Ecchymosis

MALVERN, Pa., Oct. 25, 2024 /PRNewswire/ -- Endo, Inc. announced today that a post hoc data analysis of a Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum, or CCH) in patients with Peyronie's disease will be shared during SurgeWest, the 100th annual meeting of the Western Section of the American Urological Association (AUA), taking place October 27-November 1, 2024. "I'm pleased to share this medical knowledge to help healthcare providers think of Peyronie's disease phases in a different way than the current literature suggests, which may be serving to limit or postpone treatment options for patients suffering from the condition," said Dr. Jesse Mills, urologist and presenting author of the study. "The outcomes for patients both with and without pain suggest that CCH may be an alternative to watchful waiting, regardless of the phase of disease." The Endo-supported research presentation is below: Peyronie's Disease Patients With Penile Pain at Baseline May Benefit From Collagenase Clostridium Histolyticum Treatment: A Post Hoc Analysis Authors: Jesse N. Mills, MD; Gregory A. Broderick, MD; Gregory J. Kaufman, MD; James P. Tursi, MD; Marian Ayad, PharmD, BCPS; Tina Rezakhani, PharmD, MBA; Sajel Patel, PharmD; Jeffrey Andrews, MS; Landon Trost, MD About the Post Hoc Phase 3 Data Analysis1 A post hoc analysis of pooled data from two randomized, double-blind, placebo-controlled Phase 3 trials was conducted to evaluate CCH treatment and improvement in penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or >18 months. CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or >18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline. Data support that there were no clear differences in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus >18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy. About Peyronie's Disease Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be painful during arousal and intimacy.2 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,3 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.4 About XIAFLEX® INDICATION XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Contraindications: XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method Corporal Rupture or Other Serious Injury to the Penis: Injection of XIAFLEX into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing Hypersensitivity Reactions, Including Anaphylaxis: In the double-blind, placebo-controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX- associated pruritus was similar after each injection regardless of the number of injections administered Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known Risk of Bleeding in Patients with Abnormal Coagulation: In the XIAFLEX controlled trials in Peyronie's disease, 65.5% of XIAFLEX-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin) Acute Post-Injection Back Pain Reactions: Post approval reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity Adverse Reactions Clinical trials In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain. Post-marketing experience Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie's disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported Click for full Prescribing Information , including Boxed Warning and Medication Guide. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Dr. Mills and any statements relating to product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable safety or efficacy data; uncertainties in the regulatory approval process; compliance with regulatory obligations including those under the XIAFLEX REMS Program; unexpected litigation or other disputes; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the ability to develop and expand our product pipeline and to continue to develop the market for XIAFLEX® and other branded or unbranded products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of any strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and In Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. References: Gelbard M, Goldstein I, Hellstrom W, et al. J Urol. 2013;190(1):199-207. Hellstrome WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, al. Adv Urol. 2011:282503 SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MALVERN, Pa., Oct. 17, 2024 /PRNewswire/ -- Endo, Inc. ("Endo") (OTCQX: NDOI) announced today that seven new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place October 17-20, 2024. "I'm proud to be among those in the medical community who are investigating the common but under-studied condition of Peyronie's disease," said Matthew Ziegelmann, MD, urologist and presenting author of one of the podium presentations. "Armed with new insights and data, the healthcare providers attending SMSNA will be able to better support their patients through understanding and treatment methods." The seven Endo-sponsored and Endo-supported presentations are below: Sponsored by Endo: Podium presentation: A Noninterventional, Retrospective Multicenter Study to Evaluate CCH Treatment in Adult Male Participants With Ventral Curvature of the Penis Due to Peyronie's Disease Authors: Matthew J. Ziegelmann, MD; Majdee Islam, MD; Alexander J. Tatem, MD; Richard C. Bennett, MD; James Tursi, MD; David Hurley, MD; Gregory Kaufman, MD; Kristen Gumpf, PA-C; Jeffrey Andrews, MS; Tina Rezakhani, PharmD, MBA; Marian Ayad, PharmD, BCPS; Jesse N. Mills, MD Development of a Survey to Assess Women's Sexual Health Providers' Awareness and Approach Toward Peyronie's Disease and the Impact on the Female Sexual Partner Authors: Irwin Goldstein, MD; Sue W. Goldstein, CSE, CCRC, IF; Rose Hartzell, PhD; Tami Rowen, MD; Sameena Rahman, MD; Becky Lynn, MD; Alyse Kelly-Jones, MD; David Hurley, MD; Gregory Kaufman, MD; Lisa Bathish, BA, PMP; Nicole Tay, BS; Sheryl Kingsberg, PhD Peyronie's Disease Patient Journey: An Extensive Electronic Medical Record Analysis Authors: Jill Davis, MS; David Hurley, MD; Lorraine O'Donnell, MS, MBA; Nicholas Lazarou, MPH, MBA; Kristen Gumpf, PA-C; Larry Lipshultz, MD; Alexander Tatem, MD Investigator-Initiated Research: Podium presentation: Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 2 Year Outcomes Authors: Henry Larson, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD Podium presentation: Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study Authors: Jesse Labbe, BS; Joshua Savage, PA-C; Klinton Brearton, CNP; Riley Warner, PA-C; Matthew Ziegelmann, MD; Sevann Helo, MD; Tobias Kohler, MD; Landon Trost, MD Podium presentation: Efficacy and Safety of Collagenase Clostridium Histolyticum in Treating Primary Hourglass Deformities in Atypical Peyronie's Disease Patients Authors: Dyvon Walker, MD; Majdee Islam, MD Evaluating Practice Patterns of Clostridium Collagenase Histolyticum Providers Authors: Ranveer Vasdev; Niki Parikh; Michael Sischka, MD; Mattew Ziegelmann, MD About Peyronie's Disease Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be painful during arousal and intimacy.1 It is estimated that PD can affect as many as 1 in 10 men in the U.S.,2 but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.3 About XIAFLEX® INDICATION XIAFLEX® is indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. IMPORTANT SAFETY INFORMATION FOR XIAFLEX Contraindications: XIAFLEX is contraindicated in the treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure and in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method Corporal Rupture or Other Serious Injury to the Penis: Injection of XIAFLEX into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture). Therefore, XIAFLEX should be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis. Cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma, some requiring surgical intervention, have been reported post-marketing Hypersensitivity Reactions, Including Anaphylaxis: In the double-blind, placebo-controlled portions of the clinical trials in Peyronie's disease, a greater proportion of XIAFLEX-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 XIAFLEX injection procedures). The incidence of XIAFLEX- associated pruritus was similar after each injection regardless of the number of injections administered Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections. The safety of more than one treatment course of XIAFLEX is not known Risk of Bleeding in Patients with Abnormal Coagulation: In the XIAFLEX controlled trials in Peyronie's disease, 65.5% of XIAFLEX-treated patients developed penile hematoma, and 14.5% developed penile ecchymosis. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin) Acute Post-Injection Back Pain Reactions: Post approval reports of acute lower back pain reactions, sometimes accompanied by radiation to the lower extremities, chest and arms, muscle spasms, chest pain, paresthesias, headache, and dyspnea, have been received by patients treated with XIAFLEX for Peyronie's disease. These events can be mild to severe in intensity. The events typically lasted for 15 minutes and typically did not require intervention. Administer the smallest number of treatment cycles necessary to treat the patient's curvature deformity Adverse Reactions Clinical trials In the XIAFLEX clinical trials for Peyronie's disease, the most frequently reported adverse drug reactions (≥25%) and at an incidence greater than placebo included: penile hematoma, penile swelling, and penile pain. Post-marketing experience Acute post-injection lower back pain reactions have occurred in close temporal proximity to XIAFLEX treatments Cases of localized skin and soft tissue necrosis events as sequelae of penile hematoma, some of which required surgical intervention Syncope and presyncope have been reported in men treated with XIAFLEX for Peyronie's disease. Most, but not all cases occurred in the immediate treatment period or within 1-2 days following injection. Bodily injuries associated with the syncopal events have been reported Click for full Prescribing Information , including Boxed Warning and Medication Guide. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Dr. Ziegelmann and any statements relating to product efficacy, clinical trials or studies, post-marketing experience, presentation of data, potential treatments or indications, therapeutic outcomes or treatment responses, safety or adverse reactions, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which we may not currently be able to predict. Although we believe that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable safety or efficacy data, preliminary data and trends that may not be predictive of future data or results, compliance with regulatory obligations including those under the XIAFLEX REMS Program, uncertainties and timing of the regulatory approval process, unexpected litigation or other disputes, our ability to successfully implement and execute on our strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. References: Hellstrome WJ. Int J Impot Res. 2003;15:S91-S92. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157. DiBenedetti DB, Nguyen D, Zografoset L, al. Adv Urol. 2011:282503 SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Data Highlight Positive Outcomes in Uncontrolled Gout With KRYSTEXXA ® and Progress in Addressing Sjögren's Disease THOUSAND OAKS, Calif., June 12, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of data across its diverse portfolio and pipeline at the European Alliance of Associations for Rheumatology's (EULAR) 2024 Congress, June 12-15 in Vienna. The 27 abstracts from Amgen-sponsored and partner-led studies demonstrate Amgen's commitment to improving the lives of patients living with inflammatory and rheumatic disease through the development of novel medicines. Key presentations include the first findings showing dazodalibep improved major biomarkers in Sjögren's disease, as well as data on treatment outcomes for uncontrolled gout based on a post-hoc analysis of the MIRROR trial for KRYSTEXXA® (pegloticase) with methotrexate. "We are deeply committed to advancing patient care through continuous innovation and rigorous science. The data presented at EULAR 2024 further demonstrate our efforts to address complex diseases," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "By advancing scientific research, we are not only enhancing our understanding of these conditions, but also paving the way for more effective treatments that have the potential to significantly improve patient outcomes." Additional presentations include new long-term data from the FOREMOST study of Otezla® (apremilast) in early oligoarticular psoriatic arthritis, as well as a post-hoc analysis of TAVNEOS® (avacopan) versus prednisone taper in patients with severe active MPA/GPA and active ear, nose or throat manifestations. For more information on the Amgen abstracts, see below. Abstracts and Presentation Times: Amgen-Sponsored Abstracts Dazodalibep CD40L blockade with dazodalibep significantly improves disease activity, swollen and tender joint counts, while reducing multiple T- and B-cell biomarkers in the MIDORA phase 2 study of patients with moderate-to-severe active rheumatoid arthritis Abstract #AB0746, Rheumatoid Arthritis (Publication only) Dazodalibep (anti-CD40L) effectively reduces multiple proteins associated with B-, T, and dendritic cell biomarkers in Sjögren's disease: Corroboration of immunophenotyping findings from the ALISS phase 2 study Abstract #OP0058, Clinical Abstract Sessions: New Targets and New Treatments in Sjön's Disease (Oral Abstract Presentations), Wednesday, June 12 from 5:00 to 5:10 p.m. CDT Sjögren's Disease Global burden of Sj ö gren's disease (SjD): Findings from a systematic literature review (SLR) of humanistic and clinical outcomes Abstract #AB0815, Sjögren`s syndrome (Publication Only) KRYSTEXXA® (pegloticase) Achievement of "gout remission" during intensive urate-lowering over 52 weeks of pegloticase therapy Abstract #POS0239, Clinical Poster Tours: Gout treatment in 2024 (Poster Tours), Friday, June 14 at 9:30 a.m. CDT Influence of acute gout flare and serum urate lowering on biomarkers of systemic inflammation Abstract #AB0114, Crystal related disorders (Publication Only) Patient-reported quality of life in uncontrolled gout and changes with intensive urate-lowering: Comparison of tophaceous and non-tophaceous patients Abstract #AB0112, Crystal related disorders (Publication Only) Pre-infusion glucocorticoid reduction/elimination in patients with uncontrolled gout treated with pegloticase and methotrexate: Experience of one community rheumatology practice Abstract #POS0936, Crystal related disorders (Poster View), Friday, June 14 at 9:30 a.m. CDT Uncontrolled Gout Cardiovascular disease, chronic kidney disease, pain, and psychological issues in patients with controlled vs. uncontrolled gout: A retrospective claims-based cohort analysis Abstract #POS0569, Crystal related disorders (Poster View), Wednesday, June 12 at 3:30 p.m. CDT The concept of gout remission as viewed by rheumatologists, nephrologists, and primary care physicians Abstract #POS0269, Clinical Poster Tours: Gout treatment in 2024 (Poster Tours), Friday, June 14 at 9:30 a.m. CDT Treatment patterns and quality of life in patients with controlled and uncontrolled gout Abstract #POS0940, Crystal related disorders (Poster View), Friday, June 14 at 9:30 a.m. CDT Otezla® (apremilast) Apremilast reduces axial inflammation in patients with psoriatic arthritis as assessed by CANDEN MRI scoring: Results from the phase 4 MOSAIC study Abstract #POS0982, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT Apremilast reduces inflammation as measured by MRI, clinical outcomes, and patient-reported outcomes in patients with psoriatic arthritis: Results from the phase 4 MOSAIC study Abstract #POS0968, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT Apremilast treatment in early oligoarticular psoriatic arthritis (PsA) improves clinical and patient-reported outcomes for up to 48 weeks – Data from the FOREMOST study Abstract #POS0976, Psoriatic arthritis (Poster View), Friday, June 14 at 9:30 a.m. CDT Apremilast for psoriatic arthritis in the Netherlands: Real-world data from the REWARD study Abstract #AB0453, Psoriatic arthritis (Publication Only) The use of disease activity thresholds for the Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire to assess patient perceptions of disease burden in patients with early oligoarticular psoriatic arthritis treated with apremilast in the FOREMOST study Abstract #AB0473, Psoriatic arthritis (Publication Only) Prolia® (denosumab) Comparative effectiveness of denosumab versus bisphosphonates among treatment-experienced postmenopausal women with osteoporosis in the U.S. Medicare program Abstract #POS0089, Clinical Poster Tours: Treatment Options in Metabolic bone diseases and Osteoporosis (Poster Tours), Thursday, June 13 at 9:54 a.m. CDT Comparative effectiveness of denosumab versus zoledronic acid among postmenopausal women with osteoporosis in the U.S. Medicare program Abstract #POS0583, Other diseases (Poster View), Thursday, June 13 at 9:30 a.m. CDT Risk of fragility fracture after long-term discontinuation of osteoporosis treatment in po st-menopausal osteoporosis women in France: A population-based study conducted on the nationwide claim database (SNDS) Abstract #OP0035, Clinical Abstract Sessions: Risk factors and treatment in osteoporosis (Oral Abstract Presentations), Wednesday, June 12 at 4:50 p.m. CDT TAVNEOS® (avacopan) Avacopan versus prednisone taper in patients with ANCA-associated vasculitis and ear, nose, or throat involvement Abstract #OP0174, Clinical Abstract Sessions: Vasculitis across different vessel sizes (Oral Abstract Presentations), Thursday, June 13 at 11:20 a.m. CDT Data from the ADVOCATE trial on 28 patients with ANCA-associated vasculitis who received avacopan without concomitant glucocorticoid use in the first 29 days Abstract #POS0246, Clinical Poster Tours: Miscellaneous in Vasculitis (Poster Tours), Friday, June 14 at 9:36 a.m. CDT UPLIZNA ® ( inebilizumab-cdon ) Burden of glucocorticoid use and associated toxicities in commercially insured adults with IgG4-related disease Abstract #POS0357, Clinical Poster Tours: IgG4 Related Disease (Poster Tours), Friday, June 14 at 2:45 p.m. CDT Insights into the design and study population of MITIGATE: The first multinational randomized controlled clinical trial in IgG4-related disease (IgG4-RD), evaluating the efficacy and safety of inebilizumab Abstract #POS0347, Clinical Poster Tours: IgG4 Related Disease (Poster Tours), Friday, June 14 at 2:45 p.m. CDT Partner-Led Abstracts Sjögren's Disease The use of natural language processing to characterize disease burden: Sexual distress in Sjögren's disease Abstract #AB0793, Sjön`s syndrome (Publication Only) Using social media listening to characterize the flare lexicon in patients with Sjögren's disease Abstract #AB0794, Sjön`s syndrome (Publication Only) TAVNEOS® (avacopan) Safety and effectiveness of avacopan beyond 52 weeks: Experience to date in the Early Access Program (EAP) Abstract #POS0865, Vasculitis, small and medium size vessels (Poster View), Thursday, June 13 at 2:45 p.m. CDT Design of AVACOSTAR: A real-world study of avacopan in ANCA-associated vasculitis (AAV) Abstract #AB1241, Vasculitis, small and medium size vessels (Publication Only) Uncontrolled Gout Osteoporosis in patients with gout in the United States Abstract #POS0563, Crystal related disorders (Poster View), Wednesday, June 12 at 3:30 p.m. CDT About KRYSTEXXA® (pegloticase) KRYSTEXXA ® (pegloticase) is the first and only biologic approved by the FDA to treat adults living with uncontrolled gout, a painful and debilitating inflammatory condition with which people continue to have abnormally high levels of uric acid and symptoms despite the use of conventional therapies. In 2022, the FDA approved expanding labeling to include co-administration with the immunomodulator methotrexate, based on results from the MIRROR randomized controlled trial, which showed significant improvements in efficacy and safety, including a reduction in infusion reactions. About Uncontrolled Gout Gout is a chronic, progressive inflammatory form of arthritis that is caused by high urate levels in the body. Tiny needle-like crystals can form and build up almost anywhere in the body. Patients with uncontrolled gout continue to have high levels of uric acid and ongoing symptoms of gout despite the use of oral urate-lowering therapies. Uncontrolled gout is a chronic, systemic disease, and if not addressed can have significant clinical consequences. KRYSTEXXA U.S. Indication KRYSTEXXA (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. KRYSTEXXA U.S. Important Safety Information WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids and closely monitored for anaphylaxis for an appropriate period after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to each infusion and treatment discontinued if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. Patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency should be screened prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency. CONTRAINDICATIONS In patients with G6PD deficiency. In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components. WARNINGS AND PRECAUTIONS Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Caution should be exercised in patients who have congestive heart failure and patients should be closely monitored following infusion. ADVERSE REACTIONS The most commonly reported adverse reactions (≥5%) are: KRYSTEXXA co-administration with methotrexate trial: gout flares, arthralgia, COVID-19, nausea and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reactions, pain in extremity, hypertension and vomiting. KRYSTEXXA pre-marketing placebo-controlled trials: gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting. Please see Full Prescribing Information, including Boxed Warning. About Otezla® (apremilast) Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 840,000 patients worldwide. About Psoriatic Arthritis Psoriatic arthritis is a chronic, inflammatory form of arthritis, which can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. It is estimated that nearly 38 million people worldwide have psoriatic arthritis. Around a third of people living with psoriasis may go on to develop psoriatic arthritis. If left untreated, psoriatic arthritis can cause disability. Otezla U.S. Indications Otezla (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Otezla is indicated for the treatment of adult patients with active psoriatic arthritis. Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease. Otezla U.S. Important Safety Information Contraindications Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation Warnings and Precautions Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo Behçet's Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended Adverse Reactions Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection. Use in Specific Populations Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Please click here for Otezla® Full Prescribing Information. About TAVNEOS® (avacopan) TAVNEOS® (avacopan), approved by the FDA as an adjunctive treatment of severe active ANCA-associated vasculitis (GPA/MPA), is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action. TAVNEOS blocks the complement 5a receptor (C5aR) from binding C5a, the pro-inflammatory complement system fragment. This is presumed to block C5a-mediated neutrophil activation and migration. The precise mechanism of TAVNEOS in ANCA-associated vasculitis (GPA/MPA) has not been definitively established. About ANCA-Associated Vasculitis ANCA-associated vasculitis is an umbrella term for a group of multi-system autoimmune diseases with small vessel inflammation. Inflamed vessels may rupture or become occluded giving rise to a broad array of clinical symptoms and signs related to a systemic inflammatory response which may result in profound impairment in the kidneys, lungs and other organs. Prior to the approval of TAVNEOS in severe active ANCA-associated vasculitis (GPA/MPA), the combination of immunosuppressants most often used for the treatment of ANCA-associated vasculitis (GPA/MPA) include cyclophosphamide or rituximab, combined with daily glucocorticoids (steroids) for prolonged periods, which can be associated with significant clinical consequences. TAVNEOS U.S. Indication TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS U.S. Important Safety Information Contraindications Serious hypersensitivity to avacopan or to any of the excipients. Warning and Precautions Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease. Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established. Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming. Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common. Adverse Reactions The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. Drug Interactions Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates. Please see Full Prescribing Information and Medication Guide. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads. Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Madison Howard, 773-636-4910 (media) Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors) SOURCE Amgen