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Last €2.28 EUR
Change Today -0.016 / -0.70%
Volume 39.5K
B8F On Other Exchanges
As of 11:36 AM 10/9/15 All times are local (Market data is delayed by at least 15 minutes).

biofrontera ag (B8F) Snapshot

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03/24/15 - €3.00
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08/24/15 - €1.66
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biofrontera ag (B8F) Details

Biofrontera AG, a biopharmaceutical company, primarily focuses on the discovery, development, and distribution of dermatological drugs and dermatological-tested cosmetics for the treatment and care of diseased skin. The company’s products include Ameluz, a prescription drug for the treatment of actinic keratosis, a superficial skin cancer; BF-RhodoLED, a lamp for photodynamic therapy with LEDs emitting red light at an average wavelength of 635 nm; Belixos, a cream with herbal ingredients for the care of inflamed, itchy, and flaky skin, such as localized itching, insect bites, burns, nuerodermatitis, and psoriasis; Belixos LIQUID to treat itching and scaliness, and restore the scalp’s natural balance; and Belixos GEL for use on inflamed and reddened skin, and skin prone to impurities. It is also developing BF-derm1, which is in Phase II clinical trial for the treatment of chronic and antihistamine-refractory urticaria; and BF-1, a serotonin receptor antagonist that is in Phase I clinical trial to treat migraine prophylaxis. The company was founded in 1997 and is headquartered in Leverkusen, Germany.

54 Employees
Last Reported Date: 08/14/15
Founded in 1997

biofrontera ag (B8F) Top Compensated Officers

Co-Founder, Chairman of Management Board and ...
Total Annual Compensation: €405.0K
Chief Financial Officer and Member of Managem...
Total Annual Compensation: €202.0K
Compensation as of Fiscal Year 2014.

biofrontera ag (B8F) Key Developments

Biofrontera AG Announces Long Term Results of Phase III Trial

Biofrontera AG announced that preliminary long-term results of the Phase III trial for photodynamic field therapy of actinic keratosis in combination with Biofrontera's PDT lamp BF-RhodoLED® show excellent long term results for patients. This data is a key component in the FDA approval process of Ameluz® and BF-RhodoLED® and will be included in the safety update for the FDA which is due 120 days after submission. All patients treated within the scope of the trial were further monitored by the trial doctors for one year after the last treatment. The aim of this continued patient observation was to analyze the sustainability of Ameluz®'s pharmaceutical action in terms of efficacy, safety and cosmetic outcome. During the trial entire fields of actinic keratoses on the face or scalp were treated with Ameluz® in combination with the BF-RhodoLED®. 61.8% of patients were completely cleared from all actinic keratoses after the first treatment cycle with Ameluz®. Patients with remaining lesions received a repeated field treatment, resulting in complete clearance of all actinic keratoses in 90.9% of patients. The new trial data now confirms that one year later 63.3% of the completely cleared patients are still free of symptoms, which reinforces the previous excellent results of the long-term efficacy obtained with Ameluz® spot therapy. An added benefit is the progressive improvement of skin complexion in patients treated with Ameluz®. Measuring parameters such as roughness, dryness and flakiness of the skin revealed continuous improvement of the skin surface quality, which one year after the treatment was even more pronounced than after 3 or 6 months. Prior to the PDT with Ameluz® only 14.8 % of patients did not display an impaired skin surface. Twelve weeks after the last PDT already 63% no longer had such impairments. This improvement increased even further to 72.2% of patients after one year. Similar results were obtained for pigmentation disorders. Prior to PDT hyperpigmentation was observed in 59.3%, hypopigmentation in 46.3%, and irregular pigmentation in 48.1% of patients. Twelve weeks after the Ameluz® field therapy these numbers decreased to 42.6%, 29.6% and 29.6%, and improved even further to 24.1%, 11.1% and 18.5%, respectively, within one year.

Biofrontera AG Announces Food and Drug Administration Accepts Filing of Ameluz and BF-Rhodoled

Biofrontera AG announced that the Food and Drug Administration (FDA), the responsible US government agency, has accepted filing of the New Drug Application (NDA) of Biofrontera's anti-skin cancer drug Ameluz® combined with the PDT lamp BF-RhodoLED®. This constitutes the first key step in the approval process of Ameluz® and BF-RhodoLED® in the USA. With the positive decision, an FDA Review team is assigned to evaluate the research Biofrontera has performed on the drug's safety and effectiveness as well as the control measures in place to warrant the quality of the products. Within 5 to 6 months, the FDA will now prepare the mid-term review that will identify any outstanding issues and therefore provide a good indication for the timely approvability of the products.

Biofrontera AG Reports Unaudited Consolidated Earnings Results for the Six Months Ended June 30, 2015; Provides Revenue Guidance for the Year Ending December 31, 2015

Biofrontera AG reported unaudited consolidated earnings results for the six months ended June 30, 2015. For the period, the company reporting an increase in revenues by 29% to EUR 1.57 million against EUR 1.22 million a year ago. Significant growth in sales revenue of 29% compared to the same period in the previous year. Improving sales performance in European countries outside German home market. Consolidated loss before tax was EUR 7.3 million, reflecting FDA submission fee. The majority of revenues were again recorded in Germany with EUR 1.19 million against EUR 915,000 a year ago, which represents an increase of 30%. Product revenues in other European countries also developed well with EUR 382,000 being achieved, which represents an increase of 65% compared to the first half of the previous year. The company reported a net loss before tax of EUR 7.3 million against EUR 5.4 million a year ago, which includes development costs of EUR 4.5 million against EUR 2.1 million a year ago. The increase was primarily as a result of the application fee of EUR 2.1 million which was paid to the FDA. This amount may be repaid by the FDA as Biofrontera may be eligible for a waiver for small businesses. For the year ending December 31, 2015, the company targets for revenue development and can confirm annual growth expectation of 30% with revenue of EUR 4 million to EUR 5 million for the full year to December 31, 2015.


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