Thursday, September 3, 2015

O/T -- An Elected Government Official Must Obey Governor's Lawful Orders -- And The US Supreme Court. Full Stop.

I mention this largely in passing, since we have covered the emergence of the fundamental right of people to marry whomever they love, for some time here, now.

I must say that I think this Kentucky clerk has received extemely poor legal advice from Liberty Counsel. There is no plausible reading of the existing law that would allow an elected official to choose which laws she will obey, and which she will not. Here her choices are plain: issue marriage licenses to all (as she had previously sworn to so do), or resign her office. There is simply no fundamental right to "be an elected official" -- it is a privilege -- a privilege that remains contingent upon obeying the law of the land -- and discharging the lawful duties of office. Marriage equality is now clearly the law of the land.

I am genuinely sorry she is now in a federal jail-cell (likely believing, in error, that she is somehow being persecuted for her religious views) -- but it is largely the poor legal advice of Libery Counsel that has landed her there, in my opinion. Liberty ought to admit that no good faith extension of existing law would support the position they've backed her in taking.

Onward -- and I do trust now that love will prevail.

The Strange Tale Of Rolapitant -- Now To Compete With Merck -- A Legacy Schering-Plough Chemo- Nausea Med

While I don't expect this will matter much in any negative way to Merck, given its size, and long leading position -- with Emend® in this US market space -- I do find these "Post-Script -- Epilogue" stories interesting, given that the narrative here directly involves the genesis of this blog. [My much earlier backgrounders -- here, and here.] It bears mentioning that the candidate did hit a few clinical trial bumps along the way -- as we might expect for any drug that Fred Hassan was seen touting.

I suppose one object lesson here is that a robustly active anti-trust/pro-competition FTC and/or DoJ in the US is a good thing. And -- though it took five or more years, we now have an on-market competitor, for this segment. [My experienced conjecture is that the rolapitant program would have been deep-sixed -- post the Schering-Merck deal in 2010 -- had the HSR antitrust review not required divestiture.] And that is good for patients, and payers. What a path this candidate had: from legacy S-P, to Opko, to Tesaro. . . now, to meet Merck (the old Schering-Plough entity, just renamed), head on, in late 2015. Here is FierceBiotech on the latest (an FDA thumbs up):

. . . .The FDA has given Tesaro a green light to start marketing rolapitant to help prevent some of the common side effects of chemotherapy. And now Tesaro will wage a David-vs.-Goliath battle for market share with a dominant Merck.

The Waltham, MA-based biotech had gone through an extended R&D journey before it hit the regulatory finish line with this drug, to be marketed as Varubi. The company in-licensed the drug from Opko back in 2010 for a small upfront, then ran into a bitter backlash from investors after the initial Phase III program failed to hit key secondary endpoints in late 2013.

A second Phase III that wrapped up last year, though, rang all the right clinical bells in preventing nausea and vomiting, setting up the regulatory package and today's approval. Analysts believe this drug could earn a few hundred million dollars a year. . . .

As I say, a few hundred million is peanuts to Kenilworth, but will nicely augement Tesaro's post IPO price and volume. Onward -- on a hot clear wonderful late summer afternoon -- with airport runs a'comin'!

Wednesday, September 2, 2015

Post Hoc Q: Did IMPROVE-IT Only Show Meaningful CV Benefits -- For Diabetics?

As ever, CardioBrief -- with Larry Husten on the keyboard -- does an excellent job of pointing out just how "fuzzy" the ultimate learnings may be -- from even large studies (with 18,000 patients) -- upon careful, closer (post hoc) data analysis.

In a sub-set post-hoc study, it would seem that the vast bulk of the CV outcomes benefit appeared in about only one quarter of the study's population: those who already had diabetes. Of course, correlation is not causation, and perhaps the diabetics were sicker, as a group, but it is. . . intriguing, nonetheless. Can we (as a finite resource/constrained payer-based system) justify these premium prices, for any non-diabetic cholesterol management patient in the US, where the outcome benefit seen in a very large group, over several years, was almost. . . non-existent? This is a very fair question -- and do go read it all, for some other competing theories to explain the subset data -- but here's a bit:

. . . .The beneficial effects of ezetimibe are found almost exclusively in patients with diabetes. . . .

The main IMPROVE-IT trial randomized 18,144 patients with acute coronary syndrome to the combination of ezetimibe and simvastatin or simvastatin alone. The primary endpoint of the trial– CV death, MI, documented unstable angina requiring rehospitalization, coronary revascularization after one month of treatment, or stroke– was significantly reduced in the ezetimibe group (32.7% vs. 34.7%, p = 0.016).

The ESC presentation focused on the 27% of patients in the trial (n= 4,933) who had diabetes. “We did see a quantitative, statistically significant interaction between diabetics and non diabetics,” said Giugliano. . . .

Giugliano concluded that diabetic patients were at higher risk than non-diabetic patients and that they had a greater relative and absolute benefit from the addition of ezetimibe. The greater benefit in diabetics was driven by reductions of MI and ischemic stroke. . . .

Almost a year ago, we had asked whether one fewer CV event, in 50 patients, over seven years, was worth almost an additional $750,000 in spending. [That's what the legacy Schering-Plough combo-pill Vytorin® costs, compared to a generic statin.] I think the answer now will be. . . no, unless the patient is ALSO diabetic. Harlan Krumholz (the world renown expert, at Yale University) has all but said as much, previously. And so. . . onward. . . with a lovely end to a short week approaching. . . .

Tuesday, September 1, 2015

Propecia® MDL Status Call Tomorrow -- Here's The Agreed Agenda

To be clear, this status hearing tomorrow in Brooklyn will not touch on the Cornell-Weill/Dr. Imperato-McGinley boxes of putatively "missing" clinical trial/study documents.

That discussion is slated for September 10. I thought this hearing would happen on the 10th as well -- but apparently it will go forward tomorrow. I'll keep an eye on the PACER filings, and offer any update -- as events warrants. Here's the agenda, in pertinent part:

. . . .The parties jointly submit the following agenda for this Court’s September 2, 2015 Status Conference.

1. Argument on the parties’ separate proposed Discovery Plan submissions.

2. Argument regarding the parties’ submissions related to Defense Fact Sheet/Merck Profile Form.

3. Merck’s administrative Motion to Dismiss (Doc. 233) 16 cases for failure to serve a PPF, filed April 29, 2015. Responses were due May 11, 2015, and no Responses have been filed.

4. Further discussion on Merck’s privilege log and the Court’s order of July 22, 2015. . . .

I'll let you all know -- right here -- if anything more interesting comes of this ongoing privilege log dispute, tomorrow.

Ebola Setback In Sierra Leone -- One New Fatality; Restarts The Clock

An international team of doctors and epidemiologists, with experts from The University of Bern, the University of Florida, the London School of Hygiene and Tropical Medicine, Public Health England, the European Mobile Laboratories (among others) has arrived in Guinea. This is the same team that just finished a ring-vaccination in Guinea -- vaccinating people against the latest re-appearance of a node of Ebola cases/contacts. The team drove overnight Sunday -- to Kambia District, Sierra Leone, to meet and confer with local health officials and WHO officers.

Later today, in all probability, a new ring vaccination -- once again, deploying Merck/NewLink's single course vaccine candidate will get underway, covering all known/traceable contacts of the 60 year old woman who just passed away. Here's a bit from the local news outlets:

. . . .Detection of a new case of Ebola Virus Disease in Kambia, Sierra Leone after the country had marked almost three weeks of zero cases has set in motion the first ‘ring vaccination’ use of the experimental Ebola vaccine in Sierra Leone.

A team of experts in ring vaccination has travelled from Conakry, Guinea to join a large WHO and Ministry of Health team already in Kambia District. The source of the Ebola virus transmission is being investigated and all the people who may have been in contact with the infected person are being traced.

"Although no one wanted to see more cases of Ebola virus disease in Sierra Leone, we kept all our teams on alert and ready to respond and close down any new transmission" said Dr Anders Nordstrom, WHO Representative in Sierra Leone.

Heightened surveillance for Ebola Virus Disease in Sierra Leone includes swabbing all people who have died at home and testing those swabs for Ebola virus. On Saturday 29th August 2015, a swab taken from a woman who died aged around 60, in the village of Sella, Tonko Limba, Kambia District, tested positive for Ebola virus.

Members of the team currently conducting the ring vaccination trial in Guinea drove from Conakry in Guinea to Kambia on Sunday to begin work. . . .

So it is with all of life, it would seem -- two steps ahead; one back. Ebola has the same Darwinian proclivities as we see in all other life on the planet -- it will mutate, adapt and attempt to survive. Even so -- Onward -- and keep your chin up. . . we (i.e., the collective human race "we") are beating it, bit by bit -- no doubt, now.

Monday, August 31, 2015

ENHANCE-Era Institutional Investors' Opt Out Claims May Proceed Against Merck: USDC, NJ

It has been over a year since last we looked in on this narrative. [And yes, it is -- in the main (in my opinion) -- yet another bounced check left behind, by one "Fast" Fred Hassan.] Back in April of 2014, we noted that this litigation -- by large investors like GIC, North Sound Capital and Colonial First State -- each of which declined the agreed $668 million class settlement, choosing to "opt-out", and sue on their own behalf, would have to wait for a US Supreme Court ruling on whether the claims were now time-barred. Then, in November 2014, the reference case that the Supremes had selected to review (IndyMac, on so-called American Pipe tolling) was largely settled, by an agreement of the parties. So the Supremes removed that case from the docket. And this opt out case went. . . quiet, for a bit.

In the nearly full year since then, though, the very able federal District Court Judge Freda L. Wolfson has been busy -- reviewing whether the relevant law would allow these investors' individual opt-out cases to proceed. She has now ruled (as of last week) that they indeed may. So Merck will presumably have to offer the same defenses, and presumably, end up settling with these investors -- as well, for additional sums -- due to the alleged acts and ommissions of Fast Fred Hassan, and his band of skallywags, from legacy Schering-Plough. [Background here.] Here is a bit of her opinion (and a PDF file of the whole affiar):

. . . .The tolling doctrine established in American Pipe is legal tolling and applies to the statutes of repose here. Further, the common-law fraud claim sets out sufficient allegations of actual reliance to survive a 12(b)(6) motion to dismiss. For the reasons given above, Defendants’ Motions to Dismiss is DENIED. . . .

As I say -- I'd expect a settlement here, eventually. And it will involve Merck paying more money to these three investors. Do recall here that the $668 million earlier settlement exhausted all of Merck's insurance related to these claims -- and Kenilworth keeps no reserve, for these legacy matters, as the SEC filings have long stated. So this will be a hit to quarterly earnings, when the settlement is announced -- in my estimation. However, the amount won't likely be material to Mother Merck (as she's just too. . . big).

So. . . Onward -- on an approaching long holiday weekend. . . with family nuptials in the offing! Big smile, and. . . a gathering of all!

Saturday, August 29, 2015

Class-Wide DPP-4 Diabetes Med Effect: Joint Pain -- FDA Warns, On Friday

I'll note this almost solely to complete the record, here -- since we try to run down all material items related to Merck.

As we've previously indicated, in fairly short order, the SGLT-2 class will be supplanting the DPP-4 class as the oral diabetes med of first choice (beyond metformin -- a Merck drug, but now long generic). This FDA revision will likely hasten that coming switch-over, at least for prescribers with patients complaining of recurrent joint pains, along with their diabetes. Not good news, here in the US -- for Kenilworth -- but only a minor headwind near term, overall, for the behemoth that is Merck's annual revenue tide, rolling in. Here's the FDA press alert -- and the list of covered products:

. . . .The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. We have added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.

Patients should not stop taking their DPP-4 inhibitor medicine, but should contact their health care professional right away if they experience severe and persistent joint pain. . . . [Affected DPP-4 class products]:

Januvia (sitagliptin), Janumet (sitagliptin and metformin), Janumet XR (sitagliptin and metformin extended release), Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Tradjenta (linagliptin), Glyxambi (linagliptin and empagliflozin Jentadueto (linagliptin and metformin), Nesina (alogliptin), Kazano (alogliptin and metformin), Oseni (alogliptin and pioglitazone). . . .

So it goes. . . . Meanwhile, our eyes will be on the night skies for a few evenings now. . . smilingly so, immortal and beloved. . . .

Friday, August 28, 2015

O/T: The Dream -- Set On Wings -- 52 Years On. . .

This turns out to be a Friday afternoon for. . . reflections. And reflect we shall -- on the eve of my long-gone father's own birthday. For today is the day that Dr. King spoke -- at the March on Washington. Today he set his version of the dream. . . on wing. So do take a moment and express gratitude, for all this moment did to advance our nation -- to this very day.

Below is -- of course -- from his letter inside the Birmingham Jail. . . and the YouTube below that, is "the dream" proper.

. . . .My friends, I must say to you. . . . it is an historical fact that privileged groups seldom give up their privileges voluntarily. Individuals may see the moral light and voluntarily give up their unjust posture. . . .

Frankly, I have yet to engage in a direct action campaign that was "well timed" in the view of those who have not suffered unduly from the disease of segregation. For years now I have heard the word "Wait!" It rings in the ear of every Negro with piercing familiarity. This "Wait" has almost always meant "Never." We must come to see, with one of our distinguished jurists, that "justice too long delayed is justice denied."

We have waited for more than 340 years for our constitutional and God given rights. The nations of Asia and Africa are moving with jetlike speed toward gaining political independence, but we still creep at horse and buggy pace toward gaining a cup of coffee at a lunch counter. Perhaps it is easy for those who have never felt the stinging darts of segregation to say, "Wait." But when you have seen vicious mobs lynch your mothers and fathers at will and drown your sisters and brothers at whim; when you have seen hate filled policemen curse, kick and even kill your black brothers and sisters; when you see the vast majority of your twenty million Negro brothers smothering in an airtight cage of poverty in the midst of an affluent society; when you suddenly find your tongue twisted and your speech stammering as you seek to explain to your six year old daughter why she can't go to the public amusement park that has just been advertised on television, and see tears welling up in her eyes when she is told that Funtown is closed to colored children. . . .

[W]hen you take a cross county drive and find it necessary to sleep night after night in the uncomfortable corners of your automobile because no motel will accept you; when you are humiliated day in and day out by nagging signs reading "white" and "colored". . . .

[It is also the 60th passing of the murder of young Emmett Till.] Travel light, but travel well, Dad (and Ter -- 30 years on) -- you both had to leave our party far too soon.

Wednesday, August 26, 2015

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

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

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.

Tuesday, August 25, 2015

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

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!

Monday, August 24, 2015

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

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!

Friday, August 21, 2015

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

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.

Thursday, August 20, 2015

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

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. . .

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,'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.

Tuesday, August 18, 2015

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

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 Messrs. E. & I.(!) -- 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

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

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. . .

Thursday, August 13, 2015

Exclusive -- Propecia® MDL Update: Rule To Show Cause Hearing For Dr. Imperato-McGinley: September 2, 2015

So the worm turns. Apparently, Dr. Imperato McGinley did not turn over the voluminous set of documents associated with her finasteride studies, to the plaintiffs -- as she promised she would. I would not have predicted/expected this outcome. [My May 2015 backgrounder.]

Apparently, she is being -- or has been -- represented by one of the in-house lawyers at the New York Presbyterian/Weill Cornell Medical Center. Also apparently, that in-house counsel has responded that the institution -- not the doctor -- controls custody of the 16 to 40 boxes of clinical trial records thus far pulled from storage. After some wrangling, the in-house counsel has also apparently said that she won't accept service of a subpoena for the boxes, as a representative of either the doctor, or the institution.

And so, a rule to show cause hearing is now set for September 2, 2015 -- in the Eastern District of New York. This will be a hearing as to why the doctor or the institution ought not be held in contempt of court -- for allegedly evading the lawful discovery by subpoena process under the federal rules of civil procedure. I understand that there is a lot to look through, but it will be embarrassing if either of these parties is ultimately held in contempt for failure to go through the boxes, and provide relevant documents. The plaintiffs have even offered to cover the cost of that effort. This ought to be entertaining. From the full pleading (a 6 page PDF file), then -- a bit:

. . . .The only document furnished by Dr. Imperato-McGinley was a two-page “bibliography.” Moreover, Dr. Imperato-McGinley’s responses strongly suggest, consistent with her counsel’s initial representation that there were at least sixteen boxes’ worth of documents, that numerous responsive documents do exist, but Dr. Imperato-McGinley is claiming not to have “possession, custody, or control” of those documents. Indeed, Dr. Imperato-McGinley is careful to assert, in each of her responses, that she has no responsive documents in her “possession”. . . .

Dr. Imperato-McGinley is, according to Merck, one of the most important individuals in the development of Finasteride, and the development of Finasteride in turn appears to be a major component of her life’s work. It is simply implausible – in fact, it is utterly unbelievable –- that Dr. Imperato-McGinley has no “right, authority or practical ability” to obtain and produce the relevant documents within the sixteen to forty boxes’ worth of documents at issue. Indeed, the fact that these boxes were apparently obtained by the attorney who represents her, reviewed with the assistance of a clerk at the undersigned’s expense, and then simply withheld on the eve of the date set for production conclusively demonstrates that numerous responsive documents were and remain within Dr. Imperato-McGinley’s “possession, custody, or control,” or at a bare minimum in the “possession, custody, or control” of her “representatives. . . .”

So, September 2, 2015 should be an interesting morning in the federal courts in Brooklyn. Stay tuned -- off to a charitable board meeting, tonight.

BMO Capital Markets Bumps Merck Target To $70; "Outperform" Rating

Kenilworth saw one major Wall & Broad analyst firm make a material move, north -- in its 12 month price target, this morning.

And the shares are reacting to it, on the NYSE today. $70 is a lofty goal. And we shall -- as ever -- wait to see, here. [Prior background from September 2014 here.] Here's a bit from the street trade press outlets:

. . . ."Although we didn't get the better entry point we were waiting for, we have become more optimistic on Merck's pipeline and believe that the upcoming data readouts should also raise Street expectations and lead to multiple expansion," analyst Alex Arfaei wrote.

Merck's commercial and R&D execution were impressive. The company is expected to have "a good finish" in the back half of the year, Arfaei said, while adding that Merck appeared "on the verge of" five to six years of strong growth, driven by its higher margin specialty franchises, particularly Keytruda and Hep-C. . . .

In the report BMO Capital Markets noted, "After discussions with a number of experts at AAIC, we are more bullish on MK-8931, and now assign ~50% probability of approval in 1Q-2019 with risk-adjusted sales of $4.8B by 2024. We have low expectations for the Anacetrapib REVEAL interim look this year, and estimate 35% probability of success in 2017. . . .

So, a little give and take there, in the finer details -- on Anacetrapib. But as indicated in that last link, that comes as no surprise to us -- so, onward.