Biofrontera announces full results of Phase III clinical trial evaluating BF-200 ALAfor treatment of basal cell carcinoma (BCC):
- Regulatory endpoint achieved
- European approval ofBF-200 ALA for treatment of BCC expected in Q4 2016
- European sales increase anticipatedfor BF-200 ALA
Biofrontera AG (FSE: B8F), the specialist for sun-induced skin cancer, today announcedthe full resultsof its Phase III clinical trial evaluating BF-200 ALA for the treatment of basal cell carcinoma(BCC)that demonstrate the study met its regulatory endpoints. The analysisfully confirmed the preliminary results, which were initially reported on January 28th2016.
Results of the EU multi-center study confirm that 93.4% of patients treated with BF-200 ALAwere cleared of all BCCs, compared to only 91.8% of patients treated with the comparatortreatment, methyl aminolaevulinate (MAL) photodynamic therapy, which is marketed as Metvix® or Metvixia®. In thestudy, 281 patients with 1 to3 non-aggressive BCCs, including both superficial and nodular BCC subgroups,up to a thickness of 2 mm were treated. The analysis of the individual BCCs yieldeda complete clearance rate of 94.6% after treatment with BF-200 ALA, compared to 92.9% with MAL (all values refer to the per protocol group). A stronger deviation of efficacy between the two drugs became apparent in thicker tumors. While 96.4% of tumors between 0 and 1 mm thickness were completely removed by treatment with BF-200 ALA (95.7% MAL), the value decreasedin 1-2 mm tumors to 72.7% with BF-200 ALA and 66.7% with MAL. 89.3% of nodular BCCs, a subgroup of non-aggressive BCCs,were completely cleared with BF-200 ALA in comparison to only 78.6% with MAL.
In addition, treatment with BF-200 ALA resulted in an excellent cosmetic outcome. In 60.0 % of patients treated with BF-200 ALA,skin aesthetic appearance was strongly improved and rated by study physicians as very good to excellent, compared to only 48.6 % of patients treated with MAL. To evaluate these characteristics, various skin parameters had been qualifiedby the study physicians and gradedby the severityof skin damage. The improvement of eachparameter was documented and included in theanalysis. Anunsatisfactory result without cosmetic improvement was observed in 17.1% of BF-200 ALA patients and 18.9 % of patients treated with MAL.
"These are excellent results for the treatment of an infiltrating skin cancer, which we anticipate will aid in obtaining European labeling extensionof BF-200 ALA for basal cell carcinomapotentially in Q4 of this year, which goes beyond the initial approval in actinic keratosis (AK) obtained in 2011. These results clearly demonstrate the high efficacyof PDT with BF-200 ALA's to destroy BCC tumor tissue across a range of tumor thicknesses without the formation of scar tissue and instead the promotion of skin regeneration for positive aesthetic outcomes.EMA approval of BF-200 ALA in BCC willsignificantly expand the market potentialof BF-200 ALA in the EU", said Prof. Hermann Lübbert, CEO of Biofrontera AG.
Enquiries, please contact:
Thomas Schaffer, Chief Financial Officer, +49 (0) 214 87 63 2 0
IR Germany: Brainwell Asset Solutions
Jürgen Benker, +49 (0) 152 08931514
IR UK: Seton Services
Toni Vallen, +44(0) 20 7729 0805
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 Lübbert, the Chairman of the company's Management Board, and has its headquarters in Leverkusen, Germany.
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
Hemmelrather Weg 201
|Ansprechpartner:||Investor & public relations|
|Tel.:||+49 (0) 214 87 63 20|
|Börse(n):||Regulierter Markt in Düsseldorf, Frankfurt; Freiverkehr in Berlin, München, Stuttgart|