Johnson and Johnson infection treatment rejected

Johnson & Johnson’s new drug application for ceftobiprole has been rejected by the US Food and Drug Administration (FDA).

The product – also developed by Basilea Pharmaceutica – is an antibiotic for the treatment of complicated skin and skin-structure infections, including diabetic foot infections.

In a letter to Johnson & Johnson, the FDA said the company is required to conduct additional audit work of clinical-investigator sites and to address specific questions that are related to their monitoring.

The rejection follows an approval made in May 2007, with the agency asking for more information on the drug candidate in March this year.

However, ceftobiprole has been approved in Canada and Switzerland, with an advisory committee in Europe recommending endorsement across the continent.

As a result of the rejection, shares of Basilea fell 55.5 Swiss francs (30 pounds) to 96 francs in trading yesterday.

Johnson & Johnson also noted a drop of 43 cents to close at $58.27 (37.80 pounds).

Earlier this week, Johnson & Johnson reported its intention to acquire Omrix, via a new wholly-owned subsidiary, named Binder Merger Sub.

As a result of the offer, stockholders of Omrix will receive $25.00 in cash for each of the company’s shares of common stock which has been tendered in the offer.