DGAP-News: Girindus AG: Girindus Wins Contract for Process Validation of an Oligonucleotide Orphan Drug


Girindus AG / Contract

05.07.2010 15:19 

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Bergisch Gladbach / Cincinnati, July 5, 2010. Girindus announced today that
it has won a contract to begin work on validation of a manufacturing
process for an oligonucleotide product currently in Phase III clinical
trials. The product is a single strand phosphorothioate compound, which has
received Orphan Drug designation and is destined for fast-track
development.

This is the second process validation program to be initiated by Girindus
in 2010, following a program begun in January for a small molecule product
being developed for an in vivo imaging application. Both validation
projects are being carried out at the FDA-inspected facility of Girindus
America Inc. in Cincinnati, Ohio.

Commenting on these achievements, Martin Weiland, Speaker of the Management
Board of Girindus AG, said, 'The awarding of these two contracts are
significant steps in our commercial development strategy. They are clear
demonstrations that our decision to build a strong team of leading
professionals in quality systems and pharmaceutical manufacturing has
convinced customers of our capability in the area of process validation,
and about the excellent competencies of the new team we have assembled
during the last 15 months.'

In order to support the validation efforts of the team, Girindus is also
pleased to announce that it has engaged Dr. Mark Guzman as its Validation
Consultant. Dr. Guzman has worked previously with Pfizer and with Dynavax,
where he played pivotal roles in the validation of manufacturing processes
for complex oligonucleotide products.



Contact:
Markus Georgi
Investor Relations & Public Relations
Girindus AG, 51427 Bergisch Gladbach
T: +49 (0)2204 - 926 900
F: +49 (0)2204 - 926 990
mgeorgi@girindus.com




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Language:     English
Company:      Girindus AG
              Buchenallee 20
              51427 Bergisch Gladbach
              Deutschland
Phone:        +49 2204 / 926 900
Fax:          +49 2204 / 926 990
E-mail:       mgeorgi@girindus.com
Internet:     www.girindus.com
ISIN:         DE0005880405
WKN:          588040
Listed:       Regulierter Markt in Frankfurt (General Standard);
              Freiverkehr in Berlin, München, Düsseldorf, Stuttgart,
              Hamburg
 
End of News                                     DGAP News-Service
 
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