Press Release
15.01.2008
biolitec’s amendments requested for the extension of sales and marketing of Foscan® have been approved – “Low dose” vials to be used for clinical trials in dermatology and cholangiocarcinoma
Jena, January 15th, 2008 – biolitec AG (ISIN DE0005213409) realizes another important milestone for Foscan® with the approval of an additional strength of its Foscan® vials. A less concentrated mTHPC formulation (1mg/ml concentration) in vial sizes of 1 ml, 3ml and 6 ml has now received approval in Europe for the palliative treatment of patients with advanced squamous cell carcinoma of the head and neck failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy. Low dose vials will also be used in upcoming trials in dermatology and in the treatment of cholangiocarcinoma.
Thereunto Dr. Wolfgang Neuberger, CEO of biolitec AG: “The new approval will enlarge significantly the potential for the use of Foscan® and will give the research new impetus in the field of cancer therapy.”
biolitec AG is one of the leading companies worldwide in the fields of laser treatment and photodynamic therapy. Foscan® has already been approved as a drug for the treatment of palliative head and neck cancer and is now used in over thirty clinics in Europe. Since its approval by the EMEA at the end of 2001 the drug Foscan® was used at more than 3,000 patients.
"To the therapy and its applications to establish, we are planning the development of new indications and the admission of Foscan® in the major world markets, especially in the USA", explains Dr. Wolfgang Neuberger, and further points out: "Hereunto we aim long-term sale and developing partnerships with appropriate companies. The recent signing of the distribution and development agreement for cancer indications with two leading pharmaceutical companies in Italy and Latin America shows that this strategy can be implemented successfully. "
About biolitec
biolitec is the only supplier for photodynamic therapy worldwide that offers all relevant core competencies – photosensitizers, lasers and optical fibers. Besides minimal invasive laser treatments and the oncology business biolitec has successfully developed competencies in the field of aesthetics. biolitec is listed in the Prime Standard under ISIN DE0005213409. For more information: www.biolitec.com .
