Partners

Participant 2

Zymenex

Partner 2:
Zymenex A/S, Clinical Operations, Roskildevej 12 C, DK-3400 Hillerød, Denmark

Key skills:
Research and development of pharmaceutical products for the treatment of rare, genetic diseases especially lysosomal storage disorders.

Laboratory background and technical information:
Zymenex A/S is a Scandinavian biopharmaceutical company with headquarters in Hillerød north of Copenhagen, Denmark and research laboratories in Stockholm, Sweden. The company is focused on research and development of pharmaceutical products for the treatment of rare, genetic diseases, for which there is no treatment today. The Zymenex pipeline includes the recombinant enzyme, Lamazym, for the treatment of the lysosomal disease alpha-Mannosidosis as well as Galaczym for Globoid Cell Leukodystrophy (Krabbe Disease). Lamazym has received Orphan Drug Designation in both Europe and the US. All project contract collaborations are strictly managed and controlled by Zymenex using in-house know-how in project management and pharmaceutical development. In order to conduct the clinical trials for the company’s enzyme products, Zymenex has established a clinical trials unit within the company. Close contact has been  established with international regulatory bodies to expedite the  development of projects to the market. The company has consolidated in-house expertise within Operations and Quality to efficiently manage the continued pharmaceutical production for clinical trials and launch.

Capacity to contribute to the project:
Partner 2 has a longstanding expertise in clinical development and has been involved in several clinical trials on rare diseases using ERT. Duties in the ALPHA-MAN project will be participation in WP1 (project management/coordination and in WP3 (preparation of protocols with interaction from clinicians) and interaction with participants in WP 4, 5, 6, 8, 9 and 10 as well as interaction with relevant Authorities.

Personnel involved:

• Jens Fogh (DVM, M): Company President: Jens Fogh, CEO of the company, is experienced in Clinical Development with focus on rare diseases, Protein Production, International Marketing and Contract Negotiations as well as International Regulatory Affairs. He will be involved in coordination and management of industrial and clinical actvities and will be part of the PMT and CTB.
• Pia Ringholm (MSc Pharm, F): Qualtiy Director and is experienced in Protein Production, Contract Negotiations as well as Quality Assurance and International Regulatory Affairs and will be involved in industrial management and will be part of the PMT.
• Susanne Rodholm (RN, F): Both a Registered Nurse and a Clinical Research Associate. She will be involved in monitoring clinical trials according to ICH-GCP.

Key Publications:

1. Matzner, U., Lüllmann-Rauch, R., Stroobants, S., Andersson, C., Weigelt, C., Eistrup, C., Fogh, J., D’Hooge, R. and Gieselmann, V. Enzyme replacement improves ataxic gait and central nervous system histopathology in a mouse model of metachromatic leukodystrophy. Molecular Therapy, April 2009, vol. 17, no. 4, 600-606.
2. Blanz, J., Stroobants, S., Lüllmann-Rauch, R., Morelle, W., Lüdemann, M., D’Hooge, R., Reuterwall, H., Michalski, J.C.., Fogh, J., Andersson, C. and Saftig, P. : Reversal of Peripheral and Cenral Neural Storage and Ataxia after Recombinant Enzyme Replacement Therapy in Mannosidosis Mice; Human Molecular Genetics, 2008, Vol. 17, No. 22: 3437–3445
3. Matzner, U., Matthes, F., Weigelt, C., Andersson, C., Eistrup, C., Fogh, J. and Gieselmann, V.
   Non-inhibitory antibodies impede lysosomal storage reduction during enzyme replacement therapy of a lyssosomal storage disease. Journal of Molecular Medicine, March 2008, 86:433-442.
4. Matzner, U., Matthes, F., Herbst, E., Lüllmann-Rauch, R.,Callaerts-Vegh, Z.,D’Hooge, R., Weigelt, C., Eistrup, C., Fogh, J. and Gieselmann, V. Induction of tolerance to human arylsulfatase A in a mouse model of metachromatic leukodystrophy, Molecular Medicine, September-October 2007, 13 (9-10); 1-9.
   

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