A Salmon Rises -- On Pseudoparkinsonism Events In One Quarter Of Studied Saphris® Patients

We've been graced with expert commentary, yet again -- on the latest news of a study involving Saphris^® (asenapine), New Merck's atypical antipsychotic. Take it away, Salmon:

. . . .[T]hese rates on pseudoparkinsonism are quite astounding.

One of the selling points for the 'atypical' antipsychotics (Zyprexa, Risperdal, Saphris, et al.) is that they supposedly have less extrapyramidal side effects. With the rates with the classical antipsychotics being around 20% - 25% with some of the classical antipsychotics and 10% - 15% with the atypicals. The problems with this is that studies with the classical antipsychotics typically used excessive doses and so we weren't comparing comparable dosages.

Rates of EPS for pseudoparkinsonism is likely a marker for the probability for developing another more severe EPS: Tardive Dyskinesia. TD consists of severe jerky/writhing movements typically of the mouth, face and other parts of the body and may result in death due to choking on food due to problems swallowing.

It's also very disconcerting to patients and scares others who see patients exhibiting symptoms. TD is dose and time related and tends to occur after a few years of use.

If Saphris has these high rates of pseudo-PD it raises the spectre of high rates of TD similar to Haldol with long term use. Not something you want to see in a drug with questionable efficacy and which due to being in a sublingual formulation is likely to be more heavily prescribed to children and the elderly. Both of whom are likely to be at even higher risk due to greater drug exposures secondary to smaller body size and forced compliance. Plus for the elderly especially they are also at greater risk for death due to choking due to TD as well as due to falling secondary to pseudo-PD. . . .

As for the negative symptoms. I've mentioned before that some of the new scoring methods seem to be splitting hairs. When you look at PANSS you really don't see much difference yet if you dice the negative scale on the PANSS very finely you may be able to find a statistical difference that is not clinically important.

The FDA files on Saphris indicated that it also had higher rates of severe cardiac toxicity compared to olanzapine.

So what we have is a me-too of Zyprexa that's likely more toxic in several different domains (cardiac, neuro, and hematologic). All of which are signficant.

Has questionable efficacy in schizophrenia. In fact I believe the FDA manipulated the interpretation of the statistics and it should not have been approved for this indication. In fact the main reason it likely showed efficacy in 1 of the 2 studies relied on was because the patients in the Saphris arm were sicker at baseline and so the study violated a basic condition of an adequate and well controlled study that the groups studied have to be comparable.

Plus it's coming to market close to when its competitors are going off-patent. . . .

-- Salmon

June 8, 2010 | 2:24 PM EDT

There you have it. As I said -- I knew we'd hear from an expert. We are fortunate here to have Salmon's insights. Yes, you've been warned: Tardive Dyskinesia, with longer-term Saphris use -- that would seem likely. Watch for it.

New Merck's Saphris® -- Spinning Essentially Neutral News

I just ran across this Saphris^® (asenapine) item at TradingMarkets.com, and while Merck is pitching it as a net-positive, its own disclosures make it neutral (at best), to slightly negative.

I trust Salmon will fill us in, here -- but here is a snippet:

. . . .Merck presented positive efficacy and safety data of Saphris for persistent negative symptoms of schizophrenia, thus supporting previous trial data. According to the results, over 52 weeks, treatment with Saphris significantly improved patients' negative symptoms compared to olanzapine on the 16-item Negative Symptom Assessment scale total score. However, dropout rates were higher for Saphris compared to patients on olanzapine and extrapyramidal symptoms were recorded for 24% of Saphris patients compared to only 10% in the olanzapine group. . . .

Paging Dr. Salmon. . . . um, I'm no mathematician, but that's more than two times the adverse events, compared to olanzapine arm. So-called "Extrapyramidal events" resemble Parkinson's disease, and include tremor of the limbs, and often appear with bradykinesia -- a greatly impeded ability to start and continue movements, and impaired ability to adjust the body's position. Yikes.

Wanna' Watch An Info-mercial -- For Crappy Executive Leadership?

Nah. Me either. [H/T Ed Silverman, at Pharmalot for re-posting this dated clip, though. Here's a free short snippet of it, from YouTube, below.]

This is, at bottom, simply a rather dated self-promotion piece, shot when Fred was still looking for a full-time gig. I think I saw a version of it last February, on a consultant's website -- it is drawn from a CNN Europe interview, which is blocked on YouTube in the US, due to copyright clearance issues (but if you're in Europe, you can watch it free at that last link). The erstwhile interviewer allows Fred Hassan to recite (without fact-checking follow-up questions) what are, for Hassan, empty buzz-words. If he executed any of the things he so eloquently describes here, it would be meaningful -- but because he didn't -- it's not.

. . . .“If there’s toxicity in the system, it won’t work”. . . .

-- Fred Hassan, Former Chief Executive, Schering-Plough

Or -- more likely, "toxicity" within the leader, himself.



In addition to the above, here is another longer piece (4:55), freely distributed through YouTube, that covers almost all the same ground, in late 2008. But really, why bother? You know what he's gonna' say -- he tells you about being aligned through the layers of management, while he is busily lining his own pockets, usually at your expense.

Neutrogena Gets Another Chance, In Sunscreen "Battle Royale"

So -- it turns out that J&J's Neutrogena unit will be allowed, by the very able Delaware federal District Court Judge Sue L. Robinson, to offer additional evidence that it defines Helioplex^® -- a proprietary ingredient in J&J sunscreens -- in a way that is broader than simply detecting the presence or absence of DEHN, a chemical that New Merck, as successor to Schering-Plough's Coppertone unit, claims was omitted from "Helioplex-labeled" products (allegedly creating a literally false advertising claim, under the federal Lanham Act).

Having read all the pleadings now available in the public record (which excludes a large volume of material filed under seal, in this case, presumably on trade secret grounds), I agree that the original inquiries the able judge made were likely too narrow, given the fluid way in which the term "Helioplex" is actually used by Neutrogena. And so, from her ruling today:

. . . .Mindful that the sunblock-purchasing season was nearly (or already) underway, in lieu of a response, the court ordered defendant to respond to several direct questions relevant to the court's inquiry. . . .

[Defendant Neutrogena answered the questions; the Court ruled against the Defendant. Defendant made a motion to reconsider.]

. . . .In this regard, defendant argues that "Helioplex"^® has also been defined to the public as "a breadth of stabilized sunscreen technologies that deliver superior UVNUVB protection" without specific reference to DEHN. (D.I. 18 at 5-6, n.1) It is not clear that this specific advertisement was before the court prior to its grant of partial summary judgment. Insofar as the court's prior order limited defendant's response to plaintiffs motion, the court will allow defendant to put forward its evidence that its representations that the 100+ Product contained Helioplex® during the period at issue were not false on their face. Relevant documents may be attached as exhibits to defendant's submission. . . .

We'll keep you all slathered in these competing product-charges and counter-charges -- and probably will do so, all summer long.

Blogspot Outage Ends: Fosamax® Jury Selection Underway This Morning, In Manhattan

After a week's delay, the retrial of the Boles II Fosamax^® "bellweather" case is getting underway, before Judge Keenan, in the federal District Courts, in Manhattan, this morning. Mrs. Boles’ lawyers have asked Judge Keenan to rule that at the close of the case, he instruct the jury about alleged non-compliance with FDA rules, as another basis to find liability against Merck.

The argument runs that the jury may presume Fosamax was dangerous and adulterated (in the parlance of the FDA), if Merck failed to comply with FDA rules in securing approval of it, and then later, in the way Merck marketed the drug. With a correction of some typos, I think the plaintiffs' instructions will work well -- see below -- and click to enlarge:



The FDA rules compliance issue, in turn, will squarely present the matters implicated by this chart (some background on that):



I will keep you informed as the trial progresses.

Sleep, Yoga and Cancer Patients: Encouraging Results -- ASCO 2010

The annual meeting of the American Society of Clinical Oncology is underway in Chicago -- so, I may feature a few noteworthy items from the booths during the week, time and space permitting. This first one (out of the University of Rochester) is simply obvious -- once one is alerted to it -- but highly worthy of mention, just the same.

It turns out that cancer patients who participated in a specially-tailored yoga program slept better, had less fatigue, and were less likely to need medication for sleeping problems and fatigue than patients who did not participate in such exercises.

Sleeping problems and fatigue are the most common side effects of cancer treatment, according to the Rochester researchers. In fact, most patients report that they have sleep problems during treatment, and more than half continue to have problems after treatment ends. So this is decidedly encouraging news:

. . . .In this study, cancer survivors participated in a four-week, twice-weekly yoga program called YOCAS^® (Yoga for Cancer Survivors) developed by the University of Rochester Cancer Center Community Clinical Oncology Program. . . .

[It involves] a simple method that doctors can recommend to help patients with several very common cancer-related problems. . . . included are mindfulness exercises such as breathing, meditation, visualization, and various poses. . . .

Indeed -- welcome validation, here. Sometimes, it is the simplest of things. . . .

Reuters' Errata -- Corrected, Quoting Fred Hassan

Finally, this Reuters story is set straight:

. . . .CORRECTED | UPDATE 3 | J&J sees fast-growing device market | Fri Jun 4, 2010 10:06am EDT

In third to last paragraph, corrects that Schering-Plough, not J&J, hired Hassan in 2003). . . .

That is all.

Boles v. Merck: Fosamax® Retrial Starts Monday In Manhattan Federal Court

After a week's delay, this sensational "Runaway Jury"-style retrial will get underway, in earnest.

The very able Judge Keenan has not ruled on Mrs. Boles' request to offer evidence that Merck "moved the goalposts" when it -- and it alone, in all the world -- defined "osteoporosis" to include a more robust group of post-menopausal women than either the World Health Organization, or the FDA.

Merck decided, on its own, that even women with relatively strong bones had "osteoporosis". That way, a much larger, and healthier patient population could be ultimately treated, and for many more years, with Fosamax^®, or so Merck hoped. See below -- click to enlarge:



The above chart seems decidely relevant to me, in deciding whether Merck should be at least partially responsible for the osteonecrosis of Mrs. Boles' jaw bone (or jaw bone "death"), which she claims was caused (at least in part) by her very long term use of Merck's Fosamax.

Here is how I framed this issue, about two weeks ago:

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 7 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. . . .

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.

Bad News For Intervet's PreveNile® Equine Vaccine: Nationwide Recall

A journal called "javma" -- a veterinarians' publication -- is carrying the below item, for its June 15, 2010 print edition (available in advance here on the web):

. . . .Intervet/Schering-Plough Animal Health has recalled PreveNile^®, a vaccine intended for the prevention of West Nile virus infection in horses, after identifying an increase in the incidence of adverse events related to the product currently in the market. . . .

[There have been] reports of acute anaphylaxis, gastrointestinal signs, respiratory distress, and death following vaccination with PreveNile alone or in combination with other vaccines. PreveNile will not be available while the company investigates. . . .

The recall encompasses all serial numbers of PreveNile in both one- and five-dose vials. The eight-digit serial numbers start with 9166 and end with 9001 through 9016 and 0001 through 0004.

Veterinarians with these PreveNile products should contact their distributor to arrange for the products' return and a credit. . . .

I'll keep you posted, but equine vaccines are a pretty big portion of Intervet's appeal -- in the proposed contribution of Intervet, to the New Merial joint venture between Sanofi and New Merck. In that regard, the European markets for these equine vaccines, generally, are already pretty highly-concentrated (and will be more so, if Intervet can't fix this likely manufacturing/purity issue). So, I'll also keep an eye on the ECC, as well.

In The "Well -- That Can't Be Right!" Department

Reuters began running a story by Ransdell Pierson in the last hour, which (tangentially) claims that Fred Hassan worked for J&J in 2003. That can't be right. By April of 2003, he was under a ridiculously-lucrative contract, and working full-time at Schering-Plough. Prior to that, he was selling Pharmacia to Pfizer. Must be a typo.

In any event, his actual quote is. . . well, ironic -- given what happened on his watch at Schering-Plough, after the ENHANCE clank (and attendant disclosure delays), when he was then given an FDA "no way", on Cordaptive^® that Spring, and an "unapprovable" letter from FDA -- on Bridion^® (sugammadex) that Summer (2008).

. . . .J&J's consumer unit problems could spill over into its other, more profitable, businesses if the FDA begins to scrutinize those divisions as well, one industry expert said.

"If regulators start to distrust management, then they start being strict with everything, and checking and inspecting everything," said former Schering-Plough Chief Executive Fred Hassan. J&J [sic] hired Hassan in 2003 to clean up a quality control disaster [ID:nN03224575]. . . .

[Ed. Note: I think you mean Schering there, tiger.]

Indeed, as I wrote at the time Bridion clanked: ". . .it seems [concerns about] deficient data sets out of Schering-Plough are an emerging theme -- first from two Congressional Committee Chairs, now FDA. . . ." It ultimately got so bad that by July 2008 Mr. Hassan was quoted in The Wall Street Journal as saying he no longer had "any idea" what it would take to get a drug approved at FDA.

What goes 'round -- really goes 'round, eh Freddo?

New Foradil® Asthma Label Warning Ordered By FDA

Here is the FDA ordering release -- it doesn't cover COPD, but applies to asthma. FDA was forced to take this action, due to non-cooperation by some LABA manufacturers. No names were named by FDA.

This is a legacy Schering-Plough product line, and the issue has been simmering since February 2010 (as I reported back then), but these concerns go back more than a year and a half -- to December 2008 (my backgrounder linked):

. . . .The new updated labels [must] state:

Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.

LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.

Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.

Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications. . . .

"FDA is ordering the involved companies to make labeling changes capturing these new recommendations," Dr. Badrul Chowdhury, head of the FDA's pulmonary drugs division, told Reuters. "Not all of the companies have accepted all the changes ... so that's where the ordering comes in. . . ."

Stay tuned, but this will not improve Foradil^® sales in the US.

Low US Uptake Of Gardasil® -- Among Teen Girls -- New Study Suggests

And the skew -- of the remaining market opportunity -- is apparently toward public aid-funded patients, not privately insured ones. This means Merck is likely receiving a lower average reimbursement rate, for these still relatively-rare Gardasil^® vaccination programs. More here (H/T Ed Silverman, at Pharmalot):

. . . .Only about one in three young women has received the human papillomavirus (HPV) vaccine to help prevent cervical cancer, according to a new report from researchers at Washington University School of Medicine in St. Louis. . . .

More than 70 percent of the girls in this study were white, and almost 75 percent had health insurance. Girls living in states with more poverty were less likely to get the HPV vaccine, but higher poverty rates in the individual counties within those states and lower family income levels actually made it more likely a girl would be vaccinated. Pruitt says those seemingly contradictory findings may be explained in part by the way in which funding for vaccines is allocated.

“For the neediest children, the United States has a publicly funded vaccination system, but each state sets its own guidelines for who is eligible to receive free vaccines,” she says. “Individual states set different guidelines for providing vaccines to those with no insurance versus those who may be underinsured. So girls from poorer counties may be more likely to qualify for a free vaccine, whereas those states with more poverty may not have adequate funding to provide it or may be less likely to fill in gaps for those who may not have enough private insurance coverage to pay for it. . . ."

Do go read it all for yourself, but if 75 percent had insurance, Merck may be reaching the end of that pool (fully-insured teens), already. So, the curve is likely flattening out.

Merck Reaffirms 2010 Guidance, "Excluding Certain Items"

Apparently to comply with SEC Reg FD, after some remarks by Ken Frazier at the Sanford Bernstein investor conference yesterday, Whitehouse Station put out an "Investor FAQ" this morning. My reactions?

First, this must mean that New Merck has greatly increased the amount of currency hedging it is undertaking (compared to the relative dearth of such hedging by legacy SGP) -- as I mentioned last month. This is a fairly substantial current-quarter cash cost, but may partially offset potentially-larger future European sales line declines.

Second -- as ever -- the 2010 guidance "excludes certain items". That's a green-light license to revise EPS guidance, under the guise of bust-up transaction-related costs.

Moreover, should the dollar strengthen appreciably from here (vs. the euro), Merck's reaffirmance would no longer be operative.

Finally, New Merck is buying back its own stock -- in a sign that it feels the stock has been under pressure. So Whitehouse Station has come out to defend it.

My parting observation? They'll chew through the $3 billion of buy-back authority pretty quickly, if we see a bunch of 15 million share days, with order imbalances.

In any event, here it is (linked as a PDF file):

. . . .Does the 2010 guidance still hold with all the global economic changes?

As of June 2, 2010, the company reconfirms its full year 2010 guidance non-GAAP EPS range of $3.27 to $3.41, excluding certain items and 2010 GAAP EPS range of $1.15 to $1.50. The company also reconfirms its long-term target high single digit non-GAAP EPS compound annual growth rate from 2009 to 2013.

Are you actively buying shares in the market as part of your $3 billion repurchase program?

Yes, we recently initiated repurchasing shares under our $3 billion share repurchase program which was authorized by the Board of directors in November 2009. . . .

Stay tuned.

More Matt Herper -- Quoting "Ex-Ex-CEO" Fred Hassan -- For Hassan's "Nonsense Effect"(!)

This one is trivial, but jolly-good fun. Here -- a few days back -- we have Mr. Herper quoting "Serial Ex-CEO" Fred Hassan -- for his decidedly unintended comedic effect. When quoted, Hassan was the soon-to-be Ex-CEO of Pharmacia. As we all know, he then went on to become the infamous (notorious?) Ex-CEO of Schering-Plough. . . and is now firmly on a track -- to become the Ex-Chairman of Bausch & Lomb.

[Strangely, I am here put in mind of the line Jeff Goldblum, as the mathematician Ian Malcolm, Ph.D., utters -- in the first Jurassic Park movie -- "I am always on the lookout for the next Ex-Mrs. Malcolm. . ."

Yep -- Fred's like that.] In any event, to Forbes:

. . . ."It's sort of like winning the battle and losing the war," says William Boden, a cardiologist at the University of Buffalo". . . .

Inspra was launched in 2003 by Pharmacia, with high hopes that it would become a big drug in helping to control the blood pressure of heart failure patients. Pharmacia chief executive Fred Hassan called it "a significant advance."

Pfizer bought Pharmacia later that year -- and barely marketed it. Pfizer [as corrected] barely marketed it and it flopped. Most doctors believe that spironolactone, a very old drug that costs $4 a month, does the same thing. Inspra, by contrast, costs $130 a month.

"We use a truckload of spironolactone," says James Stein of the University of Wisconsin-Madison. "It's hard to beat a drug that costs four bucks at Wal-Mart and has been around for fifty years." He says he mainly switches patients to Inspra when men had breast growth or tenderness, a side effect he says is rare. . . .

Indeed -- so, will privately-owned (but Warburg Pincus financed, and backed) Bausch & Lomb turn out to be the next Ex-Mrs. Ian Malcolm, Ph.D., or will Time-Warner ultimately fill that role? Time will tell.

Matt Herper's Follow-Up -- On "Patients Like Me": Forbes

For the second morning in a row, over at Forbes, Matt Herper is amplifying his reporting-as-advocacy (do go read it all). He none-too-subtly seeks a more open data sharing matrix, between pharma research labs -- via anonymized master vaults -- to avoid the oft'-repeated "blind alley" chases, inherent in the current non-system. The argument is quite persuasive that the current non-system does a disservice to patient-outcomes:

. . . .Gary Gilliland, the head of cancer research at Merck, did some of his important work on blood malignancies called myeloproliferative disorders with the help of the MPD Foundation, which insisted researchers share data. . . .

[Another recent Ex-Merck executive] Stephen Friend, whose nonprofit organized the the Sage Congress [click through to Mr. Herper's article to see the presentations], says the push toward making data more widely available is being driven by patients. He also thinks this kind of approach, epitomized by the Web site PatientsLikeMe, could transform the way side effects are tracked. It would be a lot easier to understand what goes wrong with a drug if people who take it were pooling and sharing their data. "I think the physician as the priest who knows things that others don't know has got to go away," he says. . . .

Indeed -- good stuff. I linked his installment of yesterday, here.

Amgen Gets FDA Nod For "Next Gen" Osteoporosis Drug -- "See Ya', Fosamax®!"

Twice a year injections are going to be a selling point, over the weekly pill regimen of Fosamax^®. Per the AP, tonight:

. . . .The injectable drug is given once every six months to increase bone mass and strength.

Analysts think Prolia should bring Amgen billions in revenue after it is approved. . . .

Global sales of osteoporosis treatments topped $8 billion last year, including hundreds of vitamin brands and drugs like GlaxoSmithKline PLC's Boniva and Merck & Co. Inc.'s Fosamax.

With eight other pills and injectable medicines on the market, analysts say Prolia's success likely will hinge on its price.

Prolia will cost $850 per injection, which the Amgen says is competitive with existing treatments. . . .

This follows a European approval of last Friday.

Wait -- I haven't even mentioned (i) the litigation pending against Merck, related to long-term Fosamax use, and (ii) that there is a generic version of Fosamax. But you already knew about all that.

Small World! -- Transocean Ltd. Taps Merck's Vioxx® Lawyer: Law.com

Who could have guessed that my off-topic image would "transmorgify -- to on-topic" -- in just three days' time?

With "top kill" an epic fail, and the possibility of cutting the riser-pipe clean away, and putting a new collecting "top hat" over the ferocious gusher -- clearly a high-risk maneuver -- Transocean (one of BP's partners on the Deepwater Horizon rig project) has tapped one of Merck's Vioxx^® lawyers, to handle fallout, and the burgeoning mass tort litigation, according to Law.com:

. . . .John Beisner, a partner in Skadden, Arps, Slate, Meagher & Flom's Washington office who specializes in mass tort defense, is working with Transocean Ltd. . . .

A decade ago, when Beisner was an O'Melveny & Myers partner, he represented Ford Motor Co. regarding defects in more than 60 million tires, and he was part of the legal team in 2007 for Merck & Co. in litigation over its prescription pain killer, Vioxx. . . .

So, that's BP's 2010 gulf oil slick -- to Vioxx. . . in one (for those of you "six degrees" fans). Wild.

Fascinating: A "Compliance" Dispute Brewing, At Merck's West Point, PA Facility?

After very acrimonious negotiations, and a tense period of working without a contract, you'll recall that the union local at Merck's West Point facility ratified a new three year contract, mid-last-month. It seems the hard-nosed Merck stance may have engendered some residual -- and ongoing -- ill-will. This per the local's website, as of yesterday:

. . . .Compliance Teams Update

Monday, 31 May 2010 @ 06:16 AM EDT

. . . .After a discussion with members of the Compliance Teams President Parente would like to convey the following. In April the Union stated that participation in Compliance would end immediately due to the contentious nature of negotiations. As of now, anyone wishing to resume working with the Company regarding Compliance is will [sic] welcome to do so. Anyone wishing to end their participation is likewise welcome to step down. It is a personal choice to made by each member. Regarding Inclusion our stance is the same as it is with Compliance. It is strictly voluntary.

Regarding all things Safety: The Union's stance is that safety affects the well-being of our membership and requires our continued active involvement. . . .

Let's see if any anonymous readers will rise, to fill us in on the particulars, here. In any event, I'll forward whatever we find out to FDA (though it is likely that many FDA staffers are already reading this, in real time). Good luck with that, Whitehouse Station!

Matt Herper -- Of Forbes -- On "Opening" One "Blind Alley": Drug Discovery

This is an excellent, well-thought-out blog piece, from Mr. Herper. Do go read it all -- but I'll give you a taste:

. . . .It may be that companies' tendency to keep their research under wraps is holding them back. Secrecy leads companies to race down the same blind alleys, to miss opportunities and to understand biology less than they otherwise might.

Now former executives from companies including Merck and Genentech are pushing to open up many stages of drug development, from basic science to human research, in the hopes of ending this drought. . . .

[I]n biological research, he argues, there is increasing evidence of "the absurdity of how data is not shared." He adds: "It's not just industry, it's academia. If patients ever came to an understanding of how people do not share data in academia, they would revolt. . . ."

Do go read it all, at Forbes. These efforts represent small -- but encouraging -- first steps.

Merck "Buys In": To Korea, To Fill Anti-Hypertension Drug "Hole"

A few weeks ago, I noted the slide at right (click to enlarge), from Merck's various "Dog & Pony" shows, and its "R&D Day" webcast. I dutifully pointed out that Merck had no follow-on for the huge Cozaar^®/Hyzaar^® franchise -- now that the same has gone the way of the dodo, erh. . . generic in the US.

Overnight, the InVivo Blog notes that Merck is going to buy its way into the next anti-hypertensive, as opposed to invent it:

. . . .A Korean blockbuster is going global, after Merck buys from Hanmi Pharmaceutical the rights to incrementally modified hypertensive amlodipine product Amosartan in North America, China and Europe, PharmAsiaNews reports. The drug will be sold under Merck's brand Cozzar XQ. . . .

Well -- that is one way to skin a cat. The margins are likely less than 10 percent of what they'd be if it was a home-grown MRL effort, though. Still, it does [albeit partially] begin to fill a yawning gap.