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8 Oct 2014 16:03
Biofrontera AG
("Biofrontera" or the "Company")
US regulatory authority gives green light to proposed approach towards approval of Ameluz® and BF-RhodoLED® in the USA
· All questions raised with the FDA were answered according to the company position
· Timetable to filing the approval dossier confirmed for end Q1 2015
Leverkusen, 08 October 2014 - Biofrontera AG (FSE: B8F), the biopharmaceutical company focusing on skin cancer, has successfully passed another important step towards the approval of Ameluz® and BF-RhodoLED® in the US. In today's pre-NDA (new drug application) meeting with the American Food- and Drug Administration (FDA) all questions raised were answered as proposed by Biofrontera.
Pre-NDA Meetings with the FDA represent the last opportunity for companies prior to submitting a drug approval to exchange positions about the approval pathway and content with the FDA. In preparation of the meeting the FDA typically receives a package containing a summary of the application documentation as well as potential questions along with proposed answers and explanatory background. The application is exceptionally complex in Biofrontera's case as in the US Ameluz® and BF-RhodoLED® have to be approved as combination of a drug and a medical device. Therefore, the Company had raised 12 groups of questions covering regulatory, clinical, preclinical, production and quality aspects.
Due to the high quality of the documentation which Biofrontera had provided in preparation of the meeting, only very few discussion points were left after the preliminary assessment of the FDA. In consequence, the meeting was held as a telephone conference, following a proposal by the FDA. During the discussion the participants reached agreement in all points. Most importantly, no additional studies were requested.
The Company now has green light to proceed according to plan towards approval of Ameluz® and BF-RhodoLED® in the US. The submission of the application is planned by the end of the first quarter 2015.
Enquiries:
Biofrontera AG |
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Prof. Hermann Lübbert, Chief Executive Officer Thomas Schaffer , Chief Financial Officer | Tel:+ 49 (0) 214 87632 22 |
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Finncap (Nomad and Broker: | Tel: +44(0) 20 7220 0500 |
Geoff Nash / Christopher Raggett (Corporate Finance) |
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Steven Norcross (Corporate Broking)
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Investor Relation: Seton Services | Tel: +44(0) 20 7603 6797 |
Toni Vallen |
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Financial PR: Gable Communications John Bick | Tel: +44(0) 20 7193 7463 Tel: +44 (0)7872 061007 |
Notes to Editors:
Biofrontera AG (AIM/FSE: B8F, ISIN DE0006046113) is a biopharmaceutical company specialising in the development and distribution of dermatological drugs and medical cosmetics for the treatment and care of skin diseases. Biofrontera's main product is Ameluz®, a prescription drug approved for use in Europe for the treatment of mild to moderate Actinic Keratosis (superficial skin cancer) by photodynamic therapy (light therapy). Biofrontera is the first small German pharmaceutical company to receive a centralized approval for a drug developed in-house. The Company is looking to further develop Ameluz® for use in Basal Cell Carcinoma and is currently progressing through regulatory approvals to sell the product in other territories, in particular the largest pharmaceutical market, the USA.
In addition, the Company markets the Belixos® cosmetic series with plant extracts, currently available in cream and liquid formulations which offer nurturing and regenerating effects for people suffering from pruritus, dry skin or chronic ailments such as eczema or psoriasis.
Biofrontera group was founded in 1997 by Prof. Dr. Hermann Lübbert, the CEO, and is headquartered in Leverkusen, Germany.
www.biofrontera.com
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