The European Medicines Agency says that it has been formally notified by Menarini of its decision to withdraw its application for a centralised marketing authorisation for the antibiotic Factive.

Factive (gemifloxacin) was expected to be used for the treatment of bacterial infections causing mild to moderate community-acquired pneumonia and acute exacerbation of chronic bronchitis. An application for marketing authorisation of the drug, which Menarini licensed from the USA’s Oscient Pharmaceuticals Corp in December 2006, was submitted to the EMEA in March 2008.

Menarini told the EMEA that the withdrawal is based on the agency’s Committee for Medicinal Products for Human Use’s view that the data provided did not allow it “to conclude on a positive benefit-risk balance for Factive at that time”.

In July 2008, Oscient was told by the US Food and Drug Administration to revise the label on Factive to include risk factors such as tendon ruptures and tendonitis among patients over 60, as well as kidney-, heart- and lung-transplant recipients. Earlier this month, Oscient discontinued its sales force promotion of Factive and the cardiovascular drug Antara (fenofibrate), a move which resulted in the loss of 180 jobs.

For the fourth quarter of 2008, Oscient noted that Factive sales were down 11.9% to $5.2 million.