Biofrontera provides update on clinical developments
June 22 2021 - 9:00AM
Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the
“Company”), an international biopharmaceutical company, today
provides an update on its clinical developments.
In February and March 2021, the Company
announced two submissions to the U.S. Food and Drug Administration
(FDA), enabling the simultaneous use of up to three tubes of
Ameluz® per photodynamic therapy (PDT) on the one hand, while
seeking approval for a larger red-light lamp, the BF-RhodoLED® XL,
on the other. In June 2021, the meeting with the FDA previously
announced for both submissions took place, in which the further
proceeding was determined. With regard to the approval process of
BF-RhodoLED®, the FDA has confirmed that the data are sufficient
for the submission and that the evaluation process will be
initiated.
The other submission, the application for
amendment of the product information to extend the posology
allowing the simultaneous use of three tubes of Ameluz®, was
discussed intensively in talks with the FDA. The regulatory agency
did not express any concerns related to efficacy or to the results
from the phase I pharmacokinetics study underlying the application.
However, to amend the product information, which currently limits
the use to one tube of Ameluz® per treatment, the FDA recommended
the submission of expanded safety data. The FDA agreed with the
proposal to observe systemic and local side effects during
treatment with three tubes of Ameluz® in 100 patients. This safety
study is scheduled to start in the second half of 2021.
With regard to the potential expansion of the
Ameluz® approval to moderate and severe acne in the USA, the
Company has finalized the design of the phase IIb trial, taking
into account the regulatory recommendations agreed upon with the
FDA in 2020. A multicenter, randomized, double-blind study with
four arms is planned for conventional PDT with Ameluz® involving
126 patients aged 16 years and older. Ameluz® incubation times of
one and three hours will be compared with placebo. The aim of the
study is to collect data on the efficacy and safety when using
Ameluz® PDT for moderate and severe acne. As previously announced,
the trial is scheduled to start in the second half of 2021.
Comparable to the European approval expansion of
Ameluz® for the treatment of mild and moderate actinic keratoses
(AK) on the extremities and trunk/neck with PDT, the Company is
currently preparing phase III trials for this approval expansion in
the USA. Patient recruitment is expected to start in the first half
of 2022.
Also scheduled to begin in the second half of
2021 in the USA is a study evaluating an illumination protocol for
which Biofrontera has filed a patent application. The goal of the
study is to reduce pain during illumination in conventional PDT for
actinic keratoses on the face and scalp.
Patient recruitment has picked up again for the
clinical trial for the treatment of superficial basal cell
carcinoma (BCC) with Ameluz® in conjunction with the BF-RhodoLED®
lamp in the USA. To date, approximately 60% of the planned 186
patients have been enrolled in the study. Due to the demanding
study protocol, the recruitment process has been very lengthy and
was heavily influenced by the pandemic last year.
-End-
Biofrontera AGPamela Keck, Head of Investor
Relationsir@biofrontera.com +49-214-87632-0
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.
Forward-Looking Statements: Certain statements
in this press release are forward-looking within the meaning of the
Private Securities Litigation Reform Act of 1995 regarding the
public offering and the intended use of proceeds from the
offering.
These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimate" and "intend," among others. Such forward-looking
statements are 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 actual results, financial condition,
performance, or achievements of the Company, or industry results,
to differ materially from the results, financial condition,
performance or achievements expressed or implied by such
forward-looking statements. These risks, uncertainties and other
factors are set forth in the Registration Statement on Form F-1
filed with the SEC, including in the section "Risk Factors," and in
future reports filed with the SEC. Given these risks, uncertainties
and other factors, prospective investors are cautioned not to place
undue reliance on these forward-looking statements. The Company
does not undertake an obligation to update or revise any
forward-looking statement.
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