Big pharma Phase III setbacks

Two pharmaceutical companies, Roche and Pharmacia (PHA), announced that they halted development of compounds following unfavorable Phase III data. Roche said it has discontinued late-stage clinical development of two matrix metalloproteinase inhibitors (MMPIs) after interim data showed that the compounds were unlikely to have significant effects on preventing structural joint damage in both rheumatoid (RA) and osteoarthritis (OA). The RA study was a Phase III trial testing Trocade (Ro-32-3555). The other MMPI - yet unnamed - was in a Phase II trial in OA. Roche does not have a timeline on when it will complete analysis of the data, but Roche spokesperson Jacqueline Wallach said both compounds have been dropped from further development.

Roche's decision to drop the compounds is the latest in a long list of MMP disappointments. Other life science companies that have had difficulty developing the compounds include British Biotech (LSE:BBG; BBIOY) and Bayer. In January, BBG reported that its marimastat MMPI and Eli Lilly's Gemzar gemcitabine failed to show a significant improvement in survival in a Phase III trial in pancreatic cancer (see BioCentury, Jan. 31). BBG and partner Schering-Plough (SGP) are expecting Phase III data from the compound this year in small cell lung cancer, glioblastoma and ovarian cancer. Bayer dropped its BAY 12-9566 MMPI last September after disappointing interim Phase II/III data in various cancers (see BioCentury, Sept. 27, 1999). Warner-Lambert (WLA) is in Phase III and Phase II testing of its oral AG3340 prinomastat MMPI in non-small cell lung cancer, advanced prostate cancer, glioma and age-related macular degeneration. AG3340 was developed by WLA's Agouron Pharmaceuticals subsidiary. ...