Aminolevulinic Acid Hydrochloride

Data from a wide range of the Sun Pharma dermatology portfolio, including data on alopecia areata, psoriasis, acne and actinic keratosis products, will be highlighted during the meeting. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced it will present more than a dozen posters at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. The presentations will include data from across the Sun Pharma dermatology portfolio, including study results for LEQSELVI™ (deuruxolitinib), WINLEVI® (clascoterone), ILUMYA® (tildrakizumab-asmn), ODOMZO® (sonidegib) and LEVULAN® KERASTICK® (aminolevulinic acid HCl) + BLU-U® (blue light photodynamic therapy). "As an organization dedicated to supporting the dermatology community, the Fall Clinical Dermatology Conference offers a vitally important forum to present new data and highlight how Sun's innovative dermatology portfolio can support those living with alopecia areata, psoriasis, acne and other skin-related diseases," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We look forward to sharing data from across our portfolio with the dermatology research community and our esteemed industry colleagues." Six abstracts, accepted for poster presentations, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib). Approved earlier this year by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata, LEQSELVI™ is an oral JAK inhibitor that interrupts the pathways thought to contribute to hair loss in severe AA and delivered statistically significant efficacy at 24 weeks across two Phase 3 clinical trials. LEQSELVI™ data being presented at Fall Clinical showcase pooled long-term results for ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata. Additionally, two posters will present patient and clinician preferences for the treatment of alopecia areata. The WINLEVI® poster presentations will include new data showing significant reductions in casual facial sebum levels from baseline, stability in the presence of other commonly prescribed acne medications, and efficacy and safety from a pilot study in patients with skin of color. The conference will also feature data from three additional WINLEVI® studies. Sun Pharma will present the following posters at the 2024 Fall Clinical Dermatology Conference: LEQSELVI™ Presentations: Deuruxolitinib results in ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata: Pooled long-term efficacy and safety data from the open-label extension studies Patient Preferences for the Treatment of Alopecia Areata A Discrete Choice Experiment to Assess Clinician Preferences for the Treatment of Alopecia Optimization of deuruxolitinib dosing in adult patients with alopecia area: Results from a randomized, parallel-group, multicenter Phase 2 trial Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials WINLEVI® Presentations: Clinical evaluation of the sebum reduction induced by clascoterone cream 1%: Week 12 interim analysis Assessment of clascoterone cream 1% levels when layered with other topical acne medications Efficacy and safety of clascoterone cream 1% in patients with acne with skin of color: 16-week interim analysis The efficacy and safety of clascoterone cream 1% for the treatment of acne vulgaris are not dependent on patient age and sex: Results of a post hoc analysis Improvement in skin moisturization and lack of barrier damage with clascoterone cream 1% treatment: Results of a randomized, single-blind, split-face study in acne-prone individuals Comparison of the efficacy of clascoterone vs trifarotene and tazarotene for the treatment of acne vulgaris at Week 12: A systematic review and meta-analysis ILUMYA® Presentation: A systematic literature review and meta-analysis of the real-world effectiveness, quality of life, and safety of tildrakizumab for moderate-to-severe plaque psoriasis ODOMZO® Presentation: Lower rate of discontinuation of sonidegib compared to vismodegib in a real-world analysis of patients with basal cell carcinoma LEVULAN® KERASTICK® + BLU-U® Presentation: Evaluating the safety and efficacy of aminolevulinic acid 20% topical solution activated by blue light in the treatment of facial cutaneous squamous cell carcinoma in situ About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

First Phase 3 PDT study in patients with sBCC in the United States. Rigorous dual endpoints requiring complete clinical and cytological clearance of malignant lesions. Data now being analyzed, interim results expected November 2024. BCC is the most common skin cancer in the US with more than 3 million cases each year 1 . WOBURN, Mass., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”) , a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), announced today that the database for the treatment phase of study ALA-BCC-CT013 has been locked. The database lock is an important milestone in the lifecycle of a clinical trial, marking the end of data collection and the point at which no further changes can be made to the trial database. The clinical data are now ready for final analysis. This Phase 3 trial is to evaluate the safety and efficacy of Ameluz ® -PDT in combination with the BF-RhodoLED ® lamp for the treatment of sBCC. It is a double-blind, randomized, placebo-controlled multi-center study involving 186 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz ® -PDT or placebo-PDT) 1-2 weeks apart, repeated after three months if required. The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were evaluated. In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for Q1 2025. “If this indication is granted by the FDA this would expand our label from premalignant application for Actinic Keratoses to the treatment of cutaneous malignancy. It would be the next stage in our continued development of PDT and part of our vision to become the market leaders in this field” stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. About Actinic Keratosis AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed. 2 1. 2. 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 Relations Andrew Barwicki 1-516-662-9461 ir@bfri.com