REG - Biofrontera AG - Excellent results in Ameluz BCC clinical study <Origin Href="QuoteRef">B8FGn.DE</Origin>

Biofrontera AGAnnouncement

28/01/2016 10:30

RNS Number : 2937N
Biofrontera AG
28 January 2016
Biofrontera AG 
("Biofrontera" or the "Company")
Biofrontera's Ameluz 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 to Metvix, 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 achieved higher clearing rates than Metvix 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 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 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 sales in Europe. 
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Enquiries, please contact:
Biofrontera AG 
Thomas Schaffer, Chief Financial Officer
+49 (0) 214 87 63 2 0
press@biofrontera.com
www.biofrontera.com
IR Germany: Brainwell Asset Solutions 
Jrgen Benker
+49 (0) 152 08931514
Nomad and Broker: Shore Capital
Bidhi Bhoma / Toby Gibbs
+44(0) 20 7408 4090
IR UK: Seton Services
Toni Vallen
+44(0) 20 7729 0805
Financial PR: Gable Communications
John Bick / Justine James
+44(0) 20 7193 7463
+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, 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 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 dermatological range of cosmetics. Belixos 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 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 Lbbert, 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. 

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