Say what? New $1 billion bet on inhaled insulin!

Pfizer recently created a complete flop out of a wonderful idea—inhaled insulin.

Exubera, the bong filled with insulin that patients could inhale only sold $12 million in the first nine months of the year and Pfizer recently said it would take a $2.8 billion charge and abandon the product.

Pfizer was in such a rush to kill Exubera, that they even failed to inform Nektar, the company from whom they had licensed the product. Nektar was reportedly not happy to read the news in a press release.

Pfizer’s failure resulted in lots of funny pictures of the Exubera bong on pharma blogs, such as the bird feeder, but now Mr. Ed Mann, the 82-year-old chief executive and controlling shareholder of the MannKind Corporation, has decided to go where Pfizer stumbled. And he is investing $1 billion of his own money to succeed.

New York Times has this amazing story.

So will he succeed?

On August 16, 2006 I wrote about Pfizer's insulin inhaler and said that “look at the Exubra inhaler! It is BIG. A foot long, when unfolded, which makes it feel like a baseball bat. Think your girlfriend would like to haul that out of her handbag while seated in a restaurant?Common sense, folks. Common sense. NO ONE would be caught dead with this foot long pocket rocket in their pocket. Or handbag.”

Unfortunately I was right, and Pfizer failed.

But Mr. Mann has the advantage of having a much smaller device, which no one should be embarassed to use.

He also claims there will be no adverse effect on lung function, but has yet to prove that assertion. If true, I think his new insulin may have a chance in the market place.

It may not become a billion dollar product, and he may not recoup his investment anytime soon, but he may get sales of $500 million per year.

If the FDA requires lung testing, however, all bets are off. After all, would YOU risk your ability to breath in order to avoid a small needle?

Comments

[Scott]

I wouldn't bet on it, as the market leaders in insulin therapy have come to view inhalable insulin as a "niche" product. have been overstated.

The worldwide insulin leader, Novo Nordisk A/S, believes its own inhaled insulin [to be called AERx iDMS] will be a niche product, not a big seller as some analysts had once predicted for Pfizer's Exubera.

"We don't think for us it's a blockbuster," Martin Soeters, president of Novo Nordisk's U.S. unit, said recently at a pharmaceutical industry conference in Philadelphia. "We think it will be for a certain part of the population."

Part of the reason for that assessment, Soeters told Dow Jones, was that one area of uncertainty is the long-term effect of inhaled insulin on the lungs.

No matter how attractive manufacturers make the inhaler, the reality is that the market has just assumed that needles were a big deterrent, when the reality is that sales of Lilly/Amylin's Byetta suggest that the type 2 diabetes market is more than willing to inject a medicine if it offers a beneficial side-effect like weight loss. But the CDC estimates that patients with type 1 diabetes (many of whom are not overweight) found the inability to refine dosages was the biggest deterrent, combined with the necessity to inject long-acting basal insulin anyway.

Ed Mann may believe he can succeed where Pfizer failed, but I would be more inclined to agree with Novo Nordisk's Martin Soeters: it will only be a niche product.

[beatty]

This infuriates me!!
The shallow people who make the comment about the foot long inhaler more than likely have not had to deal with diabetes for 47 years!!!
So now the people who greatly benefited from this product now have to suffer because someone cannot make a profit on the product. wonderful.

[Dennis Hodges]

Diabetes: An American Epidemic

Let me start out by asking you this question. Is someone in your family a diabetic or do you know of someone that is a diabetic? I will bet that everyone that reads this will answer YES to that question!

I have been a diabetic dependent on taking insulin shots for the past sixty years. I have used about every type of insulin that has ever been put on the market plus I have used an insulin pump for a short time. I was taking four shots a day and after seeing an Exubera advertisement on TV I checked with my Doctor and he wrote a prescription for me to start using Exubera.

Exubera is the first diabetic treatment of its kind where you inhale the insulin into your mouth from the Exubera Inhaler instead of taking shots. Type I and Type II diabetics can both use this medicine.

After sixty years of dealing with this disease I feel that Exubera is one of the most advanced, non-invasive methods ever devised for diabetics to take insulin. This system gives diabetics a more realistic, normal life quality as opposed to taking shots everyday. It is a lot quicker to insert a blister into the inhaler and inhale it as opposed to getting out a syringe, filling it with insulin and giving yourself an injection.

I was on Exubera for a short time and Pfizer Pharmaceutical sent me a letter announcing that it will no longer be making EXUBERA available to patients.

“ This decision was not based on any safety problems with Exubera. Exubera is a safe and effective medicine and the feedback we have had from Exubera patients has been very positive. However, Pfizer has made this decision because too few patients are taking Exubera and, since there are other medicines available that lower blood sugar, Pfizer will stop providing Exubera.”

This product was on the market less than a year and they were showing a profit but evidently not as huge as what they wanted to. Making money and showing a profit is what companies are in business for, right?

It is my understanding that Bayer is investing millions of dollars into Pfizer for this new inhaled drug delivery system that will treat pulmonary disease, migraine headaches and antibiotics. My question is: Why get the cart ahead of the horse, if they already have a working system for insulin why force all of the people that are taking Exubera back to taking shots again?

In my opinion Exubera was the only product on the market that gave diabetics that small ray of hope to live a more normal life.

[SBeatty]

The last sentence of the previous comment says it ALL!!
"In my opinion Exubera was the only product on the market that gave diabetics that small ray of hope to live a more normal life."
Mr Hodges, I dont know who you are, but that sums it up PERFECTLY!!!!

[JeriAnne Berry]

I am upset about Exubera being pulled as well. I have only been on it for 3 months but I loved it! It was so much easier to be compliant with a medication that didn't need refrigeration, syringes or injections! I often feel I am offending people when I inject in public and would find I just wouldn't do it. Of course this doesn't help my levels. I am hoping to find another inhalable form of insulin but haven't had much luck.