ACAMBIS RECEIVES RESPONSE TO BLA FOR ACAM2000 SMALLPOX VACCINE

Acambis announced it has received a complete response letter from the FDA for its biologics license application (BLA) for its ACAM2000 cell-culture smallpox vaccine.

The FDA is requesting additional information that it requires to complete its review of the BLA, which the company submitted in April 2006. Acambis is consulting with the FDA and preparing its response, which it intends to submit as soon as possible. The upcoming Vaccines and Related Biological Products Advisory Committee meeting will be rescheduled to enable the committee to review the additional information, according to the company

"Throughout the review process to date, our discussions with the FDA have been positive and constructive, and we intend to respond fully to the agency as soon as possible," Gordon Cameron, CEO of Acambis, said. "Although licensure is a precursor to securing the formal long-term warm-base manufacturing contract for ACAM2000, in preparation for that we recently delivered a further 10 million-dose order, worth $30 million, to the [Centers for Disease Control and Prevention], making a total of 192 million doses delivered to date. We remain confident that we will be able to finalize and commence the warm-base manufacturing contract during 2007."

In November 2006 the company was informed that it is no longer being considered for a contract to supply its modified vaccinia ankara (MVA) smallpox vaccine, MVA3000. Acambis requested a meeting with the HHS to discuss its rationale for excluding the company from the MVA smallpox vaccine tender process.