Ah yes - now I remember.
Here's the story again:
Cubist Pharmaceuticals Says Drug Flunked Geography Test
By Adam Feuerstein
Staff Reporter
01/16/2002 06:28 PM EST
Heck, if your drug doesn't work, then blame Eastern Europe. That's what biotech firm Cubist Pharmaceuticals (CBST:Nasdaq - news - commentary - research - analysis) did Wednesday after it warned of failing results from a late-stage test of its experimental antibiotic Cidecin.
Cubist is testing Cidecin as a treatment for serious pneumonia, but in a late-stage test that compared it with an existing treatment, the drug failed to show superior efficacy, the company said.
But Cubist believes that geography is at least partly to blame for the bad test result. The biotech said Cidecin proved effective in North American and Western European patients, but ineffective in Eastern European and South African patients. Cubist's statement did not explain precisely why it thought location mattered to the test.
Unfortunately for Cubist, it's the global results that count, so the Cidecin trial was a bust.
Shares of Cubist plunged more than 50% to $16.09 per share in Wednesday after-hours trading. The stock closed the regular session down 34 cents to $31.75 per share.
Cubist said it is suspending patient enrollment in a second, late-stage Cidecin pneumonia trial until it can further review the results from the first test. The company said one option it is exploring is to restrict patient testing to North America and Western Europe.
Cidecin has proven to be an effective antibiotic for the treatment of complicated skin and soft-tissue infection, based on results from two late-stage clinical trials. Cubist's original plan was to seek Cidecin approval from the Food and Drug Administration for both diseases in the third quarter. But given problems with the pneumonia trials, the company may now just file for approval for skin infections.
Actually it still remains unclear why the drug failed in that pneumonia indication. Here's what CBST said some six months later:
Earlier this year, Cubist announced results from the first CAP study (CAP1), in which CIDECIN was compared to ceftriaxone, the current standard of care for CAP. Analysis of the previously halted second study (CAP2) has now been completed; outcome trends from the initial analysis of 170 evaluable patients appear to be consistent with the results seen in the CAP1 study, but are not statistically meaningful given the small patient population. When data from the clinically evaluable populations in the two CAP studies are combined, CIDECIN achieved a clinical success rate of 80% versus ceftriaxone's 88% clinical success rate.
Both internal and external infectious disease medical and regulatory reviewers have now assessed many possible factors that could have contributed to the unexpected overall outcome of the CAP1 study. Notably, the reviewers concluded that there were no substantive faults in the design, conduct or analyses of the study that could have affected the outcome. The more detailed analysis also concluded that no one factor appears to explain the difference in the cure rates of CIDECIN and ceftriaxone in the study.
Peter |
