Early last week FDA regulators essentially concluded that Columbia Laboratories had blundered in its clinical trial work for a new gel to prevent preterm births. In the view of regulators, Columbia ($CBRX) had failed to offer data which clearly supported the efficacy of the treatment. And on Friday an FDA panel voted against an approval, triggering a meltdown in its share price.
The FDA advisers agreed with the regulators' assessment, concluding that investigators never proved its case that the gel provided a significant reduction in preterm birth risk among women with a short cervix when compared to a placebo.
"With such a significant disease associated with mortality and morbidity we don't want to provide things that aren't truly efficacious," noted panelist Dr. Kathleen Hoeger of the University of Rochester Medical Center, according to the AP. By the time the dust had settled over the weekend, Columbia's share price had dropped 56% as investors caught up to the implications of these latest setbacks.
With regulators clearly opposed to an approval and its experts in agreement, Columbia clearly faces an uphill fight trying to avert a complete response letter likely to include new data demands. But they are putting their best face on a bad situation.
"We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency's final decision will acknowledge the clear unmet medical need in this patient population," said Frank Condella, the CEO of Columbia.
Wells Fargo analyst Michael Tong has noted that Columbia's management outlined peak sales at around $275 million a year. Watson is partnered on the program.
- read the press release
- here's the Bloomberg report
- get the AP story