Arena Pharmaceuticals is planning to slash 66 employees from its workforce; however, the company said it will continue its fight with the FDA to gain regulatory approval for its obesity drug lorcaserin.
San Diego-based Arena said that the move, which will be completed March 28, will cost almost $3.8 million in one-time employee termination costs. However, the company said the staff reduction will save the company almost $13.5 million annually.
Arena said the layoffs will allow the company to focus on obtaining regulatory approval for lorcaserin, starting by completing its phase Ia clinical trial for APD811, an agonist of the prostacyclin receptor to treat pulmonary arterial hypertension and advance APD334, an agonist of the S1P1 receptor indicated to treat multiple sclerosis.
The FDA became concerned with the obesity drug after it found diagnostic uncertainty in the classification of mammary masses in female rats. The FDA recommended a dosing duration of three months or greater to better understand the relationship between lorcaserin, prolactin elevation and mammary tumor development in rats. The agency also required the company to undertake a 12-month study in female lab rats to test whether transient prolactin elevation mediated by short-term lorcaserin exposure could create tumors.
FDA concerns also stem from whether the drug has the potential to be abused and recommended that Arena repeat two of its non-clinical trials to provide additional safety data.
The company said that it plans to resubmit lorcaserin’s new drug application by the end of 2011 and will continue its discussions with the FDA.