Biofrontera and Allergan sign marketing and distribution agreement for Ameluz® in Spain

Biofrontera AG /
Biofrontera and Allergan sign marketing and distribution agreement for Ameluz®
in Spain
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Leverkusen, Germany - Biofrontera Pharma GmbH and Allergan announce they have
signed an agreement whereby Allergan will obtain exclusive rights to market and
distribute Biofrontera´s new prescription product, Ameluz(®) (5-aminolevulinic
acid) in Spain. In December 2011, the European Commission approved Ameluz(®) for
the treatment of actinic keratosis in the European Union. Actinic keratosis is a
superficial skin cancer, affecting the upper skin layer (the epidermis). These
tumours result from damage caused by UV-light and are therefore frequent in
countries where people commonly expose their skin to the sun, such as Spain.

In return for exclusive marketing rights in Spain, Biofrontera receives an
immediate upfront payment of EUR1.1 million plus an undisclosed percentage of all
net revenues of Ameluz(® )generated by Allergan. Biofrontera will remain
responsible for the regulatory approval, manufacturing and quality control of
the product while Allergan will be responsible for all aspects of
commercialization in Spain. Both companies will work together on
pharmacovigilance (drug safety).

Prof. Hermann Lübbert, CEO of Biofrontera, comments on the agreement: "Since the
introduction of Ameluz(®) onto the German market, we have received positive
feedback by the dermatologists and their patients due to its superior clinical
efficacy and its advantages particularly in the treatment of larger areas. We
hope to achieve a similarly positive reception in other countries. Working with
experienced and motivated local representatives will be essential to making
Ameluz® an international success. Allergan has repeatedly proven its excellence
in the marketing of innovative pharmaceuticals, and we are convinced that they
are the ideal partner for making Ameluz(®) a success in Spain."

-- ENDS --

Background
Ameluz® (developed as BF-200 ALA gel) 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). The registration was
based on two phase III clinical trials involving more than 693 patients
suffering from four to eight independent actinic keratosis lesions. These
studies demonstrated that PDT using Ameluz® and narrow spectrum LED light
sources lead to the complete removal of all actinic keratosis lesions at 12