Less than a week after Pfizer decided to stop selling Exubera inhaled insulin, the Chairman of rival drug developer Alkermes cautioned that it’s AIR inhaled insulin could also affect diabetics’ lung function.

Richard Pops, Chairman of Cambridge, Mass.-based Alkeremes, told Reuters that the inhaled insulin that the company is jointly developing with Eli Lilly & Co., may also have the potential for pulmonary risks for diabetics using the drug.

Pops explained that his company is “assuming that pulmonary insulins in that regard are all pretty much the same,” but added a caveat that the 2-year long AIR insulin drug safety trials have not been completed yet.

This blog has long-reported on concerns by doctors and diabetics about Exubera’s known and unknown pulmonary risks. The fact that a competing drug developer openly acknowledged similar concerns is significant.

A Worcester, Mass. newspaper, interviewed a senior endocrinologist at the Joslin Diabetes Center in Boston about the potential problems and pitfalls of oral insulin delivery.

Dr. Richard A. Jackson (inset, left) explained that “a chief concern in developing oral insulin products is ensuring dosage accuracy. Insulin levels are especially sensitive,” and experience has proven that injecting insulin subcutaneously using needles delivers accurate dosing.

“Small variances in the dosing and the speed of absorption is more important for insulin than other things. If absorption through the mouth varies by 15 percent, that’s a lot,” he said.

Guess what? This concern should apply to Pfizer’s Exubera inhaled insulin, as well as other potential oral insulin delivery products currently in the pipeline undergoing clinical trials.
These include Canadian-based Generex Biotechnology Corp.’s Oral-lyn, Mannkind’s Technosphere inhaled insulin, and the Alkermes / Eli Lilly & Co. AIR inhaled insulin — all of which are undergoing clinical trials.
Dr. Jackson emphasized that a critical issues is “whether [orally delivered insulin products] can achieve the accuracy and be consistent about how much is absorbed in the mouth.”

Those PR people have done it again: surveyed names of the brands that many of them work on, and rate which new products have the best names.

Pfizer’s Exubera inhaled insulin took 3rd place for the most ‘consumer-friendly’ new drug name.

Top honors went to Barr Pharmaceutical’s menopause drug Enjuvia. Eli Lilly and Co.’s Reconcile anti-anxiety medication for dogs took second place..

The survey is was done by the N.Y. branding and licensing company TippingSprung.

Alex Berenson, the New York Times business reporter who covers the pharmaceutical industry, has a new article on how Pfizer’s Exubera inhaled insulin sales are “lagging.”

The analysis discovered that many Wall Street analysts have downgraded their earnings estimates for Pfizer’s diabetes sales.

This blog hazards a guess that some of those analysts have read the research and posts here, discovering that quite a few doctors, insurers, and diabetics do not support Exubera use.

Berenson cites a February 2007 study by Citigroup’s drug industry analyst team which found that after surveying some 35 doctors, “more than half said they were concerned about Exubera’s safety. They were also concerned about its price and the bulkiness of the Exubera inhaler.”

Last July, this blog reported that Harvard Pilgrim’s Health Care’s pharmacy director was shocked that insurers would cover Exubera’s increased cost.

“I don’t get who the target market is — people with unlimited drug coverage who like gadgets?,” said Dr. Neil Minkoff, the insurer’s pharmacy director.

The two largest health insurance companies in the country, Wellpoint (which manages many Blue Cross / Blue Shield plans) and Minnesota-based UnitedHealthcare, list “Exubera in the third tier of their drug formularies. Co-pays at that level run $40 to $50 per prescription at United-Healthcare.”

Berenson also notes that sales of Type-2 diabetes drugs like Byetta and Januvia have grown rapidly compared to Pfizer’s Exubera sales

Update: Diabetic reporter Meredith Cummings has grown so frustrated with the erratic blood sugar levels that she experienced using Pfizer’s Exubera inhaled insulin, she’s going back to taking insulin shots.

In her latest report, Cummings says:

my blood sugars fluctuated wildly. A few days of this would make the most determined person physically, mentally and emotionally exhausted.

That’s not good news for Pfizer.

Just the other week, Cummings was complaining that her Exubera “inhaler was large and awkward.”

Yet what’s encouraging is that she still remains a diabetic who see’s her glass of Diet Coke half-full, not half-empty. Her decision to drop Exubera was made only after doing what Pfizer recommended: getting a spirometry (lung function) test to determine if she had any impediments to using the pulmonary drug delivery system; meeting with her endocrinologist; getting proper training on how to use the inhaler; and giving herself a chance to try using it.

Even though Exubera still didn’t work well for Cummings  (”I will gladly take insulin shots if it helps me to maintain that, as well as keeps me feeling good,” she says), that won’t trying another drugmaker’s inhaled insulin once it gets FDA approval.  “As soon as another company comes out with an inhaled insulin that is more fine-tuned, I know I will give it a try,” she says.

That could be good news for Alkermes, Inc. (NASDAQ:ALKS), Novo Nordisk (NYSE:NVO), and Eli Lilly & Co. (NYSE:LLY), and Mannkind Corporation (NASDAQ:MNKD).  Each of them are working on alternative inhaled insulin drug delivery systems.