Biofrontera submits application for FDA approval of new BF-RhodoLED® XL lamp

Rhea-AI Summary

Biofrontera AG (NASDAQ: BFRA) has submitted a request to the FDA for approval of the BF-RhodoLED XL, a new red-light source designed for photodynamic therapy (PDT) alongside its product Ameluz®. This larger lamp will treat mild to moderate actinic keratoses, enabling treatment of multiple lesions simultaneously. The BF-RhodoLED XL's patent protection is expected to bolster Ameluz's market position in the U.S. The lamp features an advanced user interface, enhancing treatment customization, but is not planned for European markets at this time.

Positive

• Submission of the BF-RhodoLED XL to the FDA for approval, expanding treatment capabilities.
• Expected increase in sales of Ameluz due to improved treatment options with the new lamp.
• Enhanced user interface and settings for individualized patient treatment.

Negative

• Current reimbursement limitations only allow the use of one tube of Ameluz per treatment.
• The approval is contingent on FDA requirements, which may delay market introduction.

Leverkusen, Germany, March 31, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the “Company”), an international biopharmaceutical company, today announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy (PDT) to be used in combination with Ameluz^®, the BF-RhodoLED^® XL, to the U.S. Food and Drug Administration (FDA).

The new BF-RhodoLED^® XL is to be approved in combination with Ameluz^® for the treatment of mild and moderate actinic keratoses on the face and scalp. This corresponds to the current approval of Ameluz^®, with plans to broaden the label to include additional indications in the future. The new PDT lamp enables the treatment of larger areas as well as the simultaneous exposure of several actinic keratoses distant from each other. This regulatory filing is independent of the change in product information submitted to the FDA in February to allow the use of up to three tubes of Ameluz® per treatment, but complements it in an effort to treat larger areas. Currently, the product information and thus reimbursement is limited to the use of one tube of Ameluz^® per treatment.

Ahead of the submission to the FDA, the new lamp was protected by several patent applications, which, due to the specifics of the FDA's combination approval, will also protect Ameluz^® itself in the US, our key market, once the patents are granted.

"The new BF-RhodoLED^® XL offers an improved control panel with a significantly enhanced graphical user interface and intuitive user navigation. The lamp’s extremely versatile setting options allow the treatment to be specifically adapted to the needs of each individual patient," explains Prof. Dr. Lübbert, CEO of Biofrontera AG. "Combined with a modern, high-quality design, we expect strong customer acceptance particularly in the U.S. and, as a result, an increase in Ameluz^® sales."

The treatment parameters of the new BF-RhodoLED^® XL, such as light dose, illumination time and wavelength of light are identical to the current model BF-RhodoLED^®. The approval, as with the BF-RhodoLED^®, will be granted as a combination approval with our prescription drug Ameluz^®, in accordance with FDA requirements. In order to meet the FDA's strict requirements for the manufacture of a class III medical device, production of the new lamp has, similar to the older model, been established at the Company's headquarters in Leverkusen. At present, there are no plans to market the new BF-RhodoLED^® XL in Europe. The current BF-RhodoLED^® model will continue to be offered in all our markets.

-End-

Biofrontera AG
Pamela Keck, Head of Investor Relations
ir@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.

FAQ

What is the BF-RhodoLED XL approved for?

The BF-RhodoLED XL is submitted for FDA approval to treat mild and moderate actinic keratoses, in combination with Ameluz®.

How does the BF-RhodoLED XL differ from the previous model?

The BF-RhodoLED XL is larger, allowing treatment of larger areas and multiple lesions at once, with improved user interface.

When was the FDA submission for BF-RhodoLED XL made?

The submission for the BF-RhodoLED XL was announced on March 31, 2021.

What are the benefits of using Ameluz® with BF-RhodoLED XL?

The combination enables more efficient treatment of actinic keratoses, potentially increasing patient throughput and sales.

Are there any limitations to the BF-RhodoLED XL's approval?

Yes, the approval is tied to FDA requirements and current reimbursement policies restrict the use of Ameluz® during treatment.