11.12.2008 – 08:00
Helsinn Birex Pharmaceuticals receives IMP Licence for storage and packaging of Clinical Trial Materials
Lugano, Switzerland (ots)
Helsinn is delighted to announce that its drug product manufacturing facility in Dublin, Ireland, Helsinn Birex Pharmaceuticals, has recently obtained an authorisation for Manufacture of Investigational Medicinal Products (IMP) for products for human use from the Irish Medicines Board according to EU Directive 2001/20/EC.
The IMP licence enables Helsinn Birex Pharmaceuticals to package, test, store and release of material for use in clinical trials and is a significant development for the company and the Helsinn Group. "Having this authorisation 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 Helsinn's Chief Operations Officer, Dr Giorgio Calderari. Since 2007 the company has invested in packaging and labelling equipment and facilities to enable it to do both primary and secondary packaging of such products. In the 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 Groups lead compound Palonosetron (ALOXI®, ONICIT®). Obtaining the IMP licence, follows on from the very successful inspection of Helsinn Birex Pharmaceuticals by the US FDA earlier this year.
About HELSINN HEALTHCARE
Helsinn Healthcare is a privately owned pharmaceutical group with headquarters in Switzerland. Helsinn Healthcare's core business is the licensing of pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain and inflammation, gastrointestinal). The company's business strategy is to in-license early-stage new chemical entities and to complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). Helsinn Healthcare's products are eventually out-licensed to its worldwide consolidated network of partners for distribution. Helsinn Healthcare's key products in the US are Aloxi® (palonosetron), distributed by Eisai Inc., USA, and Gelclair®. The active pharmaceutical ingredients and the drug products are manufactured at Helsinn Healthcare's cGMP facilities and supplied worldwide to its customers. Helsinn Healthcare's chemical business focuses on the pharmaceutical chemical process development and manufacturing of advanced intermediates, Active Pharmaceutical Ingredients (APIs) and High Potency Active Ingredients (HPAIs) for both the Helsinn group and its outsourcing partners.
For more information about Helsinn Healthcare, please visit www.helsinn.com
ots Originaltext: Helsinn Healthcare SA
Helsinn Birex Pharmaceuticals Ltd and Helsinn Chemicals Ireland Ltd:
Padraig Somers, General Manager
Irish Plants, Helsinn Birex Pharmaceuticals Ltd and
Helsinn Chemicals Ireland Ltd