CIMA Labs, which is set to be acquired by fellow US firm Cephalon in a $515 million (€449m) transaction, has licensed its OraVescent formulation of fentanyl for breakthrough cancer pain to Japan's Taiho Pharmaceutical.
Under this agreement, Taiho gains exclusive rights to the product in Japan, while CIMA will receive development and milestone payments as well as revenue from sales of the product to Taiho and royalty payments based on commercial sales volume. The product is due for launch in its first markets in 2005 or early 2006.
The license covers both the sublingual and buccal formulations of fentanyl developed using the OraVescent technology.
Steven Ratoff, CIMA's chairman and interim chief executive, noted that this is the first licensing agreement the company has signed for a product in its proprietary pipeline.
Analysts estimate that CIMA is the biggest player in the US market for fast-dissolve drugs, which has grown from around $400 million 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.