Caution emerges over inhalable insulin



The air is leaking out of what was supposed to be the next big thing in the treatment of diabetes: inhalable insulin.

"While inhalable insulins will see a reasonable level of uptake, they aren't the surefire blockbuster they were hyped to be," says a new study by British market research firm Datamonitor PLC. It points out that the new treatment isn't significantly better than existing therapies, is expensive and its long-term safety in the lungs is unknown.

On the other hand, inhalable insulin represents a convenient and alternative delivery system for diabetics who have a needle phobia, and are reluctant to inject themselves with insulin to control blood sugar levels in the blood.

The World Health Organization estimates diabetes has infected 194 million people, and predicts the incidence will reach 360 million by 2030. So finding innovative ways to administer insulin promises blockbuster revenues for the pharmaceutical industry.

But this month Pfizer Inc. decided to postpone the widespread rollout of Exubera, its inhaled insulin, and the only product approved for sale. The rollout has been changed to January from November, which will be about 12 months after U.S. regulators cleared the drug. Pfizer cited manufacturing issues as part of the two-month delay.

The world's No. 1 drug maker said it will continue educating 5,000 specialists before kick-starting a marketing campaign to general practitioners. The novelty of the technology requires a big marketing investment by New York-based Pfizer, analysts say. Besides paying France's Sanofi-Aventis SA $1.3-billion (U.S.) for full rights to Exubera, Pfizer has spent more than $700-million to develop the drug.

Now it faces insurers reluctant to pay for Exubera in order to contain rising health-care costs. Regulators in Britain and Germany have recommended against insurance coverage on grounds that Exubera doesn't treat an unmet medical need, and convenience of delivery shouldn't justify its premium price. In the United States, sources contend that insurers are unlikely to pick up the entire cost of Exubera.

The annual cost of using Exubera has been estimated at about $2,000 a patient in some countries, at least twice the cost of insulin injections.

Also weighing on the new drug is Denmark's Novo Nordisk AS, leading maker of insulin products. It sued Pfizer in August, alleging Exubera infringed on its patents for an inhaled insulin treatment, which it hopes to have on the market by 2010. Pfizer has said that won't effect the launch.

Analyst Daniel Poso at Datamonitor suggests Exubera is running into resistance from some doctors concerned about its potential risks to patients' lungs over the long-term. "Physicians will not be in any hurry to switch patients from injectables to inhalables until they have many more years of safety data, and getting these data may take up to 10 years," he said.

Touted by Pfizer as a drug that could yield annual revenue of between $1-billion and $2-billion by 2010, Mr. Poso forecasts sales will total only $207-million by 2015.

He also notes that Exubera will face competition at the end of the decade from at least three other makers of inhalable insulin, which "offer better devices." Nevertheless, he said the market is large enough to accommodate Pfizer, Novo Nordisk's AerX drug, Indianapolis-based Eli Lilly & Co.'s Air system and Valencia, Calif.-based MannKind Corp.'s Technosphere insulin.

Of those, he likes Technosphere because in clinical trials, it "exhibits a time-action profile that resembles that of a healthy person more than any other rapid-acting insulin, injectable or otherwise."