Immunsystem enter into a Contract Manufacturing Agreement with Unitech Pharma

Unitech Pharma AB has entered a contract manufacturing agreement with the Uppsala-based company Immunsystem for the drug product manufacturing of Anti-Pseudomonas IgY. In a couple of months Immunsystem will start a phase III study for treatment of cystic fibrosis (CF) patients. The study includes centers from several European countries and is planned to run for up to 4 years.  This is the last major step before the drug candidate can be filed for marketing authorization. Immunsystem´s IgY method, using antibodies from hen’s eggs, is a highly interesting alternative to antibiotics. “It is very stimulating to manufacture material for this clinical trial, which can have major advance for the patient if succeeded”, says Annette Elmqvist CEO at Unitechpharma.

Cystic fibrosis (CF) is a hereditary disorder with repeated respiratory infections and malnutrition as main clinical manifestations. Nearly all CF patients are affected by infections in the lungs by the bacteria Pseudomonas aeruginosa. To date, the only treatment has been repeated courses of antibiotics.

Anti-Pseudomonas IgY has previously been granted an Orphan Drug Designation by the European Medicines Agency (EMA) for the treatment of CF.

About Unitech Pharma AB
Unitech Pharma, has more than 20 years experience in bioproduction and provides contract manufacturing services for products used in clinical trials and for commercial sale. Unitech Pharma has invested in a state-of-the-art, flexible bioproduction and fill and finish facility licensed by EMEA. In the pharmaceutical area, medicines are filled in single-use syringes or injection vials; freeze dried – all while meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures. Unitech Pharma can offer customers a truly full-service solution for pharmaceutical manufacture, from process development and bioproduction to fill & finish of commercial products.

For more information, please contact:
Annette Elmqvist, CEO, Unitech Biopharma AB
Phone: +46 (0) 701 851 223, E-mail: annette.elmqvist@unitechbiopharma.se