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Thursday 11 December, 2008

Helsinn Healthcare SA

Helsinn Birex Pharmaceuticals Receives IMP Lice...

LUGANO, Switzerland, December 11 /PRNewswire/ --     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(R), ONICIT(R)). Obtaining the IMP
licence, follows on from the very successful inspection of Helsinn Birex
Pharmaceuticals by the US FDA earlier this year.


    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 Helsinn distribution. Helsinn Healthcare's key products in
the US are Aloxi(R) (palonosetron), distributed by Eisai Inc.,
USA, and Gelclair(R). 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

    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(0)1-822-54-04
    E-Mail: [email protected]
    E-Mail: [email protected]


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