Found this on the Yahoo board:
05/31/1999
The Pink Sheet
© Copyright 1999 F-D-C Reports, Inc. All Rights Reserved.
Agouron's next product for the AIDS market is likely to be Remune, for which the company hopes to file an NDA during 2001. The filing will be based on virologic endpoints, Johnson said. Remune is licensed from Immune Response under a June 1998 agreement.
Agouron announced May 17 that it had discontinued a 2,500-patient
clinical endpoint study of Remune with highly active antiretroviral
therapy (HAART).
The trial was discontinued after it was determined that “of more than
200 AIDS-related clinical endpoints that were originally expected to
have occurred, at this point in the study, less than one-fifth of that
number have actually” been observed, Agouron President Peter Johnson said. “With the high level of efficacy of HAART, an adequately powered study of this kind would probably have to be several times larger and several times longer than Remune study 816.”
The study was designed and initiated approximately three years ago,
“well before the broad use of HAART therapy,” Johnson said, and it
“sought to demonstrate significant difference in the rate at which
patients would hit AIDS-defining clinical endpoints or death if they add Remune to their underlying therapy.”
FDA has agreed to accept “future studies that demonstrate favorable virologic endpoints that [show] comparative improvements in the extent and duration of decreases in viral load,” Johnson reported. Agouron is preparing to initiate two new Phase III virologic endpoint studies soon.
An analysis of a surrogate marker cohort of about 240 patients from
the failed study provides support for the new approach, as “significant improvements in viral load were observed among patients who added Remune to their underlying therapy compared to the cohort who did not.”
Wild estimated that Remune represents $500 mil. to $1 bil. in sales potential, and declared that if the drug “does work out, it could become the largest product in the AIDS category.” |
