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Scil Proteins GmbH Obtains European Medicines Agency Approval for Commercial Production of Reteplase


10/22/2012 10:15:54 AM

Halle (Germany), 22 October 2012 - Scil Proteins Production GmbH, a private biotech company specializing in the research, development and production of recombinant proteins, announced today that the European Medicines Agency (EMA) has approved Scil Proteins’ Halle facilities for manufacturing of Reteplase, marketed by Actavis as Rapilysin®.

Scil Proteins originally signed an agreement with Roche in June 2008 for process transfer and manufacture of Reteplase and with this official EMA approval, Scil Proteins has successfully completed the site change from Roche. Reteplase is a recombinant protein for thrombolytic treatment of myocardial infarction.

Dr. Ulrike Fiedler, CEO of Scil Proteins, commented: “Our focus on quality enabled our experienced team of protein specialists to readily manage the manufacturing challenges of this complex biotherapeutic. We have the proven expertise and capacity to allow us to produce a number of advanced biotherapeutics and this EMA approval for our Halle facility is an important milestone for Scil Proteins.”

In addition to this agreement with Actavis, Scil Proteins has a diversified portfolio of contract development and manufacturing clients. To date, customers include Novartis, Sanofi, Dompé, Lundbeck, as well as other pharma and biotech companies.

About Scil Proteins

Scil Proteins is a biopharmaceutical company working with industry partners in the development and manufacture of protein therapeutics and diagnostics as well as discovering and developing proprietary Affilin® molecules. The Company has a longstanding expertise in protein production and development and offers GMP contract biomanufacturing and process development to biotech and pharma companies. With state of the art equipment and a particular expertise at refolding proteins, Scil Proteins has an excellent track record in supplying a top level support for its partners. Scil Proteins has supported a number of different companies in process development and biomanufacturing. Scil Proteins also has a discovery platform that is a fully patent protected screening technology for the identification of target-specific Affilin® molecules using advanced selection systems. Affilin® molecules are therapeutics and diagnostics based on a scaffold derived from the human protein Ubiquitin to form highly stable molecules with strong binding specificity and low immunogenicity. Scil Proteins has generated a pipeline of Affilin® therapeutics targeting cancer. Scil Proteins is a well-established private company located in Halle, Germany. To learn more about Scil Proteins, please visit www.scilproteins.com.

Contact

Dr. Ulrike Fiedler

CEO

Scil Proteins Production GmbH

t: +49 (0) 345 27 99 63 30

e: info@scilproteins.com

Dr. Robert Mayer

Account Director

College Hill Life Science

t: +49 (0) 89 52 38 8030

e: scilproteins@collegehill.com



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