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Positive lung data for Exubera, but is it too late to rescue the product?

New studies presented at the European Association for the Study of Diabetes underway in Amsterdam further supported the safety and efficacy profile of Exubera, but can data alone save the product?

New studies presented at the European Association for the Study of Diabetes underway in Amsterdam have further supported the safety and efficacy profile of Exubera (inhaled insulin human).

An eight-year, open-label study in adults with type 1 and type 2 diabetes, showed that rates of lung function decline with Exubera were similar to those observed in other studies of non-Exubera treated patients with diabetes. Patients using Exubera were also able to achieve sustained blood sugar control.

A three-year study of patients with type 1 diabetes showed that changes in lung function with Exubera, compared with subcutaneous insulin were small, reversible and non-progressive and consistent with previous findings.

A small, short-term study also showed that prandial insulin therapy in conjunction with Exubera use had the potential to reduce 24 hour blood glucose and lower postprandial glucose more effectively than Lantus (insulin glargine), with comparable overnight glycaemic control.

The marketing profile of Exubera has been somewhat problematic since its launch at the beginning of 2006, with some analysts predicting that Pfizer may soon halt its involvement with the product. Executives at Pfizer and its licensor partner US drug delivery company Nektar Therapeutics have not disclosed the reason for Exubera's poor sales, which were said to be in the region of USD 4m for Q2 2007.

Doctors and industry analysts have blamed the marketing campaign, while Pfizer executives did not begin manufacturing Exubera straight after the FDA approved it, because they thought the agency would take longer to review the novel product and delivery method.

Pfizer also assigned the product to a sales team with little knowledge of diabetes or medical devices (the Exubera inhaler), so the utility of the product and its advantages over injectable or oral products were unclear or explained poorly to end users.

Some industry watchers also criticised Exubera for being more expensive and complicated to use than injectable insulin, even though it is the first inhaleable product for adults.

While the new safety and efficacy data will no doubt help the product, perhaps it is too little too late.

Professor Tony Barnett, Professor of Medicine, University of Birmingham and Clinical Director Diabetes and Endocrinology, Heart of England NHS Foundation Trust said: "These data should reassure both patients and physicians that people with diabetes can use Exubera safely and effectively over an extended period. As diabetes is a progressive disease, it is important that patients have an effective and patient-friendly option for insulin administration that they can use over time."

19th September 2007

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