The Food and Drug Administration requested additional information from Johnson & Johnson and its Swiss partner Basilea Pharmaceutica AG before it will consider approving ceftobiprole, their jointly developed drug that has the ability to kill antibiotic-resistant bacteria.
The holdup was surprising to some analysts and will likely delay the antibiotic's potential market entry by at least three to six months, according to Bruce Cranna of Leerink Swann. Analysts' estimates of the drug's annual sales, should it be approved, range from about $100 million in the coming year to hundreds of millions or more at peak sales.
At least four other antibiotics are expected to be reviewed by the FDA this year, according to a Credit Suisse report. Yesterday's "approvable letter" for ceftobiprole and one issued in October for Theravance Inc.'s televancin, as well as the FDA's cancellation of advisory-committee meetings for both drugs in February, suggest to some industry experts heightened caution about approving anti-infection drugs.
"Most people understand that the FDA is getting a little more sensitive to data requirements and potential safety signals, or lack thereof," Mr. Cranna said.
Credit Suisse analyst Michael Aberman said he wonders whether "the FDA, in particular the division of anti-infectious agents, changed in a way that has made it more difficult for antibiotics to be approved."
Dr. Aberman said one reason for the agency's caution might be lawmakers' harsh response in January to the FDA's handling of Sanofi-Aventis's antibiotic Ketek. The House Energy and Commerce Committee's Subcommittee on Oversight and Investigations issued subpoenas to two FDA investigators and Secretary of Health and Human Services Michael Leavitt, who oversees the FDA, regarding a probe of allegedly compromised clinical data in a Ketek safety trial.
"One wonders how their handling of Ketek and the subsequent pressure brought on them by Congress has had an impact on how they do things moving forward," Dr. Aberman said.
Infectious-disease experts have been frustrated by the rate of novel antibiotic development, which has slowed in recent years even as bacteria have become increasingly antibiotic resistant.
Basilea's shares fell $36.50, nearly 20%, to $148.50 in trading on the SWX Swiss Exchange yesterday, while J&J's closed up $1.27, or 1.98%, to $65.31 in New York Stock Exchange trading.
Ceftobiprole is intended to treat complicated skin infections, such as abscesses, ulcers and diabetics' foot infections. In clinical trials, it appears effective at battling methicillin-resistant Staphylococcus aureus, or MRSA, a common source of hospital-acquired infections that has become a public-health concern in the U.S.
The FDA made approval of ceftobiprole conditional on inspection of study sites and review of clinical data received from the companies. The agency also wants more information about patients with diabetic foot infections, according to a Basilea statement. J&J said it is working with the FDA to address its concerns but had no estimate of the agency's timeline.