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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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August 8, 2007

Exubera Spirals Toward the Drainpipe

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Posted by Derek

You know, you can run the biggest marketing behemoth the drug industry has ever seen - but if people really aren't interested in buying your product (and if insurance companies really aren't interested in paying for it), that's not enough.

The evidence? Pfizer's Exubera, the inhaled insulin that for years was thought by some to be one of the Next Big Things. Earlier this year, a "relaunch" of the product was announced, but that doesn't seem to have helped much. Pharmalot passes on the news that one of Pfizer's main suppliers is cutting back production.

This comes after the drug ran up only $4 million in sales in the second quarter, relaunch be damned. And I mean that "only" - compared to what Pfizer and its partner Nektar spent on developing Exubera, a few million dollars is nothing at all. You'd think that if we in the industry were as powerful and as evilly resourceful as our worst critics have us, we'd be able to keep things like this from happening - wouldn't we?

Comments (19) + TrackBacks (0) | Category: Business and Markets | Diabetes and Obesity


COMMENTS

1. Tyrosine on August 8, 2007 8:04 AM writes...

Anybody see this product becoming OTC to salvage sales? I can't see Pfizer making any progress on convincing Medicare, even with their army of lobbyists.

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2. The Pharmacoepidemiologist on August 8, 2007 8:16 AM writes...

You may be right, but I think Exubra's development reflects the disconnect between those running R&D programs in big pharma and the medical community who are our customers. Let's face it, having an MBA and a marketing career doesn't prepare one to assess what the next great unmet medical need may be which one's labs have any chance of addressing. But Big Pharma sure acts like it does, and promotes accordingly. Unfortunately, that doesn't get one any closer to the sought after blockbuster than wishing for one.

The bumper sticker I've seen around Stanford of late goes, "I never thought I'd miss Nixon." For those us in pharma, that sentiment resonates on so many levels...

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3. tom bartlett on August 8, 2007 8:34 AM writes...

4 MILLION in one quarter? In our business, that's an unqualified disaster. I can't say I'm surprised, though....

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4. qetzal on August 8, 2007 9:29 AM writes...

I think Exubra's development reflects the disconnect between those running R&D programs in big pharma and the medical community who are our customers.

Probably true, but I'm curious to know where people think this disconnect occurred.

Is inhaled insulin just not a good concept in general? Or is Exubera a poor implementation of a (potentially) good concept? What do Exubera's troubles portend for other inhaled insulins that are in development? Some of those inhalers seem much more patient friendly than the current bong.

Personally, I think inhaled insulin is a potentially profitable concept, if it can be implemented properly. It may never be a blockbuster, though, simply because many people may balk at price premiums if the primary benefit is convenience (aka not being injectable).

It's also worth noting that disconnects go both ways. How many people seriously thought the Duragesic patch would become the blockbuster that it did?

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5. Hap on August 8, 2007 9:35 AM writes...

It seems like a good concept, but at 2.5-3 times the price of injectable insulin, with insurance companies unwilling to cover it (and individuals unwilling or unable to pay for it themselves), and with the potential for lung issues, it doesn't seem workable. If the lung issues are inherent to long-term inhable administration, then inhalable insulin probably won't be a good idea ever, otherwise, it's a bad implementation (or an overhyped rezsearch project which might have benefits in the future).

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6. Don't inhale on August 8, 2007 10:23 AM writes...

Lilly has a inhalation product in development. Should be interesting to compare their success and approach to that of Exubera.

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7. William Lougheed on August 8, 2007 1:45 PM writes...

Some of you may be old enough to remember the invention of insulin pumps in the mid-seventies to early 80's of which I was a part.

These devices never took off; patients could not accept their large size AND insurance companies would not cover the cost.

20 years later, the devices are small, insurance coverage is in place (in the devoped world) and sales have burgeoned into a huge market.

The ramp up for inhalable insulin, I suggest will be much faster. For example, MannKind's device now in phase III is the size of a small cellphone, posprandial efficacy is equivilant or superior to an injection and so should be insurable.

The world awaits the completion of phase IV pulmonary safety trials. If these are clean then this market should open for THOSE inhalables that have the efficacy of MannKind's insulin.

Bill Lougheed
CEO, Diabecore

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8. Tom Womack on August 8, 2007 4:38 PM writes...

If the complaint about Exubera is that the price is more than the convenience is worth, it'll presumably be a respectably profitable generic (inasmuch as you get blockbuster generics) in a decade.

Though it would be nice if it were around under patent long enough for enough well-insured early adopters to do the pulmonary safety trials.

Or is the inhaler unavoidably the size of Iowa?

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9. David Young on August 8, 2007 4:42 PM writes...

I always thought that an inhaled insulin was a bit of disconcerting idea. Let's see.... an inhaled product that could possibly produce coma or even death by overdose. And do you think that there will ever be a case of murder by foul-play with a drug that leaves no evidence because it is an inhaled drug? I don't know... do these drugs leave a residue? Can forensics determine that a person died due to hypoglycemia? Hopefully nothing of this sort will ever happen. But in this day and age.... are we doing the right thing?

David

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10. qetzal on August 8, 2007 5:59 PM writes...

David,

That's kind of an off-the-wall point, but just in case...

As a instrument of foul play, injectable insulin would be almost infinitely better than inhaled.

With injectable insulin, a murderer could load up a syringe with a large overdose, then jab and inject his victim quickly, delivering the full dose in seconds.

With inhaled insulin, a murderer would somehow have to trick or force the victim to inhale many times to deliver a reliably lethal dose.

Not to mention, with Exubera at least, you'd have to take the used insulin 'blister' out of the bong, put in a new one, and prime the bong in between each dose. It doesn't work at all like a constant delivery nebulizer or something, if that's what you're imagining.

Regarding how to detect insulin overdose, go to PubMed and search for something like "insulin AND overdose" or "insulin AND suicide". You'll find some interesting abstracts that address your question.

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11. A Nonie Mouse on August 8, 2007 8:20 PM writes...

As a diabetic, the injection of insulin has never been as much of a hassle as the finger stick that proceeds it. The glucose test is much more painful and inconvenient than the insulin.

Why pay extra for something with greater risks, when it doesn't remove the actually annoying part of taking insulin?

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12. Chrispy on August 8, 2007 9:09 PM writes...

I am curious what the skin prick is for -- do you measure blood glucose levels from that? It seems barbaric. From what you say there's big dollars in figuring out another way!

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13. qetzal on August 8, 2007 9:33 PM writes...

Chrispy - yes, it's to measure blood glucose, so you can adjust insulin dose.

Lots of groups are trying to find better ways than finger sticks. There are some partial solutions (Google "noninvasive glucose monitoring"), but they're still not ideal.

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14. befuddled on August 8, 2007 9:54 PM writes...

Derek,

I haven't followed the Exubera story much, but if insurance companies don't want to pay for it, then it's hard to determine whether its failure is due to that or to the disinterest of consumers.

In other words, the case of Exubera seems to be a poor choice to prove the lack of market power of big pharma, since it may be (at least arguably) a case of an irresistable force (big pharma) meeting an immovable object (big health insurance).

That said, Nonie's point about the glucose sticks sounds right. And I've heard that some of the electrically based glucose monitoring devices aren't too fun either.

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15. Daveh on August 9, 2007 12:20 PM writes...

The fate of non-invaisive glucose monitoring

http://www.glucowatch.com/

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16. Jen Morris on August 11, 2007 7:00 PM writes...

Reduction in lung capacity, however small, could be part of what is holding down Exubera's marketing curve and could affect other inhaled insulin products in development. This side effect is supposed to be reversible, yet what if using it over the long term turned out to be only partially reversible? Look at the people who have to be wheeled around with extra oxygen, cannula and canister, because of emphysema. The fear of having to struggle for breath years down the road might well be a deterrent for many patients.

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17. No big surprise on August 14, 2007 7:48 AM writes...

Some thoughts...

1. It's less portable than injectable forms.

3. Lack of long term safety

4. Type 2 diabetics tend to be older and may be put off by the complexity of the device. Having played with a placebo, I'm unimpressed. Perhaps in future the delivery will be easier.

5. Type 1 diabetics would be likely to be using in addition to injectable insulin. But hang on, if you are going to be injecting yourself anyway, why carry round a great big inhaler?

BTW potential murderers should forget about insulin as a method, c-peptide will catch you out

http://cat.inist.fr/?aModele=afficheN&cpsidt=865087

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18. Steve White on August 19, 2007 1:59 PM writes...

I'm an academic pulmonary physician, and when Exubera was first being launched I received (along with about every other academic pulmonary physician in the country), an invitation to their Speakers Bureau training session in some locale. What the hey? I thought, I'm not an endocrinologist, and I refer most of my patients with any degree of diabetes either to primary care or to endocrinology. I was curious enough to call the person named on the letter, and she informed me that this 'exciting opportunity' (of course it was) was sent my way because Pfizer wanted pulmonary docs to help flonk the drug, since we knew all about inhalers.

After I stopped chuckling I told her that I really didn't see much I could say at a dinner talk to other physicians other than "the patient sticks the inhaler close to his open mouth, inhales and hits the activator, and presto!" She assured me that they'd provide all the speaking materials, and I'd just have to stick to the script.

I declined the invitation, and I must honestly say that as a pulmonary doc I have never -- never -- seen a single patient using this drug.

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19. laureen on October 23, 2007 6:36 PM writes...

this is crap! I have purchased Exubera through two separate insurance companies. Both covered the majority of cost. I paid the same co-pay as I do for insulin. Get your facts straight! It is a travesty that I have to pay for Pfizer wanting to take this off the market. Exubera is a cure for me and many others.

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