IDEA AG starts Phase III study with IDEA-033 for treatment of peripheral pain

Munich, Germany – September 2004. IDEA AG announces the start of a phase III open label study testing IDEA-033, a targeted analgesic and anti-inflammatory product.

The objectives of this study are to evaluate the safety, efficacy, and compliance of IDEA-033 applied on the skin for the treatment of joint and musculoskeletal pain, as well as soft tissue inflammation. The multi-centre study will enrol up to 400 subjects focusing on patients with a diagnosis of osteoarthritis of the knee. Patients will be treated for up to 18 months to provide information about the safety and efficacy of long-term usage in situations where chronic treatment with analgesic and anti-inflammatory products is required. The study will also provide information about the product’s impact on Quality of Life.

IDEA-033 employs ultra-deformable carriers (TransfersomesÒ ) to penetrate the skin driven by the local water gradient. The Transfersomes® remain intact during this process and transport the carrier-associated drug into the peripheral target tissues below the application site. In addition, local clearance through the cutaneous microcirculation is avoided, which allows the drug to be delivered deep into the muscles or joints. IDEA-033 therefore greatly increases the ratio of target tissue to systemic drug concentration when compared with other analgesic products, which inherently improves the drug safety profile. Support for this conclusion can be drawn from the successful recently completed Phase III (EU) / II (US) clinical study, which compared IDEA’s product to placebo and an oral formulation of a market leader product.

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For further information, please contact:

IDEA AG Tel: +49 89 324 63 30

Matthias Rother MD PhD, Head Research & Clinical Development

Evert Küppers MSc., MBA, Head of Business Development

Notes to the editors:

IDEA AG is a privately held biopharmaceutical company with headquarters in Munich, Germany. IDEA develops and commercialises non-invasive, targeted therapeutics based on stable, ultra-deformable carriers that are typically applied on the skin. These proprietary carriers are driven through the skin barrier by the local water gradient and can be engineered to achieve a high, localised drug concentration at the site of application and deep below. This method of application can diminish the local or systemic adverse side effects of a drug, and often increase its potency. To date, 44 patents from 8 patent families have been granted to the Company to protect its technology.

The Company’s leading products are in the area of dermatology and pain, and have excellent market potential. The targeted analgesic product IDEA-033, with blockbuster potential, has recently completed a Ph III (EU) / Ph II (US) clinical study. The North American marketing rights for this product have been out-licensed to one of the world’s largest pharmaceutical corporations. IDEA’s pipeline also includes two therapeutics (one in Ph II, for skin pain and inflammation, and one in Ph I, with efficacy data for a dermatological indication) and two pre-clinical stage dermatological products. In-house capabilities range from formulation development and small-scale (GMP) manufacturing work to clinical testing.

 
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