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2016-02-11

Biofrontera AG: Pivotal Phase III Data Demonstrate Significant Efficacy and Excellent Safety for BF-200 ALA Treatment of Superficial Skin Cancer

Biofrontera AG / Biofrontera AG: Pivotal Phase III Data Demonstrate
Significant Efficacy andExcellent Safety for BF-200 ALA Treatment of
Superficial Skin Cancer . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
announcement.
Results Outlined in Poster and during Two Oral Presentations at 14thAnnual
South Beach Symposium
LEVERKUSEN, Germany, February 11, 2016 -
Biofrontera AG (FSE: B8F), the specialist for sun-induced skin cancer,
presents data from three pivotal Phase III trials for its lead drug candidate
BF-200 ALA at the 14th Annual South Beach Symposium. The studies demonstrate
very high efficacy, positive safety and excellent aesthetic outcomes that is
activated using photodynamic therapy (PDT) for the topical treatment of
actinic keratosis (AK), a superficial skin cancer caused by sun damage.

The results are being presented in a poster (Poster #118) on display February
11-14 and will be highlighted during two oral presentations on Friday,
February 12 by two members of Biofrontera's Scientific Advisory Board at
the14thAnnual South Beach Symposium, being held February 11-14, 2016 at the
Fontainebleau Hotel in Miami Beach, Florida.

Two of the studies formed the basis for marketing authorization approval of
BF-200 ALA as first-line treatment of mild to moderate actinic keratosis on
the face and scalp by the European Medicines Agency in December 2011. The
third study was performed to strengthen the New Drug Application submitted to
the U.S. Food and Drug Administration in July 2015. Filing of the application
was accepted in September, since when the FDA undertakes its substantive
review. No review issue was reported by the FDA following their mid-term
review meeting.

In the three Phase III trials conducted in centers in Germany, Switzerland and
Austria, a total of 779 patients with 4 to 8 mild to moderate AK lesions were
randomized, with all three studies using red light PDT with LED illumination
sources at approximately 635 nanometers (nm).

* A 122-patient Phase III study demonstrated excellent efficacy of BF-200 ALA
compared to placebo with a patient complete clearance rate of 87%, compared
to placebo response of 13%.1
* A 571-patient Phase III study showed significantly improved patient
clearance rates for BF-200 ALA (85%) compared to those of placebo (13%) and
methylaminolevulinate (MAL) (68%), which is marketed as Metvix(TM) and was
the current standard of care topical photosensitizing agent used in PDT. A
1-year follow-up showed slightly lower recurrence rates for BF-200 ALA
compared to MAL, and PDT side effects were not enhanced using BF-200 ALA.2
* An 86-patient Phase III study used a field directed approach (the entire
tube of BF-200 ALA was applied to a field of cancerized skin) and compared
efficacy and cosmetic outcome of BF-200 ALA with placebo, finding that 91%
percent of the patients completely cleared after a maximum of two
treatments with BF-200 ALA, compared to only 22% complete clearance with
placebo. With BF-200 ALA treatment, clearance was sustained over one year
of follow-up in 63.3% of the patients. Several cosmetic parameters were
followed during follow-up and found to continuously improve, for the first
time proving the strong skin rejuvenation of PDT in a controlled pivotal
trial.3

In addition to the three phase III studies on AK, results of a Phase III study
of BF-200 ALA for the treatment of non-aggressive basal cell carcinoma (BCC)
showed high clearance rates of all superficial and nodular BCCs in more than
93.4% of the patients.

Prof. Dr. Hermann Lübbert, PhD, CEO of Biofrontera AG, commented, "These
results from our three Phase III trials evaluating BF-200 ALA in actinic
keratosis are substantial as they demonstrate the clinical viability of our
novel combination therapy system. Our photosensitizer agent BF-200 ALA
utilizes a unique delivery method through nanoemulsion technology which
constitutes a stabilized and penetration-enhancing formulation for use in
PDT, making it one of the most effective treatment modalities for the removal
AK lesions and BCC tumors."

Dr. Brian Berman, MD, PhD, Professor Emeritus, Dermatology and Cutaneous
Surgery at the University of Miami Miller School of Medicine and SBS Session
Director and presenter of the oral presentationFutures Symposium: Innovations
in Clinical and Aesthetic Dermatology
, added, "Skin cancer remains the most diagnosed cancer in the U.S., and can
often be fatal, requiring better treatment options and improved outcomes for
patients. Innovations in the clinic like BF-200 ALA could offer an effective
and safe treatment option. Data from the large 570-patient comparator study
in particular demonstrated that BF-200 ALA reaches a significantly superior
patient complete clearance rate in AK-treatment as compared to Metvix®while
the side-effect profile does not differ. Furthermore, the high therapeutic
efficacy of BF-200 ALA becomes particularly evident when treating Olsen grade
II lesions and lesions on the scalp."

References

1. Szeimies et al., 2010.

2. Dirschka et al., 2012.

3. Reinhold et al, submitted.

About South Beach Symposium

The South Beach Symposium has an audience of more than 550 attendees, with
approximately 95% physicians in core specialties including Dermatology,
Plastic Surgery, Ophthalmology and Facial Plastic Surgery. The Symposium
features cutting edge educational sessions with non-overlapping CME tracks:
the Masters of Pediatric Dermatology Symposium, the South Beach Clinical
Dermatology Symposium, the South Beach Aesthetics Symposium and the Practice
Management Symposium.

About Biofrontera

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
isAmeluz®
, 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.

For more information, visitwww.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.

U.S. Contact:

The Ruth Group

Lee Roth (Investors) / Kirsten Thomas (Media)
lroth@theruthgroup.com/kthomas@theruthgroup.com

+1 646-536-7012 / +1 508-280-6592

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biofrontera AG via Globenewswire

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