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Biofrontera and Bipharma sign exclusive marketing and distribution agreement for Ameluz® for the Benelux

April 4, 2012 - London

Biofrontera AG /Biofrontera and Bipharma sign exclusive marketing and distribution agreement for Ameluz® for the Benelux . Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

Leverkusen, Germany - Biofrontera Pharma GmbH and Bipharma B.V., Almere, The Netherlands, announced that they have signed an agreement whereby Bipharma will obtain exclusive rights to market and distribute Biofrontera's new prescription product, Ameluz® (5-aminolevulinic acid) in The Netherlands, Belgium and Luxembourg. In December 2011, the European Commission approved Ameluz® for the treatment of actinic keratosis in the European Union. Actinic keratosis is a superficial, UV-light induced skin cancer that affects the upper skin layer (the epidermis).

In return for exclusive marketing rights in Benelux, Biofrontera receives an immediate cost compensation of € 100,000 plus a very significant share of all net revenues of Ameluz® generated by Bipharma. Biofrontera will remain responsible for the regulatory approval, manufacturing and quality control of the product while Bipharma will be responsible for all aspects of commercialization in the Benelux countries. Both companies will work together on pharmacovigilance (drug safety). Bipharma has accepted the obligation to launch Ameluz® in The Netherlands no later than November 1, 2012, and to devote a pre-agreed marketing and sales budget to Ameluz®.

Dr. Robert Veldman, CEO of Bipharma: "Due to its increasing prevalence and the growing awareness actinic keratosis is already the reason for an important portion of all visits to dermatologists. Bipharma is highly recognized in the field of dermatology in the Benelux. We are proud to be able to offer such an excellent PDT drug to the dermatologists in our region."

Prof. Hermann Lübbert, CEO of Biofrontera, comments on the agreement: "Following our agreements with Allergan for Spain and Desitin for Scandinavia, we have selected for the Benelux a smaller, locally concentrated company. For several years we have established close contacts to Bipharma and have been very impressed by the pragmatic and disease-oriented way in which Bipharma has grown the sales of their products, a large part of which were in dermatology. Therefore we are happy that Bipharma has now become a member of the group of companies that will be marketing Ameluz® throughout Europe, each one of them adding their particular strengths."

-- ENDS --

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 led to the complete removal of all actinic keratosis lesions at 12 weeks after the last PDT in 85% and 87% of patients[1]. The treatment can be repeated after three months if residual lesions remain. In a direct head to head comparison against a cream containing 16% methyl-aminolevulinate (MAL), 85% of the patients were totally cleared from all lesions with Ameluz® while the MAL cream cleared only 68% of the patients when LED light sources were used[1]. As with any PDT, the most common side effects occurred at the site of application and included irritation, erythema, pain, pruritus and oedema[1].

Other treatment options have lower clinical efficacy, longer-lasting side effects and many result in visible scars or pigmentation changes[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
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.

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.


[1] Ameluz® Summary of Product Characteristics;
[2] Lawrence, N., Cox, S. E., Cockerell, C. J., Freeman, R. G., & Cruz, P. D.
Jr., 1995, Arch.Dermatol, 131, 176-181.
Lebwohl, M., Dinehart, S., Whiting, D., Lee, P. K., Tawfik, N., Jorizzo, J.,
Lee, J. H., & Fox, T. L., 2004, J Am.Acad.Dermatol, 50, 714-721.
Stockfleth, E. & Kerl, H., 2006, Eur. J. Dermatol. 16, 599-606.
[3] Salasche SJ., 2000, Am Acad Dermatol, 42, 4-7.
[4] Frost, C. A. & Green, A. C., 1994, Br J Dermatol, 131, 455-464.
Memon, A. A., Tomenson, J. A., Bothwell, J., & Friedmann, P. S., 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 0
+ 49 214 87632 90

Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany

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