Biofrontera AG: Expansion of the international marketing of Ameluz®
(Thomson Reuters ONE) -
Biofrontera AG /
Biofrontera AG: Expansion of the international marketing of Ameluz®
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany: Biofrontera's prescription drug Ameluz(®), which in
December 2011 was approved by the European Commission for the treatment of mild
to moderate actinic keratosis on the face and scalp, has now been launched in
the United Kingdom and in Austria. In addition, a new license deal was closed
for the distribution in Malta with the local pharmaceutical company Pharma.MT
Ltd., Gzira, Malta.
The launches in UK and Austria were based on the agreements with Spirit
Healthcare Limited, Leicester (see ad-hoc news release of 24 July 2012), and
with Pelpharma Handels GmbH, Vienna (see ad-hoc news release of 13 August 2012).
Since November 1(st) Ameluz(®) is available for use and ordering by the UK
National Health Service and private sector organisations. Spirit Healthcare has
informed the National Health Service in the United Kingdom and is now providing
information, training and support for Dermatologogy Consultants and Dermatology
Specialist Nurses in the UK. The agreement with Spirit foresees a stronger role
of Biofrontera than standard licensing deals. In addition to training Spirit
Healthcare's sales force with respect to Ameluz(®), Biofrontera has established
logistics channels for the distribution of Ameluz in the UK, and will closely
cooperate with Spirit in all marketing activities.
Following extensive sales force training by Biofrontera last week, Pelpharma
will in the course of this week organize workshops for hospital and practicing
dermatologists in several large cities in Austria. The innovative combination of
both, drug (Ameluz(®)) and lamp (BF-RhodoLED(®)) for the treatment of actinic
keratosis has already generated great interest with office based dermatologists
throughout the country. Since November 1(st), Ameluz(®) is available through
pharmaceutical wholesalers in Austria.
As an additional component of the European marketing of Ameluz(®), a license and
supply agreement for Malta has now been formed with Pharma.MT Ltd., a privately
owned healthcare, pharmaceuticals distribution and marketing company. Pharma.MT
ranks among the top healthcare product distributors in Malta. It is managed and
driven by young professionals, concentrating on the Maltese market, where they
distribute pharmaceutical specialities in Dermatology, CNS, Oncology and generic
drugs. Pharma.MT works closely with local business partners, community
pharmacies, the government and the local medical community. Pharma.MT will
purchase Ameluz(®) from Biofrontera at 65% of its own sales price. As in all
other contracts with regional representatives, Biofrontera retains the
responsibility for manufacturing and pharmacovigilance. Since Malta allows
English language on its prescription medicinal products and patient leaflets,
specific production for Malta is not required.
Background
Ameluz(®) (developed as BF-200 ALA gel) was centrally approved in the entire
European Economic Area for the treatment of actinic keratosis in December 2011.
The product is applied in the relatively novel photodynamic therapy (PDT). PDT
of actinic keratosis lesions with Ameluz(®) leads to very high efficacy and
excellent cosmetic results, without the side-effects and discomfort of a long-
term treatment. The treatment can be repeated after three months if residual
lesions remain. A direct clinical comparator study testing the clearance of all
actinic keratoses of a patient proved the strong superiority of Ameluz(®)
compared to its closest competitor(1,2).
Actinic keratosis is a superficial skin cancer that is still restricted to the
upper skin layer (the epidermis). These tumours result from UV-light induced
damage accumulating during the entire life time. Thus, they occur very
frequently in sun-exposed skin regions. In about 10-15% of the affected people
the actinic keratosis lesions develop into malignant, potentially fatal squamous
cell carcinomas.
About Biofrontera AG
Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The
Biofrontera group aims at attending and treating the skin, recognizing the
aesthetic needs of a person's visual reflection. Biofrontera is listed at the
regulated market of the Frankfurt stock exchange under the symbol B8F and the
ISIN number DE0006046113.
www.biofrontera.com
This press release contains forward-looking statements based on the currently
held beliefs and assumptions of the management of Biofrontera AG, which are
expressed in good faith and, in their opinion, reasonable. Forward-looking
statements involve known and unknown risks, uncertainties and other factors,
which may cause the assumptions expressed or implied in this press release to be
faulty. Given these risks, uncertainties and other factors, recipients of this
document are cautioned not to place undue reliance on the forward-looking
statements. Biofrontera AG disclaims any obligation to update these forward-
looking statements to reflect future events or developments.
References
1.) Ameluz® Summary of Product Characteristics; www.ema.europa.eu.
2.) Dirschka et al. (2012) Br. J. Dermatol. 166: 137-146.
For further information please contact:
Anke zur Muehlen, Director PR/IR
or
Werner Pehlemann, CFO
+ 49 214 87632 0
+ 49 214 87632 90
a.zurmuehlen(at)biofrontera.com
w.pehlemann(at)biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1654944]
Unternehmensinformation / Kurzprofil:
Datum: 05.11.2012 - 10:00 Uhr
Sprache: Deutsch
News-ID 199272
Anzahl Zeichen: 6725
contact information:
Town:
Leverkusen
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 151 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Biofrontera AG: Expansion of the international marketing of Ameluz®"
steht unter der journalistisch-redaktionellen Verantwortung von
Biofrontera AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
