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

Language:

 

English

Company:

Girindus AG 51427

Buchenallee 20

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

Girindus AG
Name: Markus Georgi
Tel: +49 2204 / 926 900
Email: mgeorgi@girindus.com