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Reuters
EU experts have concerns over Exubera drug -report
Thursday August 5, 11:37 am ET
LONDON, Aug 5 (Reuters) - European experts assessing a marketing application from Pfizer (PFE.N.) and Aventis (Paris:AVEP.PA - News) for their inhaled insulin drug Exubera have decided it is "not licensable at this time", according to a report on Thursday.
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Online medical news service Agence de Presse Medicale (APM), citing a company source, said officials had raised objections to the product, which offers diabetics an alternative to insulin injections.
Exubera, which analysts reckon could have peak annual sales of up to $2 billion if approved, was filed early this year with the European Medicines Agency, although the companies did not confirm the filing until March.
The first hint of a setback appears in the minutes of a meeting of Britain's Committee on Safety of Medicines on April 29, which stated that objections had been raised to an unidentified diabetes drug going through the centralised European drug assessment system.
"The committee endorsed the view of the rapporteurs that this drug was not licensable at this time and raised further major objections," the minutes on the UK agency's Web site state.
Although the committee did not name the product, APM said its source had indicated the drug was Exubera.
"This is the start of the procedure, when it is normal for objections to be raised. We are confident that we can answer the question," the source stressed.
Aventis, which is in the process of being acquired by French rival Sanofi-Synthelabo (Paris:SASY.PA - News), said it had no comment, and Pfizer did not return calls.
Exubera is also an important product for Nektar Therapeutics (NasdaqNM:NKTR - News), which developed the device to deliver a fine insulin powder to the lungs.
Safety concerns have dogged Exubera for years, and it is viewed by industry analysts as a high-risk, high-reward project. Although the inhaled powder has appeared effective in clinical trials, tiny decreases in lung function and a build-up of antibodies that could potentially affect drug absorption have been reported.
The safety concerns have necessitated additional clinical trials, and the drug has yet to be filed for the all-important U.S. market.
Aventis announced in June, however, that results presented at the American Diabetes Association confirmed the drug's long-term safety and efficacy. |
