Pfizer abandons ship as Exubera sinks
blockbuster Exubera, ending months of speculation as to whether the
fledging world-first inhalable insulin would sink or swim in the
fierce waters of pharma.
In its third quarter results today, the drug titan finally admitted that the Exubera was a market flop and had decided to cut and run, forcing it to write down a whopping $2.8bn (€1.96bn) in charges.
It has now stopped manufacturing of the device at its plant in Indiana and placed 600 of its 750 workers at the site on paid leave until a decision is made as to the future of the facility, in which Pfizer has already invested over $300m. "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," conceded Pfizer's Jeff Kindler, chairman and CEO.
There were plenty of warning signs that the device was dead in the water.
In June, Bespak, one of the device's contract manufacturers, announced it would cut 160 jobs as a result of the slow uptake of the drug, and then in August, fellow Exubera device manufacturer West Pharmaceutical Services announced it would scale back production in the third quarter of this year to one shift per day.
Meanwhile, Pfizer noted in its second quarter results that sales were "disappointing" with just $4m of worldwide revenues recorded during the period and indicated that it had started development on two next generation inhalers with the aim of replacing the underperforming Exubera device.
The company's exit from the currently wide open and potentially lucrative non-injectable insulin market paves the way for Eli Lilly to have a shot at the crown.
The firm announced last month that a Phase III trial of its inhaled insulin product will finish in time to allow it to file for US Food and Drug Administration (FDA) approval in 2009.
Developed in conjunction with Alkermes, Lilly's rival device, called AIR Insulin, is smaller than the Exubera device, roughly the size of a marker pen, and has not yet shown the same questionable effects on lung function as Exubera.
These two factors may give Lilly's product an edge upon its eventual launch that Exubera didn't enjoy.
Having said that, it is still largely unclear whether the product will be able to fare any better, considering the tough business environment it faces, where patients have largely not been receptive to such a device, due to its cost and the fact that it still does not completely replace the need for insulin injections.
More will be revealed by In-PharmaTechnologist.com tomorrow after a Pfizer conference call this afternoon.