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

November 20, 2017 - Leave a Response

. . .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signed into law, most sensible corporations will not change their longer term plans, on a measure they well-know may be repealed or greatly scaled back — come midterms in late 2018.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.



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

November 19, 2017 - Leave a Response

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 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.


Ninth Circuit: Trump Administration Simply MUST “Comply With The Law” — In California DACA Case

November 17, 2017 - Leave a Response

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 256 pages of previously public materials. 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.


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

November 16, 2017 - Leave a Response

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.


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

November 16, 2017 - Leave a Response

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 capable 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.


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

November 16, 2017 - Leave a Response

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 upsleep well, one and all:


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

November 15, 2017 - Leave a Response

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.

On the main site, an anonymous commenter offered this fine life-affirming Macy Gray track, as a pick me up (in reply to my masthead edits, 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. . . .


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

November 14, 2017 - Leave a Response

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.


Letermovir Wins FDA Approval — Smallish But Steady Market Seen

November 9, 2017 - Leave a Response

Kenilworth will brand the drug as PrevymisTM. It should reach $350 million in annual 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 Admin- istration 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.]


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

November 8, 2017 - Leave a Response

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!