MediGene Initiates a Clinical Phase IIa Trial of RhuDex® in Rheumatoid Arthritis

• First patient treated January 2007
• Results expected in the last six months of 2007
• Phase II study planned for 2008

Martinsried/Munich, January 23, 2007. Today the biotech company MediGene (Frankfurt, Prime Standard: MDG) announced the initiation of a clinical phase IIa trial of the drug candidate RhuDex® for the treatment of rheumatoid arthritis. The first patient has already received treatment. The placebo-controlled trial is intended to evaluate the compound’s tolerability and to determine the appropriate dosage for a phase II trial to follow. The trial results are expected in the last half of 2007. Upon completion of this trial, which will include 35 patients, a phase II trial with more than 200 patients is scheduled, starting in 2008.
RhuDex® is a novel, orally available T cell co-stimulation modulator for the treatment of rheumatoid arthritis. By specifically blocking T-cell activation it reduces the release of inflammatory cytokines involved in this autoimmune disease. RhuDex® was added to the clinical portfolio as part of the acquisition of Avidex by MediGene last year.
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: “We are extremely pleased to be entering this phase in the development of RhuDex®. We believe RhuDex® has significant potential for the treatment of rheumatoid arthritis as not only does it intervene at the early stage of the disease process but is also orally available”. He added, “With the start of this clinical study we have reached a very important milestone on the road to opening up the market potential of this drug candidate. RhuDex® represents a major asset for MediGene.”
RhuDex® is MediGene’s third drug candidate besides EndoTAGTM-1 and NV1020 that is currently in phase II of clinical development. These drug candidates are targeted on indications of high medical need and have large market potential. In addition to the marketable products Eligard®, Oracea®, and Polyphenon E® Ointment, MediGene has a broad development pipeline and is in a strong position to take other innovative drugs through the development process.
RhuDex®: RhuDex® has been developed as an orally available, disease-modifying agent against rheumatoid arthritis. It inhibitions T cell activation by specifically blocking co-stimulation via CD80 interaction. As an oral inhibitor of this well-validated target, RhuDex® offers a clear competitive advantage. The drug candidate has successfully completed two clinical phase I trials in healthy subjects. MediGene estimates the annual peak sales potential of RhuDex® at more than 1.5 billion Euros. The initial program leading to the isolation of RhuDex® has been licensed from Active Biotech AB in Lund, Sweden.
Rheumatoid arthritis: Rheumatoid arthritis a chronic, systemic disease of the connective tissue which affects more than 1 % of the world population. It mainly attacks the joints and leads to deformity and loss of function. Two to three times as many women than men are affected by rheumatoid arthritis. The disease occurs at any age, most often, however, it starts between age thirty and fifty. The symptom intensity varies: in most cases swelling, pain, loss of function, often stiffness of the joints affected.
Traditional treatments for RA consist of fast acting, oral, first-line drugs, which include non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, and slow acting ‘second line’ drugs known as disease modifying antirheumatic drugs (DMARDs). However, over time irreversible joint destruction and disease progression still take place. Long term treatment can also cause unwanted side effects and toxicity. More recently, antibody based products to block inflammatory cytokines such as tumour necrosis factor (TNF), have come onto the market, but these have to be given parenterally.
Trial design and objectives: The trial initiated is a multicenter, randomized, placebo-controlled, double-blind dose-escalating trial. Five groups of seven patients each suffering from severe rheumatoid arthritis are to be accepted successively. Five patients in each group will receive RhuDex®, the other two will receive placebo. In addition, all patients will receive standard treatment with methotrexate. The patients receive RhuDex® or placebo for 14 days, followed by one week of observation. The primary objective of the trial is to obtain data on safety and pharmacokinetics of RhuDex®. In addition, clinical parameters will be collected, such as the CRP level, which is a biomarker for disease activity.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. EndoTAGTM-1, RhuDex® and the MediGeneTM Logo are trademarks of MediGene AG, Polyphenon E® is a trademark of Mitsui Norin, Oracea® is a trademark of CollaGenex, Inc.
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MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. A second drug, Polyphenon® E Ointment, has been approved by the FDA. A third drug, OraceaTM for the treatment of Rosacea, was recently inlicensed from the US pharma company CollaGenex to market this drug in Europe. In addition, several drug candidates are currently in clinical development. RhuDex®, NV1020 and EndoTag™ are in phase II clinical trial. MediGene also possesses innovative platform technologies. The company’s core competence lies in research and development of novel approaches in anti cancer therapies. Thus MediGene focuses on indications of high medical need and great economic opportunities.

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