Biofrontera delivers final documents for processing the last open issues in the drug application of BF-200 ALA
Leverkusen, Germany - In the new drug application for Biofrontera's medicinal product for the treatment of actinic keratosis, ongoing at the European Medicines Agency EMA, the documents for processing the last open issues have been submitted as scheduled. BF-200 ALA is in the centralized procedure for the approval of new medicinal products, in which new, innovative drugs are approved for the entire European Union in a single step.
The centralized procedure comprises two rounds in which all European agencies may request additional documents and raise open issues. In May 2011 Biofrontera delivered documents and answers to the first round of open issues, and on schedule the agencies started the second round in July. The new documents were provided to the agencies in September since the EMA does not offer a date in August.
This final step towards the expected approval in the fourth quarter of this year constitutes an important milestone in the history of the company. The responsible committee within the EMA (Committee for Medicinal Products for Human Use) should now provide their final opinion on the approval in October.
Prof. Hermann Lübbert, CEO of Biofrontera AG commented: "We have an interesting and work-intensive time behind us, in which we have progressed the development of the product towards a European approval with a very small, but highly motivated team. This is a very special milestone, not only for Biofrontera but for the entire German Biotech industry."
BF-200 ALA gel is a drug for the treatment of actinic keratosis. It is applied in the relatively novel photodynamic therapy (PDT). This therapy is a one-time treatment of actinic keratosis lesions with very high efficacy and excellent cosmetic results, without the side-effects and discomfort of a long-term treatment.
Actinic keratosis is a superficial skin cancer that is still restricted to the upper skin layer (the epidermis). These tumours result from UV-light induced damage accumulating during the entire life time. Thus, they occur very frequently in sun-exposed skin regions. In about 10-15% of the affected people the actinic keratosis lesions develop into malignant, potentially fatal squamous cell carcinomas.
About Biofrontera AG
Biofrontera aims at attending and treating the skin, recognizing the aesthetic needs of a person's visual reflection. Biofrontera is listed at the regulated market of the Düsseldorf stock exchange under the symbol B8F and the ISIN number DE0006046113.
This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the assumptions expressed or implied in this press release to be faulty. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on the forward-looking statements. Biofrontera AG disclaims any obligation to update these forward-looking statements to reflect future events or developments.
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Posted: September 2011