• History
• Mission
• Strategy
• Organization
• Key Activities

Key Activities

Key achievements 2006

• Zymenex decided to prioritize the company's Research and Development on the recombinant enzyme, Metazym, for treatment of the Lysosomal Storage Disease, Metachromatic Leukodystrophy (MLD) and to discontinue clinical development in the area of Acute Intermittent Porphyria.
• The EU 6th framework supported "Hue-Man" group with the title "Development Of An Effective Enzyme Replacement Therapy For Human Alpha-Mannosidosis" was initiated in April. The group consists of laboratoires from Germany, France, UK, Czech, Norway and Denmark, with Zymenex as the sole participating industrial partner. One of the aims of the project is to establish a Natural History Study in patients to elucidate the progression of the disease and pinpoint relevant clinical endpoints to use in a future clinical trial.

Key achievements 2005

• The European Patent Office has notified Zymenex of the decision to grant Zymenex a European Patent on the "Production of rhPBGD". The patent covers the production method for Zymenex´lead product Porphozym, for the treatment of Acute Intermittent Porphyria. This patent has already been granted in Australia and South Africa.

Key achievements 2004

• Danish Venture Investors BankInvest and Vækstfonden have converted loans of €17.5 million into equity in the company, bringing Vækstfonden to join the group of Zymenex shareholders including BankInvest and the Danish pension fund PenSam
• Toxicology testing has been initiated for the company's second project targeting the lysosomal deficiency, Metachromatic Leucodystrophy
• Received a gracious grant of 400,000 Swedish Crowns from the Folke Littner Fund to help fund clinical trials in Sweden, with Zymenex' recombinant enzyme PBGD, in Acute Intermittent Porphyria patients suffering from acute AIP attacks
• Initiated new clinical trial sites in Sweden, Norway and Finland, for it's Phase IIb AIP clinical trials of the company's recombinant enzyme PBGD. Zymenex has Phase IIb AIP clinical trials ongoing in both US and Europe

Key achievements 2003

• Initiated the international clinical Phase IIb trial with PorphozymTM (rhPBGD) in USA for IV treatment of attacks of Acute Intermittent Porphyria
• Orphan Drug Designation from the EU Commission for the product 'Recombinant Human Arylsulphatase A' as a treatment of metachromatic leukodystrophy
• Zymenex has been granted a patent in USA for the treatment of Acute Intermittent Porphyria

Key achievements 2002

• Successfully completed clinical Phase I/IIa studies of rhPBGD for the IV treatment of Acute Intermittent Porphyria
• Orphan Drug Designation in the US for rhPBGD for the treatment of Acute Intermittent Porphyria
• Orphan Drug Designation for rhPBGD for Acute Intermittent Porphyria from the EU commission
• Approval of the company's patent in EU and South Africa for the treatment of Acute Intermittent Porphyria and other porphyric diseases
• Approval of the company's patent in Australia for the invention: 'Method for treating Acute Intermittent Porphyria and other porphyric diseases'

Key achievements 2001

• §8 approval by Danish Medicines Agency for cGMP pilot purification plant in Copenhagen, Denmark
• Production of first product for clinical trials of Acute Intermittent Porphyria
• Phase I/II clinical trials initiated for HemeBiotech´s first product for Acute Intermittent Porphyria
• Second and third project for rare genetic diseases moved into pre-clinical stage
• A fourth rare genetic disease project initiated
• Third Nordic Porphyria Symposium held in Stockholm, Sweden
• Successfully secured a new round of investment of 7.7 million euro (57 million dkk) to pursue the projects in the area of rare, genetic diseases

Key achievements 2000

• Scaled-up production process for first product for Acute Intermittent Porphyria established and product produced for initial toxicity trials
• First toxicity trials initiated for first product for Acute Intermittent Porphyria
• Second and third rare genetic disease projects initiated and moving through Discovery stage
• Investment in cGMP pilot purification plant in Copenhagen, Denmark
• Investment in new Cell Biology Laboratory at R&D facility on Lidingö, Sweden
• Second International Porphyria Symposium held in Bergen, Norway
• Successful securing of a new Danish Government Support loan of 3.2 million euro (23.5 million dkk) to pursue new projects in the rare, genetic disease, lysosomal deficiency area
• Implementation of Document Management System

Key achievements 1999

• First product in Porphyria for acute Intermittent Porphyria (AIP) moved into preclinical development and second and third products in rare diseases have been identified and are in Discovery Phase
• Establishment of R&D facilities on Lidingö
• Establishment of basic research collaboration on gene therapy with Karolinska Institute, Sweden
• Establishment of the Zymenex International Scientific Board
• First Zymenex Symposium on Porphyria held in Hillerød
• Implementation of company warrants program
• Raise of second round capital of 4.1 million euro (30 million dkk)