biolitec AG

PDT Medication Foscan® Now Reimbursed in the Netherlands

Head and neck cancer patients can now temporarily be treated free of charge at medical centers in the Netherlands

In a cost effective study all medical centers in the Netherlands, patients can now be treated with the new PDT-Drug Foscan® free of charge – Experts are confident that the high technology treatment will proof as important and cost effective treatment modality in Europe and more patients will benefit from reimbursement in the future

Jena, Germany, March 29th, 2010 – www.biolitec.de – Modern cancer drugs are very expensive and the use of modern therapies is therefore tightly controlled and restricted – either to patients, who can afford to pay privately or to such therapies promising an adequate quality of additional lifetime in a cost effective manner. Now, Foscan® (active substance: temoporfin) therapy has – despite its high costs – been placed on a temporary reimbursement list in the Netherlands.
In addition, there is a study of the photodynamic therapy with Foscan with several high prestige institutions currently going on, in which the results of at least 50 patients treated with PDT and a control group should be analyzed. The study should confirm that the additional survival years claimed as a consequence of the new treatment are cost effective to the health care system.

Reimbursement of the medication in the Netherlands has been made conditional by the Reimbursement Authorities upon evidence of cost-effectiveness of Foscan®, which needs to be shown three years following the initial reimbursement.
The main objective of the trial is to compare the cost-effectiveness of the therapy and the quality of life of a group of patients receiving PDT and Foscan®
with conventional chemotherapy. It shall contribute to PDT becoming the standard therapy for patients with advanced squamous cell carcinoma.
This offers an excellent chance to patients in the Netherlands suffering from head and neck cancer to get the latest technology treatment free of charge.

With the study of cancer treatment with the medicament Foscan® in the Netherlands, biolitec now has achieved an important success in the acknowledgement and expansion of the photodynamic therapy (PDT). Dr. Wolfgang Neuberger, CEO of biolitec AG: ‘The conditional reimbursement and the cost effectiveness
study are also strong indicators for the success of our treatment. We at biolitec see this as a major step in the development of the PDT drug Foscan® and we are confident that we will be able to fulfil the demands to get permanent reimbursement
in the Netherlands and later in Europe.’ Head and neck cancer world-wide is the sixth most common type of tumor,
mostly in the form of a squamous cell carcinoma. Approximately half of patients treated with chemotherapy or surgical procedures will suffer a relapse in the form of a second primary tumor, which can be treated with the medication.
Five high prestige medical centers also participate directly in the study: Netherlands Cancer Institute (NKI) in Amsterdam (Prof. Bing Tan), Groningen University Medical Center (M.J.H. Witjes), Erasmus University Medical Center in Rotterdam
(C.A. Meeuwis), Utrecht University Medical Center (W.W. Braunius) and Maastricht Academic Hospital (K.W. Kross). Further, all academic centers in the Netherlands also participate by referring patients to these five centers.

Foscan® has already been approved by the European Medicines Agency (EMEA) for the palliative treatment of head and neck cancer in the EU. The drug is a socalled photosensitizer, a high-tech pharmaceutical, which is activated by exposure
to light. The tumors are destroyed when the agent, which has been inserted before, is activated in the tissue with the help of modern laser devices. Foscan® is currently used in more than 30 clinics throughout Europe. Over 3.000 patients
have already been treated with the drug. In Italy and Great-Britain Foscan® also has been applied successfully for several years and the costs of the treatment are reimbursed of the health insurances, when treated in-patient. In Germany, the drug is currently only reimbursed when used in an out-patient setting.

About biolitec
biolitec AG worldwide is one of the leading companies in the field of medical laser treatment and the only provider that possesses all the relevant core com-petences – photosensitizers, laser devices
and optical fibers – in the field of photodynamic therapy (PTD). Besides the laser treatment of cancer with Fo-scan®, biolitec primarily researches on minimally-invasive and gentle laser treatments and markets them. ELVeS® (Endo Laser Vein System) worldwide is the laser system most often used for the treatment of varicose veins, the Evolve™ laser has established as gentle treatment in urology. Gentle laser treatments in the fields of proctology, ENT, orthopedics and ophtalmology as well as aesthetics also belong to the business field of biolitec. biolitec AG is listed in the Prime Standard and the German Entrepreneurial Index GEX® (ISIN DE0005213409). Further information under www.biolitec.de.