Biofrontera AG: Allergan launches Ameluz® in Spain
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Biofrontera AG /
Biofrontera AG: Allergan launches Ameluz® in Spain
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Leverkusen, Germany, 21 October 2013 - Biofrontera AG (DSE : B8F) announces
today that at the end of September Allergan, her representative in Spain, had
started marketing and sales of Biofrontera's prescription drug Ameluz(®) in
Spain with an educational event for Spanish dermatologists in Madrid. This was
preceded by extensive negotiations with the Spanish authorities about
reimbursement and price. Ameluz(®) is now fully reimbursed in the photodynamic
treatment of actinic keratosis in Spain.
Actinic keratosis, a precursor of malignant skin cancer, requires medical
treatment. In countries like Spain, where people are often exposed to direct
sunlight over many years, actinic keratosis is widespread particularly among
people at higher ages. Its high incidence renders actinic keratosis one of the
five cancer types with the highest cost for the health care system(1). In up to
10% of the patients untreated actinic keratosis develops into life-threatening
squamous cell carcinoma(2).
Ameluz(®) combines the active ingredient 5-aminolevulinic acid with a
nanoemulsion that improves skin penetration. The medicine is applied in the
context of photodynamic therapy (PDT) in combination with red light, and
selectively destroys the tumor tissue(3.4).
"Due to the high number of sun hours we have in the year, actinic keratosis is a
very frequent disease in Spain," said Dr. Carlos Guillén of the Institute of
Oncology in Valencia at Allergan's event. "Men are preferentially affected. The
precancerous damage occurs especially in the face and on the scalp. With
Ameluz(®) a very effective treatment becomes available, which often erases all
tumor cells after a single application."
"We are excited about the market introduction of Ameluz(®) in Spain, since we
are aware of the large number of people suffering from this skin disease,
especially in rural areas or after frequent activities in the open. It is one of
our top priorities in Spain to help the large number of people suffering from
actinic keratosis who may benefit from this new and effective treatment," said
Christoph Duenwald, Business Unit Director, Allergan Spain. "Our exclusive
partnership with Biofrontera in marketing Ameluz(®)-PDT in Spain illustrates our
experience in dermatology and our continuous commitment to the dermatologists,"
he concludes.
Background
Ameluz® was approved by the European Commission as a first-line therapy for the
treatment of mild and moderate actinic keratosis on the face and scalp in
December 2011. Clinical studies have shown the highest cure rates of actinic
keratosis ever reported in Phase III studies with prescription drugs. The
product is a photosensitizing agent used in photodynamic therapy (PDT). Actinic
keratosis is mostly seen in fair-skinned people on skin areas that have had
long-term sun exposure. The condition affects about 10% of the entire Caucasian
population world-wide. About 5-20% of patients with actinic keratosis lesions
develop malignant and potentially fatal squamous cell carcinomas.
About Biofrontera
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
About Allergan
Allergan is a pharmaceutical company with approximately 11,200 employees and a
presence in more than 100 countries. With over 60 years of experience, the
company is specialized on the medical disciplines ophthalmology, neuroscience,
urology and aesthetic medicine. www.allergan.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 )Mudigonda T et al. (2010) The economic impact of non-melanoma
skin cancer: a review. J Natl Compr Canc Netw 8: 888-96.
(2 )Glogau RG (2000) The risk of progression to invasive disease. J
Am Acad Dermatol 42: 23-4.
(3 )Szeimies RM et al. (2010) Photodynamic therapy with BF-200 ALA
for the treatment of actinic keratosis: results of a prospective, randomized,
double-blind, placebo-controlled phase III study. Br J Dermatol 163: 386-94.
(4 )Dirschka T et al. (2013) Long-term (6 and 12 months) follow-up
of two prospective, randomized, controlled phase III trials of photodynamic
therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic
keratosis. Br J Dermatol 168: 825-36.
For further information please contact:
Anke zur Mühlen
Corporate Communication
+ 49 (0) 214 87632 22
+ 49 (0) 214 87632 90
a.zurmuehlen(at)biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
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Source: Biofrontera AG via Thomson Reuters ONE
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Unternehmensinformation / Kurzprofil:
Datum: 21.10.2013 - 10:02 Uhr
Sprache: Deutsch
News-ID 307410
Anzahl Zeichen: 6869
contact information:
Town:
Leverkusen
Kategorie:
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