REG - Biofrontera AG - FDA shortens review period for Ameluz <Origin Href="QuoteRef">B8FGn.DE</Origin>

Biofrontera AGAnnouncement

31/12/2015 13:30

RNS Number : 0089B
Biofrontera AG
02 October 2015
FDA determines May 10, 2016 as PDUFA* date for Ameluz
 74-day letter received from FDA
 No potential review issues were identified in filing review
 FDA to provide interim report with suggested labelling by 30 March 2016
 PDUFA* action date is 10 May 2016
Leverkusen, Germany, 2 October 2015 - Biofrontera (FSE/AIM:B8F), the biopharmaceutical company focusing on sun-induced skin cancer,announces that it has received the 74-day letter from the Food and Drug Administration (FDA) in the approval process of Ameluz in the USA. In its filing review, FDA did not identify any potential review issues and set the PDUFA date, the day of the approval letter, to 10 May 2016. Thus, FDA intends to use two months less than in most drug approvals for its review process.
FDA will now enter into its substantive review, which is expected to take six months. By 30 March 2016, FDA will release its interim report that will include suggested labelling and, if necessary, any post marketing commitment requests. Final labelling and potential commitments will be agreed upon between FDA and Biofrontera between 30 March 2016 and 10 May 2016. The suggested timing is based on the assumption that FDA does not identify any major issues during its substantive review.
Commenting on this milestone, Prof. Hermann Luebbert, CEO of Biofrontera said: "The choice of 10 May 2016 as PDUFA date is great news. FDA has not made use of their maximum 12-month review period, thereby potentially reducing time-to-market by two months".
* PDUFA - Prescription Drug User Fee Act
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Enquiries, please contact:
Biofrontera AG 
Prof. Hermann Lbbert, Chief Executive Officer
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 7603 6797
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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