
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. The Belixos® creme was introduced into the German market in October 2009.
www.belixos.com
The IceMask™ offers a controlled cooling and reduces pain perception after PDT treatment. The cooling effect prevents edema-formation and reduces swelling. The skin is moisturized with Aloe Vera and the healing process is facilitated.
Nanoxosan® 30 is a patented nanoemulsion, composed of fine oil particles forming under certain conditions when aqueous and oil phases are combined. Through the interaction with the nanometer-size oil drops, active ingredients can be chemically stabilized and the penetration of the skin is accelerated even in deeper skin layers. Nanoemulsions have, due to their advantageous biophysical properties, since years been used by the cosmetical industry. Many highly-priced cosmetic products benefit from the more efficient skin penetration.
Biofrontera’s lead product BF-200 ALA combines a nanoemulsion with 5-aminolevulinic acid (ALA). The product is developed in photodynamic therapy of precancerous skin lesions (actinic keratosis). The ALA nanoemulsion is applied to the skin lesions and, upon irradiation, a chemical reaction is triggered that destroys the affected skin without scar formation.
Phase II-studies for actinic keratosis, condyloma (genital warts) and basal cell carcinoma have been completed and demonstrated good efficacy and safety.
BF-200 ALA was tested in two pivotal phase III studies. The first placebo controlled phase III trial demonstrated excellent efficacy and safety. The second phase III trial compared BF-200 ALA with the registered standard medication in photodynamic therapy. The clinical development is now completed and BF-200 ALA is prepared for the centralized European drug registration process.
The second clinical product, BF-derm1, is a novel, irreversible histidine decarboxylase inhibitor that blocks the synthesis of histamine, a major trigger of allergic symptoms. BF-derm1 is in development for the treatment of chronic, antihistamine-refractory urticaria.
BF-derm1 has completed a phase II clinical trial, which demonstrated good efficacy and a lack of relevant side effects.
BF-1 is a highly specific serotonin receptor antagonist. This product candidate is developed as a drug for migraine prophylaxis. A first human trial with BF-1 was successfully completed, revealing that BF-1 has excellent pharmacokinetic properties in humans.
The further development until out-licensing includes phase I and phase II proof-of-concept trials in humans. The drug may also be applicable for the treatment of irritable bowel syndrome and pulmonary hypertension.
Three preclinical compound classes in Biofrontera’s pipeline act by inhibiting intracellular enzymes that play fundamental roles in inflammatory processes. Inflammation underlies or contributes to many diseases, including several diseases of the skin. The new compounds are currently investigated with respect to their pharmacological properties and their efficacy in animal models for inflammatory skin diseases.
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