Exubera Goes Phhhttt… What Now?

So I really don’t need to say “I told you so” on the whole Exubera flop business. It was just so darn obvious.

I don’t know if anybody noticed, but the Indy Star article (local newspaper for both the affected Pfizer plant and competitor Eli Lilly) actually quotes me, saying “It’s not just about the funny looks you might get… This is something you need to carry everywhere, to every bathroom, every bedroom, every time you walk out the door. You cannot be separated from it. I don’t think Pfizer made a product suitable for that at all.”

The reporter wanted to know what went wrong. Yeah, he’d read about the inhaler device design not being so desirable and all that… Above is my attempt to clarify the fact that in the case of 24/7 diabetes devices, the design issue is SO MUCH MORE than just a pretty case.

The other issue is of course that only about 10 percent of the insulin inhaled gets into the bloodstream, raising the question of what long-term effect the other 90 percent might have on your lungs. Ugh.

So it’s pretty darn clear to most patients and doctors alike WHY Exubera bombed; the big question is, WHAT NOW?

Exuberabomb

Image courtesy of Pharma Marketing Blog

Does this mean the end of the inhaled insulin dream? And will its costly repercussions inhibit the pharmaceutical industry moving forward?

Let’s start with the financial side of things. At a $2.8 billion loss, the Exubera bomb is officially one of the most expensive failures in the history of the pharmaceutical industry. (Pfizer spent about $370 million this year on promotion alone, financing everything from CDE and doctor training, to prime-time TV spots. Yikes!)

How could Pfizer, the world’s largest drug maker, be so short-sighted as to forecast Exubera as a billion-dollar blockbuster?! Didn’t they see the writing on the wall? Maybe this whole debacle gives us a little insight into the need for those big blockbuster drugs — to finance the inevitable, enormously costly “experiments” that don’t pan out. How else could a company like Pfizer stay in business after such a spectacular calamity?

The financial review Motley Fool says the one clear winner here is Sanofi-Aventis, “for which Exubera has been a billion-dollar blockbuster. A few weeks before the FDA approved the treatment in early 2006, Sanofi agreed to give up its co-marketing rights to the drug in exchange for $1.3 billion from Pfizer.” Check mate in this game of billion-dollar chess.

Apparently Pfizer went out on a limb cutting its losses here. The Wall St. Journal points out that the company actually “bucked an unspoken industry rule: Products can linger on life support as long as they pose no safety problems.” Good for them, I guess, since long-term patient safety is not only an ethical issue, but could come back to bite them with more losses and lawsuits.

So is inhaled insulin dead?

The NY Times asserts that “the problems that bedeviled Exubera (will) probably plague other inhaled insulin treatments under development.” They even quote a certain Dr. Joel Zonszein of Montefior Medical Center in the Bronx, saying inhaled insulin on the whole is “just not a practical way to treat this population.”

On the other hand, some folks apparently see success in the very essence of Exubera: the accomplishment of safely converting a liquid drug that formerly could be administered only by injection into an inhalable form. Pfizer was the first to break the FDA-approval barrier, which ostensibly could “open the floodgates” on development of other such medications.

Currently developing inhaled insulin:

* Eli Lilly, working with Alkermes on its AIR product, which could be submitted to the FDA in 2009. (Lilly also just purchased the rights to a molecule that may preserve beta cell function)

* Novo Nordisk, in late-stage studies with AERx, licensed from Aradigm.

* MannKind’s Technosphere, in late-stage development.

* Abbott Diabetes, presumably, since its purchase of the technology from a company called Kos.

* B&O Medicom, with its Insulair product, presumably in trials now.

From where I sit, the design of every single one of these blasts Exubera out of the water. But see THIS POST comparing Technosphere to Exubera. Here’s what bothers me: Mannkind’s “thorough” marketing research last year included surveying some 425 physicians — 150 general practitioners, 150 internists and 125 endocrinologists about their product. What about the voice of the patient?! Why aren’t these companies spending more time where we live, in order to understand what truly impacts uptake of a new diabetes treatment? Why do they just assume that we’re all so desperate to dump needles that we’ll put our lungs at risk, or risk unreliable dosing, or put up any amount of money for a new needle-free gadget no matter how bulky and inconvenient?

I’ve said it over and over again: the Diabetes OC is the cheapest and most accessible focus group any industry could wish for. Will no one learn from Exubera’s mistakes by engaging with us first?

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22 Responses

  1. RichW
    RichW October 21, 2007 at 11:55 am | | Reply

    Sounds like Pfizer’s loss is the result of the king asking the wrong people what they thought of his new clothes. More people need to read the parable.

  2. kelly
    kelly October 21, 2007 at 3:55 pm | | Reply

    Bravo, I agree Pfizer should have talked to more patients – not just patients in trials (who actually were very positive – a lot of that’s been documented by the independent researchers), but other patients more broadly. I think the ony patient interviews on Exubera I ever saw was here, called Jennifer Haws – I remember she was VERY positive – could you get her views again? That would be v interesting.

    There are said to be well over 50% of people with diabetes in the US not at an A1c of 7 or less and only 29% on insulin – clearly there is some mismatch and I think researching alternatives is a good idea and I hope that continues. Failures like this don’t make that more likely, unfortunately.

    Average A1cs in the country are said to be very high, at 8-9%, and many patients don’t want to go on insulin delivered the traditional ways. And, since hyperglycemia isn’t painful (until it’s too late), there is little incentive for many to take measures to regain control, whether exercise, better diets, insulin, incretins, etc. Other patients not in good control simply have no resources. And, the US healthcare system doesn’t reward doctors for helping patients get under better control – many doctors have no time to train patients to go on insulin and many patients have no access to good diabetes education.

    Most of the the best diabetes product launches have all shared at least one quality – simplicity. For many doctors, educators, and patients, this generation of inhaled insulin had the problem of too much hassle. By contrast, Lantus is a classic example of a terrifically successful product launch and a very easy product to use – with the right training. Not that it is right for everyone, or that it’s always used perfectly, but for teams studying how to do a great product launch, it’s a good case study and I’ll be a lot of patient research was done in that case.

    Here’s hoping access to better training and better care improves and also that more viable alternatives emerge that bring us to better control for ALL patients in our community … and that more research is done with all patient communities from the start!

  3. Angela
    Angela October 21, 2007 at 4:20 pm | | Reply

    I read a lot of comments on your post “The Stinging Cost of Glucose Test Strips” that were along the lines of Jonathan’s response: “This highlights one of the problems with the entire health care industry.”

    Has it occurred to anybody yet that one reason healthcare costs are so high is because companies have to finance so many duds like this one before they find a winner? And who would want to live without the winners! Have any of you SEEN pictures of the first-generation insulin injectors? The whole syringe system was about the size of my forearm – and it came complete with a whetstone so you could sharpen the needle before each use.

    Connect the dots now….

  4. Sarah
    Sarah October 21, 2007 at 6:08 pm | | Reply

    Excluding side effects, size, dosing issues, etc. of inhaled insulin inhalers….

    When will these companies get it that ANY kind of external insulin is crap? Insulin from outside the body is not an adequate treatment (for Type 1 diabetes, at least).

    I know few Type 1 diabetics who would rather die than take their insulin injections. It just isn’t an issue, especially with today’s syringes.

    For those with Type 2 diabetes, the vast majority need exercise, diet, and weight loss programs rather than adding *more* insulin to the mix of insulin resistance and excess weight. How is that helpful? How much can we baby people to make better choices?

    What is truly sad is that if this wasted money had gone into actual diabetes research programs and not Big Pharma, progress towards a REAL solution (i.e. a “cure”) could have been made.

    Big Pharma deserves what they got.

  5. Anne
    Anne October 21, 2007 at 6:29 pm | | Reply

    I had a couple friends ask me if I would be excited to have inhalable insulin… Uh, no. I never would even consider it since I can’t imagine how it could match the fine-tuning capabilities of a pump. I doubt I would even take insulin orally if it were available, although it depends on how many pills per day I would be popping. Still I can’t imagine how oral insulin could be dosed as easily as a pump. And it’s much more discrete to push a button on some electronic thing than pop a pill. And sometimes it’s nice to be discrete.

  6. Scott
    Scott October 21, 2007 at 8:33 pm | | Reply

    I was an early predictor of this (I am on record in March 2006). To be sure, Lilly’s AIR product is a fraction of the size, and that will be a big improvement, and Lilly is unlikely to change the unit of measurement, Pfizer’s big mistake that made Exubera a hassle for doctors to prescribe because Exubera needed different dosages than all other forms of insulin. I doubt the others will make this mistake, but above all else, they need to make sure that there is a clinical advantage or healthcare providers aren’t going to foot the bill.

    The fact is that big pharma failed in this case because they asked the wrong questions of the wrong people. Unfortunately, I’m not convinced they have learned their lesson from this case.

    But the fact is that

  7. Micheal
    Micheal October 21, 2007 at 8:58 pm | | Reply

    One of the developers of inhaled insulin is right in San Carlos, California… Nektar (formerly “Inhale”) and right on the west side of 101.

    Might be a good short road trip for DiabetesMine.

  8. Karen
    Karen October 22, 2007 at 4:26 am | | Reply

    Here’s my question…WHY do we NEED inhalable insulin? People always say “I can’t believe you give yourself shots or I can’t believe you wear an insulin pump”. What people don’t realize is THEY would do the same thing b/c if you don’t…say hello to DEATH! You know? I don’t want to inhale insulin. In fact, I have no desire to do that. WHO is this for? I don’t see a market for it.

  9. Sunil S Chiplunkar
    Sunil S Chiplunkar October 22, 2007 at 6:29 am | | Reply

    The key to understanding the failure of Exubera is “changing times”. The marketing plot or plan was warped in distant time detached from web 2.0 technologies, and the power of word-of-net. There is tremendous power of internet, in fact, this has led to the rise of blogger opinion builders like Amy whom marketers have to understand. This is a new breed of opinion builders who can influence consumption of products. Patient empowerment is such that doctors cannot just dictate prescriptions. Doctors are also sensitive to word-of-mouth about products and would like to prescribe products that are acceptable to larger patient community. The Cyber Paradigm in healthcare has arrived. One cannot ignore the internet, word-of-mouth, and word-of-net phenomena. http://www.pharmaceuticalshealthcare.blogspot.com

  10. John Mack
    John Mack October 22, 2007 at 7:16 am | | Reply

    Thanks for using my Exubera as Hindenburg image. Can you please correct the source as Pharma Marketing Blog (not PharmaGossip) and link to http://pharmamkting.blogspot.com/?

    Thank you.

  11. Kim
    Kim October 22, 2007 at 8:01 am | | Reply

    I’m w/ Karen on this. It is so very obvious that the research folks who develop inhalable insulin do not actually ask people who use insulin what they would like in an insulin delivery device. The only people who would say they want inhalable lung-damaging insulin as opposed to injecting (or hello, pumps anyone?) are people who don’t have to take insulin. I am always told by non-diabetic folk that “I could never do that” referring to injecting oneself. Whatever – I thought the same thing until a doctor told me I had to or die. And it turns out, not so bad. Although I personally hate 6 injections a day, I love my pump. Best insulin delivery device – my own body. That is what these people should be spending money on. But if they aren’t going to speak to the people who actually have said disease, then they will never get something like this done.

  12. Rob
    Rob October 22, 2007 at 8:01 am | | Reply

    Inhaled insulin is a dead-end as far as I’m concerned. If you want to see something much more promising, take a look at this:

    http://biz.yahoo.com/iw/071022/0318171.html

    This is a REALLY big deal:

    “The second recipient was implanted with her first dose of DiabeCell® in September 2007, without adverse effects and control of blood glucose has been maintained with progressive reduction of daily insulin requirements. At one month following the implant, this patient has been weaned off insulin altogether…”

  13. dan golan, israel
    dan golan, israel October 22, 2007 at 8:18 am | | Reply

    I am not a one that likes to think about cure’s research in terms of “conspiracy”. However when you combine these 2.8B that were spent on a product that no one really need, with the fact that the JDRF can fund only 200M a year for a cure research. This goes through to my mind.

  14. Rob
    Rob October 22, 2007 at 8:50 am | | Reply

    Dan Golan -

    If you check out the link I posted, you’ll see that there are companies investing in what I would functionally call a ‘cure.’ There are a number of entities engaged in islet encapsulation, islet regeneration, prevention of the immune system attacks. Not to mention the purely mechanical avenues like artificial pancreases & smart insulins. The stuff is out there, but there hasn’t been to-date (to my knowledge at least) a coalescence around the more promising areas of resaerch.

  15. Dan Fahey
    Dan Fahey October 23, 2007 at 9:27 am | | Reply

    For existing Type 1 diabetics, I don’t see that inhalable insulin would have much appeal, given its dowsides: dosage variability and potential lung damage.
    I can understand someone thinking there may be a market for Type 2 diabetics who REALLY should be using insulin but are afraid of needles, BUT the treatment must be more effective than the alternatives, and that’s where this Exubera and other inhalables have missed the boat.
    I agree with the other commentators that getting meaningful USER input is crucial to developing a viable product and they couldn’t have done that, or they would never have put forth this product.

  16. Laureen
    Laureen October 30, 2007 at 5:28 pm | | Reply

    First – For you morons who think syringers are so tiny, you take 4 shots a day!
    Idiots! Exubera is the closest thing to a cure as Type I diabetics will ever get and yes Exubera is a great product, unfortunately, Pfizer had no marketing campaign and an awful sales force.

    Pfizer says I have other options, but do I really? I can’t have an islet cell transplant due to anti-rejection drugs; I can’t take a pill because I am insulin-dependent. My only option is to go back on 4 injections a day: to have bruised, sore arms and legs again and to have to get up and run to the bathroom to give an injection before breakfast, lunch, and dinner or to get gawked at if I give an injection at the table in a restaurant. Exubera is my CURE. I don’t have the luxury of not taking insulin. I need it to survive. This may be the closest thing to a cure that many Type I diabetics will ever see.

    Pfizer says on their web site, “That’s why we at Pfizer are committed to being a global leader in health care and to helping change millions of lives for the better through providing access to safe, effective and affordable medicines and related health care services to the people who need them” (Pfizer.com). Instead of Pfizer improving my life they are taking away the ONLY non-invasive treatment option for me and the 3 million Type I diabetics in the US.

    I would love to sit down with the person who made the decision to take it off the market and give him or her 4 injections a day for a week, let alone 20 years, and see if he would change his mind.

    Fight4Exubera@aol.com

    http://www.myspace.com/reen910

  17. AmyT
    AmyT October 30, 2007 at 5:50 pm | | Reply

    Laureen,
    First off, no need to be nasty. Next time you start off a comment by calling people names, I will delete you.

    Secondly, to be clear, Exubera is NOT the closest thing to a cure. Not even close.

    I’m sorry that Pfizer is pulling the plug on a product that worked for you. But that’s business — and the consensus in the medical world is that Exubera is not really ready for PrimeTime. Hold on, Lady, I’m sure new inhalable insulin is on the way.

  18. Laureen
    Laureen October 30, 2007 at 6:18 pm | | Reply

    There is no being nasty here. The truth is until YOU have had to give yourself 4 injections a day to stay alive, you don’t know what it is like. There is no other NON-INVASIVE drug available to Type I diabetics. Nektar resumes all rights to Exbura and I ahve no doubt this product will be produces. They GET the need for a NON-INVASIVE, innovative product.

  19. AmyT
    AmyT October 30, 2007 at 9:14 pm | | Reply

    Laureen,

    I still don’t know what you’re talking about. Before I started pumping, I was on about 8-10 injections per day. There is no way some imprecise inhaler could replace that therapy.

  20. Wynema
    Wynema October 31, 2007 at 9:58 am | | Reply

    I only learned yesterday that Exubera was going out of production. I am Type 2 for 8 years, and just started Lantus in 07/07. I still needed something before meals, but didn’t want shot because of my busy life. I started using Exubera in August of 2007, after waiting a month for a diabetes educator to “teach” me how to use it. When I got to her office, she tried to read the manual to me. Turns out she didn’t know anything about it, so I felt I wasted that money. She wanted me to start on 1mg before meals. That did nothing for my numbers, so I called her back and she increased it to 2 units. That did nothing, so I increased it to 3 on my own. Still nothing. I looked on Exubera’s web site and saw for my weight (270), I should have started on 6 mg. I called Exubera to confirm my calculations, and a nurse there said yes. So, I went to 6 mg. Still no effect on my numbers. I called Exubera back and asked them what the max dosage was, and they said there were no max dosages. I asked what the people in the test trials were taking, and they said up to 27 units per meal. Since you can only inhale up to 3 units at a time, this would be 9 puffs before every meal! That’s when I suspended my use of it until I go back to see my doctor. I didn’t have a problem with the size of the unit, or the fear of lung damage, because I was just beginning to use Lantus, and didn’t want to have to use needles the rest of the day also. It’s just that it wasn’t working. I was keeping a food log, so I know that I was not increasing my carbs, just because I thought the Exubera would cover them. I’m really down it didn’t work out.

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