US biotech cleared for drug delivery deal

Related tags Heroin Opioid

US biotechnology company Cephalon says that the US Federal Trade
Commission has approved its $385 million acquisition of CIMA Labs,
nearly a year after it outbid aaiPharma for the drug delivery

The companies expect the transaction to close within the next few days.

Cephalon is particularly keen to get its hands on one of CIMA's late-stage products called OraVescent Fentanyl. This fast-melt formulation of the widely-used opioid analgesic will complement Cephalon's own Actiq (oral transmucosal fentanyl citrate) and allow it to extend its pain care franchise when the product's patent protection expires.

OraVescent fentanyl is currently in Phase III clinical trials for the treatment of breakthrough cancer pain, and Cephalon is targeting approval of this product by the US Food and Drug Administration for late 2006.

Analysts estimate that CIMA is the biggest player in the US market for fast-dissolve drugs, which has grown from around $400 million (€326m) in domestic sales in 2000 to about $800 million this year and $1.4 billion by 2005. This reflects a switch in the perception of these dosage forms as being suitable for a broad range of products, rather than just those aimed at the elderly or young children.

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