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Aventis Pharma Discontinues Development of Propentofylline
Aventis Pharma (Frankfurt, Germany) the pharmaceutical company of Aventis S.A., has announced that it is discontinuing development of propentofylline as a possible treatment for Alzheimer disease.
The decision is a result of the company's portfolio review process, which is conducted to ensure that resources are devoted only to projects with a high potential for success.
A major contributing factor in the termination of propentofylline was the disappointing outcome of the recently completed Propentofylline Long-term Use Study (PLUS). In the 72-week, phase IIIb study, there were no treatment differences detected between the study population treated with propentofylline and the population treated with placebo.
In 1996, on the basis of data from several phase III studies conducted by Aventis Pharma (formerly Hoechst Marion Roussel), approval to market propentofylline for the treatment of Alzheimer's disease and vascular dementia in the European Union was sought from the European Agency for the Evaluation of Medicinal Products (EMEA). On October 26, 1998, the company announced that the Committee for Proprietary Medicinal Products, the scientific advisory panel for the EMEA, rendered a negative opinion (which was later upheld on appeal in March 1999). In July 1999, Aventis Pharma (then Hoechst Marion Roussel) announced plans for a new pivotal phase III study in Alzheimer disease to be conducted in the United States to address regulatory concerns. That study has now been cancelled.
"Alzheimer's disease is a devastating condition with few treatment options. Therefore, we pursued propentofylline as a potential therapeutic breakthrough until we were faced with evidence which convinced us that our potential for success was severely limited," said Dr. Frank L. Douglas, executive vice president and head of Drug Innovation & Approval for Aventis Pharma. "While we are disappointed by this discontinuation, we remain focused on our larger objective of successfully completing development of an array of innovative, strategic products in the Aventis Pharma pipeline."