Roche delays taspoglutide submissions
Roche (SIX:ROG; OTCQX:RHHBY) said regulatory submissions for taspoglutide to treat Type II diabetes will be delayed by a minimum of 12-18 months after the pharma implemented a risk mitigation plan to address a higher than expected incidence of hypersensitivity reactions in Phase III trials. The news sent shares of partner Ipsen Group (Euronext:IPN) falling EUR 4.88 (15%) to EUR 27.08. Under the mitigation plan, Roche will routinely monitor patients for anti-drug antibodies (ADAs), which it said is potentially associated with the hypersensitivity reactions. Patients that develop pre-specified ADA levels will discontinue treatment.
Ipsen and Roche have reported data from six of the eight Phase III T-emerge trials of the glucagon-like peptide-1 (GLP-1) analog. In the most recent data reported in April, subcutaneous weekly taspoglutide plus metformin and Actos pioglitazone met the primary endpoint of superiority to placebo plus metformin and Actos in reducing HbA1c. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) markets Actos (See BioCentury Extra, Thursday, April 29, 2010). ...