SERONO BELIEVES CRINONE® NOT YET READY FOR RE-LAUNCH
Serono S.A. has announced that its affiliate Ares Trading S.A. would not be reintroducing Crinone® 8% (progesterone gel) into the market at this time. Based upon an evaluation of product data currently available regarding Crinone® received from the manufacturer Columbia Laboratories and its own analysis of the product, Serono believes issues related to the recall of Crinone® in April have not yet been fully addressed.
At the time of the voluntary recall by Columbia Laboratories (AMEX: COB), it was determined that Crinone® could change its consistency over time, resulting in the gel being partially expelled when opening the product applicator prior to administration. Based upon Serono's testing of the new batches produced by Columbia Labs, the problem leading to the recall, i.e., the product being expelled from the applicator prior to administration, has not been fully corrected.
Serono disputes the statements made by Columbia Labs and regrets the unilateral decisions of Columbia Labs to release the new product batches despite reservations stated by Serono. Moreover, Serono believes Columbia Labs' counterclaims are not only baseless, but will confuse and delay the reintroduction of the product to the market. Serono will vigorously defend against these counterclaims.
Serono owns the worldwide marketing rights to Crinone®, is fully committed to the worldwide marketing of Crinone® and continues to make best efforts to resolve the issues with Columbia Labs in order to bring Crinone® back to market.
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