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Intendis and Photonomic Sign Licensing and Development Agreement on 5-Aminolevulinic Acid Patch Technology

- Press Release -

Berlin, September 17, 2008

Intendis GmbH and Photonamic GmbH and Co. KG announced that the two companies have signed a License and Development Agreement that grants Intendis exclusive access outside of the US to their 5-aminolevulinic acid patch technology (5-ALA Patch) for the Photodynamic Therapy (PDT) of skin diseases. Intendis is part of Bayer HealthCare. Under the agreement Intendis has obtained the right to develop, register and commercialize products based on this technology among others for the indication actinic keratosis under the brand names Alacare® and Effala® (PD P 506 A). Actinic keratosis is a UVB-induced carcinoma in situ.

PD P 506 A is a novel approach to treat actinic keratosis by using the effective 5-ALA-based PDT in an innovative patch system, which allows for optimum targeting and exposure of the compound to the affected area. Marc Lafeuille, President and CEO of Intendis emphasized that, "PD P 506 A is a valuable addition to our portfolio of prescription dermatological drugs. I am convinced that it will provide significant value to doctors and patients alike, as the 5-ALA patch represents a novel, effective and convenient treatment of actinic keratoses. The partnership with Photonamic also provides us the opportunity to exploit further the potential of the patch technology in other indications.”

"We are very much looking forward to working together with Intendis," said Dr. Ulrich Kosciessa, Managing Director, Photonamic. "With Intendis' experience as a globally operating dermatological company, we are convinced that this partnership offers a very high level of success for the further development and marketing of PD P 506 A and the 5-ALA patch technology." Photonamic, a subsidiary of German-based Medac Gesellschaft für klininische Spezialpräparate GmbH, initiated a decentralized European registration procedure to obtain marketing authorization for the treatment of actinic keratoses. The product is expected to be launched in the European market by the end of 2009. Intendis has committed to milestone payments and will pay royalties to Photonamic on sales of any product based on the 5-ALA patch technology under license. Actinic keratosis forms dry, scaly, rough-textured patches or papules in sun-exposed areas of the skin which range in colour from skin-toned to reddish brown. If left untreated, progression to the invasive skin cancer, squamous cell carcinoma, may occur in rare cases.

About 5-ALA-based PDT

The topical application of the inactive precursor, 5-aminolevulinic acid (5-ALA), induces the porphyrin synthesis in skin cells resulting mainly in an accumulation of protoporphyrin IX (PPIX). PPIX is a photosensitizer which generates reactive oxygen species after activation with visible light of appropriate wavelengths. The accumulation of PPIX is higher in tumor cells than in most normal tissue, which after illumination leads to a higher concentration of reactive oxygen species, which in turn results in the destruction of these cells while normal tissue is preserved.

About Intendis

Intendis is an integrated pharmaceutical company based in Berlin, Germany. As part of Bayer HealthCare, Intendis is completely dedicated to Dermatology and focuses on the development and marketing of high quality, innovative topical therapies, targeted to treat skin disorders. The current product portfolio comprises treatments of eczema disorders including atopic dermatitis, as well as psoriasis, acne, rosacea, hemorrhoids and fungal skin infections (mycoses). Find out more at www.intendis.com.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About Photonamic / Medac

Photonamic GmbH and Co. KG is a subsidiary company of Medac GmbH, founded jointly with external investors. Predominant among Photonamic’s activities is the development of the chemical substance 5-aminolevulinic acid in the field of fluorescence diagnosis (FD) and photodynamic therapy (PDT). The research and development activities are presently concentrated on fluorescence diagnosis and photodynamic treatment in the areas of dermatology and neurosurgery. Furthermore, Photonamic pursues development programs in oncology as well as in immunology-related diseases.

Media Contacts:
Intendis GmbHTobias Rockel
Corporate Communication
+49 30 52 00 75 650
tobias.rockel@intendis.com 
PhotonamicUlrich Kosciessa
+49 4103 8006-701
u.kosciessa@photonamic.de 

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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