Biofrontera AG: FDA grants small business waiver

Leverkusen (pta012/23.12.2015/15:35 UTC+1) 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 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 the waiver, the US$ 2.34 million PDUFA fee is now expected to be repaid shortly.

Hermann Lübbert, 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."

Enquiries, please contact:

Biofrontera AG
Thomas Schaffer, Chief Financial Officer
+49 (0) 214 87632 0
press@biofrontera.com
http://www.biofrontera.com

IR Germany: Brainwell Asset Solutions
Jürgen 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 Lübbert, the Chairman of the company's Management Board, and has its headquarters in Leverkusen, Germany.
http://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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Emitter:	Biofrontera AG Hemmelrather Weg 201 51377 Leverkusen Germany
Contact Person:	Investor & Public Relations
Phone:	+49 (0) 214 87 63 2
E-Mail:	press@biofrontera.com
Website:	www.biofrontera.com
ISIN(s):	DE0006046113 (Share)
Stock Exchange(s):	Regulated Market in Dusseldorf, Frankfurt; Free Market in Berlin, Munich, Stuttgart