IDEA-070 SHOWS EXCELLENT EFFICACY IN THE TREATMENT OF SKIN BURNS

Munich, Germany - May 2004. IDEA AG announced the positive outcome of a clinical study testing the efficacy and safety of IDEA-070, an innovative, targeted, dermatological product for the treatment of painful and inflammatory skin reactions that can be induced by different challenges, such as sunburn.

The confirmatory, single-centre clinical study took place in Germany and had a randomised, double-blind, placebo and active controlled format. The primary objective was to compare the effects of IDEA-070 with placebo on UVB-induced skin inflammation in 37 healthy volunteers. The measure of this study was the threshold to heat-induced local pain following specified UVB irradiation. Further objectives included a comparison with an equal volume of a commercial product containing hydrocortisone-21-acetate (HC), the testing of two lower doses of IDEA-070, and an evaluation of different application regimes; either immediately after UVB irradiation or with a delay in treatment. In addition, the effects of different treatments on the irradiated-site erythema were assessed by clinical scoring.

IDEA-070 showed clear statistical significance on the primary objective. The suppression of heat-induced skin pain was significantly greater for IDEA-070 compared with placebo (p < 0.005), untreated control (p < 0.01), and HC
(p < 0.005), when the test formulation was applied immediately after UVB irradiation. In the more practical situation of a delayed treatment after irradiation, IDEA-070 was also significantly superior to placebo, untreated control, and HC (all p < 0.0001). In contrast to placebo, untreated control, and HC, IDEA-070 suppressed UVB irradiation induced skin erythema with a high statistical significance at all tested doses and irrespective of whether the product was applied immediately after an irradiation (p < 0.0001), or with a delayed treatment (p < 0.001). IDEA-070 had a good safety profile with no evidence of dermal intolerance.

Study consultant Prof. Dr. Schmelz of the University of Heidelberg, Germany, an expert regarding pain therapies, commented: "This innovative product, IDEA-070, has the full potential to dramatically improve the treatment of skin burn associated pain, which currently lacks an effective approach, especially for delayed topical treatment. In light of the good anti-inflammatory efficacy of IDEA-070, its possible use in corticosteroid-saving therapies looks promising."

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For further information, please contact:

IDEA AG Tel: +49 89 324 63 30
Matthias Rother MD PhD, Executive Board, Head of Research and Clinical Development
Evert Küppers MSc. MBA, Head of Business Development


Notes to the editors:

IDEA AG: IDEA is a privately held biopharmaceutical company with headquarters in Munich, Germany. IDEA develops and commercialise non-invasive, targeted therapeutics, applied through the skin and/or nose. The proprietary carriers are typically applied on skin and can be engineered to achieve high drug concentration at or near the site of application, diminish local or systemic adverse side effects, and often increase drug potency. Nearly 30 patents from 8 patent families protect the core technology.

The Company's leading products are in the area of dermatology and pain. IDEA-033, with excellent market potential, is currently in Ph II (US) / Ph III (EU). IDEA has partnered this targeted analgesic product with one of the largest US pharmaceutical corporations for peripheral pain treatment. IDEA's further pipeline includes two therapeutics (one in Ph II, one in Ph I with efficacy data) and two earlier stage der-matological products. In-house capabilities range from formulation and small-scale (GMP) manu-facturing work up to clinical testing.

IDEA's key investors are 3i (UK), MPM Capital (US) and TechnoStart (G).

Background information:

IDEA-070

IDEA-070 contains an analgesic drug that acts by inhibiting both cyclooxygenase (COX-1 and COX-2) as well as lipoxygenase activity; the product candidate therefore can reduce prostaglandin and leukotriene mediated inflammatory reactions. The UVB skin irradiation test in the study was used to assess the efficacy of IDEA-070 in a model of skin inflammation (sunburn).

The novel, carrier-based dosage form of an established analgesic drug, IDEA-070, targets active molecules into the skin and keeps them active in the organ for a relatively long period of time. This improves product efficacy and safety compared to conventional usage of the same non-steroidal anti-inflammatory drug.

Skin inflammation / skin pain

Sunburn is one of the most common forms of skin inflammation and a major source of the skin pain. It is a clinical response to acute cutaneous solar photodamage after an excessive exposure to ultraviolet (esp. UVB) light, and ranges from mild, painless cutaneous erythema to painful erythematous skin with associated oedema and blistering.

There are no standard treatments for sunburn. A combination of non-pharmacological and pharmacological treatment modalities is currently being utilised to treat sunburn, including topical hydrocortisone, none of which is considered to be really efficient.

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