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Biofrontera AG and Bipharma B.V.: Launch of Ameluz® in the Netherlands


October 15, 2012 - London

Biofrontera AG /Biofrontera AG and Bipharma B.V.: Launch of Ameluz® in the Netherlands. Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

Leverkusen, Germany, and Almere, The Netherlands: According to the distribution agreement between the two companies (see press release of 04 April 2012) Bipharma B.V., Almere, has now started the distribution of Ameluz® in the Netherlands. The launch was accompanied by a scientific symposium organized by the Erasmus University Medical Center Rotterdam. A group of expert speakers covered the epidemiology, aetiology and pathogenesis of actinic keratosis and basal cell carcinoma across Europe, and more specifically in Holland. The program then moved to the role of photodynamic therapy in the treatment of these diseases and to the clinical advantages and challenges of this very modern treatment form. Finally, Ameluz® was introduced to the participants by Prof. Dr. Hermann Lübbert, CEO of Biofrontera.

In December 2011 the European Commission has approved Ameluz® for marketing and distribution in the entire EU, Norway, Island and Liechtenstein. Ameluz® is offered as a 2 gram tube, which in photodynamic therapy (PDT) is distributed onto about 20 cm2 of affected skin. A large clinical Phase III trial has demonstrated that Ameluz® reaches significantly better total patient clearance rates in actinic keratosis than its nearest competitor1,2.

On the day of the launch dermatologists and hospital pharmacies in the Netherlands have been informed that, due to the availability of Ameluz®, the treatment of patients with compounded PDT products containing 5-aminolaevulinic acid (ALA, the active ingredient in Ameluz®) is, according to Dutch and European law, prohibited. The ban of pharmacy compounding with ALA is based on a Resolution of the Council of Ministers of the European Union from 2011. According to the resolution pharmacy compounding is restricted to situations where adequate, approved medicinal products are not available3.

Background
Ameluz® (developed as BF-200 ALA gel) was centrally approved in the entire European Economic Area for the treatment of actinic keratosis in December 2011. The product is applied in the relatively novel photodynamic therapy (PDT). PDT of actinic keratosis lesions with Ameluz® leads to very high efficacy and excellent cosmetic results, without the side-effects and discomfort of a long-term treatment. The treatment can be repeated after three months if residual lesions remain. A direct clinical comparator study testing the clearance of all actinic keratoses of a patient proved the strong superiority of Ameluz® compared to its closest competitor1,2.

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 Bipharma B.V.
Bipharma B.V. is a privately owned healthcare marketing and sales organisation, founded in 1946. Bipharma's mission is to market and sell products so as to prevent and cure health disorders in humans of all ages. Bipharma specializes in dermatology products. The products are selected on the basis of the contribution to the increase of quality in health and healthcare as perceived by the patient and the prescribing professionals.
www.bipharma.com

About Biofrontera AG
Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The Biofrontera group 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 Frankfurt stock exchange under the symbol B8F and the ISIN number DE0006046113.
www.biofrontera.com

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.

 

References
1.) Ameluz® Summary of Product Characteristics; www.ema.europa.eu.
2.) Dirschka et al. (2012) Br. J. Dermatol. 166: 137-146.
3.) "Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients", Council of Ministers of the European Union, 19-01-2011.

For further information please contact:

Anke zur Muehlen, Director PR/IR
or
Werner Pehlemann, CFO

+ 49 214 87632 0
+ 49 214 87632 90
a.zurmuehlen@biofrontera.com
w.pehlemann@biofrontera.com

Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany




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Source: Biofrontera AG via Thomson Reuters ONE

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