Columbia Labs axing 42% of jobs after FDA shoots down drug application

Posted under Blog, Columbia Laboratories, Companies, Diagnostics, FDA, Funding, layoffs, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaginal gel, Videos, Watson Pharmaceuticals by Ryan McBride

Fresh off the setback of an FDA denial, Columbia Laboratories ($CBRX) will cut deeply into its workforce and let go 42% of its employees, the company said. The drug developer expects to shave $1.5 million from its annual expenses and plod forward with partner Watson Pharmaceuticals ($WPI) to advance a vaginal progesterone gel that recently failed to gain FDA approval. 

In the meantime, Columbia is weighing "all strategic options moving forward," the company said.

Livingston, NJ-based Columbia is sending pink slips to 10 of its 24 workers, with the majority of the cuts made to jobs in research and development and administration, according to the company's release. The leaner workforce of 14 employees plans to forge ahead with the company's programs, which make use of its bio-adhesive drug delivery technologies.

The layoffs come after the company's announcement on Monday that the FDA handed Columbia and Watson a complete response letter for their application for approval of the progesterone gel for lowering risk of preterm births. U.S. regulators told the companies that more data on the efficacy of the treatment was needed before it could be considered for approval again.

"Our action today is difficult, particularly because we greatly appreciate the contributions of those we must let go," Columbia CEO Frank Condella said in a statement. "However, it is a step we must take to streamline operations and secure the company's positive financial position."

- here's the release

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FDA rejects Columbia Labs’ gel to prevent preterm births

Posted under Blog, Columbia Laboratories, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaginal gel, Videos, Watson Pharmaceuticals by John Carroll

Just weeks ago, after FDA regulators and agency experts lined up squarely against an approval for a vaginal gel from Columbia Laboratories ($CBRX) and Watson Pharmaceuticals to reduce the risk of preterm birth, Columbia's CEO declared himself convinced of the justification for a formal approval. This morning, when the company revealed that the FDA had rejected the application, Columbia announced that it had been handed a complete response letter "as expected."

The company stood by its complaint that regulators had zeroed in on something they never expected: The robustness--or lack thereof--of the sub-cohort of U.S. patients in the study. The agency has made it officially clear now that it wants more clinical evidence of efficacy for Prochieve before it hands out an approval.

"Watson will work directly with the FDA to address items raised in the complete response letter regarding the approvability of progresterone vaginal gel 8% for reduction of preterm birth. We have formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application," said Paul M. Bisaro, Watson's CEO. "We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth which affects approximately one-in-eight live-born infants in the U.S."

The writing on the wall for this treatment started last summer, when Columbia failed to achieve a priority review for the treatment. Then in January regulators flatly stated that investigators never presented sufficient data to make their case, and the experts agreed days later.

Evidently the rejection still caught a few people by surprise. Columbia's shares fell another 8% in premarket trading.

- here's the press release

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Columbia shares plunge after FDA staffers blast birth gel app
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Columbia shares nosedive after FDA experts reject preterm birth gel

Posted under Blog, Columbia Laboratories, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

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 

Columbia shares plunge after FDA staffers blast birth gel app

Posted under Blog, Columbia Laboratories, Companies, Diagnostics, Funding, KV Pharmaceutical, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos, Watson Pharmaceuticals by John Carroll

Regulators at the FDA issued a brutal review for Columbia Laboratories' ($CBRX) application for its progesterone vaginal gel to prevent preterm delivery, saying the developer didn't provide the data needed to make a case on efficacy. Staffers now want an upcoming expert panel to consider whether Columbia should go back to the drawing board and conduct more studies. And once investors got wind of the assessment, the developer's shares tumbled 54% in after-hours trading.

"The information and data in this application do not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks," regulators concluded. In the U.S., pregnant women who were given the gel experienced preterm birth in 16.8% of all the cases tracked, compared to 19.2% of the women taking a placebo. That's an improvement, but not a statistically significant figure.

"It does not appear that the applicant has identified a population of U.S. women who are likely to benefit from the use of progesterone gel to reduce their risk of preterm birth," noted FDA staffers. Watson Pharmaceuticals ($WPI), which is partnered on the treatment, saw its shares slide 5%.

For its part, a spokesperson for Columbia Labs told Bloomberg that the FDA was basing its conclusions on a narrow group of participants in the study, which was global. "It was designed as a global study," she said. "FDA agreed."

Columbia Labs has been angling to compete with KV's ($KV-A) Makena, a recently approved therapeutic that has been the subject of considerable controversy. Makena is an approved version of a drug regularly prepared by compounding pharmacists at a fraction of the cost.

- get the story from Bloomberg
- here's the story from Reuters

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Columbia Labs shares slide on shift in Prochieve regulatory strategy