Biofrontera submits documentation for FDA hearing
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Biofrontera AG /
Biofrontera submits documentation for FDA hearing
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Leverkusen, Germany - Biofrontera AG (DSE: B8F) has today announced that it will
now, subsequent to the successful European approval of its prescription drug
Ameluz(®) for the treatment of actinic keratosis, also pursue a USA
registration. Following intensive preparations the company has submitted the
necessary comprehensive documentation to the FDA (Food and Drug Administration).
In a hearing scheduled for the middle of July 2012 the proposed approval
strategy will be discussed with the US agency and the further procedure
assessed.
Biofrontera has, for reasons of patent rights, awaited the positive approval
decision in Europe before approaching the FDA. The results of the planned
meeting with the FDA will allow the company to curtail the cost and time frame
required to achieve US registration. The improved planning security will also
render license negotiations for the US, the world's largest Pharma market,
possible.
"Following the successful market introduction in Germany and the closing of
several agreements for the local representation of Ameluz(®) within Europe,
Biofrontera now takes the next step towards the global commercialization of
Ameluz(®). Due to the increasing UV exposure, actinic keratoses and the inherent
danger of progression towards potentially fatal squamous cell carcinomas are a
rapidly rising health problem. Pharmacoeconomic studies in the US(1) came to the
conclusion that actinic keratosis is already among the most frequent skin
diseases treated in ambulant care, and the direct treatment cost are in the
billion dollar range," commented Prof. Hermann Lübbert, CEO of Biofrontera. "The
application for the US approval of Ameluz(®) is therefore a consequent step in
the development of the product's full market potential."
Background
Ameluz(®) was approved by the European Commission for the treatment of actinic
keratosis in December 2011. The product is a photosensitizing agent used in
photodynamic therapy (PDT)(2).
Actinic keratosis is mostly seen in fair-skinned people on skin areas that have
had long-term sun exposure(3). The condition affects about 10% of the entire
Caucasian population world-wide(4). About 5-20% of patients with actinic
keratosis lesions develop malignant and potentially fatal squamous cell
carcinomas(5).
About Biofrontera AG
Biofrontera aims at attending and treating the skin, recognizing the aesthetic
needs of a person's visual reflection.
Biofrontera is listed in the regulated market of the Düsseldorf stock exchange
under the symbol B8F and the ISIN DE0006046113.
www.biofrontera.com
References
1.) Neidecker MV, Davis-Ajami ML, Balkrishnan R, Feldman SR, 2009,
Pharmacoeconomics 27: 451-64.
2.) Ameluz® Produktinformation; www.ema.europa.eu
3.) Salasche SJ, 2000, Am Acad Dermatol. 42, 4-7.
4.) Frost, CA & Green, AC, 1994, Br J Dermatol. 131, 455-464.
Memon, AA, Tomenson, JA, Bothwell, J & Friedmann, PS, 2000, Br J Dermatol.
142, 1154-1159.
5.) Braathan LR, Szeimes RM, Basset-Seguin N et al., 2007, J Am Acad Dermatol.
56, 125-143.
For further information please contact:
Anke zur Mühlen
Director PR/IR
+ 49 214 87632 22
+ 49 214 87632 90
a.zurmuehlen(at)biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
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Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1618955]
Unternehmensinformation / Kurzprofil:
Datum: 12.06.2012 - 09:34 Uhr
Sprache: Deutsch
News-ID 155376
Anzahl Zeichen: 4493
contact information:
Town:
Leverkusen
Kategorie:
Business News
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