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Wednesday, January 23, 2008
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 Keeping Your Hands Clean
Let's start with a summary of the events so far: After a nearly two-year delay, Merck and Schering-Plough finally release results of the now-notorious ENHANCE study. The study looked at 720 patients with a genetic predisposition leading to very high cholesterol levels. Researchers compared the effects of Vytorin (a combination of the generic statin Zocor and the branded drug Zetia) versus Zocor alone. They looked at the formation of arterial plaques as well as the incidence of various cardiovascular events.
The surprising result: Vytorin is seemingly no better than Zocor and actually trended worse in plaque formation. And now the fallout: Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) are investigating the delay in releasing the results, as well as the fact that the companies hired a not-so independent panel to look at changing the study endpoints after the fact.
Then renowned cardioligist Steven Nissen of the Cleveland Clinic went on NBC to say that Vytorin and Zetia should be prescribed only as drugs of "last resort." (Nissen is known, among other things, for his role in highlighting potential risks associated with GlaxoSmithKline's diabetes drug Avandia). Then the American College of Cardiologists (ACC) came out with a statement saying that reaction to the ENHANCE study has been overblown, that there is no reason to take patients off the meds, and that we should wait for further studies, expected over the next couple years, to shed further light on the situation. This echoed several Wall Street analysts, one of whom rather bizarrely called the study results a "non-event."
Still with me? Okay. ACC is right to say that there's no need to panic. Vytorin did do a good job lowering LDL cholesterol, and had a nearly identical rate of cardiovascular complications. The trend toward plaque formation was not statistically significant, and may even have something to do with lousy study design and poor data--the ultrasound images of arterial plaques were reportedly hard to read and sometimes yielded results that weren't biologically possible, leading one to question the quality of the results. It may even be that further studies will ultimately highlight advantages of the expensive branded drugs, though right now things seem to be cutting the other way.
But there's no mystery that the billions of dollars in sales brought in by Zetia and Vytorin since the conclusion of ENHANCE in April 2006 posed a pretty strong incentive to delay any bad news. No matter what the reasons were, it sure looks bad.
Is there a solution to problems like this? Yes. Put the clinical databases in the hands of the study researchers, not the company. That should be a no-brainer, and it's increasingly done in clinical trials...but it wasn't for ENHANCE. Merck and Schering-Plough claim an almost two year delay was caused by the difficulty in going through massive piles of data, but they'd be a lot more credible if the data scrubbing were out of their hands. As it stands, it's hard not to give some credence to the conspiracy theorists.
The icing on the cake? Pharmalot reports that the unsigned ACC statement urging calm was drafted in part by Roger Blumenthal, director of the Ciccarone Cardiology Center at Johns Hopkins, who is also on the speaker's bureau for Merck and Schering-Plough and has received research grants from Merck. I don't think there's anything to that--Blumenthal has been on record himself questioning the delay of the ENHANCE study results as an ominous sign. But industry and ACC need to take a reminder from this: Appearances matter. Disclosure is easy, and it takes firepower away from your enemies.
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Go back a couple years, and venture capitalists were in love with the "de-risked" model of in-licensing companies--so-called "no research, development only" (NRDO) companies that licensed in clinically advanced or otherwise overlooked products from outside. Fast forward to Cadence Pharmaceuticals' lackluster results with its IV acetaminophen: The in-licensed product doesn't look so good, the pipeline is nearly bare, and the company has no platform, no research expertise, and little cash. Now tell the shareholders again how that's de-risked? -KT
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I snuck Novo Nordisk into this section because it is planning a headcount reduction of 300 or more. But what's really interesting is that Novo's management has looked at Pfizer's experience with Exubera and decided its own troubled inhalable insulin program amounts to throwing good money after bad. Tough for employees of Novo Nordisk, and for its partner Aradigm. So does this mean Eli Lilly and Alkermes will have the inhalable insulin market mostly to themselves? Or that they will be next to bail? -KT
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Merck and Schering-Plough have claimed that Vytorin is the drug that counteracts "food and family" in lowering cholesterol--that is, it works both against dietary and genetic influences on cholesterol levels. We'll see how well that ad campaign holds up. Meanwhile, Genzyme is gunning for the "family" side of the equation, striking a major deal with Isis on a drug that targets apolipoprotein B-100 in treating familial hypercholesterolemia. The deal includes a whopping $325 million upfront payment, $825 million in developmental/regulatory milestones, and up to $750 million in additional commercial milestones. Yowza! -KT
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You've got to hand it to Antigenics CEO and chairman Garo Armen. His company has suffered through major clinical setbacks, a plummeting stock price, and a severe shortage of cash. But nothing says you're serious like putting your own money on the line. In Antigenics' latest $26 million financing round, Armen put up $5.1 million of his own wealth. Armen has been a voice for loosening FDA requirements on how drugs for very sick patients are approved, arguing that a subset analysis of Oncophage clinical trial data should be sufficient for a green light. The company hasn't made it clear whether the new cash will fund a new trial for Oncophage. -KT
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Without complete and compelling efficacy data, FDA denies approval for drugs that appear to help very sick patients who have no alternatives. Part of their justification is that patients should petition manufacturers for experimental use while clinical trials advance. Now the Supreme Court has, without comment, let stand an Appeals Court ruling that says patients have no fundamental right to experimental medications. The advocacy groups seeking to bring the case forward were making a constitutional argument that frankly seemed like a bit of a stretch, but there may now be pressure on Congress to formalize patient access to experimental medications. -KT
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Last summer, Pfizer's Lyrica became the first and only drug approved to treat fibromyalgia--a disease characterized by chronic pain of unknown origin and diverse other symptoms. Now Forest and Cypress are getting in on the game, following Eli Lilly's application to gain a fibromyalgia indication for Cymbalta. There are big markets here. The challenge is that many doctors don't even believe the disease exists per se, suspecting it is either a collection of separate complaints of diverse etiology or even an essentially mental illness. What's interesting is that ads promoting new meds seem to be aimed as much at convincing doctors as patients about the illness. -KT
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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.
You may contact Karl Thiel at Karl.thiel@biospace.com.
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