I am diabetic

BOSTON (MarketWatch) — Food and Drug Administration advisory panels will be reviewing the applications of two potential blockbuster diabetes drugs later this week, Bristol-Myers Squibb’s Pargluva and Pfizer’s Exubera.

First up will be Pfizer’s Exubera, the first inhaled form of insulin to be considered by the government agency. Pfizer hopes that if approved, inhaled insulin will woo over thousands of diabetics who loathe injecting insulin or who should be taking insulin but fear needles.

While the drug appears to be just as effective in controlling blood sugar levels as injected insulin, the FDA panel will be scrutinizing the drug’s data that to see if long-term use can diminish lung capacity in any way.

Still, many Pfizer watchers believe the FDA will give Pfizer the go- ahead, given the spike in diabetes cases due to obesity and an aging population.

Although decisions made by advisory panels aren’t binding, the FDA almost always follows their recommendations.

Pfizer developed the drug with Nektar Therapeutics , a specialist in drug-delivery systems, and Sanofi-Aventis, one of the world’s largest suppliers of insulin. The insulin is delivered through a device that resembles a large asthma inhaler.

If approved, Exubera could have peak worldwide sales of up to $1.5 billion by 2010, according to Caris & Co. analyst Le Anne Zhao.

“I think Exubera’s chances are 70% to 80% of being approved,” said Zhao.

If it’s approved, Exubera could face strong competition down the road. Eli Lilly & Co. is currently in late-stage testing with drug-delivery developer Alkermes for their version of inhaled insulin. Novo Nordisk and delivery partner Aradigm are also in the game, along with niche drug developer Mannkind.

On Friday, the same FDA panel will review Bristol-Myers’ Pargluva, also known as muraglitazar, which is used to help control blood sugar and triglyceride levels in type 2 diabetics.

If approved, Bristol-Myers would be splitting any profits with partner Merck & Co., and Pargluva would also be in competition with two other drugs in its chemical class, Eli Lilly’s Actos and GlaxoSmithKline’s Avandia.

Zhao said that she estimates Pargluva could have peak worldwide sales of $3 billion by 2010.

However, analysts say that while Pargluva appears to be slightly more effective in treating diabetes than Actos and Avandia, the drug also has a higher incidence of causing cardiovascular problems such as edema.

Because of this, analysts add, the FDA, which is still stinging from accusations that it has dropped the ball on drug safety, may be wary of approving Pargluva.

“I give it a 50-50 chance,” said Zhao. “If the FDA does give the green light, it will require extensive Phase IV [postmarket] studies, and the drug will probably have a bold-faced warning on its label.”

Lehman Brothers’ Anthony Butler said he thinks the FDA will probably approve Pargluva, although he put the odds at “a little better than 50%.”

Butler added that while Pargluva performed “marginally better” than Actos or Avandia, “it also has marginally worse side effects at higher doses.”

Pargluva’s side effects are an issue, said Butler, in that many general practitioners tend to prescribe oral diabetic medications in very high amounts to patients who still don’t have their blood sugar levels under control.

But Butler added that if Pargluva is turned down on Friday, it would probably be with the caveat that the companies conduct additional safety and dosing studies.

“There’s clearly a need for improved glucose-control drugs,” said Butler. “I think they’ll get an approval because there’s a marginal benefit.”

Val Brickates Kennedy is a reporter for MarketWatch in Boston.

This entry was posted on Tuesday, March 4th, 2008 at 4:59 am and is filed under Actos, Avandia, Medications, Type 2 Diabetes. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.