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Dermo-Cosmetics

Belixos®   is a creme with herbal ingredients for the basic care of inflamed, itchy and flaky skin, such as in localized itching, atopic dermatitis or psoriasis.
The creme combines a plant extract from Mahonia aquifolium with an innovative biocolloid formulation developed by Biofrontera. Mahonia aquifolium's properties were already recognized in traditional medicines, for instance by the American Indians. The excellent clinical efficacy of the plant extract was demonstrated in numerous clinical studies. The combination with Biofrontera‘s biocolloids optimizes the skin penetration of the extract and provides excellent cosmetic properties.

Belixos®   creme was introduced into the German market in October 2009.

www.belixos.com

Medical Devices

BF-RhodoLED®  is a lamp for photodynamic therapy (PDT) with LEDs emitting red light at a wavelength of about 630 nm. This wavelength is perfectly suited for the illumination in PDT with medicines containing ALA or methyl-ALA. No other available light source offers comparable power and flexibility. In November 2012 BF-RhodoLED®  has been CE-certified, which will enable the marketing throughout the entire EU.

Medicaments

Ameluz®  (BF-200 ALA) for actinic keratosis (marketed)

Ameluz®  (developed under the name of BF-200 ALA) is Biofrontera’s first prescription drug. It combines the active ingredient 5-aminolevulinic acid (ALA) with a proprietary nanoemulsion, thereby improving the skin penetration and the chemical stability. This medicine has recently been approved in the EU for the use in photodynamic therapy (PDT) of actinic keratoses (superficial skin cancers). In PDT Ameluz®  is applied to the skin. Through a 10- to 15-minute illumination with a strong red light a chemical reaction is triggered 3 hours later, killing the tumor cells selectively and without any scar formation. Due to a stimulation of collagen synthesis, the PDT has additionally an excellent cosmetic effect.

In the coming years Ameluz®  will also be approved in other geographic regions and for other skin tumors and warts.

www.ameluz.com

BF-derm1 for chronic, antihistamine-refractory urticaria (clinical phase II)

BF-derm1  is a tablet containing a novel, irreversible histidine decarboxylase inhibitor that in cells blocks the synthesis of histamine, a major trigger of allergic symptoms. BF-derm1  is in development for the treatment of chronic, antihistamine-refractory urticaria.

The efficacy of BF-derm1  was already demonstrated in a phase IIa trial. Taking BF-derm1  improved the symptoms of urticaria and patients required substantially less sedating antihistamines to fight their itching.

BF-1 for migraine prophylaxis (clinical phase I)

BF-1  is a highly specific serotonin receptor antagonist. This substance is developed as tablet for migraine prophylaxis. Migraine is an inflammatory reaction of the meninges. BF-1  has shown excellent efficacy in a mouse model for migraine genesis. A human trial was performed already to examine the uptake of BF-1  from the tablet into the blood (bioavailability), and its degradation and secretion (biokinetics). Due to the high stability of the compound in the human body, the intake of one tablet per day is sufficient to maintain a constant level of the active compound in the blood.

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