7th Dec 2015 07:00
Swissmedic grants marketing approval for Ameluz® in Switzerland
Leverkusen, Germany, 7 December 2015 - Biofrontera (FSE/AIM: B8F), the biopharmaceutical company focusing on sun-induced skin cancer, announces that its Swiss partner Louis Widmer SA has received approval to market Ameluz® in Switzerland.
The submission for national approval was filed by Louis Widmer in November 2014. The decision on market authorization follows the European approval granted in 2011.
The logistics for a planned launch in spring 2016 are now being prepared. In parallel, Louis Widmer has applied for reimbursement that will be decided during the next year.
Hermann Lübbert, CEO of Biofrontera AG commented: "The approval by the Swissmedic marks another important milestone towards the global commercialization of Ameluz®, and we are delighted that the innovative photodynamic therapy with its outstanding efficacy in the treatment of actinic keratoses will be available to patients in Switzerland in the spring."
Ends
Enquiries, please contact:
Biofrontera AG Thomas Schaffer, Chief Financial Officer | +49 (0) 214 87 63 2 0 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.
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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