Executive Summary

Hoechst-Roussel is in the process of submitting preliminary data to FDA to support an expanded access program for the company's Alzheimer's drug Mentane (velnacrine), Hoechst-Roussel Pharmaceuticals President Victor Bauer told a July 15 meeting of FDA's Peripheral & Central Nervous System Drugs Advisory Committee. In comments to the committee during the open hearing portion of the meeting to consider a Treatment IND for Warner-Lambert's Cognex (tacrine), Bauer announced Hoechst-Roussel's support for an expanded access program for the aminoacridine class of Alzheimer's drugs, which includes both tacrine and velnacrine. Bauer noted that Hoechst-Roussel would "offer velnacrine without charge" under their proposed expanded access program. Velnacrine is currently in Phase III trials as a cognition enhancer and the company expects to file an NDA later this year. Interim analyses of the data have shown that "clinical efficacy and safety results for both [tacrine and velnacrine] to date appear to be similar," Bauer said. He noted that the company has over six years of clinical experience with velnacrine in over 1,100 patients. Bauer acknowledged that Hoechst-Roussel has not yet formally applied for a Treatment IND for velnacrine. "We have assembled an interesting package of preliminary information on velnacrine, some of which we have recently submitted to the agency," he reported. "This information bears strongly on the question of velnacrine's safe usage in an expanded access setting." The information submitted to FDA, Bauer told the advisory committee, "suggests" that it may be possible to determine beforehand "those patients with a low prospect of having an adverse liver reaction" to the drug. Since submitting data to FDA, Bauer added, the company has "validated this information in a larger group of patients." Bauer noted that Hoechst-Roussel "would be willing to make this and other information available, through the agency, to facilitate safe use of both velnacrine and tacrine." Two other companies with Alzheimer's drugs in late clinical development, Forest Labs (Synapton)) and Sigma-Tau (Alcar) say it is premature at this point to contemplate an expanded access program for their compounds. Forest, which plans to wrap up its Phase III studies with Synapton later this year, said it will consider the possibility of a Treatment IND at that time. Sigma- Tau's 400-patient trial with Alcar is not expected to be completed until the end of 1992. A third company, DuPont Merck, has just initiated Phase III trials of DuPont's Alzheimer's drug linopirine in 750 patients ("The Pink Sheet" July 15, T&G-14).