DUSA Pharmaceuticals

Biofrontera Inc. Announces FDA Orange Book Listing of U.S. Patent for BF-RhodoLED® XL, Extends Protection of Ameluz®-PDT Through October 2040

Retrieved on: 
Monday, March 14, 2022
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BF-RhodoLED XL is a red-light lamp approved by the FDA for use in photodynamic therapy (PDT) in combination with Ameluz (Ameluz-PDT) for the treatment of mild-to-moderate actinic keratosis.

Key Points: 
  • BF-RhodoLED XL is a red-light lamp approved by the FDA for use in photodynamic therapy (PDT) in combination with Ameluz (Ameluz-PDT) for the treatment of mild-to-moderate actinic keratosis.
  • Inclusion of the 169 patent in the Orange Book provides Ameluz-PDT with protection through October 2040.
  • The listing of a patent in the Orange Book is confirmation by the FDA that such patent protects an approved drug or drug-device combination and constitutes a hurdle for generic manufacturers who wish to launch a generic product.
  • "The Orange Book listing is an endorsement by the FDA that the '169 patent covers our exclusively licensed approved drug-device combination and forestalls any potential generic competition until mid-2040.

Biofrontera Inc. Appoints Kevin D. Weber to its Board of Directors

Retrieved on: 
Monday, March 7, 2022
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WOBURN, Mass., March 07, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (the Company), a biopharmaceutical company specializing in the commercialization of dermatological products, announces the appointment of Kevin D. Weber to its Board of Directors, expanding Board membership to five Directors.

Key Points: 
  • WOBURN, Mass., March 07, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (the Company), a biopharmaceutical company specializing in the commercialization of dermatological products, announces the appointment of Kevin D. Weber to its Board of Directors, expanding Board membership to five Directors.
  • Mr. Weber is an experienced pharmaceutical executive who brings to Biofrontera more than 30 years of executive and commercialization experience with a particular expertise in product marketing.
  • Prior to Paraffin, Mr. Weber served in senior executive and marketing roles at Depomed, Hyperion Therapeutics and Medicis Pharmaceuticals.
  • From 2016 to 2021 Mr. Weber served as a member of the supervisory board of Biofrontera AG.

Biofrontera Inc. provides Update on Patient Recruitment for Phase III Study for the Treatment of sBCC with Ameluz®-PDT

Retrieved on: 
Tuesday, February 1, 2022
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Patient recruitment for this study has been ongoing since 2018 with completion of patient recruitment anticipated by the end of 2022.

Key Points: 
  • Patient recruitment for this study has been ongoing since 2018 with completion of patient recruitment anticipated by the end of 2022.
  • This randomized, double-blind and placebo-controlled study will include 186 patients at 12 study sites in the United States.
  • Patients will receive one cycle of two PDTs 1-2 weeks apart, which may be repeated after three months if required.
  • The primary study endpoint is the composite complete clinical and histological clearance of a main sBCC lesion, which will be selected at the beginning of the study.

Biofrontera Inc. Announces Preliminary Revenue for the Fourth Quarter and Full Year 2021

Retrieved on: 
Thursday, January 13, 2022
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Revenue for the fourth quarter of 2021 is anticipated to be in the range of approximately $9.1 million to $9.2 million, an increase of approximately 7% over the same quarter last year.

Key Points: 
  • Revenue for the fourth quarter of 2021 is anticipated to be in the range of approximately $9.1 million to $9.2 million, an increase of approximately 7% over the same quarter last year.
  • The preliminary unaudited revenue results described in this press release are estimates only and are based only on currently available information.
  • Our final revenue results upon completion of our closing procedures may vary from the preliminary revenue estimates.
  • We expect to issue our full audited financial results for the fourth quarter and fiscal year 2021 in March 2022.

Biofrontera Inc. Announces Participation in Two Dermatology Conferences in January

Retrieved on: 
Monday, January 10, 2022
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The presentations will be complemented by continuing medical education (CME) sessions on actinic keratosis (AK), PDT and the recent FDA-approval of the new PDT-lamp RhodoLED XL.

Key Points: 
  • The presentations will be complemented by continuing medical education (CME) sessions on actinic keratosis (AK), PDT and the recent FDA-approval of the new PDT-lamp RhodoLED XL.
  • In addition, the Company will host an expert advisory board meeting (Ad Board) with nine dermatologists at the 2022 Winter Clinical Dermatology Conference.
  • Erica Monaco, Chief Executive Officer of Biofrontera Inc., commented, We are extremely pleased with the growing body of high-quality scientific data for each product in our portfolio.
  • The IITs also represent confidence and interest within the dermatology community, strengthening the competitive positioning of Ameluz-PDT.

Biofrontera Inc. announces reduction of Biofrontera AG shareholding to less than 50% through warrant exercises

Retrieved on: 
Thursday, December 30, 2021
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Biofrontera AGs shareholding in Biofrontera Inc. of 8,000,000 shares is unchanged, but now represents approximately 47% of the currently outstanding shares.

Key Points: 
  • Biofrontera AGs shareholding in Biofrontera Inc. of 8,000,000 shares is unchanged, but now represents approximately 47% of the currently outstanding shares.
  • As a result, Biofrontera Inc. is no longer considered a subsidiary of Biofrontera AG.
  • Biofrontera Inc.s common stock and warrants are traded on the Nasdaq Capital Market under the ticker symbols BFRI and BFRIW, respectively.
  • Erica Monaco, CEO of Biofrontera Inc. states: Reducing Biofrontera AGs shareholding below 50% represents a major milestone in the development of Biofrontera Inc. towards a stand-alone entity that is independent of its former parent company.

Biofrontera Inc. Announces Enrollment of First Subject in Phase 2b Clinical Trial Evaluating Ameluz® + BF-RhodoLED® in Moderate-to-Severe Acne

Retrieved on: 
Monday, December 13, 2021
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Ameluz-PDT has the potential to improve treatment outcomes for millions of Americans with moderate-to-severe acne.

Key Points: 
  • Ameluz-PDT has the potential to improve treatment outcomes for millions of Americans with moderate-to-severe acne.
  • This study is an important component of Biofrontera groups clinical development strategy that aims to expand the FDA-label of our licensed product Ameluz.
  • The inclusion of additional indications aims at unlocking its full therapeutic and market potential in the US, stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.
  • The efficacy of Ameluz-PDT will be tested with respect to incubation periods of one and three hours compared to placebo.

Biofrontera Inc. Announces Notice of Allowance for U.S. Method-of-Use Patent on PDT-lamp

Retrieved on: 
Wednesday, December 8, 2021
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This is a patent covered by the exclusive license of Biofrontera Inc. to sell Ameluz and the RhodoLED lamp series in the USA.

Key Points: 
  • This is a patent covered by the exclusive license of Biofrontera Inc. to sell Ameluz and the RhodoLED lamp series in the USA.
  • The technical improvements claimed in the patent allow for greater standardization and procedural compliance for photodynamic therapy (PDT) with the combination product.
  • The 785 patent describes specific features of the LED arrays of the five panels constituting the lamp head of RhodoLED XL.
  • The 785 patent constitutes a continuation-in-part of U.S. patent number 17/071,496, and thus claims the same priority date of October 15, 2020.

Biofrontera Inc. Enrolls First Subject in Phase 1 Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz®

Retrieved on: 
Monday, December 6, 2021
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This open-label study is being conducted at eight sites and will enroll 100 subjects with mild-to-severe AK on the face and scalp.

Key Points: 
  • This open-label study is being conducted at eight sites and will enroll 100 subjects with mild-to-severe AK on the face and scalp.
  • The Phase 1 study follows a maximal-usage pharmacokinetics (PK) clinical study that was completed in early 2021.
  • As announced in June, results from that PK study were presented to the U.S. Food and Drug Administration (FDA).
  • With a focus on the fields of photodynamic therapy (PDT) and topical antibiotics, Biofrontera currently commercializes the FDA-approved flagship drug Ameluz in the United States.

Biofrontera Inc. Announces Notice of Allowance for U.S. Patent on Innovative Illumination Protocol

Retrieved on: 
Thursday, December 2, 2021
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This patented illumination protocol demonstrates Biofronteras commitment to the patients need for innovative treatments.

Key Points: 
  • This patented illumination protocol demonstrates Biofronteras commitment to the patients need for innovative treatments.
  • The patent application claims a method for photodynamic therapy in which a dynamic and innovative illumination protocol is implemented.
  • This protocol consists of changing illumination intensities combined in a predefined order with interruptions of the illumination to specifically modulate and reduce pain perception to the patient.
  • Implementation of the protocol to Biofronteras medical devices requires a software installation and can be rolled-out to both the BF-RhodoLED and BF-RhodoLED XL lamps.