Biofrontera and Desitin sign marketing and distribution agreement for AmeluzR in Scandinavia

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Mon Feb 6, 2012 4:17am EST

Biofrontera AG / Biofrontera and Desitin sign marketing and distribution agreement for AmeluzR in Scandinavia . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Leverkusen and Hamburg, Germany - Biofrontera Pharma GmbH and Desitin Arzneimittel GmbH have today closed an agreement according to which Desitin has obtained exclusive rights to market Biofrontera's new prescription drug AmeluzR in Denmark, Sweden and Norway. Desitin also gets a preferred right of negotiation for Finland. In December 2011 the European Commission approved AmeluzR for the treatment of actinic keratosis in the entire EU, Norway, Island and Liechtenstein.

For providing the exclusive marketing rights Biofrontera receives an immediate significant upfront-payment plus 35% of all net revenues generated by Desitin with AmeluzR . In return Biofrontera will deliver the product to Desitin and take responsibility for the pharmacovigilance structures (drug safety).

All local sales and marketing expenses and the costs required to obtain local reimbursement will be covered by Desitin. According to the contract Desitin will launch the product at the latest by October 1, 2012, and has accepted a commitment to pre-agreed minimum sales.

With this agreement Desitin Arzneimittel GmbH, which in the past was mostly present on the German market with neurological drugs, has extended its activities in the Scandinavian market. In these countries, Desitin is active since 16 years. The company introduced a botulinum toxin A product into the Scandinavian market 5 years ago, which since then is very successfully distributed.

Dr. Martin Zentgraf, General Manager of Desitin Arzneimittel GmbH: "We could convince Biofrontera of our high quality as marketing partner in Scandinavia. AmeluzR is one of the most exciting new medicines in dermatology and we are lucky to be involved in its distribution."

Comments Prof. Hermann Lübbert, CEO of Biofrontera AG: "AmeluzR is to our knowledge the first prescription drug that was both fully developed and centrally approved by a small German company. It is now of enormous importance for the future of both AmeluzR and Biofrontera to make the international marketing a success, for which the selection of experienced and motivated distribution partners is most essential. With Desitin we found an excellent partner for Scandinavia, with a sustained strength in distribution that was proven with several other products. We are thus proud that we could enthuse Desitin for the marketing of AmeluzR ."

Background
AmeluzR (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 AmeluzR 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 proved the strong superiority of AmeluzR 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 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 Düsseldorf 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.




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Biofrontera AG
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