A new research report on inhaled insulins concludes that new diabetes drugs like Exubera from Pfizer, Inc. (NYSE:PFE) and Nektar Therapeutics (NASDAQ:NKTR) are not likely to become blockbuster drugs anytime soon.

That conclusion comes from Dublin-based Research and Markets in Ireland. Many pharmaceutical and drug delivery companies are likely to be at odds with this conclusion.

Other inhaled insulins in the pipeline that the report examines include:

• ERx-iDMS,  from Novo Nordisk A/S (NYSE:NVO)
• AIR insulin, from Alkermes, Inc. (NASDAQ:ALKS) and Eli Lilly & Co. (NYSE:LLY)
• Technosphere insulin, from MannKind Corp. (NASDAQ:MNKD)
• Alveair inhalable insulin, from Coremed, Inc.
• KI-02212 inhalable insulin, from Kos Pharmaceuticals (NASDAQ:KOSP)
• Intesulin oral insulin, from Coremed, Inc.)
• Oral-lyn, from Generex Biotechnology Corp. (NASDAQ:GNBT)
• Eligen oral insulin, from Emisphere Technologies, Inc. (NASDAQ:EMIS)

A key factor stressed to support the reports conclusion is that the authors believe that:

the diabetes market will not be receptive to inhalable insulins until compelling data is generated that demonstrate compelling clinical benefits of inhalable insulins over injectables. This view is supported by the recent cost-benefit analyses of it by Germany’s IQWiG and UK’s NICE, and the distinct lack of opinion leader enthusiasm about Exubera.

Wow.  That’s a strong critique. The authors maintain that diabetes leaders are not enthusiastic about inhaled insulin. If you review observations by endocrinologists and general practitioners that this blog has tracked about Pfizer’s Exubera,  they appear cautious about using the new inhaled insulin to treat Type 1 and Type 2 diabetes.  It’s more of a wait-and-see approach.
If you’re ready to plunk down 12,198.00 Euros (almost $15,500 U.S.), you can buy a PDF copy of the full report.

Read a summary of the report here: Pipeline Insight: Insulins - Inhalable Insulins Unlikely to Become Blockbusters.

The Scottish Medicines Consortium (’SMC’) gave a thumbs down yesterday to Pfizer, Inc. (NYSE: PFE) and Nektar Therapeutic’s (NASDAQ: NKTR) Exubera inhaled insulin. Scotland’s diabetics won’t be likely to breathe inhaled insulin on the government’s two-pence any time soon.

Exubera is just too expensive to justify the increased cost, the SMC reasoned.  It concluded that :

• The results of studies showing improvement in glucose control for Type 2 diabetics relative to Type 1 diabetics are, according to the SMC, are not realistic;
• The assumption that once switched the target glycaemic level is always achieved is
  inconsistent with clinical and trial evidence and with current practice;
• The tool used to measure small changes in patient values wasn’t appropriate; and
• The uncertainty of Exubera’s dosing adjustments for Scottish diabetics also meant it wasn’t clear how much extra Pfizer’s inhaled insulin would cost Scotland, compared to subcutaneous insulin injections.

According to The Herald, a Glascow, Scotland newspaper:

[T]he SMC said it could not back [Exubera] because [Pfizer] did not back the requisite economic analysis for the drug.

In other words, they concluded that Pfizer couldn’t show that Exubera would be a cost-effective way to treat Type 1 and Type 2 diabetics.

Will U.S. health insurance companies follow this assessment by listing Exubera as a non-preferred drug in their formulary lists?

We shall see…

Click here to read a copy of Scottish Medicines Consortium’s September 11, 2006 advice concerning Pfizer’s Exubera inhaled insulin

Britain’s National Health Service (’NHS’) approved the use of Pfizer’s Exubera inhaled insulin across the U.K. last week. A big question for many diabetics and health insurance companies outside of England, however, has been just how much the new insulin will cost. Here is the information they’ve been looking for:

• Inhaler kit, £52.68 (~ $100 U.S.)
• 90 x 1mg blisters, £25.19 (~ $48 U.S.)
• 90 x 3mg blisters, £62.28 (~ $120 U.S.)

Since diabetics vary their mealtime short-acting insulin dosages based on a variety of factors, including blood sugar before mealtime, as well as the type and quanity of foods being eaten at the meal, the average daily cost per user will vary.

Approving Exubera use for diabetics in Britain has faced heavy criticism from the country’s health policy watchdog, the National Institute for Clinical Excellence (’NICE’). The group concluded in June that Exubera should only be approved for diabetics who could demonstrate a proven fear of needles. They apparently didn’t succeed.
This blog also noted NICE’s heavy criticism in June arguing that Pfizer’s submissions to seeking to win NHS health coverage for Exubera were:

“positively misleading, and biased in favour of inhaled insulin,” and that the “most misleading bit in Pfizer’s materials” was that they purported to show that Exubera gave diabetics “better blood sugar control” when, in fact, “the [inhaled insulin drug] trials showed no difference.” (emphasis added)

NICE concluded that the research just wasn’t there to support Pfizer’s contention that Exubera was better than traditional injectable insulin, and that the cost wasn’t justiable.

Source for Exubera U.K. pricing: British National Health Service

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Some of Pfizer’s Exubera drug sales reps cite an inherent contradiction they face selling the drugmaker’s inhaled insulin in the South.

On the one hand, a southern sales rep says that in his/her region, “[e]veryone is a diabetic, everyone needs insulin, so our quotas will be thru [sic] the roof.”

But according to the same rep, southern Exubera sales must be weighed against the fact that in North Carolina “everyone smokes! Are they really going to give up smoking just to take insulin??”
Uh, no!

According to a study done by Pfizer and Sanofi-Aventis (whose rights to the inhaled insulin Pfizer bought for ) the drug companies and FDA already know that smoking diabetics on Exubera put themselves at a huge risk for hypoglemcia. That’s because the study found inhaled insulin is far more concentrated in smokers’ blood than in non-smoking diabetics. Hypoglycemia, if untreated, can kill.

The Pfizer reps on Cafe Pharma’s message boards are keen to this problem. One rep asks:

“Are they really going to give up smoking just to take inusulin???”

That’s the same question asked by one U.K. nurse, representing the U.K. Association of Diabetes Nurses, in her comments to Britain’s health watchdog NICE about why England’s national heath service shouldn’t approve Exubera:

Smoking has been suggested as a contraindication for inhaled insulin. Significant numbers of people with diabetes smoke and some do not admit to smoking in routine consultations. This could cause problems as absorption has been shown to be faster in smokers. Similar concerns for people with asthma.

So there you have it: it appears that some Pfizer drug reps and diabetes professionals are keenly aware of the risk that smoking diabetics may try to lie in order to get a prescription for Exubera. That’s of little benefit if they end up killing themselves from hypoglycemia.
Another poster on the Pfizer Exubera sales team boards offers a candid agreement with the U.K. nurse, predicting that smoking diabetics will simply lie to their doctors in order to get the inhaled insulin:

Then they will get into all kinds of trouble with the product. Then the product will become “tainted” with issues and we will have another vioxx/zyprexa on our hands.

The product liablity lawyers are probably drooling over a potential for multi-million dollar verdicts if that turns out to be true.

A Pfizer spokeswoman disclosed that the cost of its Exubera inhaled insulin should be about $3.75 to $5 a day. But without more information, that cost estimate seems hard to decipher.

How would this estimate compare to the cost of a 10 ml vial of an injectable insulin analog, like Lilly’s Humalog, or NovoNordisk’s NovoLog? How much insulin does Pfizer estimate Type 1 and Type 2 diabetics would have to inhale to get that Exubera cost estimate? That’s unclear.
Exubera would seem to be more expensive when compared to buying a vial of Humalog. Walking into a U.S. pharmacy, you can buy a vial of Humalog for roughly $30.00. Then you need to estimate the number of units a diabetic would take each day before breakfast, lunch, and dinner, as well as an occasional bolus for being sick or to correct an unreasonably high blood sugar. For arguments sake, lets say that a diabetic would be taking anywhere between 30 - 45 units of Humalog a day, at 100units/1ml.

That means a diabetic would theoretically use up to one and a half (1 1/2) bottles of Humalog a month (1.5 x $30 per bottle = $45), and need roughly one (1) box of 100 insulin syringes a month to administer the dose. BD syringes can cost anyhere from $20 - $35 for a box of 100.

Anyway you inject it, that seems to be much cheaper than Exubera. That’s the conlusion that U.K.’s NICE committee of doctors, medical professionals, and health care policy analysts came up with when the decided against recommending Pfizer’s inhaled insulin for health insurance coverage under the Britain’s national health insurance program.