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Helsinn Healthcare SA

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

Contact:

Helsinn Birex Pharmaceuticals Ltd and Helsinn Chemicals Ireland Ltd:
Padraig Somers, General Manager
Irish Plants, Helsinn Birex Pharmaceuticals Ltd and
Helsinn Chemicals Ireland Ltd
Phone: +353/1/822-54-04
E-Mail: info-HBP@helsinn.com
E-Mail: manufacturing@helsinn.com
Internet: www.helsinn.com

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Plus de actualités: Helsinn Healthcare SA