Diabetics Breathing Easier

Investors in Pfizer (NYSE:PFE), Sanofi-Aventis (NYSE:SNY), and NektarTherapeutics (NASDAQ:NKTR) might be breathing a bit easier today. Late on Thursday, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7-2 in favor of recommending that the FDA approve the pre-marketing application for the Exubera inhaled insulin system.

As I pointed out in an earlier piece, this isn't a binding recommendation. The FDA will still have to consider the panel's advice and decide whether to approve Exubera, along with determining the wording on its labels and other details. That said, the FDA often follows panel recommendations; it would be quite a surprise if Exubera didn't receive prompt final approval now.

There weren't many surprises at the meeting. Panel members expressed concerns about the long-term safety of inhaled insulin but generally agreed that the benefits of an easier-to-use insulin delivery system outweighed those worries. A notable exception: The panelists felt there wasn't enough information to safely recommend Exubera to diabetics with pre-existing lung disease.

Proper training for doctors, nurses, and patients emerged as a significant issue at the hearing. One panelist voted "no" because he was pessimistic that the companies would engage in the necessary training once the drug was approved. This could ultimately have some impact upon Motley Fool Inside Value pick Pfizer, which will market Exubera in America. Complying with a more intensive training regimen could increase the company's Exubera-related SG&A costs and modestly trim some of its profitability.

Exubera has blockbuster potential, with $1 billion or more in possible sales. However, Eli Lilly (NYSE:LLY) / Alkermes (NASDAQ:ALKS) and MannKind (NASDAQ:MNKD) offer what I believe are superior delivery devices. Although the team behind Exubera is working on a better follow-up version, this could be a key point of competitive differentiation when all these products eventually reach the market.

Second, Sanofi-Aventis is not likely to be in the picture for much longer. Pfizer has talked about trying to use a "change in control" provision in the original partnership agreement to force out Sanofi, whose management hasn't entirely been exuberant about Exubera. I would expect Pfizer to buy out Sanofi's interest in the drug in some sort of negotiated settlement.

I certainly hope that Exubera (if given final approval) will help diabetics control their disease better without presenting long-term safety issues. There's a definite need for better diabetes care, and inhaled insulin could help. That said, with many competitors developing their own systems, we're still in the early days of the inhaled insulin saga.

Phurther pharmaceutical Phoolishness:

• FDA's Eye on 2 Potential Blockbusters
• Sanofi-Aventis: A Mix of News
• Sniffing Out A Possible Diabetes Blockbuster
• Novo Nordisk Perks Up

Fool contributor Stephen Simpson owns shares of Sanofi-Aventis. The Fool has a disclosure policy.