburg virus outbreak.

Here is the November 15, 2017 update, from WHO in full -- and just a little bit of it (detailing the method of transmission into Kenya):

. . . .Prior to his death, the second confirmed case travelled to Kenya where he visited his relatives in West Pokot County, as well as a traditional healer in Trans Nzoia County. On 29 October 2017, the Ugandan MoH notified WHO and the Kenyan MoH of these high-risk contacts. The traditional healer tested negative for Marburg virus disease on repeated blood specimen analyses performed at the Kenyan Medical Research Institute (KEMRI) in Nairobi. She and her family were monitored for 21 days. The two relatives from West Pokot, as well as other contacts in the same county, also completed their 21 days of follow up.

Active case search, death surveillance, safe and dignified burials and community mobilization are ongoing in Kween and Kapchorwa districts. In Uganda, of the 339 contacts listed, 283 have completed 21 days of follow-up and 56 are still being monitored. Contact follow-up is ongoing in Kween for the 56 contacts, while In Kapchorwa District, all the listed contacts have completed the 21 days follow-up period. All remaining contacts are expected to complete 21 days of follow up on 16 November 2017. Enhanced surveillance activities will continue until 7 December 2017. . . .


Now we watch, and wait. And listen to Ms. Chanté Moore in the mean time, to keep our spirits up -- sleep well, one and all:



नमस्ते

Wednesday, November 15, 2017

Will Kenilworth's $300+ Million Bet -- On Moderna's Still-In-Vitro mRNA Approach -- Pay Off?


This morning, Bloomberg has a nicely-boosterish longer story out on Moderna Therapeutics -- the privately held Cambridge company, in which Merck has made substantial early investments. Here by way of reminders, are our January 2015, and June 2016 -- backgrounders on this relationship.

Indeed, assuming the "render time" may be reliably-reduced to three or four weeks, it is hard not to be excited about designing personal cancer vaccines. But, as ever, price -- and thus access -- will be significant hurdles. Here's a bit -- from the Bloomberg "first dosing" story; do go read it all:

. . . .Six weeks ago, a 1-millimeter cube of cancer tissue collected by doctors from the right lung of 67-year-old retiree Glenda Cleaver was packed in a box at the Sarah Cannon Research Institute in Nashville, Tennessee. It was the beginning of a journey Moderna hopes will lead to a long-sought goal: a vaccine that trains the body to attack tumors. . . .

Swathed in cooling gel packs to keep it at 5 degrees Celsius, Cleaver’s tissue was sent with a second box containing a four-inch vial of Cleaver’s frozen blood to Kentucky, where it was entered into a tracking system. From there, the samples were shipped to a facility on the West Coast where machines scanned the tumor’s genetic code and compared it to the blood, hunting for the malevolent changes that spawned Cleaver’s cancer.

On Monday, Cleaver, the first person to be enrolled in Moderna’s study of its personalized cancer vaccine, returned to Sarah Cannon, where another FedEx box waited. It contained a vial no larger than Cleaver’s palm. It took about 100 people to make and will work for only one person -- her. . . .

Traditional protein-based biotechnology medicines are grown in vats and harvested from living organisms, a tedious and expensive process. The company wants to make it possible for a patient’s body to make its own medicine using strands of genetic instructions called messenger RNA, or mRNA. . . .


So it goes. Personally, I expect that this investment will prove to be one of Merck's most prescient.

Below, an anonymous commenter offered this fine life-affirming Macy Gray track, as a pick me up (in reply to my masthead revisions, overnight). In call and response fashion, and echoing that, I'll offer this one. Truly, there is so, so much joy in my world. . . full of. . . new life. But also in truth, this other Macy Gray still follows me, even all these years on, on a rainy cool Tuesday here (yes -- now you know):



Yes, now you know -- I try to play it off. . . .

नमस्ते

Tuesday, November 14, 2017

African Marburg Viral Outbreak 2017: Now In Northwest Kenya, As Well As Northeast Uganda...


It turns out that a close contact of the index case, apparently while sick with fever, journeyed into the remote mountainous reaches of northwestern Kenya -- West Pokot district. So WHO first response teams, and local health authorities are now deployed into mountainous Kenya as well.

As is true with the cases inside Uganda, reaching the affected populations is nearly half the challenge, as few passable roadways exist, in the districts. This is beautifully rugged, but truly untamed, and mountainous rural central Africa. [Our prior reporting on the outbreak began here.]

Here is the latest, which is in fact a week stale, from WHO first responders, on the ground, in Uganda -- and now Kenya:

. . . .Contact tracing and active case search is ongoing in Kween in Kapchorwa district in Uganda, as well as in Kitale district and West Pokot in Kenya. On 4 November a high risk contact of the second confirmed case, a health care worker in Kween developed symptoms and was admitted to the treatment facility in Kween. Additionally, one close contact of the second confirmed case has been reported to have travelled to Kampala. The Kampala City Authority has sent a team to the village she is reported to be visiting to trace this contact and continue 21 days follow-up. . . .

[Earlier reporting. . .] Contact tracing and follow-up activities have been initiated. As of 23 October, 155 contacts including 66 who had contact with the first case and 89 who had contact with the second case. . . have been listed in the two affected districts,including 44 health care workers. The number of family and community contacts is still being investigated. . . .


These outbreaks are particularly vexing, as they represent a near 100 per cent lethal threat -- and no vaccine candidate yet exists for Marburg virus. That must change, and change immediately. Now you know -- and I'm back from the near dead (or at least the desert southwest), myself. . . smile.

नमस्ते

Thursday, November 9, 2017

Letermovir Wins FDA Approval -- Smallish But Steady Market Seen


Kenilworth will brand the drug as PrevymisTM. It should reach $350 million in sales by 2020; we have been following its development and testing since mid-October of 2012.

From ABC News then -- a bit:

. . . .The Food and Drug Administration on Wednesday approved sales of Merck and Co.'s Prevymix (PREH'-vih-miss) to prevent infections with cytomegalovirus (sy-toe-MEG'-a-low-vy-rus), a common virus. It doesn't sicken most people, but strikes at least half of transplant patients, who are particularly vulnerable to infection. The virus can damage the eyes, lungs and other organs, trigger pneumonia and even kill.

Kenilworth, New Jersey-based Merck says the drug will cost $195 to $270 per day for 100 days. . . .


[Ahem. This is an automated post -- no human reviewed it. Errors appearing between these sheets (and I am sure there were/are some) here, will be corrected when the author is back on-line.]

नमस्ते

Wednesday, November 8, 2017

Update On Propecia®/Proscar® Litigation -- 415 Fewer Cases Pending At End Of Q3 2017, Compared To Year End 2016


The current tally of 915 individual US lawsuits is down from 1,330 as of year end 2016 -- quite a significant decline.

It is not at all clear whether Merck is settling with the more meritorious ones, any more than it is clear that these are largely (and simply) people abandoning their claims (i.e., likely the weaker ones). In any event, both the federal MDL and the NJ state MCL look to be on track for March 2018 and April 2018 bellwether trial dates, respectively. See the full SEC filing, beginning at page 18, for the rest of the updates. [If you are so inclined, you may also read the updates on other litigation, inculding one on the Fosamax® federal femur fracture MDL (beginning on page 16).]

. . . .Merck is a defendant in product liability lawsuits in the United States involving Propecia and/or Proscar. As of September 30, 2017, approximately 915 lawsuits have been filed by plaintiffs who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar. Approximately 20 of the plaintiffs also allege that Propecia or Proscar has caused or can cause prostate cancer, testicular cancer or male breast cancer. The lawsuits have been filed in various federal courts and in state court in New Jersey.

The federal lawsuits have been consolidated for pretrial purposes in a federal multidistrict litigation before Judge Brian Cogan of the Eastern District of New York. The matters pending in state court in New Jersey have been consolidated before Judge Hyland in Middlesex County. In addition, there is one matter pending in state court in California, one matter pending in state court in Ohio, and one matter on appeal in the Massachusetts Supreme Judicial Court.

The Company intends to defend against these lawsuits. . . .


Now you know. And now. . . I am off-grid, until Tuesday in all likelihood -- keep it spinning in good karma, one and all!

नमस्ते

Tuesday, November 7, 2017

Merck Provides An Update In SEC Filing -- On Hurricane Maria's Aftermath; And Cyber-Attack Remediation Progress...


After the NYSE close tonight, Kenilworth filed its SEC Form 10-Q for the third quarter of 2017.

In it, at page 28, we get more granular detail on the NotPetya attack's effects (now likely to continue through all of 2018), and on the aftermath of Hurricane Maria's direct strike on the island of Puerto Rico (and Merck's one plant there), thus:

. . . .Cyber-attack

On June 27, 2017, the Company experienced a network cyber-attack that led to a disruption of its worldwide operations, including manufacturing, research and sales operations. Most of the Company’s manufacturing sites are now largely operational, manufacturing active pharmaceutical ingredient (API), formulating, packaging and shipping product. The Company’s external manufacturing was not impacted. Throughout this time, Merck has continued to fulfill orders and ship product.

The Company is confident in the continuous supply of key products such as Keytruda, Januvia (sitagliptin) and Zepatier (elbasvir and grazoprevir). However, as anticipated, the Company was unable to fulfill orders for certain other products in certain markets, which had an unfavorable effect on sales for the third quarter and first nine months of 2017 of approximately $135 million. In addition, the Company recorded manufacturing-related expenses, primarily unfavorable manufacturing variances, in Materials and Production costs, as well as expenses related to remediation efforts in Marketing and Administrative expenses and Research and Development expenses, which aggregated $175 million for the third quarter and first nine months of 2017. The Company anticipates a similar impact to revenue and expenses in the fourth quarter of 2017 and for the full year of 2018 from the cyber-attack. Additionally, the temporary production shut-down from the cyber-attack contributed to the Company’s inability to meet higher than expected demand for Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), which resulted in Merck’s decision to borrow doses of Gardasil 9 from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile, reducing sales as discussed below. Merck does not expect a significant impairment to the value of intangible assets related to marketed products or inventories as a result of the cyber-attack.

The Company has insurance coverage insuring against costs resulting from cyber-attacks. However, there may be disputes with the insurers about the availability of the insurance coverage for claims related to this incident.

Hurricane Maria

In September 2017, Hurricane Maria made direct landfall on Puerto Rico. The Company has one plant in Puerto Rico that makes a limited number of its pharmaceutical products, and the Company also works with contract manufacturers on the island. Merck’s plant did not sustain substantial damage, and production activities at the plant have resumed, although the operations at the plant are currently reliant on alternative sources of power and water. The Company is making progress despite the significant damage to the island’s infrastructure; however, supply chains within Puerto Rico are not yet restored. Based on Merck’s current assessment, the Company expects an immaterial impact to sales in 2017 and 2018. . . .


Now you know. . . and onward, headed for points west, through Tuesday. Be excellent to one another; and. . . I can't resist: 45 just made a bad night for the GOP much worse. Smile.

नमस्ते

[U] Marburg: An Ebola-Like Threat Sees A Viral Revival -- In Remote Mountainous Uganda...


UPDATED: 11.16.2017 @ 2 PM EST -- Per the WHO reports, seems that all relevant 21 day observation periods have elapsed in both Uganda and Kenya, without any new live cases of Marburg. Thus the Fall 2017 acute phase of the African Marburg outbreak may now be declared over. That is decidedly good news. Vigilance efforts will continue in country however, with local health ministries. [End, updated portion.]

In many ways, the dread (but lesser-known) Marburg virus mimics Ebola. The symptoms are similar -- and it is every bit as lethal, if it gets free, into a human population.

But in one important way, Marburg's differs: there is no vaccine candidate -- and there is no known cure.

And so it is especially critical to keep the occasional outbreaks contained, localized, and minimized. Tamped down. That is about all the Ugandan health ministers, and the WHO can hope for, at the moment. [It is well past time to find a suitable biological container for a killed Marburg viral load, and try that as a vaccine candidate. Much the same -- as to Ebola, was a life-sciences accomplishment, in the 2013 to 2014 timeframe (by the Health Ministry of Canada using a simian container, and later NewLink Genetics and Merck, working together) to arrest that virus.]

Here is the news, from about a week ago, at
WHO (and just a bit from that comprehensive updating press release):

. . . .[T]he Ugandan Ministry of Health notified WHO of a confirmed outbreak of Marburg virus disease in Kween District, Eastern Uganda. The Ministry for Health officially declared the outbreak on 19 October 2017.

As of 24 October, five cases have been reported – one confirmed case, one probable case with an epidemiological link to the confirmed case, and three suspected cases including two health workers. . . .

Two health workers who were in contact with the confirmed case have developed symptoms consistent with Marburg virus disease and are under investigation (suspected cases). Laboratory results to rule out Marburg virus disease are pending.

Contact tracing and follow-up activities have been initiated. As of 23 October, 155 contacts including 66 who had contact with the first case and 89 who had contact with the second case-patient have been listed in the two affected districts, including 44 health care workers. The number of family and community contacts is still being investigated. . . .


We will, as ever, keep an weather eye on this one. Onward, then -- on a cool, gray Tuesday mid-morning -- headed to the warm sunny western US, come early Thursday -- off grid then until Monday night. Be well one and all.

नमस्ते

Monday, November 6, 2017

[U] Some Pretty Wise Blue-Chip Corporate Finance People Believe US Interest Rates Are Headed North, And Soon...


UPDATED: After a great comment from long time reader Billy the Kid, on the backup site. . . I had this thought, about the additional implications of this debt tender: "One other twist on it might be that Merck's finance folks are essentially throwing in the towel on an outright foreign retained earnings repatriation tax "holiday" (and perhaps, on Trump's tax package overall, at least before 2018 mid-term elections). . .

This move will not rely on any change in tax law -- to be profitable -- for Kenilworth.

Put that in your pipe and smoke it, 45. . . .
" [End, updated portion -- With a holla-back to Dante, on the backup, at 9:07 last night! Smile.]

The corporate treasury folk under Rob Davis in Kenilworth have launched a tender offer for up to eight separate tranches of longer term Merck unsecured debt obligations, today. They must assume we are reaching the bottom of the near term yield curve.

All the debt being taken out under today's offer (and likely refinanced -- or being paid off -- with some of the $70 billion in foreign trapped cash we've long discussed -- in a tax efficient manner) shows coupon-rates ranging from 5.75% to 6.55%.

In sum, Merck is offering to buy back this higher interest rate denominated debt, and effectively swap it out for lower coupon, similar maturities, now that current prevailing interest rates of like kind are well below (like a half to a third cheaper than) these older coupons. Or just retire it with a structured EU to US swap out of cash (in a tax efficient manner), using that parked cash over there. But my hunch is that the company is likely to want to keep its leverage about where it is -- in terms of capital structure -- so the treasury people are (in my humble estimation) likely to ultimately layer in more new debt of like maturities, between now and the end of Q1 2018.

The most likely reason a company of Merck's size would pull the trigger on this deal now, is to take advantage of what it sees at the bottom of the market, on interest rates. In sum, Merck expects that interest rates on similar grade corporate debt are going to increase, over the near term. So hop on it -- and be unafraid to pay up to $1.40 per $1.00 of debt redeemed, to get it all in -- and then push it back out, at half the current coupon rates.

Even on as much as $2,900,000,000 (that's $2.9 billion) in retired debt, Merck will save a bundle over the life of these notes, if the company is right that 45's ham-handed moves at the Fed are signaling a likely rate hike.

Me? I think the company is right -- rates will rise, and soon -- so this is a very savvy move.

Now I'm out (not much in the mood for trivial capitalist banter, on such a bone-chilling day) -- after all the senseless carnage in Texas. . . . Killing 26, in an escalated family squabble, whilst they are at worship? As many as half of them children? That is wantonly evil -- as well (I am sure) as clear evidence of deeply seated (and apparently long-standing) emotional illnesses. I am largely reeling, that the GOP and Trump are so stubbornly resisting trying to do anything about the 649 dead and injured Americans, just since he took office -- directly caused by automatic assault style human killing weapons, high capacity magazines, and bump-stock accelerators.

That too. . . is evil -- in my estimation. Falling silent now.

नमस्ते

In Need Of "Lego" Galileo -- On This Sad Dawn... We Sorely Need Some Good Ju Ju...


Eight members of one family -- including a mom who was five months pregnant -- gone. At least 26 snuffed out, and 20 more injured overall -- all this, while attending Sunday church services. The headlines are almost too much to bear.

And a President who tweets that laws related to easy access to assault weapons. . . aren't the issue, in his view.

He is right that the man was mentally ill. But so was the shooter in Las Vegas; and in Plano; and in Antioch; and in Orlando; and in Dallas; San Bernardino; Charleston; Chatanooga; Colorado Springs; Sandy Hook; Columbine, and on and on and on. . . . Giving mentally-ill people easy access to bump stock enabled, fully automatic assault rifles (for which the ONLY purpose is killing large numbers of human beings quickly). . . is lunacy. What is disgusting about these events is not their horrific details, but rather. . . their increasingly-mundane regularity. Their predictability. They are becoming a new "normal" -- every few months, ever since a pro-gun-lobby administration was handed the reins of power in America. And that is. . . sickening.

But regular readers know that is my view, already.

And so, I'll let the grimly-updated numbers on the masthead speak to the carnage -- just on Mr. Trump's watch -- from such weapons. And I will choose to look away, for a moment -- to a brighter side -- of our planet's ongoing scientific efforts.

As luminous dawn starts to arrive, post daylight savings time, I'll spend the rest of these electrons mentioning that right on schedule, just as Jupiter and Earth fell out of a Galileo predicted obscuring alignment with the Sun, relative to one another, sweet copper-legged twisty lil' Juno began to beam back her data. She reached out and phoned in -- to let all the hard-working people who care about her know that her birthday glide had passed well, and their faith in her sweetly sublime Galilean orbital science. . . was not in vain. [These same little Lego figures (at right) are all actually onboard, inside the shepherded satellite/moonlet we call Juno -- sprinting through the darkness, as I type this. And that makes me smile -- as does all that transpired in my extended family this past weekend. . . .]

You see -- Juno, she reaffirms (for me) that working together, and thinking nobly, we humans can do some pretty amazing things. Working together, and respecting each others' differences, we can be (as Kid President so aptly says) "pretty awesome".

I would hope that GOP leaders in Congress (with or without 45) would decide that it would be "pretty awesome" to stop making it so easy for mentally-ill criminals to get fully automatic weapons. There are no easy answers -- and no one measure will solve this long-vexing problem in America, but it is hard to see a crying need for people to own these kinds of weapons -- ones useful only in ground combat, in a theater of war, on a battlefield -- between humans.

We should be "gooder" than that. Thanks, Kid President.

नमस्ते

Saturday, November 4, 2017

Much Of Note Happened This Day -- In History...


In 1959, as well as in 1979 -- and in many many prior years. . . much of note happened. But for me, on this cool rainy Saturday morning -- the early evening hours of 2008, an unseasonably perfect and warm fourth of November evening in Grant Park -- will always stand out.

I'll hush -- and let our 44th President do the rest (we miss you, man!):

. . . .[T]onight, because of what we did on this day, in this election, at this defining moment, change has come to America. . . . The road ahead will be long, our climb will be steep. We may not get there in one year, or even in one term — but America, I have never been more hopeful than I am tonight that we will get there. . . .

As Lincoln said to a nation far more divided than ours, we are not enemies but friends. Though passion may have strained, it must not break our bonds of affection. . . .

Even as we stand here tonight, we know there are brave Americans waking up in the deserts of Iraq and the mountains of Afghanistan to risk their lives for us. There are mothers and fathers who will lie awake after the children fall asleep and wonder how they'll make the mortgage or pay their doctors' bills or save enough for their child's college education. . . .

To those — to those who would tear the world down: We will defeat you. To those who seek peace and security: We support you. And to all those who have wondered if America's beacon still burns as bright: Tonight we proved once more that the true strength of our nation comes not from the might of our arms or the scale of our wealth, but from the enduring power of our ideals: democracy, liberty, opportunity and unyielding hope. . . .

This is our time, to put our people back to work and open doors of opportunity for our kids; to restore prosperity and promote the cause of peace; to reclaim the American dream and reaffirm that fundamental truth, that, out of many, we are one; that while we breathe, we hope. . . .

And where we are met with cynicism and doubts and those who tell us that we can't, we will respond with that timeless creed that sums up the spirit of a people: Yes, we can. . . .


It seems so long ago, now -- and yet, as though it were only yesterday.

So we do celebrate this day for a host of reasons -- and we will continue to do so, for the rest of our lives. It is in fact, as though we are carrying a torch -- in the mostly dark and dangerous night, of this moment. . . a torch of. . . hope. . . . for the arc of history to once again bend toward. . . progress.

So. Don't. Give. Up. On. Me. That's what this moment is all about:







नमस्ते

Friday, November 3, 2017

[U] Under Friday Night Lights: Injured Plaintiff States (As Amici) Weigh In On Muslim Ban 3.0 -- In Seattle...


Here are those 47 pages -- a worthy read, indeed. Here's an excerpt -- one that bodes ill, for our nation maintaining a leadership role -- in the curating and advancing all those fast breaking innovations now underway in all the hard sciences -- as the future arrives on our doorstep (without even so much as a whiff of Mr. Trump's comprehension, or appreciation. . . of any of it), and then heads up to Canada:

. . . .Graduate departments in science and engineering have reported that “international student applications for many programs declined by 20 to 30 percent for 2017 programs.” Additionally, 80 percent of college registrars and admissions officials surveyed have serious concerns about their future application yields from international students. And 46 percent of graduate deans have reported “substantial” declines in admission yields for international students.

Not surprisingly, countries that are perceived as more welcoming -- such as Canada, the United Kingdom, Australia, and New Zealand -- have already seen a jump in applications in this same time period. This drain of highly qualified student talent will continue under the Proclamation. . . .


Top tier talent knows no geopolitical boundaries. Do enjoy the bedtime reading -- and see 45, for what he really is -- at base. For the sake of a complete record, here is 45's opening brief, filed late Friday night.

नमस्ते

Thursday, November 2, 2017

76 Years Ago, Tonight: The Most Widely Reprinted Fine Art B&W Photo In History Was Taken...


A diversion, from all the awful news -- if I may -- this morning. . . . just so much I'd like to forget, from just the last few days. . . .

An aside, then: my grandfather (with only an eighth grade formal education, in parochial school) was, most agree, a quite accomplished artist -- in the avocation then known as black and white photography and printing -- in the earlier half of the 20th century . So much so, that some of his freelance work appeared in newspapers of record, about events of the day, in both Denver and New York. But his landscapes of the Sawatch range, many at night, under moonlight -- are small painterly wonders to behold. [His second son, and my sister (and some of my brothers) also have this same gift of chemistry and composition. I on the other hand can lay no such claim.]

So it is that I hold a very fond place in my heart for the image at right (taken in the same years my grandfather was doing much the same), along those same majestic Rockies, but further south, and by a man whose name would become synonymous with the natural beauty of the American West, in the mid-century. All rendered in muscular half-tone grays. It was 76 years ago tonight that he shot perhaps his most iconic -- and certainly his most financially rewarding -- image (per Wikipedia):

. . . .On a trip in New Mexico in 1941, Adams shot a scene of the Moon rising above a modest village with snow-covered mountains in the background, under a dominating black sky. The photograph became one of the most famous black and white prints in history, and is named "Moonrise, Hernandez, New Mexico."

Adams's description in his later books of how it was made probably enhanced the photograph's fame: the light on the crosses in the foreground was rapidly fading, and he could not find his exposure meter; however, he remembered the luminance of the Moon and used it to calculate the proper exposure. . . .

The initial publication of Moonrise was in U.S. Camera 1943 annual, after being selected by the "photo judge" for U.S. Camera, Edward Steichen. This gave Moonrise an audience before its first formal exhibition at the Museum of Modern Art in 1944. Over nearly 40 years, Adams re-interpreted the image, his most popular by far, using the latest darkroom equipment at his disposal, making over 1,300 unique prints, most in 16″ by 20″ format. Many of the prints were made in the 1970s, finally giving Adams financial independence from commercial projects. The total value of these original prints exceeds $25,000,000; the highest price paid for a single print of Moonrise reached $609,600 at Sotheby's New York auction in 2006. . . .


Now you know. Onward, on a very gray scaled November morning here in the city of big shoulders. . . but with a smile facing in a southerly and easterly direction. Court this afternoon. Grin.

नमस्ते