REG - Biofrontera AG - FDA Grants Small Business Waiver of US$2.3m <Origin Href="QuoteRef">B8FGn.DE</Origin>

Biofrontera AGAnnouncement

05/01/2016 14:26

RNS Number : 0746K
Biofrontera AG
23 December 2015
Biofrontera AG 
("Biofrontera" or the "Company")
FDA grants small business waiver
Leverkusen, Germany, 23 December 2015 - Biofrontera (FSE/AIM: B8F), the biopharmaceutical company focusing on sun-induced skin cancer, announces that FDA has granted a small business waiver which exempts Biofrontera from a US$ 2.34 million application fee (PDUFA fee) for its ongoing drug application for Ameluz.
Such a waiver is usually granted to companies that file their first new drug application ("NDA") with FDA and that do not exceed certain size criteria. Biofrontera meets these criteria but, as previously announced, as FDA had not processed the waiver application at the time the NDA was filed, Biofrontera paid the fee in June 2015. Following the granting of this waiver, the US$ 2.34 million PDUFA fee is now expected to be repaid shortly.
Hermann Lbbert, CEO of Biofrontera AG commented: "This is good news for our company and its balance sheet shortly before Christmas. We are pleased that FDA has accepted our application for a waiver and we are now able to reclaim the PDUFA fee."
 
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Enquiries, please contact:
Biofrontera AG 
Thomas Schaffer, Chief Financial Officer
+49 (0) 214 87 63 2 0
press@biofrontera.com
www.biofrontera.com
IR Germany: Brainwell Asset Solutions 
Jrgen Benker
+49 (0) 152 08931514
Nomad and Broker: Shore Capital
Bidhi Bhoma / Toby Gibbs
+44(0) 20 7408 4090
IR UK: Seton Services
Toni Vallen
+44(0) 20 7729 0805
Financial PR: Gable Communications
John Bick / Justine James
+44(0) 20 7193 7463
+44 (0)7872 061007
Background:
Biofrontera Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical company specialising in the development, sale and distribution of drugs and medical cosmetics for the care and treatment of skin diseases. Biofrontera's most important product is Ameluz, a prescription drug which is approved in Europe for the treatment of mild and moderate actinic keratosis (superficial skin cancer) with photodynamic therapy (light therapy). Biofrontera is the first German pharmaceutical start-up company to obtain centralised approval for a drug it has developed itself. The company also plans for Ameluz to be approved for basal cell carcinoma and is currently preparing for approval in other countries, especially in the largest pharmaceutical market in the world, the United States. 
The company also markets the Belixos dermatological range of cosmetics. Belixos products, a cream, a gel and a scalp tonic, contain combinations of active substances extracted from plants, relieve itching and redness and are used for the regenerative care of chronic skin conditions such as atopic dermatitis or psoriasis. The Belixos Protect, a daily skincare for sun-damaged skin, complements this dermo-cosmetic line. All products are available through Amazon.
The Biofrontera Group was established in 1997 by Prof. Dr Hermann Lbbert, the Chairman of the company's Management Board, and has its headquarters in Leverkusen, Germany.
www.biofrontera.com
This communication expressly or implicitly contains certain forward-looking statements concerning the business activities of Biofrontera AG. These forward-looking statements reflect the opinion of Biofrontera at the time of this communication and involve certain known and unknown risks. The actual results achieved by Biofrontera may differ significantly from future results or performances which are published in its forward-looking statements. Biofrontera assumes no responsibility to update its forward-looking statements. 

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