Thursday, May 31, 2012

Bloomberg Explores The Flip-Side Of My Memorial Day Post

So far, nothing huge on the Bernstein conference-call with Chairman/CEO Frazier and Luciano Rossetti (except for a reaffirmance that Frazier is not inclined to split the company back up -- but that is scarcely news, at all), so I'll take a moment to note this Bloomberg story. Do go read it all.

Over the long weekend, I pointed out that the supposed conservative think tank that came to the Merck stockholders' meeting, and complained about Merck's support of the Affordable Care Act was taking a simply silly position. After all, Merck should support political measures that advance its shareholders' pecuniary interests, first.

This morning, Bloomberg is asking a related, but broader question: Why does PhRMA (the pharmaceutical manufacturers' trade association) heavily support Republicans candidates who are opposed to federal coverage for pharma's birth control products? While we may quibble about which party provides a more favorable climate for businesses, generally -- it is almost beyond debate that fewer Democrats try to block legitimate support for family-planning programs. In fact, Democrats see the benefit -- to society -- of allowing women to control their own bodies and reproductive choices. That, in turn, reduces endemic, generational poverty.

But I digress. What do you think? Should PhRMA skew toward Democrats, in its donations -- given the importance of reproductive franchises to Merck, and Pfizer?

Here's a bit -- do go read it all:

. . . .Whitehouse Station, New Jersey-based Merck & Co. gave $7 million to Phrma in 2010, according to the company’s voluntary disclosures. The company’s contraceptive product NuvaRing brought in $486 million in revenue last year, according to IMS Health. A spokeswoman, Kelley Dougherty, didn’t respond to requests for comment. . . .

Interesting. And a very good thesis.

Wednesday, May 30, 2012

Merck Chairman/CEO Frazier Presents Live, At Berstein Research Tomorrow Morning

It is unusual for the CEO to be the presenter at these things -- under the new Merck regime -- so this might be worth a more careful listen. I'll have a live blog window ready to go, should something material jump-off. We may hear whether Merck has bid -- and, at what price -- for Amylin Pharma.

In any event, here's the presser:

. . . .Merck. . . announced today that Kenneth C. Frazier, Merck's chairman and chief executive officer is scheduled to present at the Sanford C. Bernstein 28th Strategic Decisions Conference in New York City on May 31 at 8:00 a.m. EDT. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .

We will tune in -- and may live blog portions of it.

Monday, May 28, 2012

"One Of these Guys Is NOT Like The Others. . . One Of These Guys, Just Doesn't Belong. . ."

What on Earth is going on here?

I am put in mind of the old PBS Sesame Street song -- as it continues -- from the headline verse, with: ". . .Can you guess which one is not like the others, before I finish my song?" See:

Last week (as I mentioned here), something called the National Center for Public Policy Research -- a supposed conservative think tank and political activism organization -- in the person of its General Counsel, Mr. Justin Danhof, showed up at the Merck shareholders' meeting, to again complain about money spent, primarily through PhRMA (by Merck -- and many others), in support of closing the donut hole, via the Affordable Care Act, and measures aimed at health care reform, generally in the United States.

The organization did so at several large public multi-national pharma companies last year -- most notably at Pfizer -- making Jeff Kindler their focal point. [All to no avail, obviously. No surprise there.]

This year, it seems Mr. Danhof has focused on Merck, to the exclusion of Pfizer -- (having not bothered to put in a shareholder proposal at all, at Pfizer) -- even though Bridgewater, NJ (Merck's meeting site) is a longer drive from DC, than Morristown, NJ (Pfizer's April 26, 2012 meeting site).

And so, it occured to me (in Sesame Street fashion!) over my coffee this morning -- to ask: WHY would CPPR do that?

Why, indeed? [If you are still in the dark, here, do play part two of the compare/contrast game, below!]

In any event, here's a quote from a press clip on the CPPR:
. . . .[General Counsel Justin] Danhof also questioned how much money Merck spent to support [the Afforable Care Act] -- specifically shareholder money -- noting that the pharmaceutical company contributed to a $150 million [health care reform] ad campaign from the Pharmaceutical Research and Manufacturers of America.

"This year we went again to see, now the legislation appears poised for a downfall next month when the SCOTUS decision comes out, if they had changed their position," Danhof says. "Merk's CEO, Kenneth Frazier, informed us they stood by their support and so that's why I titled the press release, 'Merck Triples-Down on Liberalism.' Last year they doubled; this year they tripled. . . ."

Okay -- now let's play the game, again: Can you guess which one, this time? [PhRMA members, below -- one and all!]

Well, there you have it: a conservative think tank and advocacy group that -- in this election year -- chooses to complain (repeatedly in the press) only to the public pharma company with a black CEO. I'd say I'm surprised, but the truth is that I've seen too much of this to be surprised by these sorts of republicans. And yes, that's a small "r". Now you know.

Finally -- it is also worth noting that -- even if we accept CPPR's contention, that Merck shouldn't lobby for such things -- in this case, the failure to lobby would harm the shareholders' pecuniary interests. Curious. . . indeed.

Friday, May 25, 2012

RUMOR: Whitehouse Station Bidding -- Up To $4B -- For Amylin?

It makes sense, but it is still far too early to verify the accuracy of these rumor pieces -- see this from Barron's -- quoting Bloomberg:

. . . .Merck. . . put in first-round offers for diabetes drug maker Amylin Pharmaceuticals, according to sources close to the private negotiations.

As Bloomberg is reporting the bids were for at least $25 a share, valuing the company at more than $4 billion, based on its shares outstanding as of April 26. . . .

An interesting diabetes-space play, if accurate (given Merck's Januvia/Janumet franchises). Do stay tuned -- and have a safe Memorial Day Weekend!

Wednesday, May 23, 2012

Merck Video: Annual Shareholders' Meeting, Including Q&A, Now Available

Not too much real news of note (at least not much not already covered on this website), but at about two-thirds of the way through the one-hour and 12 minute video, conservative zealots from something called NCPPR sharply question Merck's CEO over bogus claims that Merck struck a collusive deal to advance supposedly "unconstitutional legislation" (presumably, with President Obama) to help ram-rod health care reform through Congress. It might all be a bit of silly street theatre, if these NCPPR folks didn't actually believe their proffered nonsense.

[BTW: Irony alert! -- these conservatives show up -- at a capitalists'/stockholders' meeting! -- to complain that Merck (if true) might have done something in its stockholders' enlightened self-interest. Wild.]

The conservatives' vendetta against our 44th President won't let their own rhetoric on economic freedom, and/or the virtues of capitalism -- to say nothing of the actual facts -- get in the way of demonizing anyone who sides with the President -- on any issue, at all. Mmmmm -- Nutty-goodness!

Here is the punch-line of the designated conservative zealot's question:

. . . .[H]as your company put any structure or review in place to ensure that you never again promote legislation that violates the Constitution of the United States?. . . .

Objection, your honor -- the questioner assumes several facts. . . that aren't in evidence -- and that aren't actually. . . facts, at all. Enjoy.

Tuesday, May 22, 2012

Wall St J: Additional Study Confirms Fosamax® Femur Fracture Risk

We've been discussing the emerging evidence for increased risk of femur fractures, from long-term Fosamax® use (over three years, without drug holidays) right here, for over over two and a half years. [More background here, from 2010.]

And so, it is particularly gratifying to see the MSM come around -- to provide serious coverage of this emerging and important public health issue. From The Wall Street Journal, overnight -- a bit (but do go read it all):

. . . .Some women age 50 and older have been taking the drugs for years to prevent common hip, spine and wrist fractures caused by the bone-weakening disease osteoporosis. Yet a small number of these patients have broken a leg by such everyday actions as stepping off a curb, which has raised questions about whether the osteoporosis treatments were responsible.

The new study, published online Monday by the Archives of Internal Medicine, a publication of the American Medical Association, said it found such a link between the drugs and so-called atypical thigh fractures.

Researchers noted that studies support the overall benefits of these osteoporosis medicines to prevent fractures, even if the drugs are taken for only a few years. They also said this type of bone break is very rare. But they said the new findings add to evidence suggesting patients should reconsider taking the drugs after three to five years of use. . . .

As the overall number of Fosmax suits heads north of 2,500 -- we will keep an eye on this rapidly growing, and accelerating sub-class.

Wednesday, May 9, 2012 Is Right -- This Is Just A Little -- "Creepy"

So -- what happens when the No. 4 pharma (by revenue) in the world (think stodgy, old guys!) sets about re-inventing a consumer advertising-driven brand? And a 75 year old brand, at that? Mistakes. Will. Ensue.

To wit --, writing on ill-conceived ad campaigns, feels this one is a complete misfire. I'd be inclined to agree solely on the grounds that it may encourage more of the toddlers in tiaras subculture to seek a $25,000 prize by exploiting their own offspring. I am mostly unconvinced that it sexualizes little girls, but I am concerned that it leaves open associations like the second image below -- do click both to enlarge.

Back to Jezebel, then: do go read all of Jezebel's take on it -- but here's a bit:

. . . .Hey, parents! Have you always dreamed of your daughter being known worldwide as an oddly sexualized orange baby whose pants are eternally being eaten off by a dog? Well, your day has come, my friend! Merck & Company is reviving their classic "Coppertone girl" campaign with the "Little Miss Coppertone" contest. The winner gets to show their butt on the internet. Forever.

Through June 22, parents can submit photos of their daughters aged 2-7 (sons are BANNED!!!) to the Little Miss Coppertone Facebook page, where other parents and, uh, sunburned baby enthusiasts, can comment and bicker. Then a panel of judges, including some lady, will choose the finalists. . . .

To be clear, here -- I am not one of those who overreacts to such things, but I'd also honestly ask whether Whitehouse Station wants its flagship Consumer Health product aligned in popular culture with. . . SNOOKI?! Forget the nostalgia-angle, I think this co-brand parody on Snooki's new book cover (original image copyright Simon & Schuster) should really have Mr. Frazier re-thinking the whole lotion notion. Ouch.

What do you think? Do you even care? Should anyone care? Let me know. Finally -- in the interest of complete coverage, only -- here's a link to the Facebook contest page -- for all the tiara-wearers out there.

Tuesday, May 8, 2012

Merck CFO Presents In Boston At 8 AM EDT This Morning

We will see if he says anything interesting -- you may listen in by registering right here:

. . . .Peter Kellogg, executive vice president and chief financial officer and Nancy Thornberry, senior vice president and franchise head for diabetes and endocrinology are scheduled to present at the Deutsche Bank 37th Annual Health Care Conference in Boston, Mass. on May 9 at 8:00 a.m. EDT. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .

Check in if you like. I might.

"Mere Rumor" Reporting: Was The Celebrex® Playbook "Stolen" From Merck's Vioxx® Playbook?

Look very closely at the unaltered images at right (I left them small, and didn't reconstitute them in Photoshop, so that you could see the way each appeared on the drugmakers' websites at the time).

Now consider my erstwhile anonymous commenter's assertion, quoted below. Of course, no one is ever going to verify this on the record. And of course, Mr. Hassan and Ms. Cox will deny that they ever even suspected anything of these alleged contractors -- but it is a fascinating bit of intertwining, just the same. Consider:

. . . .Anonymous said...

I'm not sure if you've made mention in the past, Condor, but to bring some (Legacy) Merck color to the Celebrex fold, it is used as a lesson on information security. The story goes, and is retold countless times by senior management, that the third party contractors working on the marketing campaign for Vioxx were not careful with protecting the plans prior to launch and the packaging model was stolen and used for Celebrex.

Ever notice that the Celebrex logo is Merck's teal blue? Or the flair of the 'x' that resembles the reworked Vioxx 'x'? This IP theft allegedly delayed the Vioxx launch to accommodate the packaging changes that were suddenly needed when our marketing work showed up on Celebrex's packaging.

May 1, 2012 12:51 PM. . . .

UPDATED | More, from comments below:

. . . Anonymous said...

I assure you, Condor, this is the textbook example given in (Legacy) Merck information security training for dealing with third party contractors. To also clarify, the story is told as an external marketing firm did not properly protect the materials it had prepared for Merck. How or who, specifically, boosted the imagery is not part of the lesson. Did Pharmacia's team get it presented to them by another team at the third party marketing agency, unsuspecting that it was Merck's? Did another party, say a printer, courier or external contractor of the third party, boost it from the marketing agency and use it for its own benefit? No such conclusions are part of the training but all potential scenarios are discussed to expose the risks using third parties without proper information protection can bring.

May 8, 2012 3:26 PM. . . .

[UPDATED: To be clear -- I do believe it, Anon., but without on the record sources, I feel it only fair to present it as a rumor at this point -- especially since it at least nominally links Fred Hassan's time at Pharmacia, to his later deeds, in dealing directly with Merck, about the delay of the publication of the Vytorin study called ENHANCE. You'll recall that at the time of launch of Celebrex, a similar set of events unfolded, as a not-so-favorable Celebrex study was also only partially published/delayed -- allegedly by Hassan/Cox. Then all of Pharmacia was sold by Hassan and Cox -- to Pfizer.]

It may or may not be true -- but on its face, it seems possible -- the launch time-lines for the two drugs are close enough to make it plausible.

What do YOU think? Let me know in comments. It would be yet another piece of the tantalizing enigma that makes up Fred Hassan's legacy in pharma, if confirmed. Tomorrow, Peter Kellogg is at a dog and pony show at the Deutsche Bank Health Care Conference in Boston, at 8 AM EDT -- maybe someone clould ask him if he ever heard this one, echoing in the halls of Whitehouse Station. Hmmmm.

Merck BioVentures Made Part Of Institutional R&D, At MRL, Again

I am woefully late (almost two weeks!) in getting to this (and thanks go to one of my erstwhile anonymous commenters -- for reminding me to circle back to it!), but Merck's "venture-prenurial experiment" for bio-similar candidates has come to an whimpering end.

Merck BioVentures has been folded back into Merck Research Laboratories, and the head of the BioVentures effort has departed the company. [It is often true that big pharma finds small entreprenurial units don't fare well when left mostly inside the larger corporate fold. No, it seems that the more successful ones are completely spun-off from the mothership -- not left tethered -- hanging in black space, by the institutional umbilical cord. That latter model was certainly the impression I was left with -- when I visited the Merck BioVentures Boulder, Colorado facility some years ago.]

In any event, here's a bit of the InVivo Blog's story on it -- do go read it all:

. . . .There have been several bumps in the road. The company's first big biosimilar hopeful was a version of Amgen's Aranesp. That project was discontinued in early 2010. The company also had big plans for its biosimilar version of Enbrel, which it licensed in Phase III from Korea's Hanwha in June 2011. Only a few months later Amgen laid waste to those plans, announcing a 'stealth patent' that could keep Enbrel biosimilars off the market for another 15 years.

Biosimilars may indeed be a new kind of innovation, one that brand-focused biologics companies would be foolish to discount and one they seem to be tripping over themselves to embrace (see Amgen/Watson, Baxter/Momenta, Biogen/Samsung). . . .

Indeed. In addition, Merck's SEC Form 10-Q just filed this morning, and the number of NuvaRing (1,020 cases) and Fosamax (3,100 cases) lawsuits filed (at pages 19 and 21, respectively) are both up sharply over prior periods. More on that tomorrow.

Wednesday, May 2, 2012

File This Under "Trouble, A' Brewing" -- Among Pharma's Backwater Former "Second Cousins"

It seems InSite Vision released its first quarter 2012 results this morning. You may recall (and if you don't, see here) that almost exactly a year ago, Merck closed on its acquisition of Inspire Pharmaceuticals. Inspire, in turn, has a pact to market InSite's AzaSite® eye products in the United States. So, now that duty to aggressively promote AzaSite falls to Merck.

It seems that AzaSite is losing share to a Bausch + Lomb produced product called Zilet®. AzaSite sales are down 20 percent this quarter. With me so far?

Now, the "potentially-feuding cousins" twist -- you will certainly recall that the Ex-CEO of legacy Schering-Plough (also acquired by Merck), one "Fast" Fred Hassan, is now the chairman of the board of B + L [and that his former Schering-Plough buddy, Brent Sanders, is now the CEO of B + L]. Could it be that InSite Vision sees a chance to exploit the reputed to be "less-than-cordial" relationships between current Merck management and the legacy S-P guys (who -- federal court documents have averred -- sold a sow's ear labeled as a silk purse, to Merck)?

Or, could it be that the B + L product is simply. . . superior? Finally, could it be that the Hassan-led B + L is suddenly far more adept at selling "sizzle," rather than "delivering steak"? My guess is that it is a little bit of all of these things.

In any event, here is a bit of the InSite Vision presser -- do go read it all -- it plainly hints that it will blame Merck for the downturn, here:

". . . .The first quarter was one of progress against our product development objectives to advance innovative ophthalmic therapeutics that we believe will provide a meaningful benefit to patients," said Timothy Ruane, InSite’s Chief Executive Officer. "Enrollment in the Phase 3 DOUBle clinical study of AzaSite Plus and DexaSite for the treatment of blepharitis continues to go smoothly. We have recently conducted highly productive meetings with the Food and Drug Administration to discuss the regulatory path forward for both BromSite and DexaSite, which we expect will move forward into Phase 3 clinical trials later this year. However, we continue to be disappointed in Merck’s commercialization results for AzaSite as our royalties are down significantly from a year ago. We are in communications with Merck to identify and develop a strategy designed to restore AzaSite prescription growth as soon as possible. . . ."

Do stay tuned. You know we will.

Tuesday, May 1, 2012

Successor's Celebrex® Patent Dispute -- With BYU -- Settles

I note -- simply to complete the Celebrex® record, here -- that Pfizer, as the successor to Pharmacia last led by Fred Hassan and Carrie Cox (the last pharma before Schering-Plough!), has settled a multi-year series of patent disputes in Utah federal District Court overnight -- on confidential terms.

It is known that Pfizer will create an endowed chair for Dr. Daniel Simmons, an alleged largely uncredited co-inventor of the COX-2 inhibitor compounds -- one of which became Celebrex.

I should also note that the Hassan/Cox launch and marketing efforts on Celebrex, including allegedly delaying unfavorable study results -- led to what remains the largest criminal fine in multinational pharma history. Fabulous.

Here's a 12-page PDF of the last responsive pleading in the Utah patent dispute. [When one is reduced to arguing that press releases are confidential documents. . . one is likely on the losing end of an argument. Heh.]

From the Pfizer press release, then:

. . . .The parties to Brigham Young University and Dr. Daniel Simmons v. Pfizer Inc. et al., a matter in the United States Court for the District of Utah, Central Division, announce that they have reached an amicable settlement on confidential terms. As part of the resolution, BYU will establish the Dan Simmons Chair in recognition of Dr. Simmons' lifelong work and contributions towards advancing human health in a number of important areas including oncology, pain and Alzheimer's.

We are pleased to resolve this matter and the uncertainty of litigation and to be in a position to support Dr. Simmons' research efforts at BYU. . . .

Not with a bang -- but with a whimper -- it ends.