Biofrontera submits study report of pharmacokinetics study to FDA
February 24 2021 - 8:30AM
Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the
“Company”), an international biopharmaceutical company, announces
the submission of an application to the U.S. Food and Drug
Administration (FDA) to amend the product information to allow the
simultaneous use of three tubes of Ameluz®. The application is
supported by a phase I pharmacokinetics (PK) study for the
treatment of actinic keratoses with three tubes of Ameluz®.
In October 2020 (refer to our press release
dated October 8, 2020), the Company was able to complete the
clinical phase of the PK study, which tested the safety of
photodynamic therapy (PDT) with the simultaneous use of three tubes
of Ameluz® on larger or multiple areas. Subsequently, the study
data was analyzed, the study report was prepared and then
incorporated into the regulatory dossier (NDA).
“The results of this study gave no indication
that the safety profile for treatment with three times the amount
of Ameluz® would differ from the known safety profile with one
tube," explains Dr. Hermann Lübbert, CEO of Biofrontera. " We
anticipate convincing the FDA to amend the product information for
Ameluz®, which currently limits the use to one tube of Ameluz® per
treatment. An amended product information would allow the treatment
of actinic keratoses with up to three tubes of Ameluz®. This will
make an important difference to the competitiveness of
Ameluz®."
The maximum use PK study included 32 patients
with actinic keratoses on larger or multiple areas who received PDT
treatment with a total of three tubes of Ameluz® either on the
face/scalp area or on the extremities/trunk/neck. Ameluz® was
applied in accordance with the currently licensed treatment
protocol, except that three tubes of the drug were used to treat a
skin area of 60 cm². Illumination was performed after 3 hours of
occlusion, using either one or two BF-RhodoLED® lamps
simultaneously, depending on the number and location of the
treatment area(s). The study was conducted at a specialized
dermatological phase I facility in Texas/USA.
The objective of the study was to evaluate the
safety of patients after applying three tubes of Ameluz® to the
skin by investigating the amount of active ingredient that enters
the blood stream. Further parameters related to the safety of
patients undergoing such treatment were also investigated. Based on
these results, the Company and the regulatory authority will be
able to assess whether the simultaneous treatment with three tubes
could lead to risks for patients.
-End-
For enquiries, please
contact: Biofrontera AG Thomas Schaffer,
Chief Financial Officer Pamela Keck, Head of IR |
ir@biofrontera.com +49 (0) 214 87 63 2 0 |
IR UK: Seton
Services Toni Vallen |
+44 (0) 207 229 0805 |
About Biofrontera:
Biofrontera AG is a biopharmaceutical company
specializing in the development and sale of dermatological drugs
and medical cosmetics.
The Germany-based company, with over 150
employees worldwide, develops and markets innovative products for
the care, protection and treatment of the skin. The company’s lead
product is the combination of Ameluz®, a topical prescription drug,
and medical device BF-RhodoLED® for the photodynamic therapy of
certain superficial skin cancers and their precursors. Ameluz® has
been marketed in the EU since 2012 and in the United States since
May 2016. In addition, the company markets the prescription
medication Xepi® for the treatment of impetigo in the United
States. In the EU, the company also sells the dermocosmetics series
Belixos®, which offers specialized care for damaged or diseased
skin.
Biofrontera is the first German founder-led
pharmaceutical company to receive a centralized European and a US
approval for a drug developed in-house. The Biofrontera Group was
founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is
listed on the Frankfurt Stock Exchange (Prime Standard) and on the
US NASDAQ.www.biofrontera.com.
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