July 2, 2008

Basilea: Ceftobiprole Wins First Regulatory Approval

Basilea Pharmaceuticals has obtained regulatory approval from Health Canada for its anti-MRSA drug, ceftobiprole. Although the Swiss biotech company is awaiting a decision from the FDA, the uptake of ceftobiprole in Canada could form the basis for more targeted sales and marketing decisions prior to launch in other markets.

This is the first approval for ceftobiprole which received an approvable letter from the FDA in March 2007. The anti-MRSA broad-spectrum antibiotic is to be sold under the trade name Zeftera for the treatment of complicated skin and soft tissue infections including diabetic foot infections. The agency had requested more information on its impact on diabetic foot infections, as well as more time to evaluate the clinical data in the file and inspect study sites and is expected to give a final decision in July 2008. The drug is also currently under review by European regulators.

Basilea is to co-promote ceftobiprole with Johnson & Johnson unit Janssen-Ortho. Although the Canadian market is smaller, approval here is significant since it provides Basilea and Janssen with an opportunity to assess the initial uptake of the drug. Moving forward this will enable the companies to make more targeted investment decisions for sales and marketing decisions prior to the drug's launch in other major markets, such as the US and EU. It will be interesting to see whether ceftobiprole will be positioned against generic vancomycin or against newer branded products.

The majority of the more recently launched products, and those drugs in late stage development, are designed to target bacteria such as MRSA. Indeed, several antibacterials targeting such pathogens have been introduced in the past few years, including linezolid (Zyvox), daptomycin (launched in 2003) and tigecycline (launched in 2005). Dalbavancin and telavancin are two of the newer drugs targeted towards MRSA but both received approvable letters from the FDA last year.

Consequently, Datamonitor expects this market to become increasingly crowded. Ceftobiprole, however, has the advantage being a compound derived from a class which physicians are familiar with, thereby representing a safe alternative to more novel compounds. Close monitoring of the drug's success in competing against both new launches and old products will help guide more successful launch strategies elsewhere, trends that other companies with similar late stage products will be keen to observe.