Schering voluntarily recalled Ultravist injection 370mgI/ml, its X-ray contrast agent, due to the risk that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of Ultravist.
While Schering is investigating the situation it is taking precautionary action and removing the concerned lots of this product.
In a second blow, Schering announced disappointing results from a phase III induction trial of sargramostim in Crohn’s disease. Results from the trial suggested a treatment benefit but failed to demonstrate superiority in the two primary endpoints of response and/or remission at eight weeks compared to placebo.
However, primary and secondary endpoints were met in another study with sargramostim. This phase II trial demonstrated that sargramostim was significantly more effective than placebo for induction of corticosteroid-free clinical remission in steroid-dependent Crohn’s disease patients.
Regarding Schering’s takeover by Bayer, the companies revealed that the executive board of Schering has decided to accept Bayer’s offer and, subject to approval of Schering’s supervisory board, to enter into the domination and profit and loss transfer agreement.