In May 2007,we licensed the U.S. rights to Aethoxysklerol® sclerosing agent, an injectable sclerosing drug for the treatment of varicose veins from Chemische Fabrik KREUSSLER & Co. GmbH Kreussler, a German pharmaceutical company. Injection sclerotherapy is one of the primary treatments for small to medium varicose veins in the legs, where a treatment agent is injected into the vein to cause destruction of the vein, with the intent to improve the overall aesthetic appearance.
Up to 50% of women 18 years of age and older may be affected by varicose veins. These veins, typically found on the legs, are often red or blue, are close to the surface of the skin and can look like tree branches or spider webs. ASAPS reported that approximately 559,000 sclerotherapy procedures and about 158,000 laser vein removal procedures were performed in the United States in 2006. We believe these figures demonstrate that a very small percentage of the potential market has sought treatment for this condition.
Current varicose vein treatment options available in the United States include various lasers, surgery, and sclerotherapy with hypertonic saline or other drugs. Some of the current laser treatments and sclerotherapy products in the United States may be associated with significant discomfort, which may discourage patients from seeking treatment. In contrast,Aethoxysklerol® Sclerosing Agent contains polidocanol, a chemical with anesthetic properties, which we believe may be one of the product's key advantages of Aethoxysklerol.
Aethoxysklerol® Sclerosing Agent is a leading sclerotherapy treatment in Europe for varicose veins. It was developed by Kreussler in the early 1960s and has been used safely and effectively outside of the United States for over 40 years in millions of patients. Kreussler is currently conducting a Phase III clinical study, which has been fully enrolled. The clinical trial is being conducted based on a design that was established by the manufacturer based on its communication with the FDA and a special protocol assessment, or SPA. An SPA is an agreement between the FDA and the sponsor on the design and size of a clinical trial that will, if successful, form the primary basis for a claim of the effectiveness of the drug in a new drug application or NDA. Kreussler intends to submit an NDA in 2008, if the study is successful.
For more information about Aethoxysklerol® sclerosing agent, please go to www.kreussler.com
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