Martinsried/Munich, October 28, 2011. MediGene AG (Frankfurt: MDG, Prime Standard) announced today that the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted the authorization of the planned clinical formulation study of RhuDex®, a drug candidate being developed for the treatment of rheumatoid arthritis. The objective of the RapidFACTTM trial (Rapid Formulation Development and Clinical Testing) is to determine an optimized formulation for chronic treatment. Upon the initiation of the planned study, MediGene will provide additional details on the design and duration of the trial.
Dr. Frank Mathias, MediGene's CEO, commented: "Preliminary formulations of RhuDex® permitted initial clinical trials of the drug candidate. For the long-term development and subsequent marketability of the product, however, we seek an improved formulation and dosage form of RhuDex® to facilitate a therapeutically ideal release of the active ingredient as well as patient-friendly dosing. We are delighted to be able to continue the clinical development of RhuDex® with an optimized product candidate."
RhuDex®: RhuDex® is an oral therapy being developed as a disease-modifying drug for the treatment of rheumatoid arthritis targeting the successful group of Disease-Modifying Antirheumatic Drugs (DMARDs). RhuDex® is an orally administered CD80 antagonist that blocks undesired activation of T-cells and has an immunomodulating and anti-inflammatory effects. In a Phase IIa trial in 29 patients, RhuDex® demonstrated first indications of biological activity.
This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the forward-looking statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene® and RhuDex® are registered trademarks of MediGene AG. These trademarks may be owned or licensed in select locations only.
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MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered in Martinsried/Munich, Germany. MediGene is the first German biotech company to have revenues from marketed products. It has various drug candidates in clinical development and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases.
Contact MediGene AG
Julia Hofmann, Kerstin Langlotz
Investor & Public Relations
Tel.: +49 - 89 - 85 65 - 33 01
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