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5 days ago
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Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
Biofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043. The Orange Book is published by the U.S. Food and Drug Administration (FDA) and lists all approved prescription drug products, along with patent and exclusivity information. Inclusion signifies FDA recognition of the revised formulation's approved status and its intellectual property protection. WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication 'Approved Drug Products with Therapeutic Equivalence Evaluations' (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. 'We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz® RhodoLED PDT.' References: Jacob SE, et al. 'Contact Allergy to Propylene Glycol: A Review.' Dermatitis. 2008;19(3):157–163. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-05-2025
- Business
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Biofrontera Inc. Reports First Quarter 2025 Financial Results and Provides a Business Update
WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three months ended March 31, 2025 and provided a business update. Highlights from the first quarter of 2025 and subsequent weeks included the following: Total revenues for the first quarter of 2025 were $8.6 million, a 9% increase from the same period of the prior year. Cash and cash equivalents were $1.8 million as of March 31, 2025, compared with $5.9 million on December 31, 2024. Announced the enrollment of the final patient in the Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses on the extremities, neck and trunk. Achieved a key milestone in the Phase 3 study of the use of Ameluz® and RhodoLED® photodynamic therapy ('PDT') in the treatment of sBCC (ALA-BCC-CT013), with the last patient completing the 1-year follow-up visit in December 2024. Received patent approval for a revised formulation of Ameluz® which extends protection for the treatment through to December 2043. Completed patient enrollment in phase 2b study of Ameluz® Topical Gel, 10% for the treatment of moderate to severe acne vulgaris. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated, "The beginning of 2025 has been a very encouraging and rewarding period for us, as we have improved our revenues by 9%. We continue to see current customers reordering as well as new medical offices coming on board and placing their initial orders of Ameluz®, illustrating the strength of our products and the success of our sales and marketing efforts. As part of our combination therapy, we also sold a good mix of the two differently-sized BF-RhodoLED® lamps.' "The enrollment of the final patient in the Phase 3 clinical trial evaluating Ameluz® for the treatment of mild to moderate actinic keratoses on the extremities, neck and trunk is something that we are excited about. Additionally, our past investments in PDT allow us to strategically plan and establish partnerships with dermatologists to future expansions of our label to the treatment of a cutaneous malignancy or moderate to severe acne,' concluded Mr. Luebbert. First Quarter Financial Results Total revenues for the three months ended March 31, 2025 were $8.6 million, an increase of $0.7 million, or 8.7% as compared to the three months ended March 31, 2024. The increase was driven by a $0.5 million increase in Ameluz® sales due to an increased unit price and the launch of our RhodoLED® XL Lamp, which resulted in sales of RhodoLED®XL lamps of $0.2 million. Total operating expenses were $13.1 million for the first quarter of 2025 compared with $13.4 million for the first quarter of 2024. Cost of revenues, related party was $3.1 million for the first quarter of 2025 compared with $4.0 million for the prior-year quarter. This was a decrease of $0.9 million, or 22.1%, as compared to the three months ended March 31, 2024, due to the reduced cost structure under the last amendment of the Ameluz® license and supply agreement. Selling, general and administrative expenses for the three months ended March 31, 2025 decreased by $0.6 million, or 6.5% as compared to the three months ended March 31, 2024. Selling and marketing expenses decreased $0.8 million, with a $0.3 million decrease coming from direct sales team personnel expenses due to head count fluctuation and a $0.5 million decrease driven by reduced general marketing activity and conference spending. These decreases were partially offset by an increase in legal expenses of $1.2 million due to patent claims, which was partially offset by savings of $0.8 million in personnel and financing expenses. Research and development ('R&D') expenses for the three months ended March 31, 2025 increased by $1.2 million as compared to the three months ended March 31, 2024. The increase was attributed to our assumption of all clinical trial activities for Ameluz® in the United States effective June 1, 2024, allowing for more effective cost management and direct oversight of trial efficiency. This increase in R&D expense was and will continue to be offset by a reduction in the Transfer Price of Ameluz® from 50% to 25% for inventory purchases made through 2025. The net loss for the first quarter of 2025 was $4.2 million, or $(0.47) per share, compared with a net loss of $10.4 million, or $(2.88) per share, for the prior-year quarter. The change in net loss reflects a decrease in the non-cash change in fair value of warrant liabilities driven by a decrease in the outstanding population, a decrease in interest expense due to the payoff of high-interest debt in 2024, and the aforementioned decreases in cost of revenues, related party and selling, general and administrative expenses, partially offset by increased R&D spending. Adjusted EBITDA increased from ($4.6) million for the three months ended March 31, 2024 to ($4.4) million for the three months ended March 31, 2025. The increase was driven by an increase in gross profit of $1.5 million offset by a $1.2 million increase in R&D expenses. These changes were driven by the reduced cost structure under the latest amendment of the Ameluz® license and supply agreement and assumption of all clinical trial activities for Ameluz®. Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the first quarters of 2025 and 2024. Conference Call Details Conference call: Friday, May 16, 2025 at 10:00 AM ETToll Free: 1-877-877-1275 (U.S. toll-free)International: 1-412-858-5202Webcast: First Quarter 2025 Financial Results and Business Update Conference Call About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz ® with the RhodoLED® lamp series for PDT of actinic keratoses, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and X . ContactsInvestor RelationsAndrew Barwicki1-516-662-9461ir@ Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company's revenue guidance, business and marketing strategy, revenue growth, development and expansion of the Company's sales force and commercial infrastructure, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, educational outreach efforts, and other statements that are not historical facts. The words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential," "target," "goal," "assume," "would," "could" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We have based these forward-looking statements on our current expectations and projections about future events; nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to, our ability to achieve and sustain profitability; our ability to compete effectively in selling our licensed products; our ability to compete effectively in selling our licensed products; our ability to expand, manage and maintain our direct sales and marketing organizations, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our Licensors; our Licensors' ability to manufacture our licensed products; our Licensors' ability to adequately protect their intellectual property and operate their business without infringing upon the intellectual property rights of others; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations in the healthcare industry; the willingness of healthcare providers to purchase our licensed products if coverage, reimbursement and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market, commercialize, achieve market acceptance for and sell our licensed products; any product quality issues, product defects, or product liability claims; our ability to comply with The Nasdaq Stock Market, LLC continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion of research, development and preclinical studies and clinical trials for our licensed products; our Licensors' ability to obtain and maintain the regulatory approvals necessary for the marketing of our licensed products in the United States; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not undertake to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release, except as may be required by law. (Tables follow) BIOFRONTERA CONSOLIDATED BALANCE SHEETS() March 31, 2025 December 31, 2024 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 1,785 $ 5,905 Investment, related party 7 7 Accounts receivable, net 4,031 5,315 Inventories, net 6,527 6,646 Prepaid expenses and other current assets 682 527 Asset held for sale 2,300 2,300 Total current assets 15,332 20,700 Property and equipment, net 59 80 Operating lease right-of-use assets 713 903 Intangible assets, net 31 35 Other assets 453 383 Total assets $ 16,588 $ 22,101 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable 3,300 1,856 Accounts payable, related parties, net 2,650 5,344 Operating lease liabilities 426 548 Accrued expenses and other current liabilities 4,583 4,273 Total current liabilities 10,959 12,021 Long-term liabilities: Convertible notes payable, net 4,217 4,098 Warrant liabilities 702 1,250 Operating lease liabilities, non-current 220 276 Other liabilities 21 23 Total liabilities 16,119 17,668 Commitments and contingencies Stockholders' equity: Preferred Stock, $0.001 par value, 20,000,000 shares authorized, no Series B-1, 3,366 Series B-2 and 6,763 Series B-3 shares issued and outstanding as of March 31, 2025 and December 31, 2024 - - Common Stock, $0.001 par value, 35,000,000 shares authorized; 8,873,932 and 1,517,628 shares issued and outstanding as of March 31, 2025 and December 31, 2024 9 9 Additional paid-in capital 122,072 121,833 Accumulated deficit (121,612 ) (117,409 ) Total stockholders' equity 469 4,433 Total liabilities and stockholders' equity $ 16,588 $ 22,101 BIOFRONTERA CONSOLIDATED STATEMENTS OF OPERATIONS() Three Months Ended March 31, 2025 2024 Product revenues, net $ 8,588 $ 7,901 Revenues, related party - 11 Total revenues, net 8,588 7,912 Operating expenses Cost of revenues, related party 3,075 3,946 Cost of revenues, other 193 170 Selling, general and administrative 8,653 9,250 Selling, general and administrative, related party 7 (4 ) Research and development 1,207 17 Total operating expenses 13,135 13,379 Loss from operations (4,547 ) (5,467 ) Other income (expense) Change in fair value of warrant liabilities 548 (3,429 ) Change in fair value of investment, related party - 3 Loss on debt extinguishment - (316 ) Interest expense, net (106 ) (1,407 ) Other income (expense), net (99 ) 180 Total other income (expense) 343 (4,969 ) Loss before income taxes (4,204 ) (10,436 ) Income tax expense (1 ) 1 Net loss $ (4,203 ) $ (10,437 ) Basic and diluted $ (0.47 ) $ (2.88 ) Basic and diluted 8,873,932 3,623,593 BIOFRONTERA TO NON-GAAP ADJUSTED EBITDA RECONCILIAITION(In thousands, except per share amounts and number of shares)(Unaudited) Three Months Ended March 31, 2025 2024 Net loss $ (4,203 ) $ (10,437 ) Interest expense, net 106 1,407 Income tax expenses (1 ) 1 Depreciation and amortization 29 128 EBITDA (4,069 ) (8,901 ) Loss on debt extinguishment - 316 Change in fair value of warrant liabilities (548 ) 3,429 Change in fair value of investment, related party - (3 ) Stock based compensation 239 228 Expensed issuance costs - 354 Adjusted EBITDA $ (4,378 ) $ (4,577 ) -51.0 % -57.9 %Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-05-2025
- Business
- Yahoo
Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris
Biofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043 Ameluz PDT offers the potential for effective treatment of moderate to severe acne without the side effects associated with some systemic therapies4 Approximately 50 million people in the US are suffering from acne vulgaris, including both adolescents and adults1,2 The US acne treatment market was valued at $5.7 billion in 2024 and is growing annually5 WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), received confirmation that the updated formulation of the Ameluz® nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz® by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz® against generic competition, Biofrontera today announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods —1 hour and 3 hours. One tube of Ameluz® or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place. Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz® for a potential new dermatological indication. Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed enthusiasm about its potential impact. 'We see many patients who suffer from inflammatory acne. The possibility of expanding the indication for Ameluz® PDT to treat this disorder would be welcomed by physicians and our patients. I look forward to seeing the final results of the study.' The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. Notably, over 55% of total market spending is attributed to oral antibiotics and isotretinoin, the primary treatments for moderate to severe inflammatory acne6. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. 'We are thrilled to reach this pivotal stage in our clinical program,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'The successful enrollment of our last patient in this important Phase 2b study brings us closer to offering an effective treatment option for patients with moderate to severe acne. It marks a significant step in expanding the indications for Ameluz® PDT over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Together with our patent protection now lasting to December 2043, extensions of the Ameluz approved indications position our company for future growth.' About Acne vulgaris Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people annually1. While often associated with adolescence, studies have shown that acne affects approximately 40% of the adult population2. It can range from mild (blackheads and whiteheads) to more severe forms, including inflammatory pimples, nodules, and cysts. If not treated effectively, acne may lead to permanent scarring and can significantly affect a person's mental health and self-esteem3. According to U.S. clinical guidelines, treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin which may have serious side effects4. As a result, there is a growing need for effective alternatives. References: American Academy of Dermatology Association. Acne: Overview. ↩ Collier CN et al. 'The prevalence of acne in adults 20 years and older.' J Am Acad Dermatol. 2008;58(1):56–59. ↩ Tan JK, Bhate K. 'A global perspective on the epidemiology of acne.' Br J Dermatol. 2015;172 Suppl 1:3–12. ↩ Zaenglein AL et al. 'Guidelines of care for the management of acne vulgaris.' J Am Acad Dermatol. 2016;74(5):945–973.e33. ↩ Fortune Business Insights. Acne Treatment Market Size, Share & Trends Report, 2024–2032. ↩ IQVIA Institute Report, U.S. Dermatology Market Analysis, 2023. (Note: Replace with actual IQVIA data if available or request specific spending data from your market access team.) About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@
Yahoo
15-05-2025
- Business
- Yahoo
Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris
Biofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043 Ameluz PDT offers the potential for effective treatment of moderate to severe acne without the side effects associated with some systemic therapies4 Approximately 50 million people in the US are suffering from acne vulgaris, including both adolescents and adults1,2 The US acne treatment market was valued at $5.7 billion in 2024 and is growing annually5 WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), received confirmation that the updated formulation of the Ameluz® nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz® by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz® against generic competition, Biofrontera today announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods —1 hour and 3 hours. One tube of Ameluz® or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place. Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz® for a potential new dermatological indication. Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed enthusiasm about its potential impact. 'We see many patients who suffer from inflammatory acne. The possibility of expanding the indication for Ameluz® PDT to treat this disorder would be welcomed by physicians and our patients. I look forward to seeing the final results of the study.' The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. Notably, over 55% of total market spending is attributed to oral antibiotics and isotretinoin, the primary treatments for moderate to severe inflammatory acne6. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. 'We are thrilled to reach this pivotal stage in our clinical program,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'The successful enrollment of our last patient in this important Phase 2b study brings us closer to offering an effective treatment option for patients with moderate to severe acne. It marks a significant step in expanding the indications for Ameluz® PDT over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Together with our patent protection now lasting to December 2043, extensions of the Ameluz approved indications position our company for future growth.' About Acne vulgaris Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people annually1. While often associated with adolescence, studies have shown that acne affects approximately 40% of the adult population2. It can range from mild (blackheads and whiteheads) to more severe forms, including inflammatory pimples, nodules, and cysts. If not treated effectively, acne may lead to permanent scarring and can significantly affect a person's mental health and self-esteem3. According to U.S. clinical guidelines, treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin which may have serious side effects4. As a result, there is a growing need for effective alternatives. References: American Academy of Dermatology Association. Acne: Overview. ↩ Collier CN et al. 'The prevalence of acne in adults 20 years and older.' J Am Acad Dermatol. 2008;58(1):56–59. ↩ Tan JK, Bhate K. 'A global perspective on the epidemiology of acne.' Br J Dermatol. 2015;172 Suppl 1:3–12. ↩ Zaenglein AL et al. 'Guidelines of care for the management of acne vulgaris.' J Am Acad Dermatol. 2016;74(5):945–973.e33. ↩ Fortune Business Insights. Acne Treatment Market Size, Share & Trends Report, 2024–2032. ↩ IQVIA Institute Report, U.S. Dermatology Market Analysis, 2023. (Note: Replace with actual IQVIA data if available or request specific spending data from your market access team.) About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
15-05-2025
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- Associated Press
Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris
WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), received confirmation that the updated formulation of the Ameluz® nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz® by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz® against generic competition, Biofrontera today announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods —1 hour and 3 hours. One tube of Ameluz® or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place. Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz® for a potential new dermatological indication. Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed enthusiasm about its potential impact. 'We see many patients who suffer from inflammatory acne. The possibility of expanding the indication for Ameluz® PDT to treat this disorder would be welcomed by physicians and our patients. I look forward to seeing the final results of the study.' The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. Notably, over 55% of total market spending is attributed to oral antibiotics and isotretinoin, the primary treatments for moderate to severe inflammatory acne6. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. 'We are thrilled to reach this pivotal stage in our clinical program,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'The successful enrollment of our last patient in this important Phase 2b study brings us closer to offering an effective treatment option for patients with moderate to severe acne. It marks a significant step in expanding the indications for Ameluz® PDT over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Together with our patent protection now lasting to December 2043, extensions of the Ameluz approved indications position our company for future growth.' About Acne vulgaris Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people annually1. While often associated with adolescence, studies have shown that acne affects approximately 40% of the adult population2. It can range from mild (blackheads and whiteheads) to more severe forms, including inflammatory pimples, nodules, and cysts. If not treated effectively, acne may lead to permanent scarring and can significantly affect a person's mental health and self-esteem3. According to U.S. clinical guidelines, treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin which may have serious side effects4. As a result, there is a growing need for effective alternatives. References: About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact: Investor Relations Andrew Barwicki 1-516-662-9461 [email protected]
