J&J Responds to FDA - Analyst Blog

We are pleased to hear that the US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (JNJ) response on clinical trial-related issues. Last month, the agency had warned the company for not maintaining proper records during the trial of ceftobiprole, a broad-spectrum antibiotic for the treatment of complicated skin infections and nosocomial pneumonia. J&J had licensed the drug from Swiss drugmaker Basilea Pharmaceuticals in 2005. The issue must be resolved for the drug to be approved.

The new drug application (NDA) for ceftobiprole has been pending since May 2007. The approval is getting delayed since protocol-related issues have been present from the initial stages. In November last year, the FDA issued a Complete Response letter stating that it could not approve the NDA at that time as the company did not comply with certain safeguards during the trial. J&J had not been able to convince the FDA with its response.

Apart from delay in the FDA’s decision, the European Union (EU) also deferred its ruling on the drug last February. The review process was halted until conclusion of a Good Clinical Practice inspection. After recurring delays in both US and EU approval, Basilea filed an arbitration claim against J&J seeking damages. The drug was launched in Canada and Switzerland last year under the trade name Zeftera.

On approval, ceftobiprole will have to compete with several established drugs like ViroPharma’s (VPHM) Vancocin, Cubist Pharmaceutical’s (CBST) Cubicin, Pfizer’s (PFE) Zyvox and Wyeth’s (WYE) Tygacil. These drugs recorded sales of $232 million, $422.1 million, $1.15 billion and $216.2 million, respectively, in 2008. Companies like Forest Laboratories/AstraZeneca (FRX/AZN) and Theravance (THRX) are developing candidates for this market.