Sunday, February 28, 2010

Merck Claims Additional Patent Infringements -- Via Teva's Generic Eptifibatide Formulations [Nee Integrilin®!]


Or, more potential "pay for delay" underway, now at New Merck?

[This item has been completely rewritten, thanks to an overnight (astute and observant) anonymous commenter, below. . . . Editor's Note: lack of caffiene is my sole (and completely feeble) excuse. Schering-Plough has not sued Millennium, in any capacity -- the two are co-licensed to the IP contained in the patents in suit, here. . . .]

You'll likely recall that last Spring, Teva said it was going to sell a generic version of Integrilin® (Eptifibatide) -- and legacy Schering-Plough (now New Merck) responded with a patent infringement suit -- that suit covered the '825, '902 and '447 patents, as applied to a 2 mg/mL, 10 mL vial formulation of Integrilin. That suit is wending its way toward a trial date, late this year.

In a suit just filed last week, New Merck is suing Teva, again, because on January 5, 2010, Teva formally notified New Merck that it had filed an additional ANDA with the FDA -- cementing plans to sell a generic version of the 0.75 mg/mL, 100 mL vial formulation of Integrilin. The new suit also covers the '825, the '902 and '447 patents -- each of which is now held by (or through) New Merck (as successor to legacy Schering-Plough). Thus:

. . . .[From Teva's Answer to the 2009 Complaint in the 2 mg/mL, 10 mL vial infringement suit:]

AFFIRMATIVE DEFENSES


Further responding to Plaintiffs’ Complaint. . . Teva. . . asserts the following affirmative defenses and reserves the right to amend their Answer and Affirmative Defenses as additional information becomes available:

1. TPM and Teva USA do not infringe, and have not infringed, any valid and enforceable claim of the ‘825 patent, either literally or under the doctrine of equivalents.

2. The claims of the ‘825 patent are invalid and void for failure to comply with the requirements of Title 35, United States Code, including, but not limited to, one or more of Sections 101, 102, 103, 112, and/or obviousness-type double patenting. . . .

Yeh -- these twin suits should prove interesting. Will they go all the way to the mat? Or will they each settle early, in return for payments to Teva, and extended exclusivity (beyond the November 2011 end of the 30 month stay date -- the date for Teva's "at-risk" launch, of a generic covered in the 2009 suit)? We'll see. I bet the DoJ and FTC are both popping popcorn, and watching these unfolding flicks, very closely. This is still a $300 million a year franchise -- but likely declining, over time, as competitors' branded offerings enter the market, well ahead of the nominal 2015 patent expiry. Chief among these, in the next generation of clot-reduction drugs, is the Sanofi-Aventis candidate, otamixaban.

[And. . . Yes -- this is the answer to my earlier (Tuesday) trivia question.]

Saturday, February 27, 2010

"The Way Forward" -- On US Health Care Reform


This morning, in his weekly address, the President began to outline what he thinks should happen next, to reform US health care delivery (at about 2 minutes in):


Next week, President Obama's concrete, detailed blueprint for passage will be available -- but what is already clear is that Senator Harry Reid, Chairwoman Nancy Pelosi (and a host of others) will be formally "green-lighted" by President Obama to move a reconciliation bill through the US House -- based mostly on the already-passed Senate bill's provisions, but including a newly-created federal insurance rate setting authority, and hardening the repeal of antitrust exemptions for insurers.

The time-line for, and ability of the Republicans to come forward, and join the process constructively is about wink out, leaving them behind. That will leave them to explain -- on the campaign trail, this coming fall -- why they [in-]effectively attempted to block many of the very same measures they campaigned for just last year.

As we all now know, Republicans passed Newt Gingrich's "Contract With America" (what many subsequently referred to as the "Contract ON America" -- for its oppressive takings from the lower ranks of society, and its many generous gifts, to the wealthiest one percent) with 51 Senate votes -- through reconciliation. That was every bit as fundamental a re-ordering of the way we govern, at the federal level, as this health care package is. So it will ring ironic, and hollow, if the opponents of reform now complain that reconciliation is not an appropriate mechanism to enact important packages.

Next, up? Once again -- in a second curtain call -- Harry Reid and the Blenders!

Friday, February 26, 2010

Merck To Ramp Up Its Out-Licensing (And In-Licensing) Deal Volume: InVivo


Overnight, the InVivo blog ran a very solid interview piece, with a legacy Schering-Plough, now New Merck licensing executive, David Nicholson.
The bottom line is that the No. 2 drugmaker in the world is openly admitting it won't have the financial, logistical and human resources to develop all the candidates in its pipeline -- not without partners. These deals almost never raise front-end cash for the company spinning off the patents, know-how and technology -- but offer the prospect of additional royalty income to Merck, should one or more of the candidates ever reach market. That said, however, the deals always transfer most or all of the cash burden of doing the R&D, required FDA studies, pre-marketing and scale up away from companies like Merck -- and onto the licensing party -- which, in effect, frees up that cash, for other uses, inside Merck.

And so, this is actually a quite-sensible response to the accelerating rate of resource constraints all of pharma faces: create some "pure plays" in certain niche-spaces, and let investors bet on those, separate from the blended behemoth's overall assumed rate of return. Here is a snippet -- but do go read it all:

. . . . The company has some very attractive assets, but there is "no way Merck can afford to develop everything" in its R&D program. "Our R&D model is to generate a lot of output -- more than we can deal with. So we have to make some tough choices and it poses the question: What do we do with these other assets?" And who might be potential in-licensors? Take note: Merck's not only interested in talking to biotechs and small pharma -- its Big Pharma competitors could take a look too.

Details have yet to be worked out -- Merck's looking at the best business models and deal structures for outlicensing and "brainstorming" ideas. And the company is generating a list of out-licensing assets. . . .

Interesting -- especially the idea of partnering with potential competitors (that is what this shared Pfizer, Merck and Lilly cancer database deal, announced earlier this week, is all about). The InVivo blog article goes on to address Merck's in-licensing programs, as well. A must read for anyone interested in understanding Merck's future prospects, opportunitites and potential pitfalls.

It is obvious that if Merck is going to keep spending $600 million a year on advertising, it cannot afford to fund all of its pipeline, thus the graphic at right. [I should also mention that this is, in part, why I have long referred to the Merck-Schering-Plough deal as a "bust-up" -- it has always been clear, to the more experienced observers, that New Merck would have to take this tack, with both packets of intellectual property assets, and entire business units -- like Merial, Consumer Health and eventually, the Intervet Animal Health assets, too.]

Thursday, February 25, 2010

Yale University's Dr. Krumholz -- On The Lessons of Glaxo's Avandia -- For Merck


As the Forbes opinion by-line notes, Dr. Harlan Krumholz is a cardiologist and the Harold H. Hines professor of medicine and epidemiology and public health at Yale University. In the past, he did consulting for plaintiffs' lawyers suing Merck over Vioxx. This morning (yet again!), he hits the nail on the head. Do go read it all -- as the object-lesson applies to all of pharma -- here is the concluding snippet:

. . . .What is clear: Glaxo failed to disclose its own concerns even as it sought to discredit outside researchers who were raising questions about the drug.

This type of behavior is eroding the public trust in the pharmaceutical industry. The fix is simple: Once a drug is approved, all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it. There should be big financial penalties for withholding relevant information. Drug studies sponsored by industry must be truly independent--outside of company control. Companies should give outside investigators independence over every aspect of the study. There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science.

And on all sides there should be a commitment to protect against the intimidation of academics who are willing to raise questions about the safety and effectiveness of company products. The free flow of information about the effects of drugs and medical devices will best serve the public's interest. . . .

Indeed. In so many ways, big pharma -- in the last decade, at least -- has resembled nothing so much as a 350 pound man, tip-toeing around, in a dimly-lit, bare concrete-floored basement, and in six-inch stiletto-spike heels, to boot(!) -- with the that floor covered -- wall to wall -- in banana-peels, underfoot: "all in all, it was just a matter of when, not whether. . ." he would fall -- and break his back. Yeh -- it's been like that.

[Image, above right, is from my story detailing the new whistleblower protections that all Merck employees garnered -- when the bust-up transaction closed, as a result of Schering-Plough's (and legacy Merck's) various DoJ plea bargains. Either the companies will choose to disclose voluntarily, or their employees will begin to blow the whistles. Or there will be more legislation.]

Wednesday, February 24, 2010

Watch President Obama's Health Care Reform Summit -- Right Here, Live Tomorrow. . . .


Streaming ARCHIVED live video-feed [see below, or if you cannot see it, simply click this link], beginning at 10:00 am EST, tomorrow, Thursday, February 25, 2010 -- from the www.whitehouse.gov website:




We're underway -- with some selected live-blogging:
▲ Rep. John Dingell (D, MI), sums it up -- his father first started a bid for health care for all, almost 60 years ago, now. He is suggesting that a simple majority is enough -- it was enough for the "Contract with America" nearly twenty-two years ago, now. And, that was at least as fundamental a change in our ways of governing, at the federal level. [I was off the grid with other duties.]

▲ Lunch recess now; US House members need to reach the floor, for a vote -- buses waiting. Back in an hour.

▲ President Obama is forcefully making the point that Rep. Eric Cantor's (R., VA) goofy talking points (2,700 pages is too much complication, out of Washington, DC!) are not advancing the agenda. Obama: "We could eliminate the FDA, and drug prices would come down -- but a lot more people will die. Guaranteed." Let's move beyond the posturing Eric.

▲ Now Kathy Sebelius (D., HHS Sec'y, former Gov., KS) is deriding the monopoly powers of insurers. Problems with high-risk pools -- must reform the entire system, using exchanges, not the bandaids of transitions. [Missed an hour of the intervening cross-talk.]

▲ Sen. John McCain (R., AZ) is still lost in his talking points -- from the last campaign. The President reminds him that the "election is over, John" -- and this is not a "Fox-News split screen moment". Let's move forward, and talk about common ground, not keep harping about perceived slights in the process.

▲ Sen. Max Baucus (D., MT) says "we are -- Republicans and Democrats -- pretty close to bridging all important disagreements" -- including buying insurance, across state lines. [I missed some of the dialogue, earlier.]

▲ Rep. Steny Hoyer (D., MD) on the right for every American to have health coverage.

▲ Sen. Tom Coburn (R., OK) up next. . . . talking about "bad medicine" -- and how we ought to treat the disease, not the symptoms. Agreed. One in three dollars spent on health care does not involve care for patients. Again, let's get at that. He is appropriately focusing on prevention -- I agree.

▲ Alexander is wrong about the cost of premiums increasing. Obama explains that Republicans are using "apples to oranges" comparisions -- and the CBO has said that "apples to apples" insurance premiums will drop by 12 to 14 percent, over ten years.

▲ President Obama is trying to find areas where both parties agree -- and build from those points. Back to health care insurance exchanges -- similar to Republicans' idea of letting insurance companies offer coverage across states, and purchasers to buy outside their state.

▲ 750,000 personal bankruptcies, in 2008, due to out of control health care bills -- that is unacceptable.

▲ Sen. Reid explaining the facts of the donut hole -- and the long term devastation of stopping meds mid-year. He tells Lamar Alexander that Alexander is not entitled to his own facts. Reconciliation was used 21 times in the past two decades -- most notably, on Newt Gingrich's Contract with America -- a vast sea-change in our governing approaches.

▲ Sen. Harry Reid (D., NV) explaining the devastation of post-hoc denial of coverage for a cleft palate surgery, for his infant -- the infant was claimed to have a pre-existing condition (called a birth defect), so the insurer retoractively denied coverage -- the family now owes $90,000 -- that the insurer originally had agreed to pay. Shameful.

▲ Chair Nancy Pelosi (D., CA) lauds the BI-PARTISAN vote yesterday in the House, to REPEAL health insurers' antitrust exemption. The Senate has passed such a bill, as well -- and the President has said he will sign it. So, buckle-up! -- the Sherman and Clayton Acts apply, once again, to insurers.

▲ Now Alexander is expressing fear of reconciliation process. He quotes all the opponents of Bush-Cheney's (prior) jamming efforts of the past eight years. What he ignores is that, in the end, Republicans did just that -- over the last eight years. Now is a time to act, not "start over".

▲ Alexander offers cannard of health care insurance profit limits. What he ignores is that insurance should be a public good, and thus profits should not even be relevant -- so, the comparison is senseless.

▲ Alexander suggests the problem is just too big to be addressed in one comprehensive stroke -- he'd like bit by bit approaches (to allow all the vested interests in get their pet projects in) -- now onto complaining about the lack of tort reform. Plllleeiiieizzz.

▲ Lamar Alexander (R., TN) would like to "start over". He says we should focus on "costs" -- not necessarily reform of the system.

▲ Mr. Obama hopes this is not simply political theatre. "Let us have a real dialogue -- not an exchange of talking points." Indeed.

▲ Describes health care insurance exchange -- and a proposal to end pre-existing conditions exclusions, primarily. Now wrapping up his introductory remarks.

▲ Nods to McCain, Grassley, McConnell and Enzi -- nice touch. . . .

▲ The President offers personal health care insurance horror stories -- from the end of Mr. Obama's mom's battle with ovarian cancer, most pointedly.

▲ Goodness, Mr. Obama is much taller than Henry Waxman -- he shakes hands with all attendees -- now into Mr. Obama's opening remarks.

▲ Just waiting for the video feed, but all looks good [moderately -- and pleasantly -- shocked that all my code packets appear to be running smoothly in Blogger!]. . . .

Earlier, from the Summit site:
. . . .The President's proposal will make health care more affordable, make health insurers more accountable, expand health coverage to all Americans, and make the health system sustainable, stabilizing family budgets, the Federal budget, and the economy:
▲ It makes insurance more affordable by providing the largest middle class tax cut for health care in history, reducing premium costs for tens of millions of families and small business owners who are priced out of coverage today. This helps over 31 million Americans afford health care who do not get it today – and makes coverage more affordable for many more.

▲ It sets up a new competitive health insurance market giving tens of millions of Americans the exact same insurance choices that members of Congress will have.

▲ It brings greater accountability to health care by laying out commonsense rules of the road to keep premiums down and prevent insurance industry abuses and denial of care.

▲ It will end discrimination against Americans with pre-existing conditions.

▲ It will end "pay to delay" deals that cost consumers billions in higher drug prices.

▲ It puts our budget and economy on a more stable path by reducing the deficit by $100 billion over the next ten years – and about $1 trillion over the second decade – by cutting government overspending and reining in waste, fraud and abuse. . . .

Depending on my schedule tomorrow, I may offer some live-blogged commentary. Feel free to offer your observations, in the comments.

Trailing 30 Days' NYSE Trading -- 73% Bearish on "New" Merck


I'll let the chart tell the story (click that link -- for an updated view, any time after today), despite this morning's smallish uptick:


. . . .Personally, I be very surprised if Merck gets any boost at all -- from the President's all day, wall-to-wall, televised sessions, tomorrow. . . .

So the puts should stay on, I guess -- at least to, and possibly through, Friday's witching hour. We'll see.

Tuesday, February 23, 2010

Another Voice -- In Favor Of The Senate/Obama Proposal to End "Pay For Delay"


The Wall Street Journal's Brent Kendall is reporting that a federal District Court Judge, Thomas Thrash Jr., sitting in Atlanta, has rejected attempts by the FTC to invalidate as unlawful a recent generic patent infringement settlement agreement -- also more-than-occasionally referred to as "pay for delay" agreements, since they keep generics off market for a period of years, typically in return for payments (or other valuable concessions) from the branded pharmaceuticals company. Judge Thrash tossed the FTC complaint.

The head of the FTC is right, with his quoted reaction, here:

. . . .Richard Feinstein, head of the FTC's bureau of competition, said the ruling was "obviously disappointing," but said the decision underscored the need for a legislative solution, such as the prohibition included in Obama's health-care proposal.

"A new law is the quickest and most effective way to serve the interests of the millions of U.S. consumers who take prescription drugs and deserve unfettered access to lower-cost generic alternatives," Feinstein said. . . .

Quite so. Add to this Mr. Obama's support for a repeal of the health insurers' anti-trust exemption, and there may yet emerge some real change -- toward fairer health care delivery systems, in the United States.

[Trivia challenge: Can any reader identify the generic name for the compound shown at left in the above graphic? I'll take its brand name as an alternative answer, for partial credit.]

LATER, STILL: An mp3 audio link to NPR's Scott Hensley, on how pay for delay works, and what it's all about -- a simplified primer, of sorts.

Former Schering-Plough CIO Lands -- At GEIS's Spinoff Co., GXS


GXS (which is short for what was once "Global EXchange Services" Inc.) is a privately-held B2B e-commerce firm in which GE still apparently owns a ten percent stake. GXS recently announced plans to merge with Inovis, in a transaction GXS tells us will "create the world’s premier service provider exclusively focused on B2B e-commerce and integration". Um, Okay. Karl Salnoske, former CIO of Schering-Plough was named GXS's CIO overnight:

. . . .Before joining GXS, Mr. Salnoske was the CIO at Schering-Plough, a global pharmaceutical company, where he managed a staff of over 1700 and the company’s global IT infrastructure. At Schering-Plough, he was responsible for driving change across the organization through a series of strategic business initiatives enabled by IT.

Prior to Schering-Plough, Mr. Salnoske was President and CEO of a start-up software company (Adaptive Trade). Mr. Salnoske also served as Vice President in IBM’s Global Services division where he was responsible for e-business services, including the B2B and EDI services. At IBM, he co-led the team that developed the Ariba/i2 relationship to jointly enable electronic market places. As a General Manager in IBM's Software Group, Mr. Salnoske developed and launched IBM’s e-commerce software suite, WebSphere Commerce.

Before joining IBM, Karl was a consultant at McKinsey & Company, Director of Network Management Products at Telenet, and a Manager of Systems Development at Exxon Office Systems. Mr. Salnoske received a bachelor of science in electrical engineering from Virginia Polytechnic Institute. . . .

Inovis must also already have a CIO, right? Inovis does -- though it calls the role Chief Technology Officer. His name? Erik Huddleston. That is to say, I wonder how long this relationship will last -- for Salnoske, as CIO, once the merger occurs. [Finally, in grumpy fashion, allow me to note for the record that naming companies solely by initials is a generally unhelpful marketing communications approach. GXS, GEIS, EDI, B2B, EDS and on and on.]

Monday, February 22, 2010

Lesson One: President Obama's Plan To End "Pay For Delay"


Just last night, I warned that pharmaceutical manufacturers were approaching a "bright yellow danger-zone" -- where the confluence of rule-bending, opponent bullying and excessive profiteering of the last two decades would put the industry in the President's crosshairs, for new, broad and corrective legislative solutions. This morning, President Obama's plan does just that -- at page 7 of this PDF.

I think the sea change I've been predicting repeatedly since Novemeber of 2008 is arriving in earnest, this morning -- and pharma stock prices on the NYSE are showing the real effects of it:

. . . .Preventing Delays in Access to Generic Drugs.

Currently, brand-name pharmaceutical companies can delay generic competition through agreements whereby they pay the generic company to keep its drug off the market for a period of time, called "pay-for-delay." This hurts consumers by delaying their access to generic drugs, which are usually less expensive than their branded counterparts. The Federal Trade Commission (FTC) recently estimated that this could cost consumers $35 billion over 10 years. The President's proposal adopts a provision from the bipartisan legislation that gives the FTC enforcement authority to address this problem.

Specifically, it makes anti-competitive and unlawful any agreement in which a generic drug manufacturer receives anything of value from a brand-name drug manufacturer that contains a provision in which the generic drug manufacturer agrees to limit or forego research, development, marketing, manufacturing or sales of the generic drug. This presumption can only be overcome if the parties to such an agreement demonstrate by clear and convincing evidence that the pro-competitive benefits of the agreement outweigh the anti-competitive effects of the agreement. The proposal also requires the Chief Executive Officer of the branded pharmaceutical company to certify to the accuracy and completeness of any agreements required to be filed with the FTC. . . .

This presumption of unlawfulness already appears in the Senate version, though in a slightly altered fashion from the President's language. It also varies from, but dovetails with the DoJ's currently renewed focus on prosecuting the authors of such collusive agreements -- by conferring important new evidentiary shifts, in favor of the DoJ's cases, on a prospective basis.

Atta' boy, PhRMA (under Billy Tauzin's "leadership", in particular) -- "doin' a heckuva' job," here! Next up? Reimportation, I bet.

Sunday, February 21, 2010

A Lesson Here -- For Big Pharma -- Ignore Fairness Long Enough, And Legislation Ensues


As President Obama frames the debate for his "Summit on Health Care" scheduled for Thursday -- there is a clear lesson being taught (again! -- think about the new federal rules essentially ending investment banks as we knew them in the previous 16 years). True enough, the insurer regulations strike a populist note, but they are also born of decades of health insurers' excesses: not playing fair; cutting corners and bullying opponents -- and, in large measure, taking advantage of the crazy-quilt of state-by-state insurance regulatory authorities. That time is ending, now -- with an exclamation point, too.

So -- that punctuation mark? A new, uniform, federal set of health insurance rate regulations. The President's weekly address set out a plan to regulate health insurance rates, at the federal level. And insurers like Anthem have only themselves to blame. There is a similar lesson here for big pharma -- bend the rules too much, and for too long -- and you'll be next:

. . . .Some Republicans want to allow Americans to purchase insurance from a company in another state to give people more choices and bring down costs. Some Republicans have also suggested giving small businesses the power to pool together and offer health care at lower prices, just as big companies and labor unions do. I think both of these are good ideas -– so long as we pursue them in a way that protects benefits, protects patients, and protects the American people. I hope Democrats and Republicans can come together next week around these and other ideas.

To members of Congress, I would simply say this. We know the American people want us to reform our health insurance system. We know where the broad areas of agreement are. And we know where the sources of disagreement lie. After debating this issue exhaustively for a year, let’s move forward together. Next week is our chance to finally reform our health insurance system so it works for families and small businesses. It’s our chance to finally give Americans the peace of mind of knowing that they’ll be able to have affordable coverage when they need it most.

What’s being tested here is not just our ability to solve this one problem, but our ability to solve any problem. Right now, Americans are understandably despairing about whether partisanship and the undue influence of special interests in Washington will make it impossible for us to deal with the big challenges that face our country. They want to see us focus not on scoring points, but on solving problems; not on the next election but on the next generation. That is what we can do, and that is what we must do when we come together for this bipartisan health care meeting next week. . . .

New Merck CEO Dick Clark, and (Pfizer) CEO Jeff Kindler -- and whomever you two next appoint to lead PhRMA -- are you "getting this"? I sure hope so -- for your shareholders' sakes, if none other. [Yes, my graphic above suggests that I think reimportation will be back on the table -- and soon.]

Saturday, February 20, 2010

On Tim Anderson's "Solution" For The September 2010 Remicade Arbitration


I think to be fair to the Sanford Bernstein analyst's point, in Jim Edward's (B|Net Pharma's) latest -- it should be mentioned that Tim Anderson of Sanford Bernstein probably meant handing off substantially all of the (legacy Schering-Plough) Consumer Health business franchises to Johnson & Johnson, in return for retention of at least some of the non-US distribution rights to Remicade and Simponi.

As Tim (and Jim) well know, the wrinkle here is the amount of overlap between J&J's consumer health offerings, and the New Merck's set of offerings. It would be more than a notion to try and clear this through the FTC's Hart-Scott (antitrust) review staffers. In any event, it is an interesting thought, per Jim Edwards:

. . . .[New Merck] could give Claritin and its other consumer brands to Johnson & Johnson (JNJ) in exchange for keeping some of its rights to Remicade, the $2.3 billion arthritis and psoriasis blockbuster that the two companies market jointly. [Ed. Note: Simponi likely doubles this franchise's size, over the longer term.]

That’s a speculative solution to the ongoing legal fight between Merck and J&J proposed by Tim Anderson, an analyst at Sanford Bernstein, in a recent note to investors.

The two companies are scheduled to enter arbitration in September. Anderson believes they’ll settle before then. . . .

I don't -- and I just don't see J&J making this Consumer Health swap deal.

Importantly, I think it unlikely that J&J will settle prior to (at least) seeing how the New Merck presentation to the arbitration panel (backgrounder there) plays out. If William Weldon feels his own case before the arbitrators is shaping up to be weaker than expected (based on the demeanor of the arbtrators, and the questions they ask), he can always offer an olive branch at the conclusion of the September 2010 hearing dates. That would be more in keeping with his negotiating style. He tends to want to see the other side's hand -- all cards, face up -- first. Then he makes deals. Consider here that, as the enigmatic "Company X" negotiator, in the SEC filings intitially disclosing the Merck-Schering-Plough transactions, Mr. Weldon (for J&J) ultimately up and walked away, without so much as making any firm offer -- after seeing quite a few "vest-held cards" -- i.e., due diligence materials.

Of Paxil -- And Still, A Salmon May Rise. . . .


Here is the latest Paxil opinion piece, by Evelyn Pringle (do go read it all) -- here is a snippet:

. . . .The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. "There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further," he said.

On October 14, 2009, the American Lawyer reported that the plaintiff's lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. "They said the fact that GSK never adequately studied their own drug was a big deal," Tracey said. "The animal testing they did showed that they had a potential problem, and they didn't follow up with adequate studies on animals or humans. . . ."

There are some striking similarities here -- more to come.

Friday, February 19, 2010

New Merck's Media Spend: $600 Million A Year -- Wow.


That's about $1.64 million per day, every day of the year. That's also about $1,100 a minute, for every minute of every hour, of each of those days. Wow. AdWeek tells us that the $600 million per year New Merck ad budget is the subject of a multi-agency "bake-off" -- to determine which firm(s) will win the ad work, post the Schering-Plough bust-up transaction's closing, thus:

. . . .Pharmaceutical giant Merck & Co. has called a consolidation media review after completing its merger with Schering-Plough, according to sources.

Combined estimated U.S. ad spending on the account is close to $600 million. Merck spent close to $520 million from January through November 2009 on measured media, while Schering-Plough spent $55 million during the same period, according to Nielsen. Those figures do not include digital spending by the firms.

Incumbents on the Merck business include Interpublic's Draftfcb and Initiative, which are participating in the review, per sources. Draftfcb handles planning and some buying, including digital and print. Initiative handles TV buying.

One incumbent on Schering-Plough is Havas' MPG, which is also said to be pitching. . . .

Wow. That's a lot -- more than half a billion dollars, to be spent on pitching products doctors are supposed to want to prescribe independently, as live-saving medicines, on their own merit -- without need of patients asking after them, and driving pull-through.

I do understand that some of this is for institutional ad spending -- but really, $600 million? Wouldn't R&D be a more fruitful vineyard for such expenditures (except maybe $10 million of it, allocated to institutional advertising)?

NY Legislative "Hold" Placed -- On Proposed "Secret" Gardasil Vaccinations, Of Minors


Ed Silverman, over at Pharmalot, has the story:

. . . .This bill was held in the [New York State] Senate Codes Committee on February 9, 2010 at the request of the sponsor. During this time, with the input of constituents and advocacy groups, the sponsor will have the opportunity to improve and clarify the bill’s language. . . .

This bill (more background) is unlikely to reach the floor of the New York legislative chambers any time soon -- or at all -- given its manifold constitutional infirmities. One cannot constitutionally legislate-away fundamental rights, in vague terms. And these -- in the current form, at least -- encompass the vaguest of terms. This one is plainly DOA.

One Remedial Benefit -- Of the Obscene Packages Given Hassan, Cox and Bertolini, et al.?


Overnight, New Merck filed a rather-stealthy SEC Form 8-K, in which it disclosed (in very turgid tax-lawyer speak) that the board's Compensation Committee has eliminated the IRS Section 280G "tax gross-up" payment provisions in Merck executives' golden parachutes -- as well as installed a "second trigger", in its stock options. The "double trigger" means that the executive must be involuntarily terminated without cause (as opposed to resigning voluntarily, like Ex-CEO Fred Hassan, Carrie S. Cox, Bob Bertolini, Brent Saunders, Tom Koestler and Tom Sabatino each did), within two years of a change in control event, before the options will instantly vest, and become exerciseable.

Both of these are responsible changes -- and may also, in part, be attributable to the outcry over financial executives' pay-packages, of late. However, given that New Merck is now footing the 280G tax bill (of perhaps an additional $43 million, on Ex-CEO Hassan's perhaps $205 million golden parachute), I think it fair to infer that the Ex-Schering-Plough payments -- probably near $600 million, all-in to the top six, ALSO had something to do with this change. [Remember, Patricia Russo, an Ex-Schering-Plough Compensation Committee board member, carried over to New Merck, afterall.]

Here is the filed Form 8-K, from last night:

. . . .Tax Gross Ups Eliminated: On February 15, 2010, Merck & Co., Inc. (the “Company” or “Merck”) amended its change in control plan to eliminate gross-up payment in the event that excise taxes are imposed under Sections 280G and 4999 (“280G Excise Tax”) of the Internal Revenue Code of 1986, as amended.

Previously, Executive Committee members employed by Merck Sharp & Dohme Corp. (“MSD”), a wholly-owned subsidiary of the Company, were provided with gross ups for 280G Excise Taxes imposed in the event of or threat of a change in control of the Company (or, until November 3, 2010, of MSD). The Compensation and Benefits Committee (the “Committee”) of the Company’s Board of Directors (the “Board”) amended the Merck & Co., Inc. Change in Control Separation Benefits Plan (the “CIC Plan”) to provide that Executive Committee members will be treated in the same manner as other participating executives. That is, payments that become due under the terms of the CIC Plan will be reduced if doing so would result in the participant retaining a larger amount of his or her benefits as compared to receiving his or her full benefits and paying the 280G Excise Tax. Under the amendment procedures of the CIC Plan, this amendment will not apply if, generally, a change in control occurs before February 14, 2011.

Double Trigger Vesting of Options, RSUs Adopted: Also on February 15, 2010, the Board amended the Merck Sharp & Dohme Corp. 2007 Incentive Stock Plan (“MSD 2007 ISP”) to provide that options (other than certain performance options) and Restricted Stock Units (“RSUs”) granted thereafter generally will vest upon a change in control only if the grantee’s employment is involuntarily terminated without cause within 24 months following a change in control. Previously granted options and RSUs generally vest immediately on a change in control. If options and RSUs are not continued after the change in control, the prior treatment is unchanged. . . .

One small step at a time, I guess. As of the last day of trading of old Schering-Plough, here is what the "Top Six, newly-departed" were to receive -- but this number has risen as Merck's stock price has increased from about $32 to $37. For Mr. Hassan, the amount increases about $8 million, for every $1 increase in Merck's stock price. So add about $40 million to the below figures, for Mr. Hassan alone:

Ex-CEO Fred Hassan | $205 $175 million

Ex-CFO Bob Bertolini | $117 million

Ex-EVP Carrie Cox | $52 million

Ex-EVP Brent Saunders | $51 million

Ex-EVP Tom Koestler | $54 million

Ex-GC Tom Sabatino | $55 million

Ex-Schering-Plough Top Six Five Total | $534 million

To be clear -- I only updated Mr. Hassan's haul, not the other five, in the table -- but each of their hauls would probably rise about another 15 percent, if Merck stays above $37.

Astonishing.

Thursday, February 18, 2010

FDA Issues New Cautions On Two LABAs -- Including Merck's Foradil®


Merck acquired Foradil® from legacy Schering-Plough in the bust-up, last November. The Wall Street Journal is carrying Dow Jones' Jennifer Dooren, on today's news. FDA requires pretty stern warnings on Foradil, as it is, but it did stop short of saying it was unsafe in all cases. Here's a taste:

. . . .The U.S. Food and Drug Administration said it plans to implement new "safety controls" for a class of long-acting asthma drugs, largely by adding tougher warnings about the proper use of the drugs to the product labels.

The changes affect. . . Foradil, which is marketed in the U.S. by Merck & Co. . . . The FDA said the drugs should only be used for the shortest time possible "to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved." Patients should then be maintained on another asthma controller. . . .

Top FDA officials said they wanted to see the overall use of the products reduced, saying they are only needed by the sickest of asthma patients. . . .

In December 2008, an FDA advisory panel said the risks of two asthma drugs outweighed the benefits of their usage by children and adults.

The panel said the risks of. . . Foradil were greater than the benefits of the drugs as maintenance treatments. However, the panel stopped short of recommending the drugs not be used at all. . . .

Ouch -- Foradil (my December 2008 backgrounder, here): one more headache Merck acquired from Fred Hassan and Carrie Cox.

Wednesday, February 17, 2010

Did CEO Clark "Up" The Layoff Figure -- In The "Employees Only" Briefing, Yesterday?


At least one commenter, in the "employees only" briefing -- held shortly after the external Q4 2009 earnings conference call, says so. The employee claims that CEO Dick Clark has actually put the number of layoffs at over 20,000. That's up from the external 17,500 he mentioned to Wall Street, on the earnings call. And that 17,500 figure, is itself, up from the earlier 16,000 announced at bust-up closing time (Novemeber 3, 2009).

And that total would not include any spinoff, or other transactional layoffs, or already discussed plant and facility closings. So, 28,000 might be closer to the right number, inclusive of those items. Here is a link to that comment [edited for context and clarity] -- and a snippet:

. . . .In the employee business briefing, [CEO Dick Clark] said the following:

15,000 cuts due to merger

And 3,000 positions not to be filled

And another 2,500 cuts -- due to current initiatives (that's 20,500 jobs cut so far).

He also stated that [the 20,500] doesn't include future cuts from known plant closings and consolidations of duplicate functions (not included in the original 15,000) but the majority of Merck and SGP persons will be kept.

In [the commenter's] sarcastic view of [Merck], that means that they only need to keep 50.1% of each company's employees. . . .

Interesting. It would be a sub-optimal practice -- from a securities disclosure and compliance perspective -- to make inconsistent statements (or at least differing ones) about a material matter like layoff totals, internally, as compared to less dire ones, externally -- for Wall Street consumption.

Tuesday, February 16, 2010

Interesting Observation -- By "plm408" -- On Yahoo! Stock Chatboards


Given the increased number of position reductions disclosed today by Merck on the Q4 2009 earnings conference call, a discussion on the Yahoo! chatboard for the stock ensued. A frequent (and generally level-headed) commenter known as plm408 pointed out that most of the reductions were likely to fall outside of the legacy Organon's European operations -- for a specifically negotiated reason (with the EU authorities).

Here is a link to the original comment on Yahoo!:

. . . .one more thought on the loss of employees by Merck. When Schering-Plough purchased Organon, I believe Schering-Plough had to agree not to lay off European Organon employees in order to get approval from the EU. Merck will be tied to that agreement. Therefore, the reductions will come from the US, Canada, etc., not Europe. . . .

A cogent point, true enough, but if we are to believe Sanofi's CEO, any day now he'll announce that "New" Merial (wholly-owned by Sanofi, at the moment) will be "calling" all the Schering-Plough legacy Animal Health assets. [He said Sanofi was "highly likely" to exercise the call for the Intervet assets, last week on the Sanofi earnings call.]

That call option includes a very good chunk of "legacy" Organon Animal Health assets (from old Schering-Plough).

So, that "no fire" covenant with the ECC (and the EU, more broadly), would follow the employees -- that is, it would become Sanofi's to bear.

Now, that is good news for the Merck European Animal Health employees (except that now they'll work for Sanofi). But that would make all other legacy Schering-Plough, and New Merck European employees "fair game" -- as New Merck inevitably downsizes, marching to the 17,500 layoff goal.

17,500 Positions To Be Cut: 2010-12; EPS Inline; JVs Unwound




We're underway with Merck's year-end conference call, live:

▲ Ken Frazier remains "confident" about Isentress, despite Gilead's news this morning -- Gilead is still many years away from any launch. There was some stocking effect in the sales, in Q4 2009 -- especially Januvia.

▲ Seamus Fernandez, at Leerink Swann -- foreign exchange benefits (at the revenue line) were up by one percent (Q4 2009), about the same at the EPS line -- all due to a "New Merck" currency hedging progam (something Schering-Plough didn't generally do much of).

▲ Saphris sales in Q4 2010 were only $40 million, worldwide -- that is very weak.

▲ Billy Tauzin comment from CEO Clark: Same strategy at PhRMA -- it's just a "new guy", at the helm -- Billy will stay on as a consultant to PhRMA. [Ed. Note: Fabulous. Not.]

▲ Morgan Stanley's David Reisinger: comment on CEO replacement planning (for early 2011)?: CEO Clark feels it is his most important priority -- in pretty good shape from an "internal candidate" perspective.

▲ Update on Remicade/Simponi arbitration -- hearing scheduled late September 2010, already met with the entire aritration panel, per Ken Frazier. No repsonse on the question about possible negotiated settlement talks -- with J&J.

▲ Jami Rubin, at Goldman Sachs -- what is going on with Consumer Health businesses -- what is the chance of spin-off [Ed Note: Huzzah!]? Also -- is the $3.5 billion savings gross or net? Kellog: Net figure of #3.5 billion.

Kellog's answer: On Consumer Health, and transaction possibilities -- we are "looking forward to putting a strategy together" for Consumer Health. That's a non-answer -- a "no comment", dressed up as an evasive answer.

▲ JP Morgan's Chris Schott (phonetic) asks about R&D budgets, beyond 2010 (will the size be reduced?), and the absolute size of the R&D spend -- it is in danger of continuall-growing out of scope, and unmanagable. CEO Clark answers that Merck is organizing R&D "by franchise" -- by disease, or markets. CFO Kellog offers a non-answer.

▲ Clearly Q1 2010 EPS will be weak, given CFO Kellog's remarks.

▲ 2010 earnings will be significantly "back-end loaded" in 2010, per Merck CFO Peter Kellog.

▲ Temodar patent invalidity judgment "disappointing" to Merck -- it will see generic competition soon, despite Merck's having filed an appeal, and seeking a preliminary injunction.

▲ High single digit compound annual growth in non-GAAP EPS, for the next four years, but 2010 won't be as strong -- as the mulit-year average CAGR -- due to patent expiries, and 2010 post-treansaction merger expenses.

▲ Legacy Schering-Plough's foreign exchange exposures hurt results -- primarily Euro and Japanese Yen -- moderated by new hedging efforts at New Merck.

▲ New Merck had published this, on January 10, 2010: "With respect to the arbitration with Centocor, a wholly-owned subsidiary of Johnson & Johnson, the arbitration panel has recently been selected. Since the selection, the parties have met with the panel and the hearing in this matter has been scheduled for late September 2010. . . ."

No breakdown on Saphris sales in Q4 2010 in the release. Odd.

Monday, February 15, 2010

New (Ex-JNJ) Consumer Health Leader Named -- Reports to CEO Clark


So, with her transactional background -- and an org chart role reporting directly to CEO Dick Clark -- AND CEO Clark's repeated public commentary to the effect that "[legacy Schering-Plough] Consumer Health. . . will need a partner", is the handwriting on the wall for a spinoff, splitoff, sale, joint venture or other transaction related to these Merck businesses?

I don't know, but I'll bet one of the analysts on tomorrow's earnings call will ask. See the snippet, from the longer Merck release, after-hours today:

. . . .Merck today announced the appointment of Bridgette P. Heller as Executive Vice President and President, Consumer Health Care. Ms. Heller will succeed Stanley F. Barshay, who had postponed his planned retirement to serve in a transition role following the merger of Merck and Schering-Plough. Effective March 1, 2010, Ms. Heller, 48, will report directly to Richard T. Clark, Merck’s chairman, president and chief executive officer, and will serve on the company’s Executive Committee. . . .

Ms. Heller most recently served as President of Johnson & Johnson’s Baby Global Business Unit since 2007 and prior to that she was Johnson & Johnson’s Global President, Baby, Kids and Wound Care. While at Johnson & Johnson, Ms. Heller led a global team across all functions of the business unit with worldwide revenues of over $2.5 billion.

Before joining Johnson & Johnson Ms. Heller was founder and managing partner at Heller Associates from 2004-2005, where she provided consumer-centric growth strategies for companies outside of the traditional consumer packaged goods arena. Previously, Ms. Heller provided hands-on leadership as Chief Executive Officer and Chairman of the Board of Chung’s Gourmet Foods, the second largest U.S. egg roll manufacturer. And before that Ms. Heller served as Executive Vice President and General Manager, Coffee Division at Kraft Foods, Inc. where she had full P&L responsibility for the largest coffee portfolio in the U.S. with $1.5 billion in revenues. . . .

Tune in bright and early, tomorrow!

Saturday, February 13, 2010

Jim Edwards' Latest Reminds Me -- Schering-Plough and Merck Sued Nelson Mandela(!), in 1998


This is truly a piece of historical trivia -- and I add it mostly to anchor a link to the original pleadings, for posterity's sake -- but here is a snippet:

. . . .2.1 it enables and authorises the [South African Mandela government], in conflict with Sections 43 and 44 of the Constitution of the Republic of South Africa, 1996, Act 108 of 1996 [hereinafter referred to as "the Constitution"] to determine "prescribed conditions" for the supply of "more affordable medicines" in "certain circumstances" without setting out policy considerations or any guidelines, alternatively sufficient guidelines, which would serve to limit the [South African Mandela government's] authority and power to do so.

2.2 it enables and authorises the [South African Mandela government]: in conflict with Sections 43 and 44 of the Constitution, to "determine" the extent to which rights under a patent granted in the Republic shall apply irrespective of the provisions of the Patents Act, No. 57 of 1978;

2.3 it enables and authorises the [South African Mandela government], in conflict with Section 25 of the Constitution, to deprive owners of intellectual property in respect of pharmaceutical products of such property, alternatively to expropriate such property without any provision for compensation to be paid in respect thereof;

2.4 it is discriminatory in respect of the enjoyment of patent rights in the pharmaceutical field which discrimination is in conflict with the provisions of Article 27 of the Trade Relates Aspects of Intellectual Property Rights Agreement [hereinafter referred to as the "TRIPS Agreement"], an international agreement binding the Republic and to which Parliament has given effect by the promulgation of the Intellectual Property Laws Amendment Act, No. 38 of 1997, and consequently such provision is in conflict with Section 44(4) of the Constitution read with Sections 231(2) and 231(3) of the Constitution. . . .

Actually, some 40 pharma concerns joined together to stop what they viewed as unfair advantages -- in AIDS-drug regulations (primarily concerning pricing) -- being granted to "local" South African pharma companies. President Mandela was named in the suit, personally. Fascinating, no?

Hat Tip to Jim Edwards, who cogently notes that the CEO of Sanofi mentioned the above -- as a salutory "look how far we've come!" anecdote, on the Sanofi year-end 2009 conference call last week, but inexplicably confused his role at Glaxo (at the time -- 1998), in the Mandela suit, with his current stint, at Sanofi. Sanofi was not a party; Glaxo was. Bizarre. And, now you know that Merck and Schering-Plough were, too.

File it all away, under the header "betcha' didn't know that. . . ."

Friday, February 12, 2010

Merck's February 4, 2010 "Help Wanted" Ad: Helicopter Pilot


Yikes! As an alert anonymous commenter pointed out this afternoon, at least the New Merck is creating one or two new jobs -- one for a Sikorsky S76 Helicopter pilot (AVI000100 -- put that code into the "Job Number" box, at the previous link); the other for a corporate jet pilot (Code No. AVI000102). Here is last month's approval, from Kenilworth zoning authorities -- to build the helipad; here is the job description (partial image: Mad Max Beyond Thunderdome, at Right):

Pilot - Helicopter Operations - AVI000100

. . . .Duties include:

Operate assigned aircraft in a safe and efficient manner in compliance with the company schedule and the company Flight Operations Manual, and in accordance with Federal, State and local laws.
• Ensure that pre-flight duties are performed including aircraft inspection, applicable weather conditions, flight plans, aircraft cleanliness and provisions status, weight & balance and fuel load.

• May be assigned as appropriate by the Chief Pilot as Pilot-in-Command or Second-in-Command in specific aircraft.

• Supervise Second-in-Command when assigned as Pilot-in-Command.

• Make decisions necessary for the start, delay, or cancellation of assigned flights, and for the deviation of a flight from its planned route or destination when operating conditions dictate.

• Maintain required pilot and medical certificates and pass semi-annual flight training proficiency checks as necessary for performance of assigned duties and as dictated within the Company Flight Operations Manual.

• Requires working a flexible schedule that may include overnight and weekend duty to satisfy the requirements of the on-demand nature of Aviation Service activities. . . .

Education: Bachelor's Degree or equivalent education and/or work experience.

Required Experience and Skills:
• Excellent interpersonal and leadership skills

• Minimum Commercial and Instrument Rotorcraft Helicopter Ratings. ATP Preferred.

• Ability to maintain First Class FAA medical certificate.

• Five years of aviation related experience, with a minimum of two years in an on-demand flight environment.

Flight qualifications should include:
• 3000 hours in helicopters with a minimum of 1000 hours Pilot-in-Command time.
• 500 hours in Sikorsky S76.
• 250 hours instrument time.

Desired Experience and Skills:
• 3500 hours total time. Prefer experience operating in NY area, and in an on-demand corporate flight department setting. . . .

Now, as to whether this saves the company money -- (by transforming/avoiding a 45 minute drive, making it a seven minute chopper flight, for Mr. Clark and perhaps three other high executives) -- well, color me extremely skeptical.

More On Tauzin's Ouster -- From The Sunlight Foundation


Sincere Hat Tip to Empty Wheel, at Firedoglake, for surfacing this video.

The Sunlight Foundation has a very well-sourced video out -- its only shortcoming is that it fails to mention that Tauzin's PhRMA deal appears to be tattered, as of this morning's news. Thus, reimportation may turn out to be the very thing that caused Tauzin's ouster. Take a look -- it is only 2:15 long -- with fabulous graphics, I might add:



Here is a little of the rest of the story (in text), post that video, above -- also from the Sunlight Foundation:
. . . .In the end, the pharmaceutical industry’s support for health care reform would be left up in the air . After spending $100 million in advertising in support of legislation that Tauzin and key executives hoped would be a windfall for the pharmaceutical industry, the legislative process had flat-lined. In February, the board of PhRMA, split over the deal cut by Tauzin, pushed Tauzin to resign his post. . . .

I personally think Tauzin felt — as a master Kabuki theatre director — he could promise one thing (the $80 billion, in return for support of reform), then deliver much less, when inevitably it became clear that $80 billion was too low, from the go.

Tauzin would then claim (he conjectured, anyway) the President “broke the deal” — and PhRMA would next spend perhaps $200 million opposing reform.

I think Tauzin bet nothing would actually get done. [He did not foresee reimportation being split off as a separate measure, in the wake of the Republicans' continuing obstruction of the omnibus package.]

So, now it seems possible that reimportation may pass outside of the omnibus bill, and the pharma CEOs are feeling (quite accurately) that Tauzin had miscalcuated — on a grand scale.

Did Tauzin promise the pharma CEOs that $80 billion would be all they’d ever pay? I don’t know, but it seems decidedly like his brand of hubris — to make such a sweeping promise, before the game even got underway, in earnest.

Motley Fool -- On Merck's 2009 Earnings Call -- Next Tuesday Morning


What will next Tuesday bring? We don't know -- but we do know that New Merck will not provide 2010 guidance until Q2 2010, according to CEO Clark's earlier statements.

Here is the Motley Fool's take:

. . . .Let's start with Merck. The pharmaceuticals giant has spent the past few years battling Vioxx lawsuits. Unfortunately, Merck has also been slugging it out on the bottom line. If Merck falls short of matching the $0.87-a-share profit it posted during the previous year's fourth quarter, it will have posted year-over-year net income declines in three of last four quarters. A fat 4.1% dividend can only take you so far if your fundamentals are shrinking. . . .

As ever, I'll live-blog the year-end earnings call, on next Tuesday morning, starting at 7:25 am EST, right here -- so do tune in.

Billy Tauzin -- "You're Out!" As PhRMA President -- Internal Discord Cited


So, apparently the pharma players now feel Tauzin's $80 billion deal with the Administration was too large, as a concession to reform. Now that reform faces a less certain future, and pharma may not reap all the enhanced revenue-streams it expected in return for closing the doughnut hole, Tauzin's leadership is being questioned, it seems.

In fact, it is quite possible pharma will need to kick in more than $100 billion -- perhaps $120 billion (just as I earlier predicted). Did Tauzin promise the pharma CEOs that $80 billion would be all they'd ever pay? I don't know, but it seems decidedly like his brand of hubris -- to make such a sweeping promise, before the game even got underway, in earnest.

Per The New York Times, overnight:

. . . .Billy Tauzin, one of the highest paid lobbyists in Washington, is resigning as president of PhRMA, the pharmaceutical industry’s trade group amid internal disputes over its pact with the White House to trade political support for favorable terms in the proposed health care overhaul. . . .

[My long time readers will recall that Fred Hassan last held this seat -- before Tauzin.] Good-luck in your next gig, Billy!

LATER: This will become another post in a minute, but the Sunlight Foundation has a well-sourced video out -- its only shortcoming is that it fails to mention that Tauzin's PhRMA deal appears to be tattered, as of this morning's news. Thus, reimportation may turn out tobe the very thing that caused Tauzin's ouster. Take a look -- it is only 2:15 long -- with fabulous graphics, I might add:



H/T Marcy Wheeler, a/k/a Empty Wheel, for the Sunlight Foundation video.

Thursday, February 11, 2010

Barclay's Raised Price Target On Merck; Affiliate Owned 5.29 Percent At Year End


On January 29, 2010, BlackRock, Inc. as acquiror of various Barlcays Global Investors entities, filed an SEC Schedule 13G, disclosing that the companies held aggregated long positions (as of December 31, 2009) of 5.29 percent of all the New Merck Common Stock outstanding on that date.

. . . .This Amendment to Schedule 13G this "Amendment") is filed by BlackRock, Inc. ("BlackRock"). It amends the most recent Schedule 13G filing, if any, made by BlackRock and the most recent Schedule 13G filing, if any, made by Barclays Global Investors, NA and certain of its affiliates (Barclays Global Investors, NA and such affiliates are collectively referred to as the "BGI Entities") with respect to the subject class of securities of the above-named issuer. As previously announced, on December 1, 2009 BlackRock completed its acquisition of Barclays Global Investors from Barclays Bank PLC. As a result, [substantially all of] the BGI Entities are now included as subsidiaries of BlackRock for purposes of Schedule 13G filings. . . .

Then, as we learned on Tuesday morning, February 9, 2010, Barclays Capital reiterated its "Overweight" rating on Merck, and upped its 12 month target price to $43, from $40:
. . . .Drugmaker Merck & Co., Inc. saw its price target and earnings estimates raised on Tuesday by analysts at Barclays Capital, ahead of its fourth quarter earnings report.

The analyst boosted its price target for MRK, which had closed at $36.59 on Monday, to $43 from $40. Barclays also raised its 2009 and 2010 earnings estimates to $3.26 and $3.48 per share, respectively, while maintaining its “Overweight” rating on the stock. . . .

Interesting -- so, BlackRock crests the 5 percent summit (on assumption of a legacy Barclays stockholding position) -- requiring SEC 13G disclosure -- and Barclays releases a report designed to up the price of those beefed-up holdings.

Merck will report Q4 and full year 2009 numbers, before the market opens next Tuesday, February 16, 2010. We'll see about those newly-upped estimates, right?

Me? I think trailer-truck-loads of salt ought to be distributed -- with any future Barclays price target increases -- related to Merck, no?

NY State Senator Ruben Diaz (D 32) Opposes Secret HPV Vaccines


Here's why -- and I agree with essentially all he's written, below:

. . . .Posted by Sen. Ruben Diaz

Friday, June 5, 2009

. . . .The growing rate of infection for the human papillomavirus (HPV) in young girls is indeed alarming. While the HPV vaccine may be effective in preventing infection in a number of cases, the methods that our State uses to encourage distribution of this vaccine must be closely monitored. Presently, Senator Krueger and Assemblymember Paulin are sponsoring legislation (S.4779-A/A.6702-C) that would allow minor children under the age of 18 to receive the HPV vaccine without parental consent. While I commend Senator Krueger and Assemblymember Paulin for their efforts to prevent HPV infection, minor children are not able to make medical decisions for themselves. I am not prepared to make parents irrelevant in matters of healthcare decisions involving their daughters. While HPV infection and the threat of cervical cancer are reasons for concern, parents should not be removed from such decisions.

In contrast to S.4779A /A.6702C, Assemblyman Benjamin and I offer legislation (S.1983/ A.3203) that encourages voluntary, informed vaccination against HPV for school-aged girls and their parents or guardians. Our measure encourages parents and guardians of children in New York State, through the provision of written educational materials and medical consultation, to decide if their child should receive the HPV vaccine. Parents should be actively included in their child’s health through informed and educated decisions.

Until recently, no other vaccine has been pushed so quickly to be available for use in children. No other vaccine has had a shorter period of FDA review. No commonly administered vaccine is more expensive. . . . Informed and involved parental consent is vital because the HPV vaccine has several harmful side effects including: allergic reactions, involving difficult breathing, wheezing, skin rash, itching or hives; plus diarrhea, nausea, pain at the injection site, fever, fainting, dizziness, swollen glands and joint pain.

We need to more closely examine Senate bills that reduce parental responsibility or involvement with decision-making. Families and parents have important roles to play in the lives of their children. . . .

I hope you will join me in opposing Krueger/Paulin HPV legislation. . . .

Indeed. I still have no definitive word on whether the NY State Senate Codes Committee voted this bill out of committee -- and then, onto the floor for a future vote -- though I strongly suspect they did not.