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Drug delivery firm Columbia Labs makes job cuts after FDA rejection

Watson takes over development of progesterone vaginal gel

Columbia Laboratories will make staff cut backs after the US Food and Drug Administration (FDA) decided not to approve its progesterone vaginal gel.

The US company, which specialises in developing women's health products that use its bioadhesive drug delivery technology, said its staff of 24 will be reduced to 14.

The cuts are expected to achieve annual savings of $1.5m after an initial severance cost of $0.5m. Jobs will mainly go in R&D and general administration positions.

“Our action today is difficult, particularly because we greatly appreciate the contributions of those we must let go,” said Columbia's president and CEO, Frank Condella.

“However, it is a step we must take to streamline operations and secure the company's positive financial position. The workforce reduction will lower our costs and better align operating expense with revenues. Our remaining employees will remain focused on the future course of our business.”

The decision comes after the company's New Drug Application for progesterone vaginal gel, which was seeking a licence reduce the risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy, was refused by the FDA

The US regulator said that data from the single trial to support the application did not meet the level of statistical significance expected to support the approval of the product in the US market, and that additional clinical work would be necessary.

This work will be carried out by Watson Pharmaceuticals, which acquired full rights to the drug from Columbia on February 10, 2012.

“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 Bisaro, Watson president and 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 US.”

5th March 2012

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