The overall quarterly revenue for Pfizer, the world’s largest global research-based biomedical and pharmaceutical company, fell 2.4 percent to $12 billion, and third-quarter net income dropped 77%. Additionally, the company stands to lose patent protection within the next four years on drugs accounting for about half of its 2006 revenue. Key among these products is cholesterol drug Atorvastatin® (Lipitor), the world’s single most successful drug.

In addition, the discontinuation of Exubera® leaves Pfizer with one less drug to make up for those losses. While Pfizer will live to fight another day, the same cannot now be said for Exubera.

Once touted as the next big thing in the treatment of diabetes, Exubera was forecast to be a blockbuster by most analysts. However, after separating the hype from the reality, it was quickly recognised that a number of issues plagued the inhaled insulin class and thus restricted its commercial potential.

Obviously expecting big and profitable things, Pfizer paid $1.3 billion to Paris-based Sanofi-Aventis in 2006 for the rights to Exubera and insulin production plants in Germany. The product had only $4 million in worldwide sales in the second quarter, a disappointing result, the company said. Pfizer began airing television advertisements in recent months in an unsuccessful last-ditch attempt to stimulate demand and establish a foothold in the market.

The proposed convenience advantage, and any concomitant benefit in compliance, of Exubera was negated by the fact that it was only available with a cumbersome and unwieldy delivery device.

The fact that Exubera was in essence a repackaged form of insulin, only offering a suggested convenience advantage rather than being a truly novel treatment made it unappealing to healthcare providers, who viewed the unmet need for inhaled insulin as non-existent and thus either refused to recommend it (UK and Germany) or offered reimbursement at a higher tier than most injected insulin (US).

The withdrawal of Exubera will force the developers of second generation inhaled insulins –namely Novo Nordisk, Eli Lilly and Mannkind – to assess whether the continuation of their projects is a viable decision. It has now become clear that true convenience in the form of a discreet portable device is required in order to win over patients, and a true therapeutic advantage compared to traditionally administered insulin needs to be proven to secure reimbursement.