Market Overview

Biofrontera AG: Expansion of the international marketing of Ameluz®


Biofrontera AG /
Biofrontera AG: Expansion of the international marketing of Ameluz®
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Leverkusen, Germany: Biofrontera's prescription drug Ameluz®, which in December 2011 was approved by the European Commission for the treatment of mild to moderate actinic keratosis on the face and scalp, has now been launched in the United Kingdom and in Austria. In addition, a new license deal was closed for the distribution in Malta with the local pharmaceutical company Pharma.MT Ltd., Gzira, Malta.

The launches in UK and Austria were based on the agreements with Spirit Healthcare Limited, Leicester (see ad-hoc news release of 24 July 2012), and with Pelpharma Handels GmbH, Vienna (see ad-hoc news release of 13 August 2012).

Since November 1st Ameluz® is available for use and ordering by the UK National Health Service and private sector organisations. Spirit Healthcare has informed the National Health Service in the United Kingdom and is now providing information, training and support for Dermatologogy Consultants and Dermatology Specialist Nurses in the UK. The agreement with Spirit foresees a stronger role of Biofrontera than standard licensing deals. In addition to training Spirit Healthcare's sales force with respect to Ameluz®, Biofrontera has established logistics channels for the distribution of Ameluz in the UK, and will closely cooperate with Spirit in all marketing activities.

Following extensive sales force training by Biofrontera last week, Pelpharma will in the course of this week organize workshops for hospital and practicing dermatologists in several large cities in Austria. The innovative combination of both, drug (Ameluz®) and lamp (BF-RhodoLED®) for the treatment of actinic keratosis has already generated great interest with office based dermatologists throughout the country. Since November 1st, Ameluz® is available through pharmaceutical wholesalers in Austria.

As an additional component of the European marketing of Ameluz®, a license and supply agreement for Malta has now been formed with Pharma.MT Ltd., a privately owned healthcare, pharmaceuticals distribution and marketing company. Pharma.MT ranks among the top healthcare product distributors in Malta. It is managed and driven by young professionals, concentrating on the Maltese market, where they distribute pharmaceutical specialities in Dermatology, CNS, Oncology and generic drugs. Pharma.MT works closely with local business partners, community pharmacies, the government and the local medical community. Pharma.MT will purchase Ameluz® from Biofrontera at 65% of its own sales price. As in all other contracts with regional representatives, Biofrontera retains the responsibility for manufacturing and pharmacovigilance. Since Malta allows English language on its prescription medicinal products and patient leaflets, specific production for Malta is not required.

Background
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 competitor1,2.

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 cell carcinomas.

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.
www.biofrontera.com

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.

References
1.) Ameluz® Summary of Product Characteristics; www.ema.europa.eu.
2.) Dirschka et al. (2012) Br. J. Dermatol. 166: 137-146.


For further information please contact:

Anke zur Muehlen, Director PR/IR
or
Werner Pehlemann, CFO

+ 49 214 87632 0
+ 49 214 87632 90
a.zurmuehlen@biofrontera.com
w.pehlemann@biofrontera.com

Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany






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Source: Biofrontera AG via Thomson Reuters ONE

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