2013-01-08 12:46:36 -
Biofrontera AG /
Biofrontera receives positive EMA opinion on extended storage conditions for
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Leverkusen, Germany - Biofrontera AG (DSE: B8F) today announced that the
European Medicines Agency EMA has provided a positive opinion on several
variations of the marketing authorisation of Ameluz(®) and informed the European
Commission accordingly. The variations are based on extended stability data and
related to the storage conditions of Ameluz(®), Biofrontera's first prescription
drug for the treatment of actinic keratosis. The unopened tube can now be stored
for 3 years, while 2 years had been approved before. After the first opening the
tube can be used repeatedly during 3 months. The warning 'do not freeze'
deleted since, opposite to previous concerns, freezing and thawing does not harm
the product quality.
The extended storage period of the unopened tube will reduce production costs by
facilitating the planning of production and storage at the whole salers. A cycle
of actinic keratosis treatment with Ameluz(®) includes one photodynamic therapy
that is repeated after three month if residual lesions remain. Although Ameluz
is generally used for larger skin areas where the entire tube is used up in one
treatment, residual product may now be applied in the second treatment. Freezing
the product may occur during transport in winter and in the Nordic countries,
which is now not considered critical.
'The active ingredient aminolaevulinic acid is known for its instability in
aqueous solutions. The new stability data represent an impressive confirmation
of the advantages of the innovative nanoemulsion technology developed by
Biofrontera. The three-month stability after opening allows doctors and patients
to use the same tube in a repeat of the treatment on the same patient',
commented Biofrontera's CEO, Prof. Hermann Luebbert.
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 competitor,.
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
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.
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.
 Ameluz® Summary of Product Characteristics; www.ema.europa.eu.
 Dirschka et al. (2012) Br. J. Dermatol. 166: 137-146.
For further information please contact:
Anke zur Muehlen
+ 49 214 87632 0
+ 49 214 87632 90
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
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Source: Biofrontera AG via Thomson Reuters ONE