The Big Gamble

Over the past month, I've spoken with a dozen leading scientists about delivery and formulation technologies for therapeutic proteins. Despite diverse affiliations (from top universities to Big Pharma) and varying areas of focus (from nasal to parenterals), every interviewee without fail said prospects for new delivery technologies hinge on the success of Pfizer's "Exubera" inhalable insulin launched earlier this year.

Kaylynn Chiarello-Ebner

Some believe this product will one day reach blockbuster status. Others contend it is far too early to tell, and will wait until the data are in on potential long-term side effects and efficacy issues. But one thing is certain: if inhalable insulin is a major commercial success, it will validate novel protein delivery and spur further development. If it is a failure, it will dampen enthusiasm about such techniques and make companies—as well as patients and physicians—hesitant to use the new approaches under development by the biotech industry.

If Exubera stumbles in the marketplace, the whole biotechnology sector will feel the wound—though it shouldn't. It would be as foolish as it would be natural to judge the entire category on the success or failure of one product. To do so is stifling to new and potentially valuable discoveries. Diverse delivery and formulation technologies are under development that offer a plethora of improvements over traditional methods. Each has a unique set of merits and limitations that should be evaluated on their own.

Much is riding on the success or failure of Exubera. One hopes that the outcome, whatever it may be, won't stop novel drug delivery innovators from risking it all in this high-stakes game.

Kaylynn Chiarello-Ebner is the managing editor of Pharmaceutical Technology, kchiarello@advanstar.com