Federal Propecia® MDL Status Conference — In About A Week’s Time

April 21, 2016 - One Response

Not much more additional detail is electronically available, but there will be a status update next week, on Wednesday.

I guess the update will cover (i) discovery progress, and (ii) how the 50 or so bellwether trial selection pool fact sheets are progressing. Those are now due by the first week of May. The initial case pool lists should be complete by May 27, 2016. Here’s the minute entry, in full, from yesterday:

. . . .Set/Reset Scheduling Order Deadlines:

Status Conference set for April 27, 2016 — 02:30 PM in Courtroom 322 North before Magistrate Judge Peggy Kuo. . . .

Onward. Sleep tight all of you — still stunned and saddened, that Viator is traveling out of the Cosmos now (hoping that the salacious Fox News reports are untrue). . . As ever, tomorrow will be a better day.

Merck’s Q1 2016 Lobbyist Spend More Than Doubles — Over Q1 2015 [With Prince, Footnoted.]

April 21, 2016 - Leave a Response

As we generally have in the past, we keep a weather-eye here — on what Kenilworth seeks from the halls of our Congress, and how much it spends, in doing it. Two caveats, by way of perspective, here: (i) it is a Presidential election year afterall, so much is in play (so much must be spent, at least arguably, to protect Merck’s policy positions); and (ii) Pfizer will have spent over $4 million in the quarter, in all likelihood (as ever, not all of Mr. Read’s filings are in at the Senate’s electronic disclosure desk, yet).

Even so, this is a rather amazing leap in spending — more than doubling compared to the last few regular quarters’ spends — by Merck. Here is some of the detail, just so you know:

. . . .340B (no specific bill), Hepatitis C (general education; no specific bill), general vaccine policies (no specific bill), antimicrobial resistance (general education and DISARM (H.R. 4187), biosimilars (no specific bill), 21st Century Cures (H.R.6), Senate Innovation Project (no bill number), value of medicines (no specific bill), general pharmaceutical issues. . . .

Comprehensive tax reform (no specific bill), international tax proposals (no specific bill), orphan drug legislation (S.1128), base erosion (no specific bill), territorial tax system (no specific bill), tax extenders bill. . . .

Medicare Part D (general education, no specific bill), changes to low-income subsidy structure in Medicare Part D (general education, no specific bill), Medicare Part B (general education, no specific bill); Medicaid (no specific bill). . . .

Patent reform (H.R. 9, the Innovation Act; S.632, the STRONG Patents Act). . . .

General animal health issues. . . .

Issues relating to the further development of antibiotics and antimicrobials for serious and unmet medical needs; Issues relating to 340b Drug Pricing Program; Antibiotics/stewardship; Value of prescription drugs. . . .

Trans-Pacific Partnership, data exclusivity for biologics. . . .

Medicare reimbursement; Low-income subsidy in Part D; Part B reimbursement and coding. . . .

I do read that bolded bit as tantamount to a defense of the pricing policies Merck (and Pfizer) employ in the United States. To be fair, these companies are innovators, not knock-off artists — like Valeant, Actavis and Turing (IMHO). So it goes — as we wish Viator (a/k/a Prince a/k/a Prince Rogers Nelson) a peaceful ride out of the Universe this noon-time. Travel easy; travel light. . . Only 57 — too young, was he. . . . Whoosh, and gone. Out for a breezy plaza lunch in the warm Spring sunshine here, now — but still smiling. . . .

Merck — West Point USW Local #10-86 Contract Rally Held Today

April 20, 2016 - Leave a Response

I am just dropping a lil’ squib here, to serve official notice: if any union members (or non-members) wish, anonymously, to inform us about how things are going on the ground, we will preserve your anonymity. That’s a promise — in our comment box.

This will also serve as a “stay-tuned” reminder — as this contract draws to a close — in ten days’ time.

So — do expect to hear more, at this address, as more develops (as it always does), with the USW Local #10-86, and West Point Merck management.

Know also — all you rank and file Merck workers — that this outlet appreciates the dedicated, professional and tireless work you do — to a person, we do. Onward — in solidarity. . . smile.

Harmonizing Diagnostic Tests — To Optimize Immuno-Oncology Patient Responses

April 20, 2016 - Leave a Response

Yesterday morning, I mentioned (largely by way of footnote) that there would likely be a very aggressive payer-push to use diagnostic testing — on various cancer patients, to determine which cancers, and patients, would most likely respond favorably to the new class of immno-oncology agents — Merck’s Keytruda® and BMS’s Opdivo®.

As an amplifying follow-up here, then — I will note that Merck is helping drive exactly that discussion, with the so-called Blueprint PD-L1 Assay Comparison Project — the results of which were shared at AACR last month. The idea is to calibrate diagnostic tests across both (i) the manufacturers of the tests, and (ii) the novel biological agents themselves, to confidently predict where a given therapy will do the most good. Because of the highly-daunting price point on these new therapies, that is a particularly important triage step. Here’s a bit, from a Benzinga reprinted press release — but do go read it all:

. . . .[Merck] is proud to be a part of the Blueprint PD-L1 Assay Comparison Project, an important initiative to compare several new diagnostic tests for the immune biomarker PD-L1 in non-small cell lung cancer (NSCLC). Merck believes strongly in the importance of PD-L1 testing in NSCLC, and is committed to supporting the Blueprint Project and overall efforts to use diagnostics to help physicians identify the best treatment approach for their patients with some cancers.

In oncology, testing is now common for numerous cancer biomarkers to enable physicians to better tailor treatment decisions for each patient. The data from a range of studies, including Merck’s studies of KEYTRUDA® (pembrolizumab), demonstrate that PD-L1 testing can be a useful tool to help identify patients more likely to respond to treatment with an anti-PD-1/PD-L1 therapy in certain cancers, including NSCLC. . . .

Results from the Blueprint Project, a first-of-its kind collaboration, were presented at the American Association for Cancer Research 2016 Annual Meeting.

In March 2015, the AACR in partnership with the U.S. Food and Drug Administration and the American Society of Clinical Oncology held a one-day workshop to examine whether multiple companion diagnostics intended for the same class of therapeutics could be harmonized. During the workshop, a group of four pharmaceutical companies and two diagnostic companies released a blueprint proposal to analytically compare and characterize each of their IHC-based PD-1/PD-L1 companion diagnostics for non-small cell lung cancer in the pre-approval stage. The thought was that, upon approval of these tests, the information generated by this project could lay the groundwork for additional studies that will help inform patients, physicians, pathologists, and others on how best to use the test results to determine treatment decisions. . . .

Now you know. Onward, with a crinkle-eyed grin. . . . simply lovely here, this morning!

[UPDATED; REWRITE] A Tale Of Two (Diverging?) Cities…

April 19, 2016 - Leave a Response

Updated: The Irish Times now indicates that the German Merck created the 70 new jobs in Cork. The Irish paper’s early morning copy had it as New Jersey (i.e., “our“) Merck. I’ll run this to ground in a bit — and correct mine, shortly.

I’ll leave the material below the line, as an errant footnote, really. It seems that the Irish papers “mixed up their Mercks“, this morning. [And so did I, then.]


What remains true is that the high skill USW workers — at “our” Merck’s West Point facility — are coming up on the end of their collective bargaining agreement, and they are rallying tomorrow, in support of a “no concessions” new contract. They deserve our support. And so, that is what this post is NOW about.


End, update.


~~~~~~~~~~~~~~~~~~~~~~


It has been quite a while since we mentioned the West Point, Pennsylvania facility — and its USW Local #10-86 collective bargaining agreement status.

As our commenters have correctly pointed out, that contract is set to expire at the end of this month, and while the skilled workers there have, from time to time, in the past worked long stretches without a contract — we think Merck should step right up, and renew a fair collective bargaining agreement there — with the USW Local #10-86.

I couldn’t help but notice that overnight, German Merck Kenilworth announced the creation of 70 more high-skill, high-pay jobs in Cork, Ireland — at Carrigtwohill. And that is decidedly good news, for my now rather distant cousins — who still live in Cork. That said, given that Merck is continuing to enjoy quite a bull-run, for at least the last two years, it might seem just a bit ironic to be creating jobs in tax haven Ireleand (on the very morning after most US workers dutifully paid their own personal income taxes), while beating the United Steel Workers down, essentially on nickels and dimes. But that is just one (Irish) man’s opinion.

Do go read about it — here, for the USW — and here The Irish Times, for Ireland:

. . . .Up to 70 new jobs are to be created at medical science and technology company Merck. The positions have become available following the official opening on Tuesday of manufacturing and R&D facilities at their key strategic site in Carrigtwohill, County Cork. . . .

Thanks go to my anonymous morning office-lurker, for pointing me toward linking these two cities’ tales! Onward, ever grinning. . . . I guess we all tend to mix our Mercks up, huh? I’ll leave this with the strikeouts, since clearly the USW deserves our support in its contract renewal talks. Onward.

Merck’s Keytruda® Receives Its Fourth FDA Breakthrough Designation

April 19, 2016 - Leave a Response

Even so, BMS’s Opdivo® is stll generally out ahead in immuno-oncology.

The new FDA suplemental biological license breakthrough designation — this time, for relapsed classical Hodgkin lymphoma, a blood cancer — is very good news for Kenilworth.

As more and more cancer patients, with varying cancer types are shown to benefit from this new class of immuno-oncology agents, diagnostic testing (to best match the sort of protien a patient’s tumors express, to the intended biologic) will be ever more important. These treatments are very pricey, and in some cancers only one-third of the patients experience most of the benefits — due to these protien expression differences. Payers have already taken copious note of these biological (genetic) facts.

Here’s a bit from Philly.com, but do go read it all:

. . . .The FDA gives a drug “breakthrough” status when preliminary clinical evidence indicates that the medicine may demonstrate substantial improvement over existing therapies. Once a drug is designated as breakthrough therapy, the FDA will expedite the development and review of that drug. . . .

[Exactly a year ago, the company reported its NSCLC breakthrough designation, and related FDA filing.] Onward, on a fine Spring morning, then! Smile. . .

NewLink And Merck To Collaborate Again — In Another Vaccines Deal [Multi-Valent] — Announced Over The Weekend

April 18, 2016 - Leave a Response

While these dollar amounts mean little to Merck — a rounding error, given its size — the validation of NewLink’s historical and ongoing work — in preparing a production ready Ebola vaccine last year likely led to this second “validation of concept” contract. And that’s very good news for the very able scientists in Ames, Iowa (where my great uncle John used to teach graduate geology)!

The threat reduction arm of the US Department of Defense is funding a new R&D contract, to explore a multi-valent form of the Ebola vaccine. [As we’ve been steadily reporting, the mono-valent, Zaire version is already in emergency use in Africa.] The new multi-vaccine would potentially cover both the Sudan strain and the Zaire strain (and perhaps others, in the future) — hopefully all in a single shot. Do go read all the latest, over at PharmaBiz:

. . . .NewLink Genetics Corporation, a biopharmaceutical company, announced that the Defense Threat Reduction Agency (DTRA) of the United States Department of Defense has awarded a subsidiary of NewLink Genetics a $2.8 million base contract with potential future options totaling $6.3 million to support the development of vaccines against filovirus species including Marburg and Ebola Sudan viruses, which could be combined with Ebola Zaire virus in a multivalent vaccine formulation or vaccination schedule.

The majority of the work in this contract will take place under an agreement with Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck) (known as MSD outside the United States and Canada). NewLink Genetics has licensed research, development and manufacturing of its Ebola vaccine programme, including these filovirus vaccine candidates, to Merck. NewLink Genetics and Merck are continuing efforts for development of a recombinant vesicular stomatitis virus-Ebola Zaire (rVSV-ZEBOV) vaccine (V920). The rVSV-filovirus vaccine platform was originally developed by the Public Health Agency of Canada (PHAC) and was subsequently licensed to a subsidiary of NewLink Genetics.

“Preclinical and clinical studies with the rVSV-ZEBOV candidate suggest that the inclusion of other filoviruses in this vaccine platform can be used to develop multiple vaccines or a single multivalent formula which is our ultimate goal,” said Dr. Charles Link, CEO and chief scientific officer of NewLink Genetics. “These funds will support studies to further advance these candidates. . . .”

I would expect that this new candidate would also be granted PREP Act suit-immunity status, upon completion — given the nature of the protective work here. Now, it is just an entirely magnificent mid-day here — lunch outdoors is clearly in order. Smile. . .

Merck Vaccine Leadership Hailed — WHO & CDC Talk About Arresting Ebola In Africa

April 16, 2016 - Leave a Response

Yesterday, the W.H.O. put out a backgrounder — on where we stand, in getting an approved vaccine for Ebola.

It will come as no surprise to regular readers here that Merck is leading that charge. But we may still be a year or more away from formal approval, at WHO — and therefore, in Africa, generally. In the mean time, Merck has been supplying the vaccine, in quantity, for ring arrest procedures. Here is the latest article, but do read it all. [Kudos to Kenilworth.]

. . . . The Ebola outbreak that struck Guinea, Liberia, and Sierra Leone in 2014 prompted the search, on an exceptionally accelerated schedule, for a vaccine to prevent the disease.

Although there has been more than one promising candidate, the [Merck-acquired] vesicular stomatitis virus-ebola virus (VSV-EBOV) vaccine was selected based on an algorithm produced by the WHO Scientific and Technical Advisory Committee on Ebola Experimental Interventions for the critical Phase III trial in Guinea and Sierra Leone.

The committee considered various parameters, including efficacy in non-human primates the ability to provoke an immune response in humans in the early days after vaccination, and availability.

In this article, 3 experts from WHO, the Sierra Leone Expanded Programme on Immunization (EPI) and the United States Centers for Disease Control and Prevention (CDC) comment on the future of the VSV-EBOV vaccine. . . .

As I say do go read it all. Onward, with a smile. . .

Civil Rights History: April 15, 1960 — Equal Time…

April 15, 2016 - Leave a Response

Just a short note, to link to Ella Josephine Baker (see masthead), and the formation of the Student Non-Violent Coordinating Committee, 56 years ago, this day.

In a smallish sense, this is “equal time” — given my prominent mentions of Dr. King. Not in any manner to diminish anything Dr. King did, but to acknowledge that Fundi Baker worked tirelessly behind the scenes, believing that genuinely “strong people would not need a strong leader.”

She never sought the lime-light, but was truly a driving force in all Americans’ continuing march toward full equality.

Now you know. Have a wonderful, Spring sun-drenched weekend, one and all — I’m out!

Chairman & CEO Kenneth Frazier Cashes About $1.56 Million In Equity Value (Pre-Tax)

April 14, 2016 - Leave a Response

In an SEC Form 4 just filed, we learn that in addition to his over $24 million in 2015 regular pay, the Merck Chairman & CEO has exercised and sold a bolus of his March 2008 stock options (or the underlying stock, on the NYSE) — netting (pre-tax) about $1.562 million. Not. Too. Shabby.

These sales occured in the markets today, and were conducted under his personal pre-arranged trading plan on file with the SEC. [That in turn means Mr. Frazier did not precisely pick the timing of the sale, only the general (formulaic) trigger points.]

Significantly, even after this latest transaction, he still holds well over half a million common shares of Merck, outright, and has fully vested options on more than an additional 2.6 million shares, and partially unvested options on another 1.2 million or so. So. . . he is still very heavily invested in Merck.

Just employing common sense here, I am all but certain his Merck stockholdings are his single largest asset class, by an order of magnitude — in his personal portfolio. He is — and remains — deeply engaged and aligned with Merck stockholders, in my view. Now you know — out for a walk-about, now. . . Be excellent to one another!

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