Of The Persistence Of Communicable Diseases: Three New Ebola Cases, In Guinea Last Week

August 26, 2015 - Leave a Response

The good news tonight is that Sierra Leone is approaching the 42 day marker again — on being Ebola free. However, Guinea has seen new cases — one of them a cabbie, in an urban area — so we might expect several more cases, unless all his contacts are found, and vaccinated in an immediate ring fashion. And that is exactly what the Guinea health authorities are now undertaking. [The last re-emergence in Guinea was June 2015, as we had previously reported.]

Again, it is the single course (as opposed to a “prime plus booster” approach — needed in the GSK candidate), and rVSV-ZEBOV’s extremely robust near-term efficacy, that have handed the Merck/NewLink vaccine the wheel, in Africa. Here’s the operative bit — from the online CIRAP center, on the campus of the University of Minnesota:

. . . .With three new cases, Guinea was the only country in West Africa’s outbreak region to report Ebola infections last week, and responders are on high alert because all of the confirmed case-patients, one of them a taxi driver, pose a high risk of transmission.

The World Health Organization (WHO) said in its weekly snapshot of the outbreak that Sierra Leone has gone two weeks without a new case and that the outbreak region’s weekly total has remained at three for four weeks in a row. . . .

Now, sleep well, all you young buckaroos. . . and do say your prayers — that this latest Ebola ring-outbreak is snuffed out soon. G’night!

New! With Now Daily Propecia® MDL Documents Updates: The Good Doctor Must Appear — At High Noon, On September 10, 2015, Sez US Magistrate Judge

August 26, 2015 - Leave a Response

The emminently capable Magistrate Judge Pohorelsky, sitting in Brooklyn’s federal District courthouse has ruled that the doctor will be given one additionnal week to prepare, but that both she — and her Weill-Cornell Medical Center lawyer — WILL in fact have to appear personally, to answer his questions about the state of the play, on these supposed 16 to 40 boxes of study documents. Now that is. . . fascinating.

So — if anyone were to wander by (and bring a picture ID, to be granted admission to the gallery) they could sit in that day, in Brooklyn. It could turn out to be a pretty darn interesting show cause hearing, given the interplay between what has been reported to be the doctor’s earlier position — per her lawyer — and what we all understand the federal rules governing national clinical trials for FDA approval of new drug candidates might have required of her. Do stay tuned, but I have no plans to be in New York that day, at this point. Here is the full text of today’s order — just entered, below:

. . . .Order on Motion for Discovery: the Hearing on the Order to Show Cause is adjourned to September 10, 2015 at 12:00 noon. Dr. Julianne Imperato-McGinley and her counsel are both required to attend in person. Ordered by Magistrate Judge Viktor V. Pohorelsky on 8/25/2015. . . .

The delay from September 2 — to September 10 — was designed to accommodate the doctor’s availabilty — to appear in person. Pop the popcorn folks! [And, in answer to Mr. E (below), there was no status hearing scheduled for today, given yesterdaty’s developments — it was superceded/deleted.] Onward.

August 25, 2015 Propecia® MDL Document Discovery Update — Small Delivery Of Documents Made; And An Assertion That Many More Are. . . “Missing”

August 25, 2015 - Leave a Response

Again, I must emphasize that we should not infer too terribly much from the plaintiffs’ lawyers’ claims that the vast bulk of the historical Propecia® study documents have gone “missing“. But the surprising news here (to my eye) is that only some 630 or so pages were turned over by the University hospital, as of yesterday afternoon.

And so, with that said, I do think the plaintiffs make a generally very solid point — when they ask where the doctor’s study files — as PI of the clinical trials (some of which were submitted to, or filed with federal agencies) — now reside. [There is a passing and rather vague reference, to the Dominican Republic here, as well — and it may well turn out that some records need to be culled from storage, on the island.] As I’ve indicated before, the federal rules contemplate that those documents should remain under the control, directly or indirectly, of the principal investigator — precisely in the event that questions like those raised in the present mass-tort litigation arise. The rules contemplate having a repository (under the direct supervision of a particular person — the doctor) for exactly this sort of eventuality. Here is the Response filed today (a six page PDF file), by the plaintiffs’ lawyers — and a bit of it:

. . . .On August 24, 2015, in response to the Second Subpoena, Weill Cornell Medical College produced a mere 631 pages of documents, constituting less than half a box [of a purported 40 boxes]. . . .

The documents appear to contain nothing from Dr. Imperato-McGinley’s days researching in the Dominican Republic, nothing about her discovery, and just a handful of documents related to Merck. The paltry production by Weill Cornell Medical College emphasizes, as opposed to eliminates, the continued need for a “show cause” hearing with regard to the issue of Dr. Imperato-McGinley’s documents, and where these highly relevant and probative documents went. . . .

Though Ms. Orwel repeatedly affirms that Dr. Imperato-McGinley has no documents in her possession, custody, or control, these statements must be disregarded under Second Circuit precedent, as Ms. Orwel does not claim to have personal knowledge, or even any “knowledge,” regarding the factual question of what documents Dr. Imperato-McGinley has or had in her possession, custody, or control. . . .

Dr. Imperato-McGinley should appear in Court and explain to this Court why she has produced in effect absolutely nothing in response to the Subpoena served upon her. This Court should direct Dr. Imperato-McGinley to appear before this Court and show cause why she should not have to produce all responsive documents, to provide an explanation as to what if any documents were destroyed and when they were destroyed, advise what prompted counsel to initially believe there were between sixteen and forty boxes, and what those boxes contain, and find Dr. Imperato-McGinley in contempt of Court if she continues to refuse to comply with the Subpoena. . . .

The conclusion of the just filed Response renews the plaintiffs’ request that the doctor be required to appear personally, and explain the whereabouts of the clinical trial documents. I remain skeptical that the Court is ready to order that appearance. I do think the Court will ask the counsel for Weill-Cornell to make an accounting of what was in the 40 boxes — and which parts of it might not be discoverable. So — do stay tuned for September 2, 2015. Onward — and be excellent to one another!

BioPharma Dive: On An Apparently Cardio-Protective Side-Effect Of Lilly’s Jardiance® — Longer Term Effect On Merck’s Januvia® Sales

August 24, 2015 - Leave a Response

While the markets gyrate rather wildly on concerns about emerging market growth — or the lack thereof, more precisely — we will take a moment to look forward, into 2016-2017, and predict that (if this preliminary study result holds up, upon peer review) Jardiance® may eat into Merck’s more than $5 billion franchise, here. The Boehringer Ingelheim/Lilly drug is an SGLT2 inhibitor, and Merck’s only current bet in this space is in a venture shared with Pfizer. That venture effort is not likely to reach market before 2018, in my estimation.

All of which is to say I think Merck would be quite vulnerable to product switching — away from Januvia® — should Jardiance turn out to provide a reduced cardio-vascular risk to most diabetes patients. [As we’ve reported before, repeatedly, Merck’s presently-available study data shows only that there is no increased cardiovascular risk with Januvia.] Speaking broadly, and oversimplifying, here — longer term cardio-vascular events are generally the proximate cause of disability/death for people with advanced diabetes. So it stands to reason that a drug able to mitigate that risk would be welcomed with open arms, by prescribing doctors. Here is BioPharma Dive‘s quite cogent take on it all:

. . . .Merck’s Januvia is often used as treatment for diabetes when metformin is not enough to control blood glucose. Diabetes is treated in a stepwise fashion, generally starting with metformin and adding on various classes of drugs over time. Given the new data published about Jardiance, Jardiance could become the go-to drug after metformin.

As mentioned in BioPharma Dive’s coverage last week, the positive news about Jardiance, which is an SGLT-2 inhibitor could bode well for the entire class, including Johnson & Johnsons Invokana and Bristol-Myers Squibb’s Farxiga. . . .

And so (from a larger, macro- perspective) — in the longer run, the emerging markets will be a net positive for the solid counter cyclicals, like pharma and biotech. There may — as ever — be bumps along the way (as today is no doubt proving). . . Enjoy, one and all!

Former President Carter Receiving Merck’s Keytruda® — Investigational/Experimental Use; Off Label — For Brain Tumors

August 21, 2015 - 2 Responses

I half-wondered if Mr. Carter would receive the BMS (Opdivo®) or Merck (Keytruda®) breakthrough therapy, when I read of his interview, last evening, in the Gray Lady. Now we know — he will. And we may well see outstanding results, even for a patient in his 90s. It is indeed a heady time for science.

I’ll have more later — on a train, at the moment. . . This could be a nice institutional marketing coup — for Kenilworth, if he sees any progression free survival, of statistical significance.

Okay — do go read it:

. . . [The former President] immediately began treatment with a drug that’s new to the market. Carter is receiving pembrolizumab, better known by its brand name, Keytruda, according to the Washington Post. . . .

Of course, since the use is experimental — and prescribed directly by his oncologists — presumably without any input from Merck, proper, there is no off-label regulatory concern, for Merck. More soon… Onward — and we wish Mr. Carter the very best here.

I’d Not Bet On Intarcia’s Implantable Device Besting Merck’s Januvia® — Before 2019, At Least

August 20, 2015 - Leave a Response

To be sure, the just reported results look promising: using a matchstick sized implantable pump to release diabetes meds like Byetta® continuously, and silently.

The new tech has done well against Merck’s sitagliptin franchise — in early efficacy tests. The problem (as I see it) with the tech is that an oral treatment is likely going to be vastly preferred by patients (compared to any implantation), and compounding that, the SGLT2 class of diabetes meds are due to come online, and may well leapfrog this device, altogether. Merck has a bet in the SGLT2 class, via a venture with Pfizer, of course. Some of those competitors may come online in late 2016. [Intarcia is partnered with French megalith Servier, on this device.]

It is not so much that Inarcia will best Merck, today, as it is that other diabetes drugs are showing a cardiovascular risk benefit not seen in Januvia®, that is moving Merck stock today. In any event, a bit, from Bloomberg Biz, then:

. . . .Intarcia’s pump is implanted under the skin for up to a year and continuously delivers a diabetes drug known as a GLP-1 receptor agonist. The pump reduced a measure of blood glucose by 1.5 percentage points, compared with 0.8 percentage point for Januvia, in a yearlong study of 535 patients, the company said Tuesday in a statement. The device also led to an average weight loss of 4 kilograms (9 pounds), compared with a loss of 1.3 kilograms in the patients taking Januvia.

Intarcia, a closely held company backed by venture-capital firms including New Enterprise Associates Inc. and Venrock, is seeking to challenge the crowded field of type 2 diabetes treatments with its device, called ITCA 650. . . .

And so — the 4 per cent sacking of Merck’s NYSE price seems. . . a little overwrought, to my experienced eye. Onward!

I’ve Been Generally Impressed By USW Local 10-86’s Merck Strategies, But This I Don’t Entirely Follow. . .

August 20, 2015 - Leave a Response

Longer term readers will recall that I have generally been a strong supporter of the plight of the unionized workforce at West Point — some 1,800 strong (down from over 2,000 in 2010).

This week, however, Philly.com’s blogs have been covering an emerging email debate between Local 10-86’s leadership, and Merck’s CEO. What seems to be lost in the dust up here is that it apparently broke into the public over what union leadership has characterized as Mr. Frazier’s granting all non-unionized workers at Merck an “extra” day off, in appreciation of their efforts, this year — on the Friday before Labor Day. [In the last contract negotiations — in 2013 — so-called floating holidays were a rather contentious issue with Local 10-86, and Merck management.]

In point of fact, Mr. Frazier granted the non-unionized workers a day off — one that the collective bargaining agreement for Local 10-86 already made a “floating holiday” — for all the union workers. That’s in addition to Monday, Labor Day. Here’s FiercePharma, restating what I think SHOULD be the more salient bits of the discussion:

. . . .Frazier in return, explains that collective bargaining agreements make it hard sometimes to offer the same perks to all employees.

The CEO assured Bangert that union workers are appreciated and added, “Merck goes to great lengths to protect the safety and well-being of our employees.” He assured him that manufacturing management and HR would “work with local site leaders to address your concerns directly”. . . .

From my perspective, all Mr. Frazier is guilty of. . . is granting all employees an equal right — to that enjoyed by the union employees — a floating day off on the Friday before Labor Day weekend.

Now, it is true that the remainder of the layoffs mentioned in the Form 10-Q are still coming — some 2,600 of them — and mostly to shop floor workers, as opposed to office dwellers — who’ve already been cut by around 40,000 over the past five years, world-wide (inclusive of legacy Schering-Plough’s cuts).

That should be the focus of the discussions — not whether there was any disrespect of the unionized workers (by the CEO), in granting all others the same paid holiday the union presently enjoys. That — and the “compulsory overtime” at West Point (with its attendant potential safety issues) — those are serious, and public-debate worthy, topics for the union’s public letter writing campaign, from my perspective.

UPDATED Propecia® MDL Documents Spat: The Weill-Cornell Med Center In-House Lawyer Weighs In, This Afternoon

August 18, 2015 - Leave a Response

Well, it once again seems unlikely that there will be any high drama show-down in Brooklyn’s federal District Court, on September 2, 2015. It seems that the in-house lawyer for the entities served subpoenas intends to deliver relevant documents prior to that day.

At least that’s what her sworn statements — before the federal trial court now aver. And I trust she will. She claims the earlier mix-up was plaintiffs’ counsel’s fault — that they had served a party (the doctor) who did not control the documents in question. I personally think that’s a rather dangerous argument to make, because under applicable federal law, various clinical trial documents, like these — are to remain (essentially forever) the responsibility of the so-called Principal Investigator under the clinical trial/study. The idea here is that a real person, not a company, hospital or university — under federal law — should be signing on for, and responsible for the safe and ethical conduct of the trial. If memory serves, the doctor was the P.I. on those old studies — some dating back 25 or more years.

In any event, the plaintiffs have now served everyone that might have control of the study documents, and so, their in-house lawyer says the documents will be forthcoming. Here’s a bit from her response — filed today (and the full PDF of it):

. . . .I am Associate University Counsel in the Cornell University Office of University Counsel and counsel for non-party witness Dr. Julianne Imperato-McGinley (“Dr. McGinley”). Dr. McGinley is a full-time member of the faculty of Weill Cornell Medical College (“WCMC”). . . .

[Plaintiffs’ counsel] mischaracterizes my communication with him to suggest we have more documents than we do. The available records responsive to the subpoena Plaintiffs served on Dr. McGinley are in the possession, custody and control of WCMC, not Dr. McGinley in her individual capacity. Dr. McGinley, as an individual, has no records in her personal possession that are responsive to the subpoena duces tecum, beyond the information produced. . . .

Most of these records are from 30, 20 and 15 years ago. WCMC reviewed a list of records it had stored, which turned up 16 boxes and potentially more (possibly up to 40) that may include records related to the subject matter of the subpoena. It is important to emphasize that not all of the documents contained in those 16 to 40 boxes are relevant records. The boxes identified in storage were for review to identify the relevant documents. . . .

She goes on to say that at least some will be produced — but many may not be relevant — or may be privileged. So. . . I trust that all those following this closely — you know who you are(!) — will enjoy this above bit of federal civil practice “street theater.” Now you know. Onward — and a river runs through it.

Smallish Temodar® Recall — Cracks In The Childproof Bottle Caps

August 18, 2015 - Leave a Response

This is a long standing Schering- Plough/Merck legacy product (now as an authorized generic) — and the smallish issue has to do with the cap remaining childproof — not anything to do with purity or safety of the medicine inside the bottle.

Even so, we will note it. Just for a complete record — from a wire-service press release:

. . . .Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of TEMODAR and Temozolomide capsules (generic) could potentially have cracked caps. . . .

Onward — some of my Temodar background here — do use the search box to find more, going back seven years, if you are curious.

Like BMS Before It, Merck Announces A Slowed FDA Timeline In One Anti PD-1 Melanoma Indication, And Acceleration, In Another

August 18, 2015 - Leave a Response

About a week ago, BMS announced that its targeted complete response date from FDA had been pushed into November 2015 on an Opdivo® label expansion into other melanoma indications. This morning Merck has done much the same, and this time, in first line melanoma treatments.

Also like BMS, FDA has accepted for priority review Merck’s submission in melanoma with differing treatment precursors. Sort of a good news, and delay news — as a two for one — echoing BMS of a few weeks past. Here’s the bit from StreetInsider:

. . . .The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015. . . .

I might suggest, without looking into it too deeply, that FDA suspects BMS will have better efficacy here in the delayed indication — thus the November 2015 date for Opdivo, compared to a December date for Keytruda. I’ll trust the readership to correct me if I am mistaken about that. Smile. . .

My overall assessment is unchanged. BMS has a clear timing lead. Having said that, the overall market opportunity is so vast, that Merck will generate multiple billions in new reveue here, as well, going into mid-2017 (even as the payers seek limits on price). So, onward — out into a hot likely rain soaked August workaday world — but it is teeming with possibilities, as well. . .


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