GLYCOTOPE Moves FSH-GEX™ into Phase-II Clinical Development

Berlin, Germany, June 08, 2012 / B3C newswire/ ­ After successful completion of Phase I, the German biotech company GLYCOTOPE moves its glycooptimized therapeutic protein FSH-GEXinto Phase II of clinical development in In-Vitro-Fertilisation.

FSH-GEX is based on Glycotope's unique and proprietary GlycoExpressplatform of glycooptimized human cell lines. The follicle-stimulating hormone FSH-GEX is produced recombinantly with a fully human and optimized glycolysation. Phase I studies of FSH-GEX (single dose escalation, multiple dose escalation) have been successfully completed, showing no toxicity and providing in a direct head-to-head comparison strong signals for highly improved efficacy vs. marketed urinary and recombinant products.

The current market value of FSH treatment of female infertility is USD 1.7 billion, reflecting the high medical need in this therapeutic area.

We continue to deliver states Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. Beside our ongoing clinical antibody programs with PankoMab , CetuGEX and TrasGEX , we have now a strong clinical proof of concept for our unique GlycoExpress platform in non-antibodies, further underlining the substantial medical and commercial potential of our proprietary technology². Dr. Franzpeter Bracht, CFO & CBO adds: This is another milestone reached for Glycotope, demonstrating our capability to build a strong and competitive product portfolio, offering the opportunity for substantial value for patients and our business partners.

About Glycotope

GLYCOTOPE, founded in 2001 in Berlin, focuses on the development of innovative antibodies for the treatment of various cancer types, targeting glycostructures on cell surfaces. In addition, Glycotope develops so-called BioBetters, recombinant biopharmaceuticals with optimized and fully human sugar structures (via glycolysation), leading to improved efficacy, reduced immunogenicity and correspondingly improved patient outcome. The company¹s technologies will also enable a broadening of eligible patient populations and indications as well as improved cost-effectiveness. Glycotope currently has four products in clinical development stage. The company¹s additional pipeline includes preclinical proteins for various indications.

Together with Glycotope-Biotechnology in Heidelberg, Glycotope evolved into a leading integrated glycobiology company, covering all phases in preclinical and clinical drug development and GMP production. With more than 150 employees and a strong and broad IP-platform, Glycotope has grown to one of the largest Biotech companies in Germany.


Glycotope GmbH
Dr. Franzpeter Bracht, CFO & CBO
Robert-Roessle-Str. 10
D-13125 Berlin
Phone: +49-(0)30 94 89-2600
Fax: +49-(0)30 94 89-2609
Email: [email protected]