Helsinn Birex plant in Ireland gets authorization

Switzerland-based Helsinn says that its drug product manufacturing facility in Dublin, Ireland, Helsinn Birex Pharmaceuticals, has recently obtained an authorization for Manufacture of Investigational Medicinal Products for products for human use from the Irish Medicines Board according to European Union Directive 2001/20/EC.

The IMP licence enables Helsinn Birex to package, test, store and release material for use in clinical trials and is a significant development for the company and the group, says the firm. "Having this authorization expands the range of development activities we can manage within the company and can offer as a service to our partners and confirms again the company's advanced quality systems and technical capabilities," says chief operations officer Giorgio Calderari. Since 2007 the company has invested in packaging and labeling equipment and facilities to enable it to do both primary and secondary work on such products. In future, these activities can be managed directly by Helsinn thus ensuring better cost control and ability to react to last minute changes which can often arise with development projects.

The first packaging run has been completed for a study involving the group's lead compound palonosetron (trade named Aloxi and Onicit ). Obtaining the IMP licence, follows on from the successful inspection of Helsinn Birex by the US Food and Drug Administration earlier this year, the firm notes.