The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients > 6 years of age with EB simplex generalized . The main question it aims to answer are: describe efficacity of this treatment.
Participants will take treatments and have to use bullets during the study period.

Start Date01 Nov 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nice

100 Clinical Results associated with Apremilast

100 Translational Medicine associated with Apremilast

100 Patents (Medical) associated with Apremilast

1,182

Literatures (Medical) associated with Apremilast

01 Feb 2025·ALCOHOL

Alcohol drinking is attenuated by PDE4 inhibition but partial microglia depletion is not sufficient to block stress-induced escalation of alcohol intake in female mice

Article

Author: Soares, Alexa R ; Garcia-Rivas, Vernon ; Mineur, Yann S ; Na, Jessica J ; Thomas, Merrilee A ; Picciotto, Marina R ; Smith, Asia

Stress is a major contributing factor to binge drinking and development of alcohol use disorders (AUD), particularly in women. Both stress and chronic ethanol can enhance neuroinflammatory processes, which may dysregulate limbic circuits involved in ethanol reinforcement. Clinical and preclinical studies have identified sex differences in alcohol intake in response to neuroinflammatory triggers. Since both cyclic AMP (cAMP) signaling and microglial activation contribute to neuroinflammation, we explored their contribution to stress-induced ethanol drinking in mice. To this end, we first trained C57BL/6J male and female mice to volitionally drink ethanol through a modified version of the "Drinking-in-the-Dark" paradigm. We then assessed whether exposure to foot shock stress followed by repeated exposure to the previously stress-paired context might alter volitional ethanol drinking. We observed that stress exposure resulted in a delayed increase in ethanol intake, but only in female mice. The anti-inflammatory drug Apremilast, an inhibitor of phosphodiesterase type 4 (PDE4; the primary enzyme for cAMP degradation in the brain), reduced ethanol intake and decreased preference for ethanol regardless of stress exposure in females. In contrast, a partial pharmacological depletion of microglia via PLX3397 treatment did not significantly alter baseline ethanol drinking or stress-induced ethanol drinking in female mice. This study shows that female mice are more susceptible to stress-induced ethanol drinking than males, and that this occurs even after partial microglial depletion. In addition, modulation of cAMP signaling by Apremilast administration reduced ethanol drinking regardless of stress exposure, supporting the idea that it might be useful for treatment of AUD.

01 Jan 2025·EBioMedicine

Biological, as opposed to classic antipsoriatic drug or apremilast, treatment mitigates the risk of death and cardiovascular disease in psoriasis

Article

Author: Thaci, Diamant ; Zirpel, Henner ; Ludwig, Ralf J ; Vorobyev, Artem ; Moderegger, Eva Lotta ; Bieber, Katja ; Gershater, Bernard ; Olbrich, Henning ; Hernandez, Gema ; Kridin, Khalaf ; Ludwig, Marlene A

BACKGROUND:

Cardiovascular comorbidity increases morbidity and mortality in psoriasis. Systemic treatments, particularly biologics, are effective in alleviating skin and joint inflammation. Conversely, the impact of systemic therapy on cardiovascular disease risk and mortality in psoriasis remains uncertain.

METHODS:

Impact of systemic treatments on all-cause mortality and cardiovascular disease risk in psoriasis patients' electronic health records (EHRs) from TriNetX was assessed. Treatment categories included apremilast, IL-17 inhibitors (IL-17i), IL23i, TNFi, and classic antipsoriatic drugs. Index event was the first prescription of each treatment, requiring a two-year continuous treatment with exclusion of other systemic antipsoriatic drugs. Propensity-score matching was used to improve comparability. Sensitivity analyses ensured study robustness.

FINDINGS:

In descriptive analysis, all-cause mortality rates were 0.61% (classic antipsoriatics, n = 7929), 0.91% (apremilast, n = 1101), 0.00% (IL17i, n = 677), 0.81% (IL23i, n = 1242), and 0.20% (TNFi, n = 6468). Major adverse cardiac events (MACE) were documented in 8.49% (classic antipsoriatics), 5.14% (apremilast), 2.99% (IL17i), 2.09% (IL23i), and 3.74% (TNFi) EHRs. Propensity-score matching showed all-cause mortality rates of 0.23% for any biologic vs. 0.49% for classic antipsoriatics or apremilast, resulting in an HR of 2.21 (95% CI 1.21-3.71, p = 0.0073). MACE risk was also higher with classic antipsoriatics or apremilast (HR 1.66, CI 1.43-1.93, p < 0.0001). The majority of findings were consistent across all four sensitivity analyses. No significant differences in all-cause mortality or MACE risk were observed among biologics.

INTERPRETATION:

Biological treatment, as opposed to classic antipsoriatic drugs or apremilast, reduces risk of death and cardiovascular disease in psoriasis. Prospective trials are required to validate these findings.

FUNDING:

DFG: EXC 2167 and LU 877/25-1. State of Schleswig Holstein: Excellence-Chair Program.

01 Jan 2025·JOURNAL OF DERMATOLOGY

Successful treatment of Darier's disease with apremilast and review of reported cases

Article

Author: Kinjyo, Kengo ; Asano, Yoshihide ; Muto, Yusuke

Abstract:

Darier's disease (DD) is a rare autosomal dominant genetic disorder caused by a mutation in ATP2A2, which encodes calcium (Ca2+) ATPase pumps in the endoplasmic reticulum. In this report, we present the first documented case in Japan successfully treated with apremilast. An 18‐year‐old female presented with red or brown hyperkeratotic papules and plaques on her head, neck, and chest. Histopathological examination revealed a hyperkeratotic, acanthotic epidermis, along with suprabasal acantholysis characterized by corps ronds and grains. Exome sequencing of DNA from peripheral blood mononuclear cells identified a missense mutation in ATP2A2. Based on the above results, we diagnosed her with DD despite the absence of a family history. Given the effectiveness of apremilast, a phosphodiesterase 4 inhibitor, in treating Hailey‐Hailey disease (HHD), a genetically related disorder involving ATPases in epidermal calcium channels, we opted for apremilast therapy. Eight weeks post‐initiation, significant improvement was observed in the patient's skin lesions on the head, neck, and chest. In this paper, we discuss the successful treatment of DD and HHD cases with apremilast, providing insights into its therapeutic potential, and offer a comprehensive review.

268

News (Medical) associated with Apremilast

24 Dec 2024

·www.echemi.com

AbbVie Acquires Nimble, Accelerating the Development of Oral Peptide Therapies

In the field of immunotherapy, the market for oral peptide therapies is gradually emerging. Recently, AbbVie announced that it has reached a final acquisition agreement with Nimble Therapeutics. This transaction will enable AbbVie to obtain Nimble's core assets, including its oral peptide IL-23 inhibitor project, which is in the preclinical research stage and aims to treat psoriasis, as well as an innovative pipeline of oral peptide candidates targeting various autoimmune diseases. Additionally, AbbVie will gain access to Nimble's peptide synthesis, screening, and optimization platform, which employs proprietary technology to accelerate the discovery and optimization of peptide candidates targeting multiple pathways. AbbVie has long been active in the field of immunotherapy, and as its flagship product Humira faces patent expiration, the company is actively seeking new growth opportunities. This acquisition of Nimble Therapeutics not only enriches AbbVie's product pipeline but also strengthens its research and development capabilities in the field of oral peptide therapies. In the realm of oral medications for psoriasis, Johnson & Johnson's JNJ-2113 shows best-in-class potential, leading over other competitors. Just last month, Johnson & Johnson announced that the ICONIC-LEAD clinical trial achieved top-line results, marking the imminent market entry of the world's first targeted oral peptide Icotrokinra that selectively blocks IL-23 receptors. In light of Johnson & Johnson's progress, AbbVie is making every effort to ensure it maintains a leading position in this competition. Globally, there are over 125 million psoriasis patients, and this chronic disease requires long-term treatment, giving rise to a substantial treatment market. The global psoriasis market has reached $26.5 billion, and it is expected to maintain a 8.6% compound annual growth rate (CAGR) from 2022 to 2030. For the treatment of plaque psoriasis, 22 targeted therapies have been approved worldwide. Among these therapies, AbbVie and Johnson & Johnson are undoubtedly market leaders. Oral medications are increasingly favored by long-term treatment patients due to their convenience. Current oral medications include PDE4 inhibitor apremilast, TYK2 allosteric inhibitor deucravacitinib, and JAK inhibitor upadacitinib. Moreover, numerous multinational companies are actively entering the oral medication market for psoriasis. Johnson & Johnson's JNJ-2113 (Icotrokinra), as the world's first oral IL-23 receptor antagonist, relies on Protagonist Therapeutics' unique peptide technology platform, successfully overcoming challenges related to the low bioavailability, permeability, and stability of oral peptides, as well as gastrointestinal degradation. In the Phase III ICONIC-LEAD study, it demonstrated superior data compared to other oral competitors. With strong efficacy data, Johnson & Johnson is highly confident in JNJ-2113, predicting that the drug could achieve a market potential of $5 billion. Observing Johnson & Johnson's breakthrough progress in the oral medication space for psoriasis, AbbVie is also stepping up its efforts to expand its product line and maintain its leadership in the treatment of autoimmune diseases. AbbVie has turned its attention to Nimble Therapeutics, a biotechnology company focused on developing oral peptide therapies. Nimble's research achievements, particularly the IL-23R inhibitor, are noteworthy; this is a preclinical oral therapy designed to provide new treatment options for patients with psoriasis and inflammatory bowel disease (IBD). Importantly, this target shares the same profile as AbbVie's existing blockbuster injectable Risankizumab, indicating that Nimble's research results could synergize with AbbVie's current product line. Nimble claims that its designed drugs not only inherit the strong activity of injectable IL-23 medications but also have an extended half-life. Furthermore, Nimble has disclosed two additional candidates targeting systemic severe myasthenia gravis and IBD, both of which are also in preclinical testing. Through this acquisition, AbbVie will not only incorporate Nimble's product line but also gain advanced technology from this Madison, Wisconsin-based company for synthesizing, screening, and optimizing peptide candidates. This will provide powerful technical support for AbbVie in the field of oral peptide therapies, accelerating its R&D progress in this emerging area. In fact, AbbVie’s acquisition of Nimble marks its third significant acquisition in the immunotherapy developer space this year. This series of consecutive acquisitions not only highlights AbbVie's proactive positioning in the field of immunotherapy but also reveals the company's urgency in maintaining its market leadership, especially against the backdrop of competitors like Johnson & Johnson making strides in oral medications for psoriasis. The peptide industry is currently experiencing an unprecedented golden development period. Compared to small molecular chemical drugs, peptide drugs exhibit higher bioactivity and specificity; compared to biological drugs, they stand out due to low immunogenicity, high purity, and lower production costs. Overall, peptide drugs are favored for their high activity, low dosage, and low toxicity. Frost & Sullivan predicts that the global peptide drug market will grow from $60.7 billion in 2018 to $89.5 billion in 2023, and is expected to reach $189 billion by 2028. When efficacy reaches a certain level, oral medications often become the treatment choice for patients due to their adherence advantages. However, due to the unique chemical and biological characteristics of peptide drugs, their oral delivery remains one of the significant challenges in the pharmaceutical field. Since the discovery of insulin, research on oral peptides has never ceased. Due to the poor permeability of peptide drugs and their susceptibility to degradation by proteases in the gastrointestinal tract, most available peptide drugs are in injectable form. However, the long-term repeated injection not only affects patients' quality of life but also increases the complexity of manufacturing and storage, ultimately leading to higher medical costs. Thus, although the development of oral peptide drugs has been a research hotspot in the pharmaceutical field, few successful products have emerged due to the numerous challenges in absorption. With in-depth studies on the absorption mechanisms of peptides, innovative technologies developed by scientists are gradually breaking the barriers to peptide absorption in the gastrointestinal tract, and some oral peptide drugs have successfully hit the market. For example, the recently spotlighted Semaglutide is a GLP-1 peptide drug that traditionally has been administered via subcutaneous injection. With the help of the innovative SNAC absorption enhancer, the Semaglutide tablet (Rybelsus) has successfully overcome technical barriers, achieving a historic breakthrough in the oral administration of GLP-1 drugs, thus becoming the first truly oral peptide drug. The active pharmaceutical ingredient (API) of Rybelsus is identical to that of its injectable counterpart and is modified with a fatty acid chain, additionally incorporating 300 mg of SNAC molecules. The inclusion of SNAC instantaneously raises the gastric pH, promoting transcellular absorption through the gastric mucosa at specific concentrations. In human NCI-N87 gastric epithelial cell models, adding SNAC increased the absorption capacity of gastric epithelial cells by 100 times. After entering the market, Rybelsus also performed impressively, with demand so great that it led to supply shortages. In the first half of 2024, Rybelsus achieved sales of $1.587 billion, representing a 32% year-over-year growth. Equally noteworthy is the Israeli pharmaceutical company Chiasma Inc., which successfully developed the oral capsule Mycapssa through innovative formulation and received approval in the U.S. in 2020 via the 505(b)(2) regulatory pathway. Mycapssa is the first and only approved oral somatostatin analog capsule for treating acromegaly, offering patients a new treatment option. The transient permeability enhancer (TPE™) technology employed by Chiasma provides critical technical support for developing oral peptide drugs. Merck has also recognized the potential of oral peptides. In January 2024, Merck signed a $220 million collaboration agreement with Unnatural Products. Through this collaboration, Merck intends to leverage Unnatural Products' technology to develop cyclic peptide candidates, primarily targeting the challenging oncology field. Merck has previously likened cyclic peptides to "Goldilocks," as their molecular size falls between small molecules and biologics, offering numerous unique advantages. Previously, Merck launched the Phase III clinical project for MK-0616, a cyclic peptide that binds to PCSK9. Currently, PCSK9-targeted therapies can only be administered via injection, and the cost-effectiveness issues related to using biologics to lower cholesterol have yet to be effectively addressed. Developing an oral PCSK9 inhibitor is a goal in this field, and the R&D of MK-0616 cyclic peptide is expected to make significant breakthroughs in this area. According to a report by MARKET MONITOR GLOBAL, INC (MMG), the global oral peptide therapeutic drug market was approximately $1886.4 million in 2023, with an expected annual compound growth rate (CAGR) of 15.8% over the next six years, reaching $7843.2 million by 2030. Industry perspectives generally indicate that the treatment market for autoimmune diseases is experiencing rapid growth. As the technology for oral peptide therapies continues to advance and the market expands quickly, AbbVie is solidifying its R&D position in the oral peptide field through the acquisition of Nimble Therapeutics. Whether AbbVie can reclaim the title of "King of Immunology" and continue leading innovation in the treatment of autoimmune diseases will be closely monitored by Pharmaceutical Economic News.

Phase 3Clinical ResultAcquisitionDrug ApprovalImmunotherapy

23 Dec 2024

·www.businesswire.com

Bristol Myers Squibb Announces Positive Topline Results from Two Pivotal Phase 3 Trials Evaluating Sotyktu (deucravacitinib) in Adults with Psoriatic Arthritis

PRINCETON, N.J.--( BUSINESS WIRE )-- Bristol Myers Squibb (NYSE: BMY) today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase 3 trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu -treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met important secondary endpoints across PsA disease activity at Week 16. The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials. "Psoriatic arthritis is a heterogenous disease that causes a range of different symptoms, including joint pain and swelling, as well as psoriatic skin lesions. Despite available therapies, rheumatologists continue to express a need for a safe and effective oral treatment," said Roland Chen , MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. "These POETYK PsA-1 and POETYK PsA-2 findings demonstrate that oral Sotyktu has the potential to be the first TYK2 inhibitor for people living with psoriatic arthritis and reinforce the established efficacy and safety profile of Sotyktu . We are encouraged by the positive data across both Phase 3 trials and look forward to discussing the results with health authorities." Bristol Myers Squibb will work with key investigators to present detailed results at upcoming medical congresses. These topline results represent the first Phase 3 clinical trials for Sotyktu in a rheumatic condition. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis. Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in these clinical trials. About the Sotyktu Phase 3 Psoriatic Arthritis Trial Program The Phase 3 Sotyktu psoriatic arthritis (PsA) program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202 ) and POETYK PsA-2 (IM011-055; NCT04908189 ). POETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm. The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Important secondary endpoints were also assessed at Week 16 across measures of PsA disease activity. Patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in the open-label extension study. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis will develop PsA. In addition to the loss of physical function, pain and fatigue caused by PsA, the disease can significantly impact the mental and emotional well-being of patients. Patients with PsA are also at increased risk of serious comorbidities, including cardiovascular disease, metabolic syndrome, depression and anxiety. About Sotyktu (deucravacitinib) Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis. Bristol Myers Squibb: Pursuing Bold Science in Immunology to Transform Patients’ Lives Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures. Our collaborations with patients, caregivers, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most – the promise of living a better life. SOTYKTU U.S. INDICATION SOTYKTU ® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU. WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU. Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or an opportunistic infection with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated. Viral Reactivation Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C. Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment. Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU. Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded. Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated. Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA. ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne. SPECIFIC POPULATIONS Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072. Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition. Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment. SOTYKTU is available in 6 mg tablets. Please see U.S. Full Prescribing Information , including Medication Guide , for SOTYKTU. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that Sotyktu (deucravacitinib) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Sotyktu for such additional indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

Clinical ResultPhase 3Drug ApprovalImmunotherapyPhase 2

10 Dec 2024

·www.amgen.com

AMGEN ANNOUNCES 2025 FIRST QUARTER DIVIDEND

THOUSAND OAKS, Calif. , Dec. 10, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.38 per share dividend for the first quarter of 2025. The dividend will be paid on March 7, 2025 , to all stockholders of record as of the close of business on February 14, 2025 . 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 . 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. 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. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. 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. 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, 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. CONTACT: Amgen , Thousand Oaks Elissa Snook , 609-251-1407 (media) Justin Claeys , 805-313-9775 (investors) View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-announces-2025-first-quarter-dividend-302328180.html SOURCE Amgen

Acquisition

100 Deals associated with Apremilast

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KEGG	Wiki	ATC	Drug Bank
D08860	Apremilast	L04AA32	DB05676

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Behcet Syndrome	US	Amgen, Inc.	19 Jul 2019
Oral Ulcer	AU	Amgen Australia Pty Ltd.	19 Mar 2015
Plaque psoriasis	EU	Amgen Europe BV	15 Jan 2015
Plaque psoriasis	IS	Amgen Europe BV	15 Jan 2015
Plaque psoriasis	LI	Amgen Europe BV	15 Jan 2015
Plaque psoriasis	NO	Amgen Europe BV	15 Jan 2015
Psoriasis	US	Celgene Corp.	23 Sep 2014
Arthritis, Psoriatic	US	Amgen, Inc.	21 Mar 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autoimmune Diseases	NDA/BLA	CN	3SBio, Inc.	30 Jan 2022
Pustular psoriasis	Phase 3	JP	Amgen, Inc.	08 Mar 2022
Pustulosis of Palms and Soles	Phase 3	JP	Amgen, Inc.	08 Mar 2022
Genital Diseases	Phase 3	US	Amgen, Inc.	30 Jan 2022
Juvenile Idiopathic Arthritis	Phase 3	US	Amgen, Inc.	30 Jan 2022
COVID-19	Phase 3	US	Amgen, Inc.	24 Nov 2020
COVID-19	Phase 3	AR	Amgen, Inc.	24 Nov 2020
COVID-19	Phase 3	BR	Amgen, Inc.	24 Nov 2020
COVID-19	Phase 3	CL	Amgen, Inc.	24 Nov 2020
COVID-19	Phase 3	MX	Amgen, Inc.	24 Nov 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03747939 (FOREMOST, Pubmed \| Ann Rheum Dis) Manual	Phase 4	Arthritis, Psoriatic	308	Apremilast 30 mg	mghgrgmzku(niyscbdsof) = hyhoxczfjb ztacccokvd (vvjeiocqbc ) View more	Positive	20 Aug 2024
				Placebo	mghgrgmzku(niyscbdsof) = hwfakoqnxg ztacccokvd (vvjeiocqbc ) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic	-	Apremilast 30mg BID	adhgtzoahv(yozsdqfuqk) = ggirfgulgh mmzthdczcc (fwlftgvssh ) View more	Positive	05 Jun 2024
NCT03747939 (FOREMOST, EULAR2024)	Phase 4	Arthritis, Psoriatic	308	Apremilast 30 mg twice daily	msgghkrdul(falcxqkgdc) = zhrqvhfvhj mcwdxhvwhs (wqnnzrldvl ) View more	Positive	05 Jun 2024
				Placebo	msgghkrdul(falcxqkgdc) = plnloaojfv mcwdxhvwhs (wqnnzrldvl ) View more
NCT03747939 (FOREMOST, EULAR2024)	Phase 4	Arthritis, Psoriatic	308	Apremilast	jcntypdwbs(hawqrsbutd) = ttnhiwnumk ljbfuonkol (zhiwhejrku )	Positive	05 Jun 2024
				Placebo	jcntypdwbs(hawqrsbutd) = vtkrerqykr ljbfuonkol (zhiwhejrku )
NCT04908475 (IMMpulse, CTgov)	Phase 4	Plaque psoriasis	352	Apremilast (Period A: APR)	nznuumkahp(wuuejyqxzm) = klcohenhkq hdpgghfmhp (yaeavxvelu, zeszikrhgq - nnxnsqhqig) View more	-	30 Apr 2024
				Risankizumab (Period A: RZB)	nznuumkahp(wuuejyqxzm) = sjnohqmoxk hdpgghfmhp (yaeavxvelu, bfhimbgdbi - bmvlsymfmq) View more
NCT04306965 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	10	Apremilast	xursdoqnso(ltuntxxrcc) = rzcjhgptpl nshwccxxpx (filyloktmd, jnfnrjxwmq - ywvufeuxbh) View more	-	19 Apr 2024
NCT03587194 (CTgov)	Phase 4	Plaque psoriasis	50	Otezla	oqfossvyvb(brpvgnvxio) = euvfhlasgq mrbdpztqxj (alpdqjqcox, ifggvrkure - wdirizqalb) View more	-	16 Apr 2024
NCT03608657 (APPRAISE, Pubmed \| Rheumatol Ther)	Not Applicable	Arthritis, Psoriatic	102	Apremilast	pblapalyir(yjfpihvtmg) = 9/102 [8.8%] emkvbuzcpw (gdhakedyfz ) View more	Positive	01 Apr 2024
PRNewswire Manual	Phase 3	Psoriasis	176	APREMILAST	xcpsrdyanx(wdzktkhdot) = haszylqinz dakzeogsel (rmzbzsuokx ) Met	Positive	09 Mar 2024
				placebo	xcpsrdyanx(wdzktkhdot) = iscamgkgev dakzeogsel (rmzbzsuokx ) Met
NCT03747939 (FOREMOST, CTgov)	Phase 4	Arthritis, Psoriatic	310	placebo (Placebo-controlled Phase: Placebo)	ntoadwtsqq(bsjoqdxwpu) = tjoopibwnz kkaqdxfwcd (aqflcyvpjp, bbwhmxfeqd - evqmckhbzb) View more	-	05 Jan 2024
				Apremilast (Placebo-controlled Phase: Apremilast 30 mg)	ntoadwtsqq(bsjoqdxwpu) = wcuybpddum kkaqdxfwcd (aqflcyvpjp, oqbdxeamoh - tzyfliczmg) View more

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