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.”

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.

In what appears to be the longest inhaled insulin trial to date, a Scottish hospital is currently recruiting Type 2 diabetics for a two-year study of inhaled insulin.

The Edinburgh Evening News reports that the study at the Edinburgh Royal Infirmary teaching hospital is seeking Type 2’s for the study.

Scotland Currently Rejected Inhaled Insulin For Nat’l Health Service Drug Formulary List

A Scottish drug forumlary committee listed inhaled insulin in an October-November 2006 report on new drugs that included inhaled insulin.  Evaluations by both the Scottish Medical Consortium (’SMC’) and the Lothian Recommendation and Forumarly Committee (from Scotland’s National Health Service) concluded, at that time, that inhaled insulin was not recommended for use by diabetics.

Only 8 Diabetics Currently Enrolled in the Drug Trial

Very few diabetics are currently enrolled in the trial.  At present there are only eight (8): four who are using inhaled insulin, and four taking subcutaneous insulin injections.
‘Needle Phobia’ Emphasized

It appears that a big push is being made by the head of the Scottish study to emphasize ‘needle phobia’ as a reason for enrolling in the study. The Infirmary’s Dr. Nicola Zammitt believes that “inhaled insulin could represent a major breakthrough in the treatment of diabetes for those with bad needle phobias.”

This has been a major emphasis by pharmaceutical companies like Pfizer when trying to get regulatory approval for inhaled insulin, and seems a likely component of any future Exubera Direct to Consumer (’DTC’) marketing and advertising campaigns.

Unclear Which Drugmaker is Conducted the Inhaled Insulin Trial

It is currently unclear exactly which pharmaceutical company is participating in the Scottish inhaled insulin trial.  It could be Pfizer, Inc.’s Exubera, Novo-Nordisk’s AERx inhaler, Mannkind’s Technosphere inhaled insulin, or AIR inhaled insulin which is being jointly developed by Alkermes & Eli Lilly & Co.

Competition for introducing inhaled insulin in India is heating up. The country has what could become one of the larger pharmaceutical markets.

A new report from Express Pharma, India’s pharmaceutical industry newspaper, has one Indian doctor suggesting that inhaled insulin may be available in the country as early as 2009.

Eli Lilly & Co. (NYSE: LLY) is currently conducting inhaled insulin trials at Indraprastha Applo Hospital based in New Delhi.

Lilly and Alkermes, Inc. (NASDAQ:ALKS) recently extended extended their agreement covering the development of Alkermes’ AIR inhaled inhaled insulin. AIR is currently undergoing FDA Phase 3 clinical trials.

Dr. A. Ramachandran of MV Diabetes Hospital and Research Centre in Chennai, India ackowledged: “We are currently doing research on insulin inhalers.” He did not cite exactly which drug that the diabetes hospital is testing.

Novo-Nordisk also reportedly plans to introduce inhaled insulin in India by 2009. This blog recently reported on the size of Novo’s AERx inhaled insulin device, with a picture of the device’s large form-factor being tested in the U.S.

Novo is currently engaged in intellectual property litigation with Pfizer over Exubera’s drug patent. Pfizer filed an answer slamming Novo for trying to halt sales of the first FDA-approved inhaled insulin. In December, a federal judge denied Novo’s request for an injunction to Exubera sales pending the outcome of the litigation.

It’s too early to tell, but it seems unlikely that Novo would try to start similar patent litigation in India.