Isofol Medical and Merck & Cie enter into a Contract Manufacturing Agreement with Unitech Pharma

Unitech Pharma AB today announced that the company has entered into a contract manufacturing agreement with Isofol Medical AB and Merck & Cie for the drug product manufacturing of the novel folate-based investigational drug product Modufolin^®. Isofol Medical will initiate clinical trials on Modufolin^® in 2011, initially in an already approved combined phase I/IIa trial on neoadjuvant rectal cancer patients.

Unitech Pharma will manufacture Modufolin^® injection vials using its novel and highly advanced manufacturing facilities in Matfors, Sweden. Unitech Pharma was selected as service provider for its excellent suitability and capacity for drug product manufacturing of injectable pharmaceuticals, including freeze drying, for clinical trial purposes.

Modufolin^® is a novel, naturally occurring reduced folate with the potential to increase the efficacy and reduce the side effects of a large number of cytotoxic pharmaceuticals. Merck.&.Cie is the inventor and manufacturer of the Modufolin^® drug substance. An exclusive global research collaboration agreement was established in 2009 between Isofol Medical and Merck & Cie.

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

About Isofol Medical AB
Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss partner Merck & Cie. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.  

For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB
Phone: +46 (0) 707 646 500, E-mail: anders.rabbe@isofolmedical.com 

About Merck & Cie
Merck & Cie, Switzerland, is a wholly owned subsidiary of Merck KGaA located in Darmstadt, Germany, and belongs to the newly created Merck Millipore division of Merck Chemicals. Merck & Cie is a centre of excellence for folates in the pharmaceutical and nutritional field and the world’s leading supplier of reduced folates. In addition Merck & Cie produces active pharmaceutical ingredients, media for the biochromatography, and is specialized in the development and production of high quality drug delivery compounds. Find more information at www.merck-schaffhausen.ch.

For more information, please contact:
Dr. Rudolf Moser, Scientific Director, Merck & Cie
Phone: +41 (0) 52 6307 215, E-mail: rudolf.moser@merckgroup.com

Modufolin® is a registered trademark of Merck KGaA, Darmstadt, Germany