Further progress in international approval processes of Biofrontera's Ameluz®
(Thomson Reuters ONE) -
Biofrontera AG /
Further progress in international approval processes of Biofrontera's Ameluz®
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* Successful filing of waivers in the US
* Ameluz(®) applied for registration in Switzerland
Leverkusen, Germany, 26. November, 2014 - Biofrontera (FSE / AIM: B8F), the
specialist for sun-induced skin cancer, has taken important steps towards
further international approvals of Ameluz(®). As part of the approval process
for Ameluz(®) in the US, Biofrontera had discussed with the FDA to submit the
"Pediatric Waiver" and the "User Fee Waiver" before submitting the complete
registration dossier. These filings have now occurred. An approved Pediatric
Waiver avoids the obligation for conducting studies with children. The User Fee
Waiver is given to small enterprises and allows them to apply for their first
drug approval without the need to pay further FDA fees, which would otherwise
amount to the payment of fees by Biofrontera of in excess of US$2 million.
Previously Biofrontera had obtained a similar status by the European Medicines
Agency.
In Switzerland, the Company's licensing partner, Louis Widmer SA has, in
collaboration with Biofrontera, submitted the registration dossier of Ameluz(®)
to the local health authorities, the Swissmedic. After a technical validation of
the application the authority has now accepted Ameluz(®) for registration, by
which the next step of the approval process was initiated. Within the scope of
the authorization procedure, Swissmedic assesses the quality, safety and
efficacy of the drug on the basis of the comprehensive scientific documentation
submitted, and approves the information provided to healthcare professionals and
patients.
Prof. Dr. Hermann Lübbert, CEO of the Biofrontera: "In a close cooperation
between Louis Widmer and Biofrontera the European drug approval dossier has been
adapted to the Swiss regulations. In Switzerland Biofrontera's drug for
photodynamic treatment of actinic keratosis will, as in all other European
countries, be marketed under the brand name Ameluz(®). The market authorization
in Switzerland will represent another important milestone in the international
expansion of the business with Ameluz(®). The application of the two waivers is
another important step within the scope of the US registration process."
Enquiries:
Biofrontera AG +49 (0) 214 87 63 20
Thomas Schaffer, CFO press(at)biofrontera.com
www.biofrontera.com
IR Germany: Brainwell Asset Solutions +49 (0) 152 08931514
Jürgen Benker
Nomad and Broker: Shore Capital +44(0) 20 7408 4090
Bidhi Bhoma / Toby Gibbs
IR UK: Seton Services +44(0) 20 7603 6797
Toni Vallen
Financial PR: Gable Communications +44(0) 20 7193 7463
John Bick +44 (0)7872 061007
Background:
The 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(®) contains a combination of active substances extracted from plants,
relieves itching and redness and is used for the regenerative treatment of
chronic skin conditions such as atopic dermatitis or psoriasis. At the moment,
Belixos(®) is available as a cream and scalp tonic. 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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Source: Biofrontera AG via GlobeNewswire
[HUG#1874346]
Unternehmensinformation / Kurzprofil:
Datum: 26.11.2014 - 08:00 Uhr
Sprache: Deutsch
News-ID 355537
Anzahl Zeichen: 6216
contact information:
Town:
Leverkusen
Kategorie:
Business News
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