TIDMB8F

RNS Number : 2937N

Biofrontera AG

28 January 2016

Biofrontera AG

("Biofrontera" or the "Company")

Biofrontera's Ameluz(R) achieves excellent results in clinical study for basal cell carcinoma

Leverkusen, Germany, January 28, 2016 - Biofrontera AG (FSE: B8F), the specialist for sun-induced skin cancer, has received preliminary phase III study results for the treatment of basal cell carcinoma using PDT, photodynamic therapy. The results confirm the company's positive expectations. The clinical study compared the efficacy and safety of Ameluz(R) to Metvix(R) , a drug approved for BCC in the European Union. Included in the study were non-aggressive, superficial or nodular BCCs with a thickness of up to 2 mm. With 93.4% removal of all BCCS Ameluz(R) achieved higher clearing rates than Metvix(R) with 91.8%. The calculation of the relationship between total clearance and tumor thickness will be reported when available.

A total of 278 patients were treated in the pivotal phase III study. The study was performed at 27 clinical centers in Britain and Germany with Principal investigators Prof. Dr. Colin Morton (Great Britain) and Prof. Dr. Markus Szeimies (Germany).

Based on the results of the phase III study Biofrontera will apply with the European Medicines Agency for approval of Ameluz(R) for treatment of BCC in the EU. The expanded approval only requires an extension of the existing approval, which is expected to be granted later this year.

BCCs are the most frequent infiltrating tumors in humans and represent 50-80% of all infiltrating non-melanoma skin cancers. Approximately 30% of Caucasians worldwide develop at least one BCC in their lifetime, with increasing incidence due to higher UV load. BCCs are most frequently removed by surgery, a procedure that often leads to scar formation. The use of photodynamic therapy (PDT) is a highly effective alternative which leads to excellent cosmetic results.

The BCC expanded approval for Ameluz(R) will provide Biofrontera the opportunity to increase market share through market penetration in clinical settings. With the anticipated indication expansion the company expects a substantial increase of Ameluz(R) sales in Europe.

Ends

Enquiries, please contact:

 
 Biofrontera AG                        +49 (0) 214 87 
  Thomas Schaffer, Chief Financial      63 2 0 
  Officer                               press@biofrontera.com 
                                        www.biofrontera.com 
 IR Germany: Brainwell Asset 
  Solutions 
  Jürgen Benker                   +49 (0) 152 08931514 
 Nomad and Broker: Shore 
  Capital                              +44(0) 20 7408 
  Bidhi Bhoma / Toby Gibbs              4090 
 IR UK: Seton Services                 +44(0) 20 7729 
  Toni Vallen                           0805 
                                       +44(0) 20 7193 
 Financial PR: Gable Communications     7463 
  John Bick / Justine James             +44 (0)7872 061007

Background:

Biofrontera Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical company specialising in the development, sale and distribution of drugs and medical cosmetics for the care and treatment of skin diseases. Biofrontera's most important product is Ameluz(R) , a prescription drug which is approved in Europe for the treatment of mild and moderate actinic keratosis (superficial skin cancer) with photodynamic therapy (light therapy). Biofrontera is the first German pharmaceutical start-up company to obtain centralised approval for a drug it has developed itself. The company also plans for Ameluz(R) to be approved for basal cell carcinoma and is currently preparing for approval in other countries, especially in the largest pharmaceutical market in the world, the United States.

The company also markets the Belixos(R) dermatological range of cosmetics. Belixos(R) products, a cream, a gel and a scalp tonic, contain combinations of active substances extracted from plants, relieve itching and redness and are used for the regenerative care of chronic skin conditions such as atopic dermatitis or psoriasis. The Belixos(R) Protect, a daily skincare for sun-damaged skin, complements this dermo-cosmetic line. All products are available through Amazon.

The Biofrontera Group was established in 1997 by Prof. Dr Hermann Lübbert, the Chairman of the company's Management Board, and has its headquarters in Leverkusen, Germany.

www.biofrontera.com

This communication expressly or implicitly contains certain forward-looking statements concerning the business activities of Biofrontera AG. These forward-looking statements reflect the opinion of Biofrontera at the time of this communication and involve certain known and unknown risks. The actual results achieved by Biofrontera may differ significantly from future results or performances which are published in its forward-looking statements. Biofrontera assumes no responsibility to update its forward-looking statements.

This information is provided by RNS

The company news service from the London Stock Exchange

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January 28, 2016 05:28 ET (10:28 GMT)

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