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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

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February 15, 2006

Pfizer Takes a Deep Breath

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Posted by Derek

I haven't mentioned Pfizer's inhaled insulin project in a while, but a few weeks ago they got the stuff approved, at (very) long last. The development of Exubera, which is certainly a cheerful brand name, has been anything but uplifting, though Here's a piece I did three years ago, when the story already seemed to have been going on for a long time.

Insulin, of course, is the very definition of a well-established drug, but that's only if you inject it. Slowing things down have been problems which are unique to inhaled powders: the effect on lung function over time, the changes in dosage under suboptimal conditions (allergy, flu, etc.), and the reproducibility of the dose. These are particularly worrisome for insulin, which is a tough situation: it's vital to its users, and it has a lower margin for error (both under- and over-dosing) than most other drugs. As I put it in that 2003 post, if you take twice as much aspirin as you should, it'll be rough on your stomach. If you take twice as much insulin, you're going to end up on the floor (and there had better be someone around with a candy bar).

You can see this troubled history in the drug's labeling, which Frederick Cohen at Crownstone has been going over. To pick one interesting detail, patients will be required to have a baseline pulmonary function test before starting the drug, with monitoring thereafter. And this brings up the current worry: how much will Exubera (and its baggage) cost, and who's going to pay for it? The product won't be launched until mid-year, and no one knows quite what its price will be. Pfizer's just saying that it will be "competitive", an answer which is synonymous with "Go away", but you can find estimates of up to four times the cost of injectable insulin (my guess is 2.5x). Call it a convenience premium. Will it fly?

Well, here's a piece in Business Week that's enough to make you wonder. It's written by a pair of consultants from the Bruckner Group, an outfit that's very big on outcome-based medicine, and from that perspective they think Exubera's in trouble even before it launches:

". . . Based on our analyses and interviews with major managed-care decision-makers, we expect that payers will either dramatically limit Exubera's availability to patients, impose very high co-payments, or reject coverage of it outright. . .For Exubera to achieve widespread preferential formulary status, payers will need to see a credible and compelling value proposition rather than an argument centered on patient convenience. The crux of the issue is whether an inhaled therapy will improve compliance and lead to significant improvements in patient health."

As they point out, the data on other inhaled therapies isn't too reassuring. Studies have indicated that asthma inhalers, for example, are often misused, both quantitatively and qualitatively. The Flumist inhaled flu vaccine has also been a disappointment compared to its injectable competition.

Pfizer may be counting on its (justly) famous marketing powers to put Exubera over. If the landscape, though, really is changing to more rigorous cost/benefit calculations, that might not do the trick. I realize that the BW authors have an interest in promoting this viewpoint, but I hope that they're on to something. I'd rather see more of the competition between drug companies taking place over medical evidence and financial benefit, rather than the size of the sales forces. Salesmanship alone can't put over a lousy drug. But it can take away from the issues that really should be decisive.

Tomorrow we'll take a look at how this applies to oncology, where things are getting really interesting. . .

Comments (18) + TrackBacks (0) | Category: Diabetes and Obesity | Drug Prices


COMMENTS

1. Daniel Vachon on February 15, 2006 11:00 PM writes...

I think Pfizer will do a grand slam with EXUBERA....why??? Because who likes "NEEDLE" I'M a nurse for 23 years and half my family have diabetic issues.... Pfizer think of peoples not Analysts and some idiots from Business week.....LOL

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2. Paul Hughes on February 16, 2006 1:51 AM writes...

I also believe Pfizer has a winner on its hands.

Firstly, I like and read your column and agree with most of your opinions on most things.

However I understand that you are not a pharmacologist but a chemist. I am a pharmacologist (PhD level and have worked in drug discovery) and I can see many reasons why this improved delivery mechanism for Insulin will help patients and Pfizers shareholders (me being one) greatly.

Sure I am biased, but I am just posting to even up the bias I see here often posted against Pfizer. I don't and have never worked for Pfizer.

I don't think sales force size really overwhelms medical evidence and financial benefit w.r.t drugs. With Exubera I don't think this is even going to be close. This will sell itself as the poster of the first comment states above.

People don't like needles. Is this really news to you. Do you know any diabetics?

Anyhow, your first poster hit the nail on the head. What do MBA analysts and Business Week ever get right. In terms of investing they are both a contrarian indicator. If Business week says buy stocks, Ill sell. Same with analysts.

Inhaled insulin will be a blockbuster for Pfizer.


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3. Jack Friday on February 16, 2006 5:00 AM writes...

Take a look at the Exubera thread on the Pfizer bulletin board of CafePharma.com

Even the reps who will be selling it think its a dog!

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4. michael on February 16, 2006 8:08 AM writes...

Pfizer will have to persuade clinicians and the diabetes community that inhaled insulin offers real benefits, and so far they haven't done that. Diabetes experts like Prof George Alberti and bodies like Diabetes Australia have expressed deep scepticism that inhaled insulin offers more benefits than risks. And with increasing pressure on pharmaceutical budgets I think they will have an uphill struggle persuading health providers to fund inhaled insulin when even lifesaving new drugs like Herceptin can't get the green light.

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5. Derek Lowe on February 16, 2006 8:50 AM writes...

Oh, I understand the desire not to inject insulin. My father died of diabetic complications, and both he and my brother had to use insulin (and no, in case anyone's wondering, I'm glad to report that my last physical a few weeks ago showed my own fasting blood and urine sugar levels to be just fine).

But I can't help but think that Exubera's cost (and the restrictions on patient suitability) will have a big effect on its sales. It'll sell, no doubt - but Pfizer needs more than just another drug that sells pretty well. Given their situation, and the amount that they've spent on Exubera, they need a monster. I don't think it's going to be one.

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6. Timothy on February 16, 2006 10:39 AM writes...

There's a reason people don't go to MBA analysts for their insulin prescription.

And an equally good reason people don't go to their doctors for market predictions.

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7. Theodore Price on February 16, 2006 11:20 AM writes...

A common complication of diabetes is peripheral neuropathy which is often very painful. While I haven't seen any direct evidence, many of the clinicians and nurses I've spoken to think that the constant injections have some relation to the peripheral nerve damage. Moreover, many of these patients have such severe allodynia and hyperalgesia that they avoid giving themselves injections at the expense of their health. This seems like an outstanding alternative. I'm still somewhat skeptical that it will be a blockbuster, but my wife, who sees these patients everyday in large numbers, thinks it'll be huge.

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8. Rob Cyran on February 16, 2006 12:31 PM writes...

The sales estimates from analysts are all over the map on this one. My guess is that it will be a blockbuster.

Seems to me it's a question of compliance. Many diabetics are really poor at taking their drugs when they should.

If diabetics are more willing to inhale than to jab, then insurance companies will gladly pay up -it's much cheaper paying for insulin at 4 times the price than hospital and rehabilitation costs of amputation, blindness etc. I would guess the price of one day of hospitalisation is equal to a year's worth of insulin.

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9. Palecur on February 16, 2006 2:01 PM writes...

Sure, folks don't like needles. But Exubera isn't being sold to _patients_. It's being sold to _Insurance Companies_. Derek's points apply precisely because of the gigantic distorting effect insurance company intermediation has on the health-products -- personal patient aversion to needles isn't enough to make Exubera a huge seller. Convincing arguments on improved compliance and long-term health benefits need to happen for that, as the original post said.

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10. impatientpatient on February 18, 2006 4:55 PM writes...

I have a question- why are there not special clinics where kids can go and learn how to effectively use their puffer/insulin/whatever they need to mange a chronic condition. If drug companies and managed care organizations were serious about dealing with improper usage of the products meant to help- why not focus on kids and require that these be attended. ( Don't tell me it is not possible- especially with insuranace companies- because in order to be covered people already give up their basic right to privacy and rights to their arm and leg- oops-LOL. As well, NY is mandating that their citizens with diabetes give up their right to privacy and be followed to watch what happens with their condition.) It could cost less in the long run if there was real follow-up and results from the program that meant something- both to pharmaceutical companies, insurance companies AND to add to the mix- governments.

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11. Matt Schiller on February 21, 2006 8:58 AM writes...

I just want to say that it is my understanding that Exubura is really going to be intended for Type II patients (non-insulin dependent) who have poor post-prandial control. Exubura will not really see much use in the Type I (insulin dependent) population, so your concern regarding therapeutic window is not really an issue. The drug really will be used by patients who are not on insulin, but could benefit from insulin in addition to the oral meds that they are taking to control their disease. It is really a tool for a doc to say to a hard to control Typed II patient: 'well you can have insulin without a needle'. I have heard that Type I's would never be prescribed Exubura for the reasons you stated along with the fact that injected insulin works and has countless patient hours of safety data. Exubura would have to be superior from a safety and efficacy standpoint to injected insulin for endocrinologists to switch (or even start) patients on Exubura.

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12. Derek Lowe on February 21, 2006 9:23 AM writes...

Makes sense to me. If it's several steps down the line in Type II therapy, though, you have to wonder just what the sales are going to be.

I mean, it'll sell. But I don't see it selling like the drug's boosters are hoping for, and I don't see it selling well enough to help Pfizer out to any great extent. (Nektar gets a cut, naturally, and there are going to be significant advertising costs).

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13. leehoming on February 23, 2006 12:07 AM writes...

I am from PR China. I think the success of Exubera will depend on its price. People don't like needle ,it's true! but , people must think over if they can afford this especially it is long-term.
I hope my parents( they are both diabetes ) could afford Exubera or something which replace it in the coming days.

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14. Wondering on March 8, 2006 4:00 PM writes...

Reading the name Pfizer over and over in these comments I would just like to remind everyone that without Nektar, Pfizer would not even have this drug to market. The same applies to Warner-Lambert in the case of Lipitor and lets not forget Pharmacia.

When will Pfizer develop it's own pipeline so that it can stop gobbling up other companies for their products in development, which they then take all the credit for. To top it off they can no longer afford to grow from an organizational standpoint so thousands of people have been unemployed due to this practice. Take a look at the last 5 years, the history speaks for itself.

This seems like a very short sighted practice which in the long run hurts both the economy and the shareholders. How long before they run out of places to go outside the company to make the numbers look good?

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15. Michael Shulman on May 30, 2006 8:36 AM writes...

I do investment research and write the ChangeWave Biotech Investor newsletter and much of my work is based on surveys of physicians and other folks in the healh care industry -- not blind surveys but monthly surveys of people we have worked with for more than five years. Bottom line: Exubera will be a smash hit, based on the same surveys that predicted the success of Amylin's Byetta. Patient convenience nad compliance in the diabetes market is an overwhelming priority for everyone and cannot be compared to asthma and inhalers. Please write with questions.

Michael Shulman

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16. Ron Fay on March 21, 2007 12:08 PM writes...

At first glance I thought Exubera was a winner. I bought stock in the company that makes it...and have watched it sink ever since.

Who would want to poke themselves with a needle rather than inhale a puff of insulin?

I still have stock in the company, quite frankly because I don't believe the commentators and speculators know a fraction of what Pfizer knows about the market.

We'll find out this summer.

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17. Carlos on June 5, 2007 9:21 AM writes...

I used to be on niddles 4 time a day , since my sugar levels were 250 to 400 everyday my doctor told me that instead I had to increase to 7 times a day.. I've ask my doctor about Exubera so they test my lungs first and I was ok , now Iam usin Exubera and my sugar levels are between 80 and 150,189 after a meal....This Insulin works if you don't smoke it is a great insulin.

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18. Ralph Culver on October 17, 2007 10:18 AM writes...

I have been on Exubera for about 6 months and found it to be an excellent product. I have cut my daily glucose level in half and expect normal levels by the end of the end of the next 6 months. My HbA1c has gone from 11 to less tha 8.
Using the inhaler in public or anywhere is no problem for me. For those who have not tried it, don't knock it

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