Analysts writing in Business Week have questioned whether Pfizer’s recently approved inhaled insulin product, Exubera, will become the big success everyone expects, saying there is a major discrepancy between the drug’s clinical and marketing profile and revenue expectations in a market that is dominated by healthcare payers looking for evidence-based medicine.

The article, written by Michael Russo and David Balekdijan of the Bruckner Group, says there has been a “fundamental shift” in the way in which medicines are reimbursed and consequently in what payers are prepared to pay for. “In practical terms, we believe Exubera is more likely to become a disappointment for Pfizer,” they note.

Exubera won approval in the USA at the end of January as the first non-injectable insulin to be cleared for marketing in the USA and Europe, and has been widely predicted to become a $1 billion-plus product. Pfizer said it plans to introduce Exubera in both territories in the middle of 2006.

However, Russo and Balekdijan point out that payers are now only prepared to open the purse strings for new technology if it leads to significant advances in patient care. “Exubera is simply a new delivery technology for an old drug, insulin. Can a therapeutic that primarily offers improved convenience to patients produce improved health outcomes that are valuable to payers?,” they ask in the Business Week report, adding that Pfizer has yet to demonstrate that switching patients from injection to inhaled Exubera – at a premium cost - actually leads to an improvement in treatment compliance or cuts diabetes complications in a real-world setting.

Exubera is a powdered formulation of insulin that is delivered via a hand-held inhaler, and is designed to be used in place of short-acting insulin injections before meals in patients with both type 1 and type 2 diabetes. Most patients will still have to use a long-acting injectable insulin to provide background cover, but Exubera could dramatically cut the number of injections they need to control their blood sugar each day.