Exubera: what went wrong?   (October 18, 2007)

In a statement at their website, Pfizer has announced they are discontinuing the sale of their inhaled insulin product, Exubera: "we made an important decision regarding Exubera, a product for which we initially had high expectations," said Jeff Kindler, Chairman and Chief Executive Officer. "Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted."

"We will work with physicians to transition Exubera patients to other treatment options in the next three months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines."

What went wrong? There are certainly enough candidates to share the blame:

• an awkward ungainly ugly big inhaler device;
• questions about pulmonary safety, and subsequent need for patients to have pulmonary function testing and abstain from smoking for at least six months;
• inability of Pfizer's marketers to persuade the average physician of the need to provide bolus insulin therapy to patients failing oral agents;
• a rather stupid name that didn't in any way connote what the purpose of the product was;
• and perhaps most importantly, the apparent failure of Pfizer's marketers to realize the impact of Byetta (summer 2005) and Januvia (autumn 2006) on the marketplace for Exubera (which was released in summer 2006): these two alternative medications for treatment of type 2 diabetes simply elbowed Exubera out of the marketplace.

So now what?

• 600 of the 750 workers at its Vigo County plant - Pfizer's sole Exubera production center - are now on paid leave as Pfizer weighs the plant's future, according to a company spokesman.
• Patients on Exubera will switch to injections of insulin or resume their prior pills (or perhaps switch to Byetta or Januvia!).
• Other companies doing clinical trials on inhaled insulin will inevitably think long and hard before spending more money on their trials.
• The manufacturer of the inhaler device for Exubera (Nektar Therapeutics) is left without a product on the market, and its share price "swooned."
• Sanofi-Aventis (who sold their share of the Exubera project to Pfizer a year ago) will laugh loud and long.

Inhaled insulin sure sounded like a good idea. But it turned out that Exubera was an Edsel.