Bayer AG has halted development of BAY 19-8004, its key PDE-4 inhibitorfor the treatment of asthma. The drug, which is at the Phase II stage, did not meet the target product profile that the company regarded as essential for successful marketing. According to Bayer spokesman Michael Diehl, toleration and effect were among factors considered when deciding to halt development of the product for the asthma indication, but he declined to give more details. Further development of the drug for the treatment of chronic obstructive pulmonary disease has been put on hold until all Phase II findings have been evaluated.
Bayer had initially planned to launch BAY 19-8004 for both indications in 2004, and had estimated peak sales of 750 million euros ($626 million) and 1.25 billion euros for asthma and COPD, respectively. Peter Mackay, an analyst at Dresdner Kleinwort Wasserstein, said that "this is their single largest product in development so it's very disappointing for them. It's our view that the efficacy for COPD trials has yet to be determined." On June 12, Bayer stock was down 2.19% at 46.5 euros.
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