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.]

नमस्ते

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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!

नमस्ते

Merck Provides An Update In SEC Filing — On Hurricane Maria’s Aftermath; And Cyber-Attack Remediation Progress…

November 7, 2017 - Leave a Response

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…

November 7, 2017 - Leave a Response

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

Some Pretty Wise Blue-Chip Corporate Finance People Believe US Interest Rates Are Headed North, And Soon…

November 6, 2017 - 2 Responses

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…

November 6, 2017 - Leave a Response

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

Much Of Note Happened This Day — In History…

November 4, 2017 - Leave a Response

In 1959, as well as in 1979 — and in many many prior years. . . much of note happened. But for me, on this rainy cool 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

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

November 3, 2017 - Leave a Response

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.

Namaste

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

November 2, 2017 - Leave a Response

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

[U] Maryland/Virginia Briefing Schedule — For Muslim Ban 3.0

November 1, 2017 - Leave a Response

Meanwhile. . . back in the Fourth Circuit, out of Maryland — while we wait on the first briefs out west to hit the public PACER feed (they were due yesterday, if the State of Hawaii was going to file one opposing the emergency stay request of 45 — but the court indicated it would address all at once, so it seems Hawaii has elected not to brief that issue separately). So nothing from the west coast yesterday Updated prior post — for PACER filings now public, and available — in the Ninth Circuit.

Out east: a quite unsurprisingly similar schedule — making for cross country filings all through the holidays, at and from 45’s law offices. Nice.

And. . . now, a confidential note to 45: “more extreme vetting” would have done nothing to deter the long present in the US, Uber driving (“apparently friendly“) DOMESTIC terrorist in Manhattan yesterday. You cannot fix this with ham-handed demonizing of primarily brown people, as they enter, Mr. Trump. You just can’t. Here’s that Fourth Circuit order, entered yesterday:

. . . .Upon consideration of the Government’s Motion to Expedite Merits Briefing Schedule, the Court expedites the cross-appeal briefing schedule as follows:

Opening Brief: Due November 1, 2017 [And a link to the as filed 71 pages of warmed over, previously rejected arguments made by 45, tonight.]

Opening/Response Brief: Due November 15, 2017

Response/Reply Brief: Due November 22, 2017

Reply Brief: Due November 29, 2017.

Any amicus curiae brief in support of the Government shall be filed by November 6, 2017. Any amicus curiae brief in support of Plaintiffs shall be filed by November 17, 2017. Amicus curiae briefs shall be filed on the merits only, not on the motion for stay.

Oral argument is scheduled for December 8, 2017, at 9:00 a.m. in Richmond, Virginia. . . .

I certainly wish a grown-up was President. Any grown-up. Sheesh. Onward.

UPDATED: 11.02.2017 @ 2:20 PM EDT — As I wait in the well, for court to start here, in the federal “sanctuary city” case (pro bono publico). . . I noticed that 45 called for the death penalty late last night in the case of the Manhattan terrorist. He also suggested Gitmo. Just as he did in talking about Beau Bergdahl’s case — Trump has increased the odds that this murderous attacker gets off — entirely.

As the Commander in Chief, he cannot weigh in on prosecutorial decisions with impunity. He has immensely hampered his own Justice Department by making truly stupid remarks. I get that he is upset. We all are. But his lack of filter is going to cost the people of this nation — cost them, in the measure of justice that may be imposed, on a clearly guilty terrorist. This man is simply not up to the job. Period. He is handing out hall passes to terrorists, with his nonsense bluster. Fugly. End, update.

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