Friday, November 29, 2013

O/T: ISON May Yet Live -- Latest SOHO Imagery -- "The (Now) Little Comet That COULD!"


UPDATED | December 3, 2013: It would seem that ISON is finally. . . ICE-OFF. We will miss ye, oh celestial sojourner.

“. . .A learned woman is thought to be a comet that bodes mischief whenever she appears. . . .

-- Fred L. Whipple

"Comets are like cats; they both have tails and do precisely what they want. . . ."

-- David H. Levy

Wilfred Campbell wrote about the "flaming star" [Haley's Comet] in his diary on April 13,1910: "I believe that the Comet has its appointed place and task in the universe. It may be a vast carrier of necessary elements or gases or other substances necessary to life on the planets so that they may revive or receive new life. No one can fathom the vast unplumbed deeps of the mystery of the universe. Our mind is finite, but the soul is wider in its dim consciousness of things outside its comprehension. . . ."

-- Carl F. Klinck, Wilfred Campbell: A Study in Late Provincial Victorianism


So, it seems more and more likely that ISON has survived, at least in parts, as it hit the 1,000 degree temps, and bent real hard, around the sun. It may or may not be visible to the naked eye at dawn now, come early December -- but it likely will be visible by telescope, during that time.



From NASA.gov -- then:

. . . .Continuing a history of surprising behavior, material from Comet ISON appeared on the other side of the sun on the evening on Nov. 28, 2013, despite not having been seen in observations during its closest approach to the sun. The question remains whether it is merely debris from the comet, or if some portion of the comet's nucleus survived, but late-night analysis from scientists with NASA's Comet ISON Observing campaign suggest that there is at least a small nucleus intact. . . .

Thursday, November 28, 2013

Merck (MSD Ireland) Closing Swords, 570 Jobs In North Dublin, Ireland Plant Within Six Months


Buried deep underneath the Thanksgiving feel good news stories -- here in the US, is a less sunny one, for my cousins on the Emerald Isle -- in Dublin. Swords is a legacy Organon facility -- and thus is also a legacy Schering-Plough facility.

Here is the Irish Independent.ie story on it -- do go read it all:

. . . .The factory, which employs 570 people, is the second to be closed here by the company, once called Merck Sharp & Dohme, this year as the global drugmaker shifts operations to the Netherlands, Belgium and the US. . . .

Around 130 staff will be made redundant in six months' time and the remainder will be "phased out" over three years. . . .


My thoughts, prayers and meditations are with you, at Swords. We send positive energy your way.

Wednesday, November 27, 2013

O/T: ISON Comet Watch -- Around Noon -- To A Bit After 2 PM EST Tomorrow



UPDATED: 1 PM EST -- IMAGE!





. . . .“I have realized; it is during the times I am far outside my element that I experience myself the most. That I see and feel who I really am, the most! I think that's what a comet is like, you see, a comet is born in the outer realms of the universe! But it's only when it ventures too close to our sun or to other stars that it releases the blazing "tail" behind it and shoots brazen through the heavens!. . . . That's why I enjoy taking myself out of my own element, my own comfort zone, and hurling myself out into the unknown. Because it's during those scary moments, those unsure steps taken, that I am able to see that I'm like a comet hitting a new atmosphere: suddenly I illuminate magnificently and fire dusts begin to fall off of me! I discover a smile I didn't know I had, I uncover a feeling that I didn't know existed in me. . . I see myself. I'm a shooting star. A meteor shower. But I'm not going to die out. I guess I'm more like a comet then. I'm just going to keep on coming back. . . .”

-― C. JoyBell C.

. . . .“It may well be on such a night of clouds and cruel colors that there is brought forth upon the earth such a portent as a respectable poet. You say you are a poet of law; I say you are a contradiction in terms. I only wonder there were not comets and earthquakes on the night you appeared in this garden. . . .”

― G.K. Chesterton, The Man Who Was Thursday


I am a geek. I'll confess it openly, here. Yes, I am completely and forever captivated by celestial events.

Tomorrow's could potentially be one we all remember for the rest of our lives, and our children, likewise. Or it could be. . . a dud. No way to know -- gotta show up, and see. But this one may unfold -- while we are preparing our turkey-feasts, here in the US -- around midday, Eastern tomorrow. Go here for near real-time updates, images and movies, from Comet ISON HQ -- starting at around 12:45 pm Eastern, on Thanksgiving Day.

Until then, do take a look at this YouTube, from NASA, about the possibility of being able -- very early on December 1 through 4, 2013 -- to easily see with your naked eye, the comet ISON (possibly quite a bright object) in the luminous yet clear dawn skies. [Of course, it may also disintegrate under the massive gravitational/tidal stresses of bending such a tight loop around our sun. We will have to wait and see, tomorrow. And that's eternally fascinating -- to me, at least.]



In Which Barron's Restates Our Analysis Of Two Weeks Ago


It is right jolly well (heh!) to see Barron's get a pretty definitive piece out -- on how the new US heart risk/cholesterol guidelines will affect various investors in the pharma sector, in the coming months. We would just note that we said very much the same, and more directly, over two weeks ago, now.

[A smallish housekeeping note, now: We will probably fall silent starting this afternoon, likely until Sunday or so -- Happy Thanksgiving, one and all.] Here is the Barron's story -- do go read it all:

. . . .Merck isn't so fortunate. Its drug Zetia, which blocks cholesterol absorption from food, is one of many drugs doctors prescribe in combination with statins for patients unable to meet the old cholesterol targets. But the new guidelines discourage using medications that haven't been shown to prevent heart attacks or strokes, including Zetia.

Zetia's patent expires in 2017, so the hit is short-lived. Still, sales totaled $2.6 billion last year. Also, the drug is an ingredient in Vytorin – a combination of Zetia and Merck's Zocor – which generated 2012 sales of $1.8 billion.

A clinical trial now underway could boost Merck's fortunes – it is studying whether Vytorin can reduce the risk of heart attack or stroke. The data are due in the fall of 2014. . . .


My only quibble would be that IMPROVE-IT may not be published until early 2015, if all the stars don't align now, pretty quickly.

And so ("irony alert," given the topic of tis post!), there is a huge wedge of sweet potato pie, with my name tatooed all over it -- come tomorrow afternoon -- warmed, with a big dollop of whipped cream. Carry on, citizens!

Tuesday, November 26, 2013

Whitehouse Station Ups The Quarterly Cash Dividend By A Penny (Per Quarter) -- $0.44 Now


Along with all the other measures undertaken by the executive team this year -- in order to support the stock price, while the company rides out its version of the big pharma patent cliff -- a dividend bump should come as no surprise.

Four cents more a year. See here:

. . . .[Merck's Board of Directors] today announced that the company's quarterly dividend [increased] to $0.44 per outstanding share of the company's common stock, up $0.01 from $0.43 per outstanding share paid last quarter. Payment will be made on January 8, 2014, to stockholders of record at the close of business on December 16, 2013.

"This increase in our dividend reflects our focus on creating value for shareholders and our confidence in Merck's future as we increase productivity and invest in our most promising R&D opportunities," said Kenneth C. Frazier, chairman and chief executive officer, Merck.

Merck last announced a dividend increase in November 2012, when the Board raised the dividend from $0.42 to $0.43 per common share. . . .


Carry on -- and if you like -- get it, while it's hot. Merck also today announced it received an FDA approval for a new dosing/formulation of Noxafil (posaconazole), now available as 100 mg delayed-release tablets. Good news, but plainly immaterial, overall.

Monday, November 25, 2013

Pre-Holiday FDA $99 Pot Boiler: Maybe I Should Have Done More Due Diligence. . . [Sorta' On, and Off, Topic]


Okay -- I'll admit it -- along with my daughter, I've become a customer, here -- we each spat into sterile test-tubes, and shipped our DNA off to a company run by one Anne Wojcicki, the wife of probably the best known of the Google founders, one Sergey Brin. That was a few weeks ago.

Now I am bemused to read -- (on the front page of the Gray Lady, no less!) that the company has no FDA clearance for the kits. I am also learning that some of the company's materials purport to make medical dianoses and causual predictions -- or at least, nearly purport to do so. Even so, I am still keenly interested in whatever the tests turn up about my ancestry, looking back ten or more generations.

So -- I am conflicted: I don't want my $99 back; I was prepared to discount a fair bit of the purported medical information, in any event. I do want to know what my chromosomes might tell me -- or even hint at -- about the roots of our family tree still buried by a deep, peaty bog, and then further enshrouded by the mists of time long settled, and our forebears' only oral traditions -- now forever silenced, in the same bog.

I for one am hoping that the results already in process at 23&me.com will be mailed out. Here's a bit of the New York Times story -- and the FDA warning letter, below the slug line in the pull quote:

. . . .In a scathing warning letter that the agency posted on its website on Monday, it said that 23andMe had failed to provide adequate evidence that its product, Personal Genome Service, provided accurate results.

“F.D.A. is concerned about the public health consequences of inaccurate results from the P.G.S. device,” the agency said in its letter.

Of the personal genome testing companies, 23andMe may be the best known, in part because it is backed by Google. The company is also run by Anne Wojcicki, the wife of a Google founder, Sergey Brin, though they are separated.

Its $99 test is sold only through the company’s website, and has been used by about half a million people. It analyzes the DNA in a saliva sample to tell consumers, among other things, whether they might be at a higher or lower risk of developing certain diseases. . . .

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

[11.22.13 FDA Warning Letter:]

. . . .Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. . . .


Fascinating. I will update this, as I learn more -- and receive my results -- as my view is that I have a contractual right to them. I've paid for them -- I'd like to see them. My understanding is that the company is using third party contractor labs to generate the reports, and my strong suspicion is that each of those labs have appropriate FDA paperwork. I suppose the kit could have been so poorly packed as to be contaminated upon delivery -- though it surely didn't look to be so. This will be a fun little side story, here.

The Ongoing Fallout Of Law 154 In Puerto Rico: Pfizer Shutters Facilities In Barceloneta By 2017, Too


Okay. Most pundits are pointing to the patent cliff (currently roiling all of the multinational pharma concerns) as the main culprit for the closings of facilities in Puerto Rico. That may not be the whole story though. No, I'd certainly also point to a change in the Puerto Rico tax code, called Law 154 (it greatly blunted the nearly half-century old tax incentives for pharma to manufacture its most-labor intensive components on the island). We've been over this here at length, in 2010, but pharma has been a driving force for robust employment on the island since the mid-1960s. Coincidentally, that is also when so-called tax haven status -- for manufacturing -- became fully operational -- from the point of view of U.S. multinationals, especially high margin multinationals. . . like pharma.

Now, half a century later, there is a vast, deep, well-trained labor force on the island. And post Law 154, that labor force has fewer and fewer places -- to ply its various trades. In short, a more gradual ramp up of taxes on multinationals might have been a wiser choice here, by the Puerto Rican legislature, in my opinion.

Here is but one version of this continuing "under-"employment story -- of a very well-trained, highly motivated and able workforce, on the island -- via InPharma -- do go read it all:

. . . .Pfizer says it intends to shutter a manufacturing facility in Puerto Rico just days after Merck & Co. announced it was reducing its footprint on the island.

The Pharma Giant has three Puerto Rican manufacturing plants but late last week Pfizer announced operations at its active product ingredients (APIs) and solid dosage products in Barceloneta are to be phased out by the end of 2017. . . .

The [Pfizer] Barceloneta facility manufactures 13 APIs - Amlodipine, Azithromycin, Celecoxib, Doxazosin, Exemestane, Fluconazole, Linezolid, Nifedipine, Parecoxib, Sertraline, Tolterodine, Varenicline, Latanoprost - as well as several branded drugs, including Cardura, Diflucan, Glucotrol, Minipress, Norvasc, Procardia, Tikosyn, Xanax/Halcion, Zithromax and Zoloft. . . .


I am amenable to the argument that Puerto Rico needed to begin to move toward a more "market-based" system of taxation of companies whose headquarters were not on the island (for its longer term economic prosperity to continue), but Law 154's "off the cliff taxation" may have been "too much, too soon". And that is extremely unfortunate -- for the people who've previously made their careers on the relatively high-skill, high paying jobs -- primarily in pharma (but also in electronics) there.

Sunday, November 24, 2013

More -- From An Anon. Commenter -- On "New" (Legacy S-P) Kenilworth HQ


A significant part of what's really satisfying about having an unmonitored, largely-anonymous blog like this, is that people with knowledge (real, experienced knowledge) -- over longer stretches of time -- become comfortable, here. They get a sense of what my take is on things. . . then in time, they feel free to share, as they know I'll never "out" them. There is no "on the record" from my readership, here ever (unless they say otherwise, explicitly).

And so, we are able to source items that MSM cannot. This is one of those, from an erstwhile commenter, below:

. . . .I never really thought that the Kenilworth site would have been split up as proposed. Many of the KW buildings are connected by an underground tunnel system. That makes security an issue in piecemeal sales. Also, when S/P built K15, it got a special single site environmental permit for the whole property due to the construction around a flood plain.

I'd bet that was the true reason they couldn't get Kenilworth town to approve the split sale.

November 23, 2013 at 2:59 PM. . . .


Could well be -- could well be. Thanks, Anon.! And, blow on, jazzman -- new masthead art, above -- for a Sunday, with my hot coffee.

Saturday, November 23, 2013

This Blog Will Quietly Monitor -- But Not Write Features On -- The Gender- And Pregnancy-Discrimination Would Be Federal Class Action Case


Back in May of 2013, I was asked by anonymous commenters to report on this case, right after the initial complaint was filed. I declined to offer an in-depth disclosure and analysis of the claims (filed in the federal District Courts in New Jersey), then -- instead waiting for Merck's right to formally respond, in a sworn Answer to Complaint. Law 360 alerted me to this latest development. On Wednesday of this week, Merck has done so -- Full Answer to Complaint (a 19 page PDF file).

Merck says regardless of what the complaint claims, all of the individual putative discrimination claims are too dissimilar from one another to warrant federal class action treatment. Merck points to highly similar (virtually identical) complaints against other companies, held by other courts not to be adequate to invoke the federal class action mechanics (primarily on lack of commonality). Without a careful review of the individual cases' evidence, and without discovery, it would be irresponsible to lend too much credence to the plaintiffs' assertions. At least for now.

Having said that, various legacy Schering-Plough managers are mentioned by name in the suit. And that is a matter of public record. Here is original 44 page complaint, as a PDF.

To be fair, Merck is regularly lauded, by numerous independent analyses, for being a very-mom friendly place to work. That doesn't mean the plaintiffs aren't right -- it just gives me a little pause.

Friday, November 22, 2013

New Feature, Here: "Two Good Reads" -- Every Friday, On Slow News Fridays


This Friday, I'll highlight this New York Times piece -- on what the Republican state governors are doing about the realities of the ACA of 2010 -- especially the Ohio governor. Good reading.

But I 'll feature this story -- a story so compelling it is hard to imagine that it is all fact, rather than a dose of tragic, and yet redemptive, fiction:

. . . .On May 7 of this year, I received a Facebook message from a woman named Stephanie Lee:

Hey Mark, I found that I have colon cancer today. I go for surgery Thursday morning. Please keep me in your prayers.

At the time, Stephanie was thirty-six and lived on the Gulf Coast of Mississippi, in the town of Ocean Springs. I had met her eight years before, when I worked with Tom Junod on a story for Esquire ("Mississippi Goddamn," November 2005) about how Hurricane Katrina had affected military families already enduring the calamities of the war in Iraq — the families whose suffering had been doubled by the wind and the rain and the floods. Junod and I met Stephanie at her grandmother's house in Lucedale, Mississippi, where she told her story. She was a small woman who worked as a pipe fitter at the Northrop Grumman shipyard, a fine-boned beauty with an intimidating reserve of tensile strength, a single mother whose face settled easily into stoicism and whose eyes lit up with challenge and dare. She'd spent most of her life bedeviled by inconstant men until she met Terrance Lee where she worked. He was a welder. He was younger than Stephanie, and quiet, but she thought he was like her in that he had a plan for making something of himself. Like her, he'd joined the Mississippi National Guard. They married and she e-mailed with him every night after he was called to Iraq in January 2005. She was seven months pregnant when his Humvee went over an IED. She was nine months pregnant when Katrina ravaged the Gulf Coast, and she got in her truck with her husband's .45 and drove nearly eight hours on snarled roads to Shreveport to find a generator so that her baby — Terrance's baby — wouldn't have to be born in darkness. Three days later, she gave birth to Marchelle, who never stopped reminding Stephanie both of her life with Terrance and of the impossibility of life without him. . . .


Just go read it all.

Thursday, November 21, 2013

As Is True With Politics, So Too, With Corporate Campus Real Estate: "It's ALL. . . Local"


The state-wide economic impact of Merck's worldwide HQ move "back" to Kenilworth (legacy Schering-Plough's global HQ) will be pretty moderate, actually -- as all the state wide taxes paid will stay, in state -- in New Jersey, proper.

However, it is hard to overestimate the "local" -- township, and county-level effects of such a complete dislocation. Summit's Mayor is worried, so too is Readington's council (the locus where Whitehouse Station is actually deeded, and titled). Local taxes pay for schools, and garbage pickups, and snowplows. It's all local -- and when the multinationals move -- the local economy takes a hit beyond the obvious job losses. The entire community shrinks. It is inevitable -- but it is sad.

Here's just a bit from NJ.com -- do go read it all:

. . . .In June, the governor vetoed legislation to give funding to towns that lose drugmakers and other companies whose departures may stress the tax base. Colin Reed, a spokesman for Christie, declined to comment and referred to the governor’s veto message, in which he lumped the measure with others that he said should have been part of annual budget negotiations.

Merck is seeking a buyer for its 88 acres (36 hectares) in Summit, which has Moody’s highest Aaa rating. Residents there paid an average property-tax bill of $16,051 in 2012, more than twice the statewide figure.

“We’re mildly concerned at this point,” said Mayor Ellen Dickson, 61, a Republican. “They are 7.2 percent of our tax base. They pay $9 million a year in real-estate taxes. They’re committed to paying the taxes through 2014, but of course they’ll be doing a tax appeal effective 2015.”

Kelley Dougherty, a spokeswoman for Merck, declined to comment on the company’s plans for the sites. She referred to an Oct. 1 news release that said the closures were part of worldwide cost reductions. . . .


We will keep you informed, here.

Merck's Simcere (China) Venture Loses Its Main Man -- To Aetna (China)


Well, with a long history as an ex-McKinsey & Co. China-based health care guru, Dr. Yehong Zhang (at right, in 2011) has all the proper pedigree for a multinational's leading man in China. And China for Merck, as we've previously noted, circa late 2011 -- might be as much as 25 per cent of all of Merck's revenue growth (come 2014). It is, in short, an extremely important emerging growth market.

Problem is, MSD China, via Simcere. . . no longer has him. He was the President of the operation there. He's been recruited away to Aetna, as President, China. That's bad news for Merck. Here's a link to the MenaFN.com press story -- and a bit:

. . . .Aetna reported on Wednesday the appointment of Dr. Yehong Zhang, Ph.D. as general manager of Greater China.

Effective immediately, Dr Zhang will oversee and lead the company's growth in China, Hong Kong, Macau and Taiwan. He will be based in Shanghai.

Most recently, Dr Zhang has served as CEO of Simcere MSD Pharmaceutical Co Ltd, a joint venture between Simcere and Merck & Co. . . .

Previously, Dr Zhang was a practice leader for McKinsey & Co's health care consultancy efforts in China as well as the China president for Merck and IMS Health. . . .


So it goes.

Tuesday, November 19, 2013

Why Health Care Reform Is Needed (ACA of 2010): Moms And Babies Are At "Appalling" Risk, In The US


Merck is bringing its developing world maternity initiatives to the US. That is both wonderful -- and terrifying.

How can it be that pregnancy related deaths have doubled in the United States since 1990? I would point directly to the reduced access to affordable health care -- particularly in the lower income strata of the US population. [Recall that the US is the most expensive place on Earth to give birth. That itself is a crime, given the plainly sub-standard job we are doing of keeping moms and babies alive.]

But, no, all I'll now suggest -- is that Mr. Frazier is to be applauded for having the courage to talk openly about a national disgrace. And -- more importantly -- to do something about it. Something that is already working in Uganda and India. That alone should be a sobering call -- to those who still oppose health care reform. From Reuters, then, a bit:

. . . ."As Americans, we simply should not accept that 46 countries have lower rates" of reported maternal mortality, said Merck Chief Executive Ken Frazier. The fact that U.S. pregnancy-related deaths have nearly doubled since 1990 is "appalling" and "something we ought to be ashamed of," he said.

"Given how sophisticated medical care is in this country, I think most Americans would be astonished" that almost 900 women die each year as a result of pregnancy or childbirth and 50,000 have close calls, Frazier said. . . .

The U.S. drugmaker launched the $500 million global program in 2011 to reduce pregnancy-related deaths, focusing on India, Uganda and other poor countries with only rudimentary healthcare systems. . . .

However, pregnancy-related deaths in the United States have risen from 7.2 per 100,000 live births in 1987 to 17.8 per 100,000 in 2009 (the latest year with reliable data), according to the U.S. Centers for Disease Control and Prevention. The rate among African-American women is more than triple that of white women: 35.6 versus 11.7 deaths per 100,000 live births. . . .


I applaud the US roll-out of a great initiative; I cringe that we need it so desperately, here.

Monday, November 18, 2013

Interim Data Due Out, This Morning, On Merck's Melanoma Candidate, Lambolizumab -- MK-3475


UPDATED | Noon | 11.18.13: At the outset, we should note that BMS's Anti-PD-1 melanoma candidate, nivolumab, is about two years ahead of Merck's MK-3475 candidate, here. Even so, the early Phase IB data shown by Whitehouse Station is. . . promising. It just may reach market a little too late to reap a full windfall, here. [Thus far -- and we are still in Phase I here (safety; smaller studies -- 165 patients) -- side effects include general fatigue, itching, rash, diarrhea, joint pain, headache and nausea. Signs of liver damage and kidney failure occurred in two patients. So far, no autoimmune disorders have presented -- see below the updated portion.]

This is a bit, from Bloomberg's coverage of the morning's Philly ICSMR meeting, then -- do go read it all -- 81 per cent are showing a continued one year response:

. . .“It looks quite promising,” said Eric Rubin, Merck’s vice president of oncology, in a telephone interview. “At one year, 81 percent of patients are alive, which in an advanced melanoma population is quite striking. Forty percent or less are typically alive at one year. . . .”


Do stay tuned -- a nice data set, all in all, given the severity of the study-patients' conditions. [END, UPDATED PORTION]

While we haven't seen the data sets to be released yet, a prior anonymous commenter asked if there would appear an elevated risk for autoimmune diseases in the MK-3475 co-hort. It is likely that this commenter has scientific reason to ask the question.

It is fair to suggest (as he does) that -- if you have late stage cancer, an elevated risk of a long-term autoimmune disorder may be an acceptable tradeoff -- as death may loom without an oncology therapy regime. Will this data show anything along these lines -- a statistically-significant elevated risk of autoimmune disorders? We will see.

Here is a bit of Merck's press release, from Friday evening:

. . . .Merck will present additional data from patients with advanced melanoma from the Phase IB trial of MK-3475 on Monday, Nov. 18 at the 10th International Congress of the Society for Melanoma Research in Philadelphia. MK-3475 is Merck’s investigational anti-PD-1 immunotherapy. The additional data are from PN001, an ongoing multi-center, single-arm open-label study evaluating MK-3475 monotherapy in more than 1,000 patients with diverse late-stage cancers (metastatic carcinoma), predominantly lung and melanoma. The data to be presented are for patients in the melanoma cohort. . . .


We will report whatever emerges from Philadelphia this morning -- to the extent that any of it contains any surprises.

Saturday, November 16, 2013

Tennessee Governor Haslam: Denying Poor People Basic Health Benefits Today, And, Why?


Okay - I'm officially disgusted. It's all dressed up in a paragraph of (falsely) compassionate posturing, but the upshot is both illogical, and criminally inhumane. This may be the most pathetic "reason" I've ever seen offered, in public discourse, by a sitting Governor -- for not accepting the ACA of 2010-alloted Medicaid expansion, in his state (which, by the way, is 100 per cent paid for by the federal government, through 2017).

Governor Haslam's logic -- such as it is -- runs that he should today deny several hundred thousand of his own poorest citizens basic health benefits -- even though they desperately need them, because at some potential future date, under some future new Presidential administration, he might not be able to keep them fully-covered, for free, in his state. So. . . don't ever give them coverage?! Deny all of them a minimum of three years' worth of very basic health care benefits?

Governor Haslam, your fellow Tennesseeans are quite literally dying, right now, in their homes, of advanced untreated heart conditions (of painful heart attacks and strokes), advanced untreated diabetes (going blind, and losing limbs -- before dying in agonizing pain), and cancers -- also wracked by unspeakable pain.

And the Governor Haslam answer is "I don't care that there is TODAY federal money to treat them." I don't care that they will die. I just don't want to face the politics of some distant future potential (not actual) retrenching of the subsidy for Medicaid, in my state. So let the poor die, today.

Here is the salient bit of a longish New York Times article, tonight, pointedly concluding that Gov. Haslam has missed yet another deadline to elect either the federal exchange system, or build his own state system. Instead, Haslam is trying to craft a "hybrid" solution -- one that is very likely a windfall for a select sub-set of his Republican political base: the private insururers in Tennessee. He is negotiating with HHS -- to use the Tennessee allotment of the Medicaid expansion funding available under the ACA of 2010 to "privatize" this low end care -- by allowing for profit insurers to exclusively provide the added coverage/eligibility, and likely on terms they themselves primarily set. Take a program of basic care for the poor, and make it a new profits generator, for entrenched wealth. Nice. Quoting the Gray Lady, then:

. . . .Deepening the angst over this decision is the state’s own history with managed health care. Tennessee’s homegrown health care system, TennCare, went through a wrenching downsizing in 2005, when the program was totally state sponsored. More than 170,000 people [were] thrown off the TennCare rolls. . . .

Even though the federal government is promising to pay 100 percent of the new Medicaid costs for the first three years and most of the costs after that, Mr. Haslam said he was worried that later administrations might renege on that promise.

If at some point we’re going to have to cut people off the rolls,” he said, “I’m not sure we’d want to go through that again. Our history makes us a little wary. . . .”


Here are three prior background pieces, on the sad, twisted and unneeded path Tennessee's Governor Haslam has chosen, to put (his potential) political gains ahead of crying, dying human needs. Just a few of my prior backgrounders -- here (we learned that -- if he'd tackle waste at for profit hospital systems operating in his state, like HCA and Anderson, he'd have plenty to cover these folks!). Here (on his endless waffling), and here (on other alternatives available -- all while he missed deadline after deadline).

In fairness, a part of this Tennessee mess -- is HHS Secretary Sebelius' fault -- for not holding his feet to the fire, sooner, after he missed numerous earlier deadlines (but HHS's main weapon, the cutoff of federal funding for existing medicaid patients, would simply punish Tennessee's poorest citizens, yet again, for Haslam's failure of leadership). We are now about 45 business days from when the system is to go live, and he won't decide what to do. Meanwhile, Tennessee's poorest citizens go without care, and many will die, all while he waffles for political gain. Disgusting.

Friday, November 15, 2013

Merck Announces Late 2104 Closures -- Of Puerto Rico API Facility In Barceloneta; Arecibo Also Impacted


UPDATED | 11.15.13 @ 5:35 EST: As an erstwhile anonymous -- but very well informed -- commenter points out, this was largely inevitable, when Schering-Plough was made the subject of a yard-sale, to Merck. First, there are generally too many facilities now under one corporate roof, in Puerto Rico, and (as we have explained here before, repeatedly -- now over three years ago). . . there is only a shadow of a tax incentive to locate large manufacturing facilities on the island, compared to even four to forty years ago. [In addition, the Las Piedras facility was a legacy Schering-Plough site, as the commenter notes.] All very sad -- but all still quite true. END | UPDATED PORTION

Well, this is all part of the previously-announced global footprint repositioning effort being directed from Whitehouse Station, but that is of scant comfort to the families in Arecibo and Barceloneta, Puerto Rico, tonight.

By late 2014, their employer, MSD, will have shuttered their plants -- and facilities. APIs are the precursor ingredients for drugs -- the raw materials, if you will. Here's a bit from the Calgary Herald (Canada) paper, that first sourced the news -- do go read it all:

. . . .The company said Friday that production in Barceloneta will end by late 2014 as part of a global restructuring. Merck said formulation and packaging operations at that plant will continue under a third-party contract.

The company also will consolidate formulation operations at its plant in Arecibo with another plant in the eastern city of Las Piedras, where it has invested more than $100 million in recent years to launch three new products. . . .


These sorts of "sad news" announcements almost always appear on Friday afternoons, so that they are long buried by the time the Monday morning news cycles start. So it goes, yet again.

Akorn Picked Up Merck's AzaSite® Rights. . . Sweet Deal!


While completely immaterial to Whitehouse Station's results and outlook, there are some good reasons to highlight this great deal, for Akorn, Inc.

So -- the folks at Akorn will make a killing with this line. Good for them! From The Street Insider, then -- a bit:

. . . .Akorn, Inc. announced that it has acquired from Merck, the U.S. rights to three branded ophthalmic products, including those product rights obtained through the acquisition of Inspire Pharmaceuticals, Inc., a subsidiary of Merck, for $52.8 million in cash. Products included in this transaction are AzaSite®, COSOPT® and COSOPT® PF. In addition, Akorn has signed a two-year supply agreement with Merck as well as a transition services agreement with customary terms. Akorn plans to ship COSOPT® and COSOPT® PF immediately upon close and expects to begin shipping AzaSite® in the first quarter of 2014.

"We are excited to announce this transaction which will further expand Akorn’s position as a leader in U.S. ophthalmology products," said Raj Rai, CEO, Akorn. "The addition of these branded products to Akorn’s portfolio strengthens our business and leverages our existing ophthalmic sales force and physician relationships. . . ."


Kudos go to Mr. John N. Kapoor, here. . . carry on.

Thursday, November 14, 2013

Just A Little More Complete Information -- On Various Pieces Of Propecia®/Proscar® Litigation -- From The Merck Q3 2013 SEC Form 10-Q


My early morning entry referred only to the federal MDL -- I'll toss up this update, as a new post, to give a sense of scale, here (there are only about one-fifth as many of these cases, as there are of the Fosamax® ONJ or Femur ones), and to include the state court proceedings. Only 20 cases allege cancers of any kind.

Here is the bit -- from page 21 of the Form 10-Q:

. . . . As of September 30, 2013, approximately 1,130 lawsuits involving a total of approximately 1,380 plaintiffs (in some instances spouses are joined as plaintiffs in the suits) who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia® and/or Proscar® have been filed against Merck. . . .

Approximately 20 of the plaintiffs also allege that Propecia or Proscar has caused or can cause prostate 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 MDL before Judge John Gleeson of the Eastern District of New York. The matters pending in state court in New Jersey have been consolidated before Judge Jessica Mayer in Middlesex County. The Company intends to defend against these lawsuits. . . .


There -- now you know.

The Merck Propecia® (Alleged Sexual Side Effects) MDL Is Slowly Gathering Steam


Thanks to an anonymous commenter on the backup blog, we will offer this long-overdue update on the federal Merck Propecia® litigation, this morning:

Yes, you are right, Anon. -- the Magistrate is holding an adjourned status conference on November 20, in MDL 12-2331, in the Eastern District of New York:

This is the alleged sexual side effects (primarily erectile dysfunction) MDL. We will report as a new post, any material development, but discovery is just getting underway here -- so it may be a bit before anything big shakes loose. And I'd not expect settlement talks will get anywhere, in earnest, until much more discovery has been completed.

. . . .ORDER granting (No. 138 in 1:12-md-02331-JG-VVP) letter application to adjourn. The 10/16/13 conference is rescheduled for Wednesday, November 20, 2013 at 2:00 p.m. Ordered by Magistrate Judge Viktor V. Pohorelsky on 10/3/2013. Associated Cases: 1:12-md-02331-JG-VVP et al. . . .


[My backgrounder, here.] Thanks for asking, and Namaste!

Wednesday, November 13, 2013

Merck CFO's "Body English" -- At Credit Suisse Yesterday? An Animal Health Deal Is Not As Probable As Consumer Health Deal. And, Maybe Neither One.


Of course, every one of these statements comes so heavily veiled, in qualifiers and hedging lead in language -- and exit -- language. . . not too much of anything, really, can be said with any conviction, here.

But, even so. . . Mr. Kellogg's remarks -- in Scottsdale, yesterday afternoon -- seemed to shade a little bit closer to a divestiture, partner or spin off related to non-North American Consumer Health businesses, at a minimum. And if I might step a bit further out on the limb, here, his remarks relative to Animal Health might be read as "Merck could potentially shed all of Consumer Health" -- before any of Animal Health would be on the block. But I could certainly be wrong. Here is the Credit Suisse hosted bit of "chin-waggle," in context:

. . . .Merck EVP & CFO Peter N. Kellogg:

. . . .And so, specifically, to the Animal Health and the Consumer business is these are, as you know, and I think you've highlighted as well, very attractive businesses both in terms of Animal Health and Consumer being in very exciting areas. But likewise, our businesses, I think, are very well positioned.

The Animal Health business is number two in the industry, has a tremendous portfolio of innovative vaccines and therapeutics. We do very strongly in the production animal space, everything from fish farms all the way up to cattle. We are not quite as strong in the companion animal space, but we have a very strong pipeline of innovation there that we think actually will play out quite well in the next few years.

So in that case, obviously, we're thinking about how do we maximize the value of that very strong business that has a global footprint? Are there opportunities to expand it? Are there opportunities to partner it or do other things? And so, we'll look at all options there. But we have always said that we think that's a really good business and we really like it, and it's a very strong performing business for us, both the topline and the bottom line. . . .

The consumer business, likewise, is a very good business. I would just highlight that it had very strong brand and performance in North America over the last few years, despite the fact that in three out of the four years, we've had a very strong competitive launch of a new product against Claritin. First, we had Zyrtec and then we had Allegra launching against it. So in many ways, if you look at the revenue performance, which has been good over the last few years, that's in the face of a very strong competitive series of launches that have gone against us. But yet, we've still held our position and grown with those businesses.

However, what's one thing that I think we've always recognized is that it is -- while it's very strong and outstanding performance in North America, outside of North America and the rest of the world, it's not quite as strong. Certainly, we have businesses in Russia, and China, and Brazil, and all the other countries. But it's not quite the same scale as we have in North America. So I think that has provoked some evaluation and people have thought about it, and I think certainly there's a lot of interest in consumer assets around the world. So we are currently evaluating that. . .


As ever, we will keep you posted. But I'd say -- on balance, Merck is thinking more deeply about a transaction (divestiture/spin-off) in the Consumer Health businesses, than the Animal Health ones, at least from Mr. Kellogg's "Body English", yesterday in Arizona. [My 2011 era backgrounder, here.]

Deeper, Clearer Analysis: Merck's Zetia® And Vytorin® Now Complete Their Fall From Grace, In US -- New Guidelines


In my haste to get the news out yesterday, I didn't make myself very clear, here. My apologies.

Under the new treatment guidelines announced last night, Merck's Zetia® and Vytorin®, will no longer be recommended for most patients, in most cases, at least here in the United States.

Now that specific goal numbers are de-emphasized, it will likely mean that statins will not ordinarily be supplemented with a second drug, in all but the most unusual cases. Statins are of course now generic -- Pfizer's Lipitor® having gone generic just a year ago.

So, the 2014 or 2015 outcome of IMPROVE-IT may not matter much anymore, at least here in the US. And, that my friends, could be material, to Merck's fortunes, longer term. Just to be clear. And so, the countdown timer, at left (curently at 381 days, and change), may become a dead letter.

Formerly "Feuding Cousins" Have Agreed To Part Ways: Merck No Longer Handles InSite's AzaSite® Opti Products


Regular readers will recall that about two and a quarter years ago, Merck closed on its acquisition of Inspire Pharmaceuticals. Inspire, in turn, had a pact to market InSite's AzaSite® eye products in the United States. And so -- on closing the acquision, that duty to aggressively promote AzaSite -- fell to Merck.

But there were stormy seas throughout apparently, with InSite suggesting that Merck wasn't spending heavily enough to promote AzaSite, and (it claimed) Zylet® -- a Bausch + Lomb product was gaining ground, against it. Merck responded by offering to pay more, and then made an additional marketing license payment.

Now we learn that Merck has decided to end the relationship, opting to quit -- rather than (likely continuing to) fight -- the B + L tide. Interesting. Merck made one final "true-up" marketing license payment to Insight in Q3 2013, and is now finished. Here is the Q3 2013 official report, from InSite, itself:

. . . .On August 1, 2013, Merck notified the Company [Insight] that it had ceased sales representative promotion of their ophthalmic products, including AzaSite, in the United States. The ophthalmic products, including AzaSite, will continue to be commercially available in the United States and physicians will be able to continue to prescribe the products for their patients. Merck’s obligation to make minimum royalty payments terminated on September 30, 2013. . . .


Some times, it's wiser to quit -- than fight. This was never going to be a material frnachise for Merck. So it goes. Finally, I'll note that this may be one time where a "Fast" Fred Hassan led company actually had a better product, on market, than the competing Merck-promoted one. Small world. Huh.