Tuesday, February 28, 2012

Merck Science Team To Webcast Tomorrow Morning -- At Citi/NYC

Tomorrow, at 10 AM EST, Merck will make a presentation at the 2012 Citi global health care conference in Manhattan:

. . . .Luciano Rossetti, senior vice president of Global Scientific Strategy at Merck Research Laboratories, and Frank Clyburn, president of Primary Care and Women's Health in Merck's Global Human Health division, are scheduled to present at the Citi 2012 Global Healthcare Conference in New York City on Feb. 29, at 10:00 a.m. EST. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at: http://www.merck.com/investors/events-and-presentations/home.html. . . .

In addition, a state court trial is underway (see graphic, at right) related to claims of ONJ, allegedly caused by Fosamax®, in Atlantic City, New Jersey this week. We will report on that, shortly.

Pharmalot's Scoop: Januvia® Deemed "Misbranded" -- And In Violation of FDA Safety Rules

Ed has a great long story on the Merck cock-up of today, unduly delaying an FDA required post-marketing study, related to safety of Januvia® (sitagliptin). Do go read all of Ed's insights, then come back here. [For my part, I'll note that, in its just filed SEC Form 10-K (table on page 49) Merck sold over $3.3 billion worth of Januvia in 2011, up almost a billion dollars, compared to 2010. This regulatory non-compliance potentially jeopardizes that revenue stream. Astonishing.]

From the FDA's warning letter to Merck, then:

. . . .FDA has not been provided sufficient information to determine whether the proposed independent study is adequate to satisfy the PMRs.

Therefore, you have submitted neither a study protocol for a new rodent study, nor a final study report for the independent study that you proposed would satisfy the PMRs. You have not provided an adequate explanation for the cause of the delay of either of the milestones in the timetable for completion of the postmarketing requirement, nor did you propose to revise the agreed-upon timeline.

As a result, you are more than 20 months late in achieving the June 15, 2010 final protocol submission milestone and more than 8 months late in achieving the final protocol submission milestone in the timetable, and you have not demonstrated good cause for these delays.

Conclusion and Requested Action

Under section 502(z) of the Act [21 U.S.C. 352(z)], your product is considered misbranded because you are in violation of a postmarketing requirement (PMR) established under section 505(o)(3) of the Act. You have failed to comply with the approved timetable and periodic report submissions of section 505(o)(3)(E)(ii) of the Act and failed to show good cause for not conducting the additional testing required to further assess whether a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with the use of sitagliptin, represents a public health risk.

Failure to promptly correct this violation may result in regulatory actions by the FDA without further notice. These actions include, but are not limited to, civil money penalties. Other federal agencies may take this Warning Letter into account when considering the award of contracts. In addition, civil money penalties under section 303(f)(4) of the Act [21 U.S.C. 333(f)(4)] could be levied for a maximum of $250,000 per violation, with the possibility of additional penalties if the violation continues uncorrected. . . .

Bewteen Ed Silverman's Pharmalot, and this joint, we will keep you posted. [My September 2009 background on the Januvia®/pancreatitis concerns.]

Sunday, February 26, 2012

More Experts Weigh In, Criticizing Fred Hassan's Avon/Jung Decision

More and more corporate governance experts -- usually quite careful about ciriticizing current large public company board chairmen -- are speaking openly about how Mr. Hassan's misguided loyalty to another high executive has put a company he stewards in a difficult position. [Regular readers will recall here, the echo of the Carrie Cox situation(s) -- at both Pharmacia I (and Pharmacia II), and Schering-Plough.]

Having Ms. Jung "hang around" the board simply makes very difficult the task of retaining a truly hard-nosed, effective leader -- to turn the Avon debacle around. Why would a top flight person want to try to run interference between an entrenched lead director (Hassan), and the close friendly relationship he has with Ms. Jung -- now the nominal Chairman of the Board -- for two years? There are always going to be better situations that this -- for the best people, with all the right skills, it would seem. Nicely-done (again!), Fred!

In any event, here's the concluding bit from this week's Bloomberg story -- do go read it all:

. . . .Most Avon board members have worked closely with Jung for most of her tenure. Five of the nine independent directors have served on the board for a decade or longer. They include lead director Fred Hassan, managing director and partner at Warburg Pincus and chairman of Bausch & Lomb Inc.

"The kind of compromise directors reached to keep Jung on as chairman while also recruiting a new CEO serves no good purpose for investors," Charles Elson, head of the University of Delaware’s Weinberg Center for Corporate Governance in Newark, Delaware, said in a telephone interview. "But at least the board limited Jung to a two-year contract. It’s a lot harder to terminate an executive with an open-ended contract that automatically gets renewed over and over. . . ."

Caustic -- but correct, in my view. And I've plainly said so, before -- back in December of 2011.

Tuesday, February 21, 2012

Can Whitehouse Station "En-Hip-[Hop]-ster" Dr. Scholls' Image?

I hate to be the wet blanket here, but the idea that urban 20-something hip hop artists are going to endorse orthotic insoles seems. . . well, a stretch.

I guess stranger things have happened (witness Beyonce & Jay-Z trademarking their daughter's surname -- "Blue Ivy Carter"!). I'll keep you posted, but here's a bit from this longer Wa Po article, and if flash is enabled on your device, do watch the video below:

. . . .Dr. Scholl's wants to massage its arthritic image. The 106-year-old company began airing TV ads Monday to recast its orthopedic shoe inserts as "energizing cushions" that help people live life to the fullest. . . .

Company executives hope the new "Get Up and Go" tag line turns attention to how the inserts might enhance a wide range of lifestyles. They want to dispel the notion that Dr. Scholl's products are only for older people suffering aches and pains. One ad shows a break-dancer slipping a gel pad into his shoe before flipping in the air. . . .

Seriously? Yep (at about 22 seconds in):

No comment needed -- or adequate, here. That's all I've got this post-Presidents' Day morning -- something better, tomorrow -- I hope.

Monday, February 20, 2012

BlackRock Has Upped Its Stake In Merck -- To 5.75% -- 175,312,709 Shares

Here is that latest BlackRock SEC Schedule 13 filing.

Meanwhile, the only other remaining shareholders known to beneficially own more than 5% of Merck, have each cut their holdings in the company -- one very significantly. The big seller, for the year 2011, was Capital Research Global Investors (down from 5.3%, to only 2%, or now holding 60,246,383 shares).
Capital World Investors holdings are also down -- from 6.8%, to 6.4% -- a much smaller sell-off, and it still holds 195,693,450 Merck shares.

It should be noted that these figures were only current as of December 30, 2011, as SEC Schedule 13 rules only require year-end reporting. Even so, if all holders are complying with SEC rules, this means that the number of institutional shareholders owning truly massive stakes (north of 5%) in the world's No. 4 drugmaker have been reduced from at least six in 2008 (counting both legacy companies), to two, at year end 2011.

. . . .Capital Research Global Investors is deemed to be the beneficial owner of 60,246,383 shares or 2%. . . .

BlackRock, Inc. is deemed to be the beneficial owner of 175,312,709 shares or 5.75%. . . .

Capital World Investors is deemed to be the beneficial owner of 195,693,450 shares or 6.4% of the 3,047,921,407 shares believed to be outstanding. . . .

Fascinating. For reference, here is last year's Merck proxy disclosure related to these holders.

Friday, February 17, 2012

Gilead Down 15%; Vertex Up 6.5%; Merck Up 1.6% — Hep C Wars, Rebooted

I think I said, when this deal was announced, that everything needed to go perfectly, to defend the price paid (and of course, nothing ever does).

Apparently Gilead has suffered its first setback in the Pharmasset-acquired next generation (all oral) Hep C program. Gilead’s experimental GS-7977 plus ribavirin failed to suppress the hepatitis C virus in a group of difficult-to-treat patients who had also failed prior therapy, Gilead just announced, this morning.

Gilead stock is down 15 percent on huge volume.

More soon.

Per the Wall Street Journal, now:

. . . .Gilead obtained the drug, GS-7977, with its $11 billion purchase of Pharmasset last month. Gilead has billed GS-7977 as the anchor of what the company expects to be the first all-oral regimen for hepatitis C to reach the market, potentially in 2014, and analysts have predicted the drug has multibillion-dollar annual sales potential. Current standard treatments include an injectable drug.

A clinical trial of GS-7977, titled "Electron," included an arm testing the drug in patients with a form of hepatitis C known as genotype 1, who had previously seen little or no decrease in the virus after treatment with a regimen containing an older drug, interferon.

Gilead said a majority of these patients experienced viral relapse within four weeks of completing 12 weeks of treatment of GS-7977 plus another drug called ribavirin. . . .

That's bad news for Gilead -- and a much longer "leading-in-the-existing market" time, for Vertex (and to a lesser extent, Merck).

We will keep you posted, but my earlier prediction (November 2011) that this market belongs to Vertex until at least 2016, looks to be dead on. I'm not quite ready to say, definitively, that Gilead overpaid, but it sure looks like it, given today's news.

Marilyn Mann Points Us To New, Detailed Post-Hoc Vioxx® Data Analysis

An abiding and constant friend of this blog has pointed us to yet another Merck-related story we missed, when it originally came out. So, we are belatedly highlighting it here, with sincere thanks to Marilyn Mann.

A blogger who studies math has spent some time corroborating one of the Vioxx® case plaintiffs' expert data-analysis -- assembled largely from the trial work on the US Vioxx cases. Do go read it all, but here is a bit:

. . . .Yesterday I caught a lecture at Columbia given by statistics professor David Madigan, who explained to us the story of Vioxx and Merck. It’s fascinating and I was lucky to get permission to retell it here.


Madigan has been a paid consultant to work on litigation against Merck. He doesn’t consider Merck to be an evil company by any means, and says it does lots of good by producing medicines for people. According to him, the following Vioxx story is “a line of work where they went astray”.

Yet Madigan’s own data strongly suggests that Merck was well aware of the fatalities resulting from Vioxx, a blockbuster drug that earned them $2.4b in 2003, the year before it “voluntarily” pulled it from the market in September 2004. What you will read below shows that the company set up standard data protection and analysis plans which they later either revoked or didn’t follow through with, they gave the FDA misleading statistics to trick them into thinking the drug was safe, and set up a biased filter on an Alzheimer’s patient study to make the results look better. They hoodwinked the FDA and the New England Journal of Medicine and took advantage of the public trust which ultimately caused the deaths of thousands of people.

The data for this talk came from published papers, internal Merck documents that he saw through the litigation process, FDA documents, and SAS files with primary data coming from Merck’s clinical trials. So not all of the numbers I will state below can be corroborated, unfortunately, due to the fact that this data is not all publicly available. This is particularly outrageous considering the repercussions that this data represents to the public. . . .

As I say, it is well worth the 15 minutes or so it will take to digest it all. For those interested, here is a similar, September 2011 post on the L'Affair Vioxx, also courtesy of the same friend of the blog.

Thursday, February 16, 2012

Jon Secada Joins Natalie Cole, And Gregg Allman: "Tune In To Hep C" Campaign

Both Vertex and Merck -- makers of cutting-edge Hep C drugs -- are sponsors of this 501(c)(3). The "Tune In" campaign uses recording artists -- and their music -- to raise Hep C awareness, globally. Here is a bit of Jon's story (modified small image of Jon, at right, courtesy the foundation) -- but go listen about it all, and read it all, at the foundation site:

. . . .My father, José, passed away in 2011 from cirrhosis of the liver. It was the result of a complication from having chronic hepatitis C infection that went untreated. Although he had been diagnosed for years, he never gave his chronic hepatitis C the attention it required and did not follow up with his doctor promptly. He didn't tell me about his diagnosis for more than a decade. My father did not understand the potential consequences of chronic hepatitis C and it cost him, and our family, dearly.

I wish I could have done more to help my father, and I wish I had known more about the disease. That's why I'm sharing my family's personal story with others.

I believe my father was living with chronic hepatitis C as far back as the 1970s when he left Cuba. He periodically had health issues, but didn't get diagnosed until the 1980s. He never really dealt with the fact that he was living with this potentially serious disease and he waited too long to do something about it. . . .

I applaud all of pharma's efforts here -- this disease is now effectively curable -- in most cases. We need to begin to do just that -- cure all those we can. And like José's story, the first step is discovery -- as it so often goes undetected, for decades. Go get tested.

Wednesday, February 15, 2012

CFO Kellogg To Discuss Brazil JV; New Glaucoma FDA Approval -- At Leerink Swann Conference This Morning

It seems likely that topics for today's prepared remarks will include the just-announced JV in Brazil, and the FDA approval of Zioptan™, for glaucoma. What else will Peter Kellogg discuss? Probably nothing new and material, but you might want to tune in at 11 a.m. Eastern, to be sure (you'll need to leave a working e-mail address, and a name to do so):

. . . .Merck, known as MSD outside the United States and Canada, announced today that Peter N. Kellogg, Merck's chief financial officer is scheduled to present at the Leerink Swann 2012 Global Healthcare Conference in New York City on Feb. 15, at 11:00 a.m. EST. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation. . . .

I'll catch the replay, as I am busy at that time, but will post anything significant. It would seem unlikely there would be such a development, unless he decides to describe the terms of the Cobb v. Merck settlement.

Tuesday, February 14, 2012

"Mediation Day" Results In Settlement Of Cobb v. Merck -- ENHANCE ERISA Class Action

Back on January 18, 2012, I mentioned that yesterday would be "mediation day" -- on the ERISA federal class action related to the ENHANCE disclosure delays.

As a Valentine's Day present, we just learned that Merck's trial counsel has filed a letter with the court this afternoon, indicating that -- subject to the approval of Merck's board of directors -- an agreement has been reached to settle the ERISA matters. In short, the mediation day. . . worked. As I suggested back then:

. . . .I do think it a sign of emerging wisdom on Mr. Frazier's part -- that he no longer seeks to litigate these claims (recall his directly contrary stance, as General Counsel, on the Vioxx® claims). First, in my estimation, there is arguable merit to each of them -- and second, even if one believes there is not -- it is high time to put the ENHANCE matter in Whitehouse Station's rear-view mirror, and permanently so. Little might be gained, even in a complete victory, here -- and each time a court date is scheduled, a rehash of the facts will likely run in the popular press. Just no longer worth it. . . .

When the specific terms of the settlement are made public, we will let you know -- for now, here is the letter from Merck's counsel (a one page PDF file).

"That's Some Box Of Chocolates!" -- Mr. Obama Just Took Pharma's $80 Billion "Voluntary" Offer. . . And Doubled It

Regular readers may well recall that, back in June of 2009, I said the $80 billion that multinational pharmaceutical manufacturers had agreed to kick in -- toward rebates for the health care reform package -- was a nice start, but only a start.

The President's new 2012 budget makes that clear.

While Mr. Obama may not ultimately get the entirety of his nearly doubled ($156 billion) pharma rebate amount in his budgetary request, from Congress, here -- it is likely that he will get a goodly chunk of it.

My best guess is that the number will end up around $130 billion, when all the shouting and moaning is over. In any event, here is Ed's fine take on it all, over at Pharmalot -- and just a bit of that (do go read it all!):

. . . .The response was swift. In a statement, PhRMA ceo John Castellini lambasted most everything and warned that the “proposed mandatory rebates in Medicare Part D are a short-sighted proposition that could destabilize the program and threaten hundreds of thousands of American jobs… This is not an investment in America’s future and these proposals should not be considered.”

Drugmakers are being asked to provide $156 billion in discounts over the next decade as part of a proposal to save $362 billion. Pharma, you may recall, agreed to provide $80 billion in discounts and rebates under the 2010 health-care law. And brand-name drugmakers currently provide rebates of up to 15 percent for Medicaid, but the White House wants to cover the so-called dual eligibles, or about 9 million seniors who qualify for both programs. . . .

Meanwhile, the White House noted that the FDA budget would total $4.49 billion for the year beginning October 1, which would amount to a 17 percent boost, reflecting increased user fees, in particular. These include a new user fee totaling $299 million to support generics and another $20 million for biosimilars. Over the past five years, about a third of FDA funding was generated by industry fees, but this would increase to 45 percent in the proposed budget. . . .

Do stay tuned, here -- as the proverbial fat lady isn't even clearing her throat, just yet. It is certain, though, that Merck will pay more than the perhaps $140 million a year I had earlier predicted, now. I'll update as developments warrant.

Monday, February 13, 2012

Merck's Good News Monday -- Zioptan™ (Tafluprost, Ophthalmic Solution) Approved

FDA has approved Merck's newest glaucoma treatment, per a Whitehouse Station press release:

. . . .Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Zioptan™ (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution. Zioptan (pronounced zye-OP-tan) is approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension. Open-angle glaucoma is the most common form of glaucoma, while ocular hypertension is a condition characterized by an increase in pressure inside the eye.

"Prostaglandin analogs are often used as a first line of treatment to lower intraocular pressure in patients with open-angle glaucoma. The approval of Zioptan will provide a new, effective option to lower IOP," said George L. Spaeth, M.D., Wills Eye Institute, Philadelphia, "I anticipate using Zioptan in many of these patients in my practice."

Zioptan may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

The FDA approval of Zioptan was based on efficacy and safety results from five controlled clinical studies of up to two years in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies.

Zioptan was shown to have powerful IOP-lowering effects. In clinical studies of up to two years in duration, Zioptan, dosed once-daily in the evening lowered IOP at 3 and 6 months by 6-8 mmHg and 5-8 mmHg respectively, from a baseline pressure of 23-26 mmHg (mmHg = millimeters of mercury, a measurement of fluid pressure in the eye). . . .

Good news -- but do see the side-effects/risk information, for prospective patients -- and do talk to your doctor. [This site is in no manner affiliated with the doctor(s) quoted, nor Merck itself. End, FDA disclaimer.]

Of Merck -- My "Told Ya' So!" Moment: IMPROVE-IT Likely Comes In 2014 -- Morgan Stanley's Analyst Report

I quote this morning from Benzinga's wire stories -- which, in turn reports on an updated Morgan Stanley analyst outlook:

. . . .Morgan Stanley says, "We raise our PT on MRK from $34 to $37, based on extending our model through 2020 and pushing IMPROVE-IT-driven Vytorin cliff from 2013 to 2014. We maintain 60% odds that IMPROVE-IT fails to show Vytorin is better than Zocor. . . ."

Do go read it all, but as you can tell from my left margin graphic, I've long held (since 2008) that the effects of IMPROVE-IT won't be known until 2014 -- that is 687 days, 58 minutes and 10 seconds from the moment I write this(!).

With Whitehouse Station lately saying openly that it will get an interim look at the 75 percent of events mark (strokes, cardiac events, etc.), Wall Street seems to be betting that the 75 percent of events data will be inconclusive (as to outcome benefits) -- so, Merck will need to finish the study, and run it until all events are known. And even then, sometime in 2014, it may well be that no statistically significant outcome benefit is seen. In fact, Morgan Stanley puts the odds of that "ultimate null result" outcome at 60 percent.

So it goes.

Sunday, February 12, 2012

When Did Merck Delete The Wavy, Windswept Hair From The Propecia® Logo?

When I wrote late last week about the removal of the content from Merck's Propecia® website, for male pattern baldness, I didn't notice that the logo had been revamped.

Look closely at the "P" in Propecia -- old and new, at right.

No more implication that the diluted-dose prostate drug would grow a full head of wavy, windblown hair, on the top of a balding man's scalp. Nope. Does anyone out there know -- when, exactly, Merck revamped the "P" in the logo? Let me know, in the comments.

It makes sense, in any event, if the FDA is getting ready to greatly revamp the label, or if Merck is considering pulling the drug altogether.

. . . .Thank you for visiting propecia.com.

This Web site is not currently available.

Click here for: Prescribing Information

Click here for: Patient Product Information

For more information or to enroll in the PROPECIA—Persistence Program, click here.

For more information about, or to download a refund request form for the PROPECIA Promise Program, click here. . . .

I strongly suspect there will be a fairly significant Propecia announcement -- and fairly soon.

We shall see.

Friday, February 10, 2012

The Full Amended ENHANCE-Era Putative Securities Class Action Complaint: 234 Pages Of PDF Goodness

Since the opinion allowing the same was entered two days ago, the plaintiffs have now filed the "as newly amended" complaint. It weighs in at 234 pages. Paragraphs 356 and 357 were the last two that the defense was trying to prevent being added. The court said otherwise, so now we have the full complaint as an 890 Kb PDF file. And just one bit, here:

. . . .240. Also on January 24, 2008, Senator Charles Grassley, ranking member of the Senate Committee on Finance, opened his own probe into Merck’s and S-P’s conduct, sending a letter to Merck’s CEO, Richard Clark, and to S-P’s CEO, Fred Hassan, requesting documents and the answers to questions regarding the delay in releasing the results of ENHANCE. Senator Grassley wrote that “there is no apparent gain in health benefits from using Vytorin over the much cheaper generic statin, simvastatin” but the Companies had the study results since April 2006, more than 20 months before releasing them. Senator Grassley also wrote to ACC President James Dove, AHA CEO M. Cass Wheeler, and SEC Chairman Christopher Cox to express his concerns about the extraordinary delay in releasing the ENHANCE study results. . . .

My take: This one is simply going to have to settle (given that personal liability is at stake for the legacy Schering-Plough, and legacy Merck, officers and directors, from that era) -- and it is likely to settle for boxcar-style numbers.

Thursday, February 9, 2012

Merck's Victrelis® (boceprevir) -- FDA Drug Safety Communication -- Drug Interaction

An anonymous commenter has very helpfully pointed us to a WSJ blurb -- but I've decided to run the entire FDA communication, since it involves issues of patient safety, and it is not uncommon to find Hep C co-infection in HIV-positive patient populations. Without additional introduction, then (more general FDA communication):

. . . .AUDIENCE: Infectious Disease, Pharmacy

ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis® (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body (see Data Summary below). FDA will be updating the Victrelis drug label to include information about these drug interactions.

BACKGROUND: Victrelis is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to “boost” other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

RECOMMENDATION: Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. . . .

This will only widen the revenue/market-share gulf between Victrelis® and Incivek®, in my opinion, to Merck's material detriment.

Dr. Shenk Leaves Merck Board -- To Found New Antiviral Therapies Company

Dr. Shenk intends to "commercialize discoveries made in his Princeton University laboratory in the area of antiviral therapeutics," according to published reports -- and since these would likely compete with Merck's vaccine businesses, he has rightly decided to step down. Thus, from last year's Merck proxy statement:

. . . .Thomas E. Shenk, Ph.D., Age — 65, Elkins Professor, Department of Molecular Biology, Princeton University since 1984. Dr. Shenk was also the Chairman from 1996 to 2004.

Director, Fox Chase Cancer Center since December 2009; Fellow, American Academy of Arts and Sciences; Member, American Academy of Microbiology and National Academy of Sciences and its Institute of Medicine. Dr. Shenk was also a director of Cell Genesys, Inc. from 2001 to 2009 (biotechnology company), CV Therapeutics, Inc. from 2004 to 2009 (biotechnology company) and Merck Sharp & Dohme Corp. (formerly known as Merck & Co., Inc.) from 2001 to November 2009. . . .

So it goes.

Merck Pulls Its Propecia® Web-Content

I won't engage in the speculation that the plaintiffs' bar is offering, here -- but I will note that Merck may need to revise its labeling for Propecia® (Finasteride), according to FDA sources. Thus, removing some of the positive statements (relative to male pattern baldness) is a wise move. The rub is, though, that to remove those statements without updating the side-effects, and risks sections would be odd, indeed (and perhaps frowned upon by FDA). So -- my guess is that it was thought to be safer to simply disable the web-content (see image at right -- click to enlarge).

Sourced out of Baltimore, here is a bit from one of the more speculative, sensationalistic guesses -- as to why this has occured.

. . . .Amid growing medical evidence that its hair growth drug causes. . . [various] side effects, Merck & Co. has pulled Propecia® content from the company’s website. (www.propecia.com)

Merck offered no explanation for the unusual move. . . .

In any event, I will keep one hairy eyeball on this one, for the readership.

Wednesday, February 8, 2012

ENHANCE-Era Securities Plaintiffs Allowed To Plead New December 6, 2006 Vytorin 2007 Guidance Claim: Court Opinion

Two new paragraphs -- numbered 356 and 357 -- which point to allegedly material, knowing falsehoods in a December 6, 2006 legacy Schering-Plough guidance press release, and accompanying statements, related to 2007 revenue projections for Vytorin and Zetia, have been allowed by the New Jersey federal District Courts. Here is U.S. Magistrate Dickson's just-entered opinion (an eight-page PDF file). Note that this is the same set of suits that are based on up to eight confidential witnesses, each of whom were -- at the time -- employees of legacy Schering-Plough.

This latest federal District Court opinion will strengthen the plaintiffs' hand in settlement negotiations significantly.

Merck Sponsors PBS Black History Program On Pulitzer-Winning Book

I whole-heartedly applaud Merck's visionary financial support of the production of this documentary. The program relies heavily, for its visuals and narrative, upon the Pulitzer-prize winning book of the same name -- do go read all about it, and watch selected clips, at the PBS.org site dedicated to promoting it:

. . . .Slavery by Another Name is a 90-minute documentary that challenges one of Americans’ most cherished assumptions: the belief that slavery in this country ended with the Emancipation Proclamation. The film tells how even as chattel slavery came to an end in the South in 1865, thousands of African Americans were pulled back into forced labor with shocking force and brutality. It was a system in which men, often guilty of no crime at all, were arrested, compelled to work without pay, repeatedly bought and sold, and coerced to do the bidding of masters. Tolerated by both the North and South, forced labor lasted well into the 20th century. . . .

For most Americans this is entirely new history. Slavery by Another Name gives voice to the largely forgotten victims and perpetrators of forced labor and features their descendants living today. . . .

Check your local listings, for the evening of Monday, February 13, 2012 -- and do watch.

Tuesday, February 7, 2012

Analysts' Puzzling Merck Vorapaxar Reaction: Did They "Forget" That 2010 $1.7 Billion Write-Off?

Peter Loftus is covering a head-scratcher today. While the latest top-line news on Merck's (actually legacy Schering-Plough's) vorapaxar studies doesn't represent the absolute worst case scenario, it is nearly unfathomable that Merck might now seek FDA approval for the candidate -- with a label indicating that it is only for patients with no history of strokes.

Seriously, folks -- this is a candidate that was previously shown to triple bleeding risk, and in a large study, to boot.

Think about that for a minute -- Merck already wrote off $1.7 billion, understanding that the risk of brain-bleeds would doom its prescribing chances. Will a US-licensed-doctor really write a scrip for it, saying "Well, you haven't had a stroke, so your risk of blood clots in the brain from vorapaxar is smaller than other patients. . ."?

C'mon -- given the rather-alarming data on bleed risks (in late 2010), and the presently-available drug alternatives, that simply amounts to a medical-malpractice claim, albeit "still on the hoof."

In addition, it might yet take another $100 million of new money, from Whitehouse Station, to win that "unicorn's" approval -- for a drug with essentially no realistic US market narrative.

Two words: No way. And. No how. [Even so, Merck's stock is rising slightly, on the NYSE, in a generally flat market today.]

Here is a bit of the Pete Loftus by-lined story -- do go read it all (as he is the most experienced of the writers covering it today):

. . . .[A]fter the bleeding risk was observed last year, vorapaxar was discontinued in people with a history of stroke. Patients with a history of heart attack or peripheral artery disease -- about 75% of enrolled patients -- continued to receive vorapaxar.

Tuesday, Merck said the risk of bleeding inside the skull was lower among vorapaxar users with no history of stroke.

This raises the possibility that vorapaxar could get regulatory approval for use in patients with no history of stroke.

ISI Group analyst Mark Schoenebaum said regulatory approval of vorapaxar in this patient population would represent upside from his current forecast of zero sales for vorapaxar. But he discouraged investors from assuming that this would materialize, saying more will be known when full data are presented in March. . . .

It will astound me if Chairman Ken Frazier decides to spend another perhaps $100 million to seek such a narrow label -- and aim for a non-existent market. Even Forbes' Matt Herper is suggesting (by inference) that the $1.7 billion 2010 write-off might have been premature. I am all but certain it wasn't. And in March, we will know with certainty -- as the full study results will be available to the ordinary investing public. For today, though, I's say beware the desperation narratives out of Sanford Bernstein & Co.