Galida No More and other news

Galida No More and other news

This morning AstraZeneca (NYSE:AZN) announced that they have decided to stop development of Galida its phase 3 dual-PPAR agonist for type 2 diabetes. While this announcement isn’t totally unexpected, the news does remind everyone just how perilous drug development can be. It also brings into question whether or not we will ever see a dual-PPAR brought to market.

At one time many on the Street believed dual-PPAR’s would be the next multibillion-dollar drug for type 2 diabetes. However concerns over links to cancer and heart failure have doomed what was once a promising drug category.

Also today Sanofi-Aventis (NYSE:SNY) reported 1st quarter earnings and as expected everyone was interested in the status of Acomplia, the company’s obesity drug that is currently before the Food and Drug Administration (FDA) and has already received approval in Europe. While the company would not go into any details on their discussions with the FDA they remain confident that the drug will be approved by the FDA and launched in the second half of 2006.

Sales of Lantus®, the company’s long-acting insulin, continues its strong growth rate and the introduction of Novo Nordisk (NYSE:NVO) Levemir® into the European market does not appear to have stalled Lantus sales.

Joining the earnings parade was MannKind (NASDAQ:MNKD) who’s inhaled insulin is gaining the attention of both researchers and investors. Mannkind’s Technosphere insulin now in Phase 3 trials, appears to be more effective than Exubera, the inhaled insulin from Pfizer (NYSE:PFE) that is already approved by the FDA and set to launch this summer. Although there was no earth shattering news to come out of the call today Diabetic Investor believes that company is getting very close to signing a major partnership agreement.

On a side note at last weeks American Association of Endocrinologist (AACE) meeting here in Chicago, Diabetic Investor finally had the chance to see the Exubera delivery device up close. According to the people at the Pfizer booth, the company plans on giving away the device for free as well as the release unit which must be replaced every two weeks. While they did not reveal what Exubera would cost, it appears the company will be pursuing a strategy similar to the blood glucose monitoring market, where the meters are given away for free and revenue is generated from the ongoing sales of test strips.

Getting back to the device, Diabetic Investor watched the presentation given by the company demonstrating how the device is used. Given all the steps involved Diabetic Investor maintains our belief that patients will find the device difficult to use. We also remain firm in our belief that patients will be uncomfortable using this rather large device in a public setting.

After the presentation was over Diabetic Investor spoke with diabetes educators Pfizer hired to promote Exubera. When asked about dosing variability, the size of the device, concerns of antibody formation the party line was that Exubera was another tool in the continuing struggle for patients to achieve solid control of their diabetes. It wasn’t long before the actual Pfizer employees came over to put a stop to our chat. Employees who when asked seem to know very little about a product which many believe is a billion dollar product.

Look for Pfizer to make an all out effort at the upcoming ADA show in June. With Mannkind’s inhaled insulin gaining momentum, the company will use their considerable resources to get Exubera off to a strong start. Diabetic Investor does not believe any amount of financial or human capital can turn Exubera into a commercial success. As we have said before, normally being first to market with a new product is a major advantage, this will not be the case with Exubera. Besides its expected higher cost and cumbersome delivery device, the final nail in Exubera’s coffin will be patient reaction. Diabetic Investor strongly suspects that early adopters of Exubera will not have favorable things to report to their physician. We further suspect that primary care providers in particular are unprepared for the additional attention required by insulin using patients.

Investors betting that Exubera would be the next big thing in diabetes care have put their money on the wrong horse.

David Kliff
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