While Avandia declines have weighed heavily on GlaxoSmithKline's top line in the past year, the company believes the type 2 diabetes drug's U.S. market share has stabilized, according to outgoing CEO JP Garnier.

"We had this brutal drop in May last year, and then, of course, there was a slight erosion that was going on," he noted during an April 23 first quarter earnings call. "But for the last eight weeks or so, I think we have reached some kind of equilibrium," he said.

"It's early days before we can tell you whether this franchise will become a growth driver again. I think we had said at the beginning, at the last quarter review, that we wouldn't see anything move for at least six to nine months, and I think there is nothing new there. We are sticking to the same forecast."

Sales of the brand - which also includes Avandamet and Avandaryl - plummeted 66 percent to £99 million ($196 million) in the U.S. and 56 percent globally to £191 million ($378.3 million) at constant exchange rates in the first quarter, the company reported.

The drop contributed to a 4 percent decline at constant exchange rates of pharmaceutical revenues to £4.79 billion ($9.5 billion).

Revenues from Avandia (rosiglitazone) began to decline last year in the wake of heavily publicized reports linking use of the drug with cardiovascular events. In November, FDA expanded a "black box" warning on the Avandia label to include data on the risk of heart attacks (¹ Also see "Avandia Expands Black Box With Heart Attack Risk Information" - Pink Sheet, 14 November, 2007.).

Sales of the firm's biggest growth driver, long-acting beta2 adrenergic agonist Advair (fluticasone/salmeterol), were up 10 percent in the quarter to £954 million ($1.18 billion), helping to offset Avandia losses. Garnier noted that the launch of AstraZeneca's Symbicort (budesonide/formoterol fumarate) in the U.S. had less of an impact on the brand than analysts projected.

"We're not suffering from Symbicort. ...This is just not happening in the U.S. They represent less than 5 percent of our volume, and we had an uneventful quarter as far as Advair is concerned."

GSK is hoping to extend the franchise with an expanded indication for obstructive pulmonary disease for Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg.

The firm plans to expand the label to include a survival indication and a claim that Advair reduces exacerbations of COPD. However, FDA deemed the application "not approvable" last fall (² Also see "FDA Says GlaxoSmithKline’s Advair 500/50 “Not Approvable” For COPD" - Pink Sheet, 8 August, 2007.).

The agency asked for head-to-head data with the lower 250/50 mcg strength, and the new user fee date is May 1.

If GSK gains the indication, "we will be the only medicine now with an exacerbation claim," President, U.S. Pharmaceuticals Chris Viehbacher said. "And given that other drugs are potentially going through some difficulty in this area, I think the whole opportunity in COPD is going to be even more attractive than it is."

"We've had some very good growth in that area, and we believe that this will buttress our position," he added.

FDA recently announced it will conduct a risk/benefit assessment of LABAs in adults and children at an advisory committee meeting in the fall or winter of 2008 (³ Also see "Risk/Benefit Of Asthma Drugs To Be Debated At Future Advisory Committee" - Pink Sheet, 6 March, 2008.).

Viehbacher did not express concern when asked about the committee meeting.

"We think this latest round of interest is actually not driven by Advair; it was really driven by [Novartis'] Foradil ," he noted, "And I can't really tell you what data [FDA] may or may not have seen. But I think that's why they decided to have a look at everything in this class and it started off with pediatrics, and so they will just do another review."

"We've had an awful lot of data come forward, certainly showing the benefit of combination therapy versus an [inhaled corticosteroid] alone," Viehbacher said. "So I think we feel very confident going into that advisory committee. I think part of this is just a fact of life of the environment that we are in and where the FDA is, and we will deal with that again as we have done in the past."

The earnings presentation was the last for Garnier, GSK's longtime CEO; at the end of May, Andrew Witty will succeed him at the helm of the British drug maker (⁴ Also see "GSK Makes Clever Decision Choosing Witty As New CEO" - Pink Sheet, 8 October, 2007.).

-Brooke McManus (b.mcmanus@elsevier.com)

Avandia Market Share Stabilizing, GSK CEO Garnier Says

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