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24 août, 2005 12:50

Adviser Soapbox

David Kliff, 08.24.05, 10:00 AM ET

By now everyone has had the opportunity to read something about the $253 million verdict against Merck. While the pundits discuss the ramifications of the verdict on the entire drug industry, there are some very real consequences for people with diabetes.

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In particular, what this means for the many drugs under development. Given that FDA is also under scrutiny for the role they played in approving Vioxx, people with diabetes are now likely to wait even longer for new drugs to come to market.

Our first clear evidence of this will come in early September, when two FDA panels will meet to discuss two new diabetes drugs. Exubera, the inhaled form of insulin from Pfizer (nyse: PFE - news - people ), Sanofi-Aventis (nyse : SNY - news - people ) and Nektar Pharmaceuticals (nasdaq: NKTR - news - people ) goes before a panel on Sept. 8; while Muraglitazar from Bristol-Myers Squibb (nyse: BMY - news - people ) and Merck (nyse: MRK - news - people ) goes before a panel on Sept. 9. Both drugs are targeted at the lucrative type 2 market, and if approved could have an immediate impact on the market.

Regular readers know that Diabetic Investor has never held Exubera in high regard. Besides the poor design of the delivery device, there are just too many questions surrounding the long-term safety of the drug. While we agree people with diabetes would benefit from a non-injectable form of insulin, we don't believe Exubera is the answer. It will be interesting with all the data that has been gathered on Exubera and the increased scrutiny sure to be given by the FDA panel, if Exubera gains clearance. Unfortunately for Exubera, it will be the first diabetes drug to go before the FDA after the Vioxx verdict, something that will be fresh in the mind of panel members.

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The story for Muraglitazar will likely be different, as there has not been as much controversy as with Exubera. However, during Phase III studies there were two deaths reported for patients on the drug. Although the investigators reported these cases not to drug-related, this fact will be closely looked at by the panel.

Herein lies the problem: While the drug has been shown to be effective in reducing patients A1C levels and the main reported adverse events were edema and weight gain, the panel may well decide in this new environment that additional studies are needed. The last thing the FDA wants is another drug on the market that might result in the death of a patient. And let's not forget that Merck, the makers of Vioxx, are also involved with Muraglitazar, a fact that will not go unnoticed by panel members, who might just believe it's better to be safe than sorry.

Diabetes is one of the few areas where drug companies are accelerating their research and development efforts. Besides the epidemic growth rate of the disease, they are aware of the additional 41 million Americans with prediabetes. This is one reason analysts have projected that the market for diabetes drugs will reach $30 billion by 2009.

It's an open question how drugmakers will proceed with these projects, given what is likely to be even closer examination by the FDA. Our first clues will come in early September. Stay tuned.

David Kliff is editor and publisher of Diabetic Investor.

For more of Kliff's analysis and to subscribe to Diabetic Investor, click here.

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