Monday, May 31, 2010

[At Least One] Answer, In Arizona: O/T

More from the ACLU, out of Arizona.

. . . .In Arizona, beginning on July 28, 2010 (unless something fundamentally-changes), this should be the answer -- to any police stop asking for "your papers". . . .

. . . .Another plaintiff, Jesus Cuauhtémoc Villa, is a resident of the state of New Mexico who is currently attending Arizona State University. The state of New Mexico does not require proof of U.S. citizenship or immigration status to obtain a driver's license. Villa does not have a U.S. passport and does not want to risk losing his birth certificate by carrying it with him. He worries about traveling in Arizona without a valid form of identification that would prove his citizenship to police if he is pulled over. If he cannot supply proof upon demand, Arizona law enforcement is required to arrest and detain him.

Several prominent law enforcement groups, including the Arizona Association of Chiefs of Police, oppose the law because it diverts limited resources from law enforcement's primary responsibility of providing protection and promoting public safety in the community and undermines trust and cooperation between local police and immigrant communities.

"This ill-conceived law sends a clear message to communities of color that the authorities are not to be trusted, making them less likely to come forward as victims of or witnesses to crime," said Linton Joaquin, General Counsel of NILC. "Arizona's authorities should not allow public safety to take a back seat to racial profiling. . . ."

[From the Complaint:]

. . . .SB 1070 is unconstitutional. It violates the Supremacy Clause and core civil rights and civil liberties secured by the United States Constitution, including the First Amendment right to freedom of speech and expressive activity, the Fourth Amendment right to freedom from unreasonable searches and seizures, and the Equal Protection Clause guarantee of equal protection under the law. . . .


Sunday, May 30, 2010

What Now? O/T. . . .

Simply depressing. . . . I have no answers; only (mostly impotent) anger.

Friday, May 28, 2010

Next Fosamax® "Bellweather" Trial -- Boles v. Merck -- Postponed, To June 7, 2010

This case -- Boles v. Merck -- was all set to start picking a jury on Tuesday afternoon, immediately after Memorial Day weekend.

I suspect another (unrelated) trial must be running long, in the very-able Judge Keenan's federal courtroom, above 28 Centre Street (or 500 Pearle, if you prefer), in Manhattan. In any event, we will dial it forward, to the following Monday:

. . . .ORDER: The trial date in the above-captioned matter is adjourned until Monday, June 7, 2010. The parties are to appear for jury selection at 10:00 am.

Jury Trial set for June 7, 2010 at 10:00 AM before Judge John F. Keenan.

/s/ Judge John F. Keenan
May 28, 2010

Filed In Associated Cases: 1:06-md-01789-JFK-JCF, 1:06-cv-09455-JFK. . . .

Thursday, May 27, 2010

Pfizer/Wyeth: New Pig Vaccine Patent; New Suit -- Against New Merck's Intervet

In March of 2009, Wyeth sued then Schering-Plough's Intervet in Delaware federal court, for patent infringement -- the patents in issue relate to several of Wyeth's pig virus vaccine products. It was then alleged that Intervet infringed those patents when making and selling its Circumvet® PCV and Porcilis® vaccines, for PCVAD. Just a couple of days ago, New Wyeth (now owned by Pfizer), was issued a new patent, on more of its pig virus vaccine technology -- technology useful in making the PCVAD vaccine.

So -- New Wyeth sued New Merck again, yesterday, also in Delaware federal court, for infringing this newly-issued patent. The complaints -- March 2009 and May 2010 (as a pair of PDF files).

Responsibility for any damages here will presumably transfer over to the New Merial Joint Venture, when and if these vaccine products are transferred to the Merck-Sanofi-Aventis joint venture, in 2011. That's about when both of these pieces of litigation are likely to draw near to a trial date. I'll keep an eye on 'em, just the same.

Sanofi CEO's Comments: On Merial (To Be) JV -- Asset Divestitures

Overnight, Reuters is reporting on the Sanofi CEO's remarks -- and suggesting that deals may be announced as early as next quarter -- as New Merck, too, may shed some of its remaining legacy Organon (more recently legacy Schering-Plough) animal vaccine and parasiticides assets, in order to clear these antitrust hurdles:

. . . .Sources have told Reuters that Bayer AG, Pfizer, Boehringer Ingelheim, and Novartis AG are among the bidders eyeing the assets, which include vaccines and parasiticides.

"I would certainly confirm that there is significant interest in the assets that might be divested," Viehbacher said, declining to name potential bidders. "I think the whole industry really is recognising the strategic interest in animal health."

Merck & Co's $46 billion merger with Schering-Plough last year gave it the latter's Intervet/Schering Plough Animal Health business, which it is now combining with Sanofi's Merial in a joint venture with $5.3 billion in sales.

As part of that process, Sanofi and Merck are now looking to shed assets worth several hundreds of millions of dollars, as they await regulatory approval to create a group that would hold 29 percent of the global animal health market.

"Of course we would rather not sell off anything, but the competition authorities may not see it that same way and so we have to continue our dialogue with the competition authorities in markets everywhere," Viehbacher said. . . .

I will keep you posted, but look for Abbott to be among the top three stalking horses here.

Wednesday, May 26, 2010

Latest Fosamax® Court Battle: Should Merck's "Creative" Osteoporosis Definition Be Admissable?

With the retrial of Boles v. Merck about a week away, the filings are a-flyin', today -- in the federal District courthouse in Manhattan where Judge Keenan presides.

At issue, at the moment, is whether the plaintiff, Shirley Boles -- who alleges her ONJ was made worse by long-term use of Fosamax® -- will be allowed to introduce any evidence that Merck's non-standard, overly-inclusive purported defintion of the disease "osteoporosis" was challenged by FDA, during a time-frame relevant to Mrs. Boles' claims. If FDA objected to the definition, the argument goes, Merck should be allowed less protection from the imprimatur of safety an FDA approval would otherwise hold.

Lawyers for Mrs. Boles want to call a Merck witness to establish that by 2007, Merck had been clearly told by FDA to revise the Fosamax labeling, to bring it into line with the widely-accepted (WHO and FDA) definitions of what constitutes osteoporosis. [Here is a rundown on the difference, from last weekend.]

Merck's lawyers claim that since FDA first complained about the definition, in writing, after Mrs. Boles' injuries, such a showing ought not be admissable.

Presumably, Mrs. Boles' lawyers would reply that they want to call the Merck label copy witness primarily to find out whether she is aware of any earlier non-written complaints (in oral, face to face meetings, or telephonic conversations) from any FDA staffer, that might even go back to 2004 or earlier.

. . . .Merck can only assume that Plaintiff has subpoenaed Ms. Birzin to establish that in April 2007. . . the FDA proposed that Merck change the definition of osteoporosis in the Fosamax Plus D label to include a T score of -2.5 and below. This assumption is based on Plaintiff’s motion in limine papers, which cite an April 2007 email from Ms. Birzin to Dr. Santora attaching the proposed label change. . . .

I'll let you know what Judge Keenan decides.

Tuesday, May 25, 2010

Vertex's Teleprevir® Cures 3 of 4 (!) Treatment-Naïve Hep C Patients

I think the comparable rate -- for legacy Schering-Plough/New Merck's Boceprevir® (in its preliminarily released "top-line" study results) was just a little less than 50 percent, on a 24 week schedule. The fat lady is clearing her throat, here folks -- Vertex's Teleprevir® is showing 50 percent better efficacy, and in about half the time. Vertex will very likely file with FDA first; and will now clearly show better efficacy than Merck's candidate, in its application. Here's the Reuters version of the story, tonight:

. . . .A hepatitis C treatment being developed by Vertex Pharmaceuticals led to a 75 percent cure rate in a pivotal trial of previously untreated patients, the company said on Tuesday.

The results from the first late-stage Phase III study of telaprevir came in at the high end of expectations for a cure rate of 70 to 75 percent, with slightly lower discontinuation rates due to side effects than previously seen.

Investors cheered the data, sending Vertex shares, which have slumped recently, up more than 12 percent in after-hours trading. . . .


LiveBlogging, Today Tomorrow -- Stockholders' Meeting @ 1 PM EDT

I'll liveblog the webcast of the public remarks portion of tomorrow's stockholders' meeting. Click this link to watch, and/or listen in:

▲ All proposals were approved; meeting adjourned.

▲ No current plan to increase the dividend.

▲ General Q&A -- "What will be the impact of a loss of Remicade arbitration?" CEO Clark takes a no comment.

▲ "What is board doing to help stock price?" CEO Clark says pharma and economy are both down, but he expects the pipeline will be the answer.

▲ "What impact will the euro exposures have over next three quarters?" Diversification is Clark's non-answer. Really no answer.

▲ The auditors's approval, and the stock compensation plan proposals moved and seconded -- now polls are closed.

▲ "Why is Pat Russo on board -- she did nothing for Lucent?" CEO Clark rebuts this, saying he thinks she adds value on Merck's board, and the rest of the board believes so as well.

▲ "Are any Merck directors board members of other pharma?" No says CEO Clark.

▲ Directors nominated, and seconded.

▲ Quorum present -- inspectors of election appointed; polls open -- resolutions presented; 3 min max on questions.

▲ Pipeline review with Peter Kim -- nothing new.

▲ Mentions the expanded HIV medicine subsidies here in the US. That's a good thing -- fixed prices for people of limited means through 2013.

▲ Listing the strengths of the business lines. . . nothing new.

▲ Explaining Ken Frazier's new role -- and Adam Schecter's as well.

▲ Director Thomas H. Glocer (Chief Executive Officer, Thomson Reuters Corporation) misses the meeting. Odd.

▲ Business portion of meeting now underway. Introductions of PWC, the auditors, and the board.

▲ Video on Merck's rotavirus vaccines delivery program, in Latin America, now. . . .

▲ Dick Clark approaches the stage, with other Merck officers -- welcoming the shareholders now.

▲ We're underway -- Merck is showing its pre-meeting institutional commercials on the big screen.

▲ The information contained in the [Merck] presentation [is]. . . current as of May 25, 2010. While the presentation remains on the company’s website the company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the presentation and investors should not rely upon the information as current or accurate after May 25, 2010. . . .

Check back then, but Merck has two more "Dog & Pony shows" scheduled, with Wall Street sponsorships, later this week.

Jim Cramer Is Sure "Funny" -- Except When He's Not. He MAY Be Right About This, Though

Oh, that zany Jim Cramer (subscription $ required -- "don't pay for it"!) -- this morning:

. . . .Merck: The Schering-Plough deal allows it to grow, but it has huge exposure to the euro and has exposure to universal health care [branded drug price reimbursement reduction problems]. . . .

Oddly, I agree with Jim, today (though I mentioned the euro stuff last Sunday). But I agree, perhaps for today only, viz:

To be fair, two weeks ago, Cramer said Merck was a great buy at $33.50 -- it stands at 31.40 as I write this squib. Finally, just four weeks ago, Cramer called Merck a "dog" -- at $34.20(!). So take everything he says for what it is worth -- almost zilch.

BONUS: Here's a link to my longer rundown of his flip-flopping on legacy Schering-Plough -- from last summer.

Sunday, May 23, 2010

Merck's Fosamax® -- The Making Of A U.S. Market, And A Legal Defense -- With A Keystroke

Here is the answer to my weekend brain teaser. The FDA and the W.H.O. both define "osteoporosis" as a bone mass density reading (measured by T-scores) of at least 2.5 standard deviations below the average, for pre-menopausal women. Because the number of women in the United States is very large, and the number of women aged 44 and beyond is also very large, we may safely assume that bone density is normally distributed over these populations, as a whole. See below, click to enlarge:

So -- when Merck arbitrarily chose to "move the goal posts in" (by just one-half of one standard deviation), with the stroke of a pen, it likely more than doubled the number of US women to whom it could push Fosamax®. [The horizontal scale, in the above graphic, is set in numbers of standard deviations, from the average -- the center of that bell-curve. There were in 2008, according to the datasets of the US Census, more than 60 million US women aged 44 and beyond. So, based on several extrapolations, and assumptions, I think it would be reasonable to guess that Merck's "creative" re-defining of osteoporosis generated as many as 12 million additional potential customers for Fosamax.]

Moreover, of perhaps even surpassing importance, now that there are over 1,100 lawsuits pending -- against Merck -- for jaw and femur bone-death, allegedly caused by long-term use of Fosamax, this "moving of the goal posts" gave Merck a "healthier" base population, by including many, many women in its targeted market population that consensus standards (WHO and FDA) would say don't have osteoporosis, at all.

In fact, then -- not only did Merck likely double its US market, it also set up a "stacked deck" legal defense, as problems began to appear in longer term users of Fosamax. So that is why this bit of package insert will be an important part of the Boles v. Merck retrial, beginning June 2, 2010:

. . . .Effect on bone mineral density

The efficacy of Fosamax 10 mg once daily in postmenopausal women, 44 to 84 years of age, with osteoporosis (lumbar spine bone mineral density [BMD] of at least 2 standard deviations [NOT 2.5 standard deviations] below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration. . . .

Now you know.

And, as irony would have it, it may ultimately turn out (five or ten years from now) that Merck's "creative" definition has, all these years later, greatly increased the number of claims for injuries it will face. This is likely so, because these "healthier" women will have been on Fosamax longer (at every age -- and there will be more of them), than would have obtained -- had only women with real osteoporosis been targeted for prescriptions by Merck. Odd. And sad.

Merck 2010 Sales Line Exposed -- To Euro's Woes

Prior to Merck's take-over of Schering-Plough, about 55 percent of legacy Schering-Plough's sales were exposed to movements in the euro. Pre-takeover, Old Merck was less than 30 percent, but I don't ever recall seeing a specific figure. [My guess is that the "blended rate" is likely to be in the high 30s or low 40s, all in, for full year 2010.]

Now, post the bust-up, New Merck indicates that EU and Canadian sales, aggregated in Q1 2010 were 32 percent of total revenue -- but much is clearly excluded, there (both animal health and consumer health businesses are missing). See chart at right, a cut-out from one of the New Merck R&D Day presentation slides.

In addition, Merck primarily manages currencies to minimize impact on the balance sheet (i.e., assets), not the income statement -- that is, not to "normalize" the sales revenue comparisons, period to period.

So, net/net -- as the euro weakens against the US Dollar (think: good for US tourists; bad for Merck), New Merck's reported European sales, converted to US Dollars, at the end of each quarter, will fall -- unless hedged. Merck is more aggressively hedged than legacy Schering-Plough historically was, but still the exposure is large.

My guess? Merck's reported sales, globally, are likely to be lower in Q2 2010 by about 10 percent due to the most recent euro weakening. From Merck's SEC Form 10-Q for the first quarter (at page 11):

. . . .Where the U.S. dollar is the functional currency of the Company’s foreign subsidiaries, the primary objective of the balance sheet risk management program is to protect the U.S. dollar value of foreign currency denominated net monetary assets from the effects of volatility in foreign exchange that might occur prior to their conversion to U.S. dollars. In these instances, Merck principally utilizes forward exchange contracts, which enable the Company to buy and sell foreign currencies in the future at fixed exchange rates and economically offset the consequences of changes in foreign exchange on the amount of U.S. dollar cash flows derived from the net assets. Where the U.S. dollar is not the functional currency of the Company’s foreign subsidiaries, Merck executes spot trades to convert foreign currencies into U.S. dollars based on short-term forecast needs. These U.S. dollar proceeds are then invested until required by the Company’s foreign subsidiaries. Merck routinely enters into contracts to offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro and Japanese yen. For exposures in developing country currencies, the Company will enter into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of exchange on monetary assets and liabilities by managing operating activities and net asset positions at the local level. . . .

We shall see.

Friday, May 21, 2010

Okay, Head's Up! -- Weekend Brain Teaser: "Dueling Definitions" of Osteoporosis

I am going to add to this post at some point over the weekend (if the commenters don't solve it themselves, prior to Sunday night), but see if you can figure out why Merck's definition of what constitutes the medical condition "osteoporosis" differs from the one the World Health Organization and the FDA both agree upon, and use.

Here's a hint: Merck's supposed definition has become important, in both (i) its marketing efforts, and (ii) in one of the pending "bellweather" trials -- due to begin jury selection on June 2, 2010 in Manhattan federal District Court, before Judge Keenan. I'll be back to add more, by Sunday late evening, if not before. Here is Merck's FDA-filed package insert copy -- at page 4, of 32 -- still apparently operative, to this day (despite FDA requests to revise the same, to bring it into conformance with the WHO osteoporosis definition):

. . . .Effect on bone mineral density

The efficacy of Fosamax 10 mg once daily in postmenopausal women, 44 to 84 years of age, with osteoporosis (lumbar spine bone mineral density [BMD] of at least 2 standard deviations below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration. . . .

What's going on here? Answers soon. The W.H.O. definition:

More Allegations Of Improper PegIntron® Sales Practices In Vietnam

In the latest English-language version of this still evolving story (earlier April 2010 backgrounders here and here), we learn that doctors prescribing New Merck/Legacy Schering-Plough's PegIntron® for Hep C were requiring patients to pay vastly marked up prices, either by essentially "forcing" purchases directly from the doctors, or from a pharmacy with which the doctors had reciprocal profit sharing arrangements.

We also learn that, according to the multiple published reports, in-country Schering/Merck representatives both encouraged, and fostered this practice -- profiting from it, as well -- do go read it all at VietNamNet:

. . . .Triple Alliance

. . .[S]ales of Peg-Intron in 2008 were around $4 million and rose to $5 million in 2009. In 2008 and 2009, Phytopharma conducted promotional programmes, discounting 23 percent on price (registration), totaling 18.8 billion dong. Actually, some pharmacies enjoyed a discount rate of up to 30 percent from Zuellig Pharma under the instruction of the Schering-Plough representative office in HCM City.

Hoang Lan and Cam Ha pharmacys are the two major buyers of Peg-Intron and Pegasys.

Apart from the collusion between doctors and pharmacies, Tuoi Tre concludes, there was an alliance among the representative offices of the drugs’ producers, the importers and the distributors. . . .

A woman in Binh Thanh district, ‘M’ said she has had to sell her house and other assets to raise over 100 million dong to treat hepatitis C. She started using Peg-Intron 80mcg in early April 2010, on the prescription of Dr. ‘BHH,’ who works at the HCM City Medical University Hospital. The doctor charged ‘M’ 3.4 million dong for a phial of Peg-Intron plus some pills. . . .

The doctor told M that his medicine is guaranteed because he bought it directly from the producer and has preserved it well. However, since Tuoi Tre newspaper denounced high markups on hepatitis C medicines, Dr. BHH has refused to provide Peg-Intron to patients, saying that the situation had changed and he didn’t have the medicine, so patients must buy it themselves. . . .

Hmmmm. . . smells a lot like an [alleged] Foreign Corrupt Practices Act violation to me. We'll keep you informed.

Thursday, May 20, 2010

New Merck Doubled Its Spend -- On Lobbyists -- In Q1 2010

The AP is running this story, tonight:

. . . .Merck & Co. spent $3.2 million lobbying the federal government on health care reform, drug pricing and coverage for its products in the first quarter, according to a recent FEC disclosure form.

That was slightly more than double the $1.5 million the Whitehouse Station, N.J.-based company spent on lobbying in the first quarter of 2009.

The company lobbied Congress on issues related to the U.S. health care overhaul that was enacted in late March, including on increasing coverage of uninsured people, maintaining a private-sector health care system and promoting research to compare the effectiveness of medical treatments. . . .

[New Merck] lobbied to oppose or limit reimportation of drugs made here from foreign countries where prices are lower, something that the pharmaceutical industry has long opposed.

It also lobbied against increasing rebates that drugmakers pay to the government under the Medicaid program -- something the overhaul did require. . . .

Americans sorely need lower priced medicines. Come rescue us, Canada (even while Merck spends $12 million a year to prevent it)!

Why -- Exactly -- Is Zetia® + Lipitor® Combo Delayed, At FDA?

This all started at New Merck's R&D Day webcast last Tuesday, and continued at the Banc of America conference presentation made by Merck, a few days later, on Thursday.

Tonight, as Matt Herper, for Forbes, ably notes, if the FDA's increased disclosures initiative makes its way into the rule book intact, we will no longer be left to wonder what -- exactly -- is the holdup at FDA on putatively new drugs, like a Zetia® (ezetimibe) plus Lipitor® (atorvastatin) combo. Here's Matt's piece -- do go read it all:

. . . .Making the [FDA's] letters public will prevent companies from misleading investors about what went wrong, he wrote, but it will also prevent rumors that things are worst than they are. . . .

For instance, at Merck's recent analyst meeting some Wall Streeters wonder whether an FDA delay in approving a combination of Merck's Zetia and the soon-to-be-generic Lipitor reflects concerns on the FDA's part about Zetia. Merck says it comes down to manufacturing issues. In the future, there may not be any argument to have. . . .

Let us all hope so. [A private commenter points out that I have been too opaque, above. So -- for the record, I think such a pill isn't much of a meaningfully "new drug", at all -- and while Lipitor is a wonderful drug, there is little evidence to suggest that Zetia is doing anything to improve clinical outcomes. So, it would be reasonable to infer that FDA is taking a "wait and see" approach, until the results from IMPROVE-IT become known (that is Zocor® plus Zetia®, in the Merck-marketed combo pill called Vytorin®) -- as it is also a statin (simvastatin), plus ezetimibe. Could well be. And that could be 2014, or even beyond.]

Ex-Schering-Plough Executive Added To Geron's Board

Geron, a Menlo Park, California based developer of biopharmaceuticals for the treatment of cancer and chronic degenerative diseases by targeting the enzyme telomerase, added an ex-CMO of SPRI (the research arm of legacy Schering-Plough) to its board:

. . . .Geron Corporation today announced the appointment of Hoyoung Huh, M.D., Ph.D. and Robert J. Spiegel, M.D., FACP to its board of directors. . . .

After 26 years with the Schering-Plough Corporation, Dr. Spiegel retired in 2009 as chief medical officer and senior vice president of the Schering-Plough Research Institute, the pharmaceutical research arm of the Schering-Plough Corporation. He initially joined Schering-Plough as director of clinical research for oncology and rose to hold various positions including senior director of clinical research for oncology and anti-infectives, vice president of clinical research and senior vice president of worldwide clinical research. Prior to Schering-Plough, Dr. Spiegel held academic positions at the National Cancer Institute and New York University Cancer Center. Following a residency in internal medicine, he completed a fellowship in medical oncology at the National Cancer Institute. He currently is an adjunct assistant professor at New York University Medical Center. Dr. Spiegel holds an M.D. from the University of Pennsylvania and a B.A. from Yale University. . . .

The talent is now nearly completely scattered -- to the four winds.

Wednesday, May 19, 2010

Slow Actual News Day? How 'Bout Ex-CEO Hassan Rumor-Mongering, Then?

No actual news? Okay -- the papers will apparently just make some up. Witness this, from a few days ago, at -- you know the place must be awash in problems if even the slippery Ex-CEO of legacy Schering-Plough, Fred Hassan, declines to take a paycheck [my earlier backgrounder]:

. . . .[S]everal sources [say] that Biogen has been having a tough time finding outside candidates interested in the job, having talked to people like former Genentech executive Sue Desmond-Helmond (now chancellor of UCSF), ex-Schering-Plough head Fred Hassan, and Deborah Dunsire, who runs Millennium Pharmaceuticals in Cambridge, now a division of the Japanese company Takeda. . . .

Then there was this -- in full irony-alert -- a few days before that, from Reuters, of all places [and my much earlier backgrounder]:
. . . .Termeer insists . . . "We are on our way to overcoming the manufacturing challenges we have faced," he said in an interview, "but still ahead is the need to regain the trust of our patients and physicians. I have known this community for many years. In fact, I developed this market from its inception. This isn't the time to have someone else try to understand it."

Some industry experts agree.

"Clearly there is a challenge to the company's reputation, and clearly the products were not being made to the quality that is needed, and he needs to take ownership of that," said Fred Hassan, the former chief executive of drugmaker Schering-Plough. . . .

"But it is important that if investors ever consider changing him, whoever they replace him with must be immediately experienced in handling major manufacturing problems, and there are very few people like that," he added. "Sometimes it is better to bring in the right crew and get on with it. . . ."

Sheesh. Slow news day, indeed.