Date: 2015-10-08
Type of information: Licensing agreement
Compound: human blood coagulation factors
Company: Glycotope (Germany) Octapharma (Switzerland)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: licensing
Action mechanism: protein/coagulation factor
Disease: hemophilia
Details: * On October 8, 2015, Glycotope GmbH, a global leader in glyco-optimization of biopharmaceuticals, and Octapharma AG, one of the worldwide largest human protein product manufacturers, announced that they have entered into an exclusive worldwide licensing agreement for Glycotope\'s portfolio of preclinical human blood coagulation factors based on its unique and proprietary GlycoExpress™ (GEX™) technology platform. Glycotope\'s GEX™ platform comprises a comprehensive portfolio of proprietary glyco-engineered human suspension cell lines, which allow for the production of complex proteins with fully human and tailored glycosylation patterns. With the combined advantages of optimized sialylation, galactosylation, fucosylation, branching and lack of non-human sugar structures, GEX™ products deliver improved bioactivity, stability, serum half-life and immunogenicity of biopharmaceuticals. Glycotope has demonstrated with three different antibodies in advanced stage clinical development that cost efficient production with unmet quality is achieved through a proprietary perfusion process with outstanding productivity of 10-20 g/L bioreactor volume and up to 0.8 g/L per day. To date, more than 40 GMP production runs have been performed, showing unique reproducibility with no measurable differences between batches, batch sizes, process strategies, scales and production sites, all of which guarantees flexible production. The GEX™ platform has been approved by several regulatory authorities for clinical use (including EMA, FDA). Under the terms of the agreement, Octapharma will gain exclusive worldwide rights to research, develop and commercialize candidates from Glycotope\'s preclinical human blood coagulation factor portfolio based on Glycotope\'s proprietary GlycoExpress™ platform. Octapharma will be responsible for all research and development costs and will pursue major activities within the clinical development by its own development organization.
Financial terms: In addition, Octapharma will take a stake in the Company by purchasing new Glycotope shares generated through a capital increase at a premium price. Under this agreement, Glycotope receives an initial payment of € 80 million from Octapharma. Glycotope will receive an upfront payment and is eligible for substantial research and manufacturing related revenues during the life of the agreement for a series of products. In addition, Glycotope will receive further development and sales related milestone payments and royalties for a defined number of projects.
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