A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome

The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.

Start Date13 Dec 2023

Sponsor / Collaborator

Medical Research Agency

CTRI/2023/11/059887 / Not yet recruitingPhase 4

Effect of Transforaminal Epidural Etanercept on Lumbar Radicular Pain: A Prospective Interventional Study - NIL

Start Date20 Nov 2023

Sponsor / Collaborator-

NCT05950724 / Enrolling by invitationEarly Phase 1IIT

RENAL: Randomized Clinical Trial of TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant.

Start Date17 Sep 2023

Sponsor / Collaborator

Northwestern University

100 Clinical Results associated with Etanercept

100 Translational Medicine associated with Etanercept

100 Patents (Medical) associated with Etanercept

9,231

Literatures (Medical) associated with Etanercept

01 Dec 2024·Molecular Biology Reports

Oxidative stress in Alzheimer’s disease: current knowledge of signaling pathways and therapeutics

Review

Author: Beura, Samir K ; HariKrishnaReddy, Dibbanti ; Singh, Sunil K ; Sharma, Prajjwal ; Dhapola, Rishika

Alzheimer's disease's pathophysiology is still a conundrum. Growing number of evidences have elucidated the involvement of oxidative stress in the pathology of AD rendering it a major target for therapeutic development. Reactive oxygen species (ROS) generated by altered mitochondrial function, dysregulated electron transport chain and other sources elevate aggregated Aβ and neurofibrillary tangles which further stimulating the production of ROS. Oxidative stress induced damage to lipids, proteins and DNA result in neuronal death which leads to AD. In addition, oxidative stress induces apoptosis that is triggered by the modulation of ERK1/2 and Nrf2 pathway followed by increased GSK-3β expression and decreased PP2A activity. Oxidative stress exaggerates disease condition by interfering with various signaling pathways like RCAN1, CREB/ERK, Nrf2, PP2A, NFκB and PI3K/Akt. Studies have reported the role of TNF-α in oxidative stress stimulation that has been regulated by drugs like etanercept increasing the level of anti-oxidants. Other drugs like pramipexole, memantine, carvedilol, and melatonin have been reported to activate CREB/RCAN1 and Nrf2 pathways. In line with this, epigallocatechin gallate and genistein also target Nrf2 and CREB pathway leading to activation of downstream pathways like ARE and Keap1 which ameliorate oxidative stress condition. Donepezil and resveratrol reduce oxidative stress and activate AMPK pathway along with PP2A activation thus promoting tau dephosphorylation and neuronal survival. This study describes in detail the role of oxidative stress in AD, major signaling pathways involving oxidative stress induced AD and drugs under development targeting these pathways which may aid in therapeutic advances for AD.

01 Oct 2024·Current Drug Delivery

A Novel Etanercept-loaded Nano-emulsion for Targeted Treatment of Inflammatory Arthritis via Draining Lymph Node

Article

Author: Li, Chenglong ; lu, Guanting ; Li, Chen ; Jiang, Yue ; Su, Huaiyu

Background:Rheumatoid arthritis (RA) is a systemic autoimmune disease (AD), and the global incidence rate is 0.5 ~ 1%. Existing medications might reduce symptoms, however, there is no known cure for this illness. Etanercept (EN) can competitively inhibit TNF-α binding to the TNF receptor on the cell surface to treat RA. However, subcutaneous injection of free EN predisposes to systemic distribution and induces immune system hypofunction. Draining lymph nodes (LNs) play a significant role in the onset, maintenance, and progression of RA as they are the primary sites of aberrant immune response and inflammatory cytokine production.Aim:The purpose of this study was to successfully treat RA with etanercept by encapsulating it in nanoemulsions (NEs/EN) and then delivering it specifically to draining LNs. The EN-loaded NEs were prepared by high-pressure homogenization method and modified with DSPE-mPEG2000 and Ca(OH)2.Methods:A novel nano-emulsion (NE) was constructed to deliver EN (NE/EN) to RA-draining LNs. To decrease aggregation and load EN, DSPE-mPEG2000 and Ca(OH)2 were successively decorated on the surface of the lipid injectable emulsions. The hydrodynamic diameter and morphology of NEs/EN were investigated by using a laser particle size analyzer and transmission electron microscopy, respectively. The in vivo fluorescence imaging system was used to study the in vivo LN targeting ability of the formulation. In the therapeutic experiment, NEs/EN was subcutaneously administrated to inhibit the development of the mouse arthritis model.Results:Circular dichroism spectrum and L929 cell experiment confirmed that NEs encapsulation had no impact on the biological activity of EN. In vivo investigation on collagen-induced arthritis (CIA) mouse model showed that NEs/EN have good inguinal lymph node targeting capabilities, as well as, anti-inflammatory effect against RA. Compared with the free group, the paw thickness and arthritic score in NEs/EN group were significantly alleviated. Moreover, the concentration of pro-inflammatory cytokines TNF-α and IL-1β in NEs/EN-treated mice was lower than that in free EN.Conclusion:NEs/EN effectively improve the effectiveness of EN in the treatment of RA. Our work provides an experimental foundation for expanding the clinical application of EN.

01 Sep 2024·Joint Bone Spine

Targeted therapies for uveitis in spondyloarthritis: A narrative review

Article

Author: Chapurlat, Roland ; Jacquot, Robin ; Sève, Pascal ; Kodjikian, Laurent

Spondyloarthritis (SpA) encompasses a group of chronic inflammatory disorders of the joints frequently associated with uveitis in almost a quarter of cases. SpA-related uveitis typically affects the eye anterior chamber with sudden onset, causing pain, redness, photophobia, and blurred vision. Ophthalmologists will describe an acute anterior unilateral uveitis. Most patients present with episodic acute anterior non-granulomatous uveitis and retain excellent visual acuity. However, systemic treatments are recommended in the event of frequent relapses (2-3/year) or in rare cases of sight-threatening with ocular complications. The improved understanding of the pathogenesis of SpA has led to the management of this disease by biologics. Here, we review the main data regarding the opportunity to target specific components in inflammatory pathways for the treatment of SpA-related uveitis. These therapies are recommended for long-term control when uveitis relapses occur too frequently despite conventional systemic treatments. Significant benefits have been obtained with the tumor necrosis factor-α inhibitors (TNFis), particularly infliximab and adalimumab. Paradoxically, a high number of uveitis occurrences have been shown on etanercept. Mixed results have been demonstrated with interleukin-17 antagonists (secukinumab) and interleukin-12/interleukin-23 antagonists (ustekinumab) in cases of failure of TNFis. JAK inhibitors seem to be a valuable class of medications for these patients in the future. Although SpA-related uveitis is typically managed with conventional local and/or systemic treatments, these biological/targeted therapies may provide avenues to control both the underlying SpA and uveitis manifestations. Thus, a close collaboration between patients, rheumatologists, internists, and ophthalmologists is needed to optimally manage ocular inflammation in SpA.

141

News (Medical) associated with Etanercept

13 May 2024

·www.prnewswire.com

Boehringer Ingelheim expands access to adalimumab-adbm injection, the company's biosimilar to Humira®

Under agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent Pharmaceuticals Agreement supports Boehringer Ingelheim's commitment to providing affordable medications to patients RIDGEFIELD, Conn., May 13, 2024 /PRNewswire/ -- Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer's biosimilar to Humira® (adalimumab), in the U.S. "Boehringer Ingelheim is dedicated to broadening access to essential biologic medicines, and our collaboration with Quallent will increase availability of our adalimumab biosimilar for patients living with certain chronic inflammatory diseases," said Chris Marsh, Senior Vice President of Value and Access at Boehringer Ingelheim. "The utilization of biosimilars such as adalimumab-adbm provides the potential for more patients to benefit from biologic medicines and saves costs for both patients and the U.S. healthcare system overall. We're committed to helping the biosimilar market reach its potential, and this partnership is an important step in enabling greater adoption of these lower-cost options." Under the terms of the agreement, Boehringer Ingelheim will manufacture adalimumab-adbm for Quallent. Boehringer Ingelheim will continue to commercialize Boehringer Ingelheim-labeled Cyltezo® (adalimumab-adbm) injection and Adalimumab-adbm. "We are pleased to be working with Boehringer Ingelheim to bring adalimumab-adbm to more patients. Our intent is to offer a copay assistance program, which will provide eligible patients access," said John Caulfield, President of Quallent Pharmaceuticals Health, LLC. "Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal." Quallent will be offering both high-concentration (40 mg/0.4 mL) and low-concentration (40 mg/0.8 mL) citrate-free formulations of adalimumab-adbm as a pre-filled syringe or pen. Adalimumab-adbm's interchangeability designation* for the low-concentration formulation will extend to Quallent's 40 mg/0.8 mL private-labeled adalimumab-adbm. *For more information on interchangeability for adalimumab-adbm, please refer to the Purple Book: . About Biosimilars A biosimilar is a biologic medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity. A biosimilar with an interchangeable designation, which is designated by the FDA, may be auto-substituted for the reference product by a pharmacist. Individual state laws control how and whether providers and patients must be notified. An interchangeable biosimilar first must meet the high FDA standards of a biosimilar. Then, to achieve the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy compared with remaining on the reference product in any given patient. About Boehringer Ingelheim in Biologics and Biosimilars Through novel biologics and our biosimilar, we strive to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide. Boehringer Ingelheim is one of the largest producers of biologic medicines in the world, producing biologic medicines to support our diverse pipeline, as well as other companies' biopharmaceuticals on a contract basis. As a pioneer in biologics, to date, Boehringer Ingelheim's Biopharmaceutical Contract Manufacturing business has supported our customers to bring dozens of biologics to the market in therapeutic areas that include oncology, immunology and cardiovascular indications. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here: . Please see CYLTEZO Prescribing Information, including BOXED WARNING, and Medication Guide; and Adalimumab-adbm Prescribing Information, including BOXED WARNING and Medication Guide. What is Adalimumab-adbm ? This information also applies to CYLTEZO® (adalimumab-adbm) injection for subcutaneous use. Adalimumab-adbm is a medicine called a tumor necrosis factor (TNF) blocker. Adalimumab-adbm is used: To reduce the signs and symptoms of: moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-adbm can be used alone, with methotrexate, or with certain other medicines. moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Adalimumab-adbm can be used alone or with methotrexate. psoriatic arthritis (PsA) in adults. Adalimumab-adbm can be used alone or with certain other medicines. ankylosing spondylitis (AS) in adults. moderate to severe hidradenitis suppurativa (HS) in adults. To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). To treat non-infectious intermediate, posterior, and panuveitis in adults. Important Safety Information for Adalimumab-adbm injection, for subcutaneous use This important information also applies to CYLTEZO® (adalimumab-adbm) injection for subcutaneous use. What is the most important information I should know about Adalimumab-adbm? You should discuss the potential benefits and risks of Adalimumab-adbm with your doctor. Adalimumab-adbm is a TNF-blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking Adalimumab-adbm if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting Adalimumab-adbm and check you closely for signs and symptoms of TB during treatment with Adalimumab-adbm, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB. Cancer. For children and adults taking TNF blockers, including Adalimumab-adbm, the chances of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including Adalimumab-adbm, your chances of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn't heal. What should I tell my doctor BEFORE starting Adalimumab-adbm? Tell your doctor about all of your health conditions, including if you: Have an infection, are being treated for infection, or have symptoms of an infection. Get a lot of infections or have infections that keep coming back. Have diabetes. Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB. Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use Adalimumab-adbm. Ask your doctor if you are unsure whether you have lived in an area where these infections are common. Have or have had hepatitis B. Are scheduled for major surgery. Have or have had cancer. Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome. Have or had heart failure. Have recently received or are scheduled to receive a vaccine. Adalimumab-adbm patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting Adalimumab-adbm. Are allergic to rubber or latex. Are allergic to any Adalimumab-adbm ingredients. Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Have a baby and you were using Adalimumab-adbm during your pregnancy. Tell your baby's doctor before your baby receives any vaccines. Also tell your doctor about all the medicines you take. You should not take Adalimumab-adbm with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP). What should I watch for AFTER starting Adalimumab-adbm? Adalimumab-adbm can cause serious side effects, including: Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle. Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash. Allergic reactions. Symptoms of a serious allergic reaction include hives; trouble breathing; and swelling of your face, eyes, lips, or mouth. Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain. Immune reactions, including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun. Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death. Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus. Call your doctor or get medical care right away if you develop any of the above symptoms. The most common side effects of Adalimumab-adbm include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash. These are not all the possible side effects with Adalimumab-adbm. Tell your doctor if you have any side effect that bothers you or that does not go away. Remember to tell your doctor right away if you have an infection or symptoms of an infection, including: Fever, sweats, or chills Muscle aches Cough Shortness of breath Blood in phlegm Warm, red, or painful skin or sores on your body Diarrhea or stomach pain Burning when you urinate Urinating more often than normal Feeling very tired Weight loss These are not all the possible side effects of Adalimumab-adbm. For more information, speak with your doctor or pharmacist . You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-CTZ-100018 SEPT 2023 Please see CYLTEZO Prescribing Information, including BOXED WARNING, and Medication Guide; and Adalimumab-adbm Prescribing Information, including BOXED WARNING and Medication Guide. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Discover more at . Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Cyltezo® trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc. MPR-US-103110 05/24 Taylor Pepe Senior Associate Director, Human Pharma Communications [email protected] SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

License out/inDrug Approval

07 May 2024

·www.globenewswire.com

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates Q1 financial highlights Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated full year guidance Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1. Significantly extended cash runway with recent update of debt financing agreement2Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter Net Profit of €58.9 million, reflecting PRV sale 2024 financial guidance confirmed Expected total revenues between €170 million and €190 million, including: €160 million to €180 million of sales driven by growth of Valneva’s proprietary products Expected R&D investments between €60 million and €75 million, mostly dedicated to ongoing chikungunya development activities, the Zika trial and advancement of pre-clinical programsExpected Other income between €100 million and €110 million, reflecting €95 million in proceeds from the PRV sale Strong R&D execution Single-shot chikungunya vaccine IXCHIQ® recommended by ACIP and adopted by U.S. CDC3; Regulatory processes with the European, Canadian and Brazilian authorities on track; Six-month data for Phase 3 adolescent study of IXCHIQ® to be reported shortly and label extensions to be submitted based on results; Enrolment of children for pediatric Phase 2 study on track; Primary vaccinations for all participants in the VALOR Lyme disease Phase 3 trial expected to be completed in Q2;Phase 1 clinical trial for second-generation Zika vaccine candidate initiated4. Financial Information(Unaudited results, consolidated per IFRS) € in million 3 months ending March 31 2024 2023 Product sales 32.1 32.1 Total revenues 32.8 33.5 Net profit/(loss) 58.9 (18.1) Adjusted EBITDA (profit/loss) 73.0 (12.3) Cash 176.6 254.5 Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates. The condensed consolidated interim financial results are available on the Company’s website (Financial Reports – Valneva). Valneva will host a live webcast of its first quarter 2024 results conference call at 3 p.m. CEST/9 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/wrc2a7s3. Peter Bühler, Valneva’s Chief Financial Officer, commented, “The first quarter performance has been in line with our expectations. We are aiming to further capitalize on the travel industry recovery during the rest of the year including ramping-up sales for IXCHIQ® to support our commercial sales growth while executing on our key R&D milestones. The successful sale of our PRV and deferral of our loan reimbursement in Q1 allowed us to maintain a solid cash position and, with the expected completion of our payments for the Lyme Phase 3 trial in the second quarter, we anticipate a significantly lower cash burn in 2024.” Commercial Portfolio Valneva’s commercial portfolio is composed of three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure. JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT®In the first quarter of 2024, IXIARO®/JESPECT® sales were €16.6 million compared to €17.4 million in the first quarter of 2023. Sales to the U.S. military counterbalanced most of the supply constraints experienced during the period. These constraints have now been resolved, and as communicated last month in its full-year publication5, Valneva expects double-digit annual growth for IXIARO® sales for at least the next three years. CHOLERA / ETEC6-DIARRHEA VACCINE DUKORAL® In the first quarter of 2024, DUKORAL® sales increased by 10.3% to €11.3 million compared to €10.2 million in the first quarter of 2023, as the vaccine continued to benefit from the significant recovery in the private travel markets. CHIKUNGUNYA VACCINE IXCHIQ® IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. Following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations7 by the U.S. Centers for Disease Control and Prevention (CDC)8 at the beginning of March 2024, Valneva has focused on launching its single-dose chikungunya vaccine in the U.S. and recorded initial sales of €0.2 million in the first quarter. IXCHIQ® is also under regulatory review in Canada, Brazil and Europe, where it was granted accelerated assessment by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP). Decisions on these submissions are expected in 2024. A clinical study in adolescents, VLA1553-321, is ongoing. Valneva reported initial safety data in August 20239 and expects to report six-month data in the coming weeks. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in Brazil in collaboration with Instituto Butantan, the VLA1553-321 adolescent trial is intended to support the label extension to this age group following initial approvals in adults. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. Additionally, the Company initiated a Phase 2 pediatric trial, VLA1553-221, in children aged 1 to 11 years, in January 202410. This is designed to support a Phase 3 pivotal pediatric study and potentially extend the label to this age group following initial regulatory approvals in adults and possibly in adolescents. THIRD-PARTY DISTRIBUTION Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. During the first quarter of 2024, third-party sales decreased by 8.9% to €4.1 million compared to €4.5 million in the first quarter of 2023 as a result of anticipated supply constraints. Valneva expects that third-party sales will gradually wind down to less than 5% of overall product sales by 2026/2027, allowing the Company to improve gross margins. Clinical Stage Vaccine Candidates LYME DISEASE VACCINE CANDIDATE – VLA15 Phase 3 study ongoing Valneva and Pfizer are developing VLA15, a Phase 3 vaccine candidate targeting Borrelia, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common strains found in the United States and Europe. VLA15 is the only Lyme disease program in late-stage clinical development today and has received Fast Track designation from the FDA. Vaccinations across the two cohorts of the Phase 3 trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) are on track and Valneva and Pfizer expect all participants (9,437) to complete primary vaccinations (three doses) in the coming weeks. Topline data from the VALOR trial are expected by the end of 2025, with the aim for Pfizer to submit a Biologic License Application (BLA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in 2026, subject to positive data. Valneva’s cost contributions for the Lyme disease Phase 3 study are expected to be completed in the second quarter of 2024. All remaining payments to Pfizer are included in current refund liability at December 31, 2023, and will not impact the Profit & Loss statement in 2024. ZIKA VACCINE CANDIDATE – VLA1601Phase 1 ongoing with second-generation vaccine candidate VLA1601 is a second-generation adjuvanted inactivated vaccine candidate against the mosquito-borne viral disease caused by the Zika virus (ZIKV). In March 2024, Valneva initiated a Phase 1 clinical trial to investigate the safety and immunogenicity of VLA160111. The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Participants will receive a low, medium or high dose of VLA1601. In addition, the low dose of VLA1601 will be evaluated with an additional adjuvant. Topline data from the trial are expected in the first half of 2025. Zika disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, since 2015, in the Americas. Zika virus transmission persists in several countries in the Americas and in other endemic regions. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection12; however, surveillance remains limited globally. There are no preventive vaccines or effective treatments available and, as such, Zika remains a public health threat and is included in theFDA’s Tropical Disease Priority Review Voucher Program13. A vaccine against ZIKV would be a valuable addition to Valneva’s portfolio of travel vaccines against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®. First Quarter 2024 Financial Review (Unaudited, consolidated under IFRS) Revenues Valneva’s total revenues were €32.8 million in the first quarter of 2024 compared to €33.5 million in the first quarter of 2023. Valneva’s sales reached €32.1 million in the first quarter of 2024 and remained comparable to the first quarter of 2023. Currency fluctuations had an immaterial impact on sales compared to the comparator period. IXIARO®/JESPECT® sales were €16.6 million in the first quarter of 2024 compared to €17.4 million in the first quarter of 2023. The 4% decrease in sales is primarily the result of constrained supplies, which temporarily impacted sales during the first quarter and are now resolved. DUKORAL® sales were €11.3 million in the first quarter of 2024 compared to €10.2 million in the first quarter of 2023. This 10% increase results from the continued recovery in the private travel markets primarily driven by Canada, and price increases. IXCHIQ® sales were €0.2 million in the first quarter of 2024. The U.S. CDC adopted recommendations by the ACIP14 at the beginning of March 2024. Third Party product sales were €4.1 million in the first quarter of 2024 compared to €4.5 million in the first quarter of 2023, a 9% decrease which was mainly driven by supply constraints of Rabipur®/RabAvert® and Encepur® sold under the distribution agreement with Bavarian Nordic. Other revenues, including revenues from collaborations, licensing and services amounted to €0.6 million in the first quarter of 2024 compared to €1.4 million in the first quarter of 2023 with the reduction mainly resulting from lower revenue recognition related to the R&D collaboration activities for chikungunya with Instituto Butantan. Operating Result and adjusted EBITDA Costs of goods and services sold (COGS) were €22.2 million in the first quarter of 2024. The gross margin on commercial product sales amounted to 43.9% (excluding IXCHIQ®) compared to 48.4% in the first quarter of 2023. COGS of €8.0 million related to IXIARO® sales, yielding a product gross margin of 52.0%, which was impacted by €1.7 million recorded as write-offs for failed batches. COGS of €7.0 million related to DUKORAL® sales, yielding a product gross margin of 37.9%. Of the remaining COGS in the first quarter of 2024, €3.0 million related to the third-party products distribution business, €0.8 million to IXCHIQ®, €1.0 million to idle capacity costs and €2.4 million to cost of services. In the first quarter of 2023, overall COGS were €20.5 million, of which €17.9 million related to cost of goods and €2.6 million related to cost of services. Research and development expenses amounted to €13.1 million in the first quarter of 2024, compared to €14.1 million in the first quarter of 2023. This decrease was mainly driven by lower spend on Valneva’s COVID-19 vaccine, VLA2001 as well as lower spend on IXCHIQ® following licensure in the fourth quarter of 2023. At the same time, costs related to the ongoing transfer of operations into the new Almeida manufacturing facility resulted in higher R&D spend on commercial products. Marketing and distribution expenses in the first quarter of 2024 amounted to €11.3 million compared to €9.0 million in the first quarter of 2023. The increase is mainly related to €4.9 million of expenses associated with launch activities for IXCHIQ® (first quarter of 2023: €3.4 million). In the first quarter of 2024, general and administrative expenses increased to €11.7 million from €10.0 million in the first quarter of 2023, mainly resulting from higher costs related to the Company’s stock-based employee compensation program, higher recruiting charges and higher costs for digitalization & automation initiatives. During the first quarter of 2024, a net gain of €90.8 million from the sale of the PRV was recorded in the income statement. The net proceeds of $103 million were reduced by transaction costs as well as contractual payment obligations related to the sale of the PRV. Other income, net of other expenses, decreased to €2.9 million in the first quarter of 2024 from €3.5 million in the first quarter of 2023. The decrease was mainly driven by lower R&D tax credits recorded in the first quarter of 2024 following the reduction in eligible R&D spend. Valneva recorded an operating profit of €68.2 million in the first quarter of 2024 compared to an operating loss of €16.6 million in the first quarter of 2023. The significant improvement is largely related to the proceeds from the sales of the PRV recorded in the income statement in the first quarter of 2024. Adjusted EBITDA (as defined below) profit in the first quarter of 2024 was €73.0 million, compared to an EBITDA loss of €12.3 million in the first quarter of 2023. Net Result In the first quarter of 2024, Valneva generated a net profit of €58.9 million compared to a net loss of €18.1 million in the first quarter of 2023. Finance expenses and currency effects in the first quarter of 2024 resulted in a net finance expense of €9.3 million, compared to a net finance expense of €1.7 million in the first quarter of 2023. The increase in finance expenses, net was mainly due to foreign exchange losses of €2.5 million in the first quarter of 2024 compared to a profit of €3.2 million in the first quarter of 2023, primarily related to the development of the USD / EUR exchange rate. In addition, interest charges increased to €7.0 million in the first quarter of 2024 compared to €5.1 million in the first quarter of 2023 following the increase of the Deerfield Management Company and OrbiMed (D&O) loan facility during the second half of 2023. Cash Flow and Liquidity Net cash used in operating activities amounted to €28.4 million in the first quarter of 2024 compared to €24.3 million in the first quarter of 2023. Cash outflows in the first quarter of 2024 were mainly a result of the net loss for the period excluding proceeds from the sale of the PRV and by increases in working capital. Cash inflows from investing activities amounted to €86.7 million in the first quarter of 2024 compared to cash outflows of €3.6 million in the first quarter of 2023. Cash inflows in the first quarter of 2024 were driven by €90.8 million net proceeds from the sale of the PRV, partly offset by construction activities in the Almeida manufacturing site in Scotland as well as equipment purchases. Net cash used in financing activities increased to €7.5 million in the first quarter of 2024 from €3.8 million in the first quarter of 2023. The increase in cash outflows in the first quarter of 2024 were primarily due to increased interest payments and transaction costs resulting from the upsized loan facility provided by D&O. Cash and cash equivalents were €176.6 million as at March 31, 2024, compared to €126.1 million as at December 31, 2023. Non-IFRS Financial Measures Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition. Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provide additional analytical tools. Adjusted EBITDA is defined as earnings (loss) for the period before income tax, finance income/expense, foreign exchange gain/(loss), amortization, depreciation, and impairment (excluding impairment loss of disposal). A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below: € in million Three months ending March 31 (consolidated per IFRS) 2024 2023 Profit/(Loss) for the period 58.9 (18.1) Add: Income tax expense - (0.1) Total Finance income (0.3) (0.3) Total Finance expense 7.0 5.1 Foreign exchange gain/(loss) – net 2.5 (3.2) Amortization 1.3 1.6 Depreciation 3.5 2.6 Impairment - - Adjusted EBITDA 73.0 (12.3) About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats. About IXCHIQ®In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies. Please click here for full Prescribing Information for IXCHIQ®. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineVP, Global Communications and European Investor RelationsM +33 (0)6 4516 7099investors@valneva.com Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815 4520joshua.drumm@valneva.com Forward-Looking StatementsThis press release contains certain forward-looking statements relating to the business of Valneva, including with respect to guidance for certain financial results in fiscal year 2024 and mid-term outlook on financial results, cash position, and other business developments, including results of ongoing clinical trials, the timing and possible occurrence of further or initial regulatory approvals of its product candidates, the anticipated size of markets for its approved products and sales of those products, receipt of funding from external sources, supply of products sold by Valneva, and relationships with current business partners. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. These risks and uncertainties include those developed or identified in any public documents filed with the French financial markets authority (Autorité des marchés financiers) and the U.S. Securities and Exchange Commission made or to be made by Valneva. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines (including in relation to organic or strategic expansion of Valneva’s clinical pipeline), unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis and other global economic or political events, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, the impact of a pandemic, and changes in the regulatory environment in which Valneva operates. The occurrence of any of these risks and uncertainties could substantially harm Valneva’s business, financial condition, prospects and results of operations. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Valneva Announces Sale of Priority Review Voucher for $103 Million - Valneva2 Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed - Valneva3 ACIP Vaccine Recommendations and Schedules | CDC4 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate - Valneva5 Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook - Valneva6 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium.7 ACIP Vaccine Recommendations and Schedules | CDC8 ACIP Vaccine Recommendations and Schedules | CDC9 Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate - Valneva10 Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine - Valneva11 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate - Valneva12 Zika virus disease (who.int)13 Tropical Disease Priority Review Voucher Program | FDA14 ACIP Vaccine Recommendations and Schedules | CDC Attachment 2024_05_07_VLA_Q1_Results_PR_EN_Final

VaccinePhase 3Financial StatementPhase 2Phase 1

03 May 2024

·www.fiercepharma.com

Amgen's new Horizon products bolster top line despite continued Tepezza struggles

Much of Amgen's 22% revenue increase can be attributed to sales of products acquired in the company's $27.8 billion buyout of Horizon Therapeutics. Assets brought by the subsidiary accounted for sales of $914 million, which was a 10% increase on the $832 million the rare disease specialist generated in the first quarter of last year. During the Q&A portion of Amgen’s quarterly conference call Thursday, eight of the first nine questions were about the company’s investigational efforts in obesity. The buzz about Amgen’s pipeline—and specifically about its promising weight loss therapy MariTide—overshadowed the company’s solid work on the top line, where revenue came in at $7.4 billion. It was a 22% increase on the $6.1 billion in sales the company achieved in the first quarter of last year. Much of the boost can be attributed to sales of products acquired in Amgen’s $27.8 billion buyout of Horizon Therapeutics, which was completed early in the fourth quarter of last year. Assets brought by Horizon accounted for sales of $914 million, a 10% increase on the $832 million the rare disease specialist generated in the first quarter of last year. The big gainers from Horizon were gout treatment Krystexxa, which was up 26% to $235 million, and neuromyelitis optica spectrum disorder drug Uplizna, which saw an increase of 48% year over year to $80 million. Thyroid eye disease (TED) drug Tepezza was the top-selling Horizon import, generating $424 million in the quarter. While that represented a 5% increase year over year, sales were down sequentially, dropping from $467 million in the fourth quarter of 2023. Tepezza has been on a curious roller coaster ride, raking in sales of $1.7 billion in 2021 in its first full year on the market, followed by $2 billion in 2022. Since then, however, Tepezza’s momentum has stalled, despite it being the world’s lone treatment for TED. The risk of developing hearing loss—which has been added to Tepezza’s label—has contributed to the stagnation in sales, Amgen’s rare disease chief Vikram Karnani said on Thursday. He added that, over time, physicians have come to “generally understand the favorable risk/benefit profile of Tepezza.” Additionally, a phase 3 trial is underway, testing a more user-friendly subcutaneous version of Tepezza that the company believes will help it regain its traction. Amgen also has submitted for approval of the treatment in Europe. "Tepezza came in slightly below consensus estimates, although in line with management guidance and our estimates," William Blair analyst Matt Phipps, Ph.D., wrote in a note to clients. "We continue to have reservations on the near-term growth of Tepezza prior to geographic expansion." Without breaking them out individually, Amgen said that five other ultra-rare disease drugs from Horizon combined to generate $169 million in sales. In the first quarter of 2023, these treatments—Procysbi (nephropathic cystinosis), Quinsair (lung infection), Actimmune (chronic granulomatous disease) and Ravicti and Burhenyl (both for urea cycle disorder)—combined for revenue of $172 million. As for Amgen’s stalwarts, osteoporosis treatment Prolia had an 8% increase year over year to $1 billion. Meanwhile, rheumatoid arthritis drug Enbrel—which is one of 10 products identified for Medicare negotiations under the Inflation Reduction Act—saw sales drop 2% compared to a year ago, to $567 million. That decline was even starker on a sequential basis, plummeting from sales of $1 billion in the previous quarter. The company said the drop happens annually because of the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients work through deductibles. Amgen’s big gainers were asthma drug Tezspire, which was up 80% to $173 million; osteoporosis therapy Evenity, which grew $35% to $342 million; cholesterol treatment Repatha, which increased sales 33% to $517 million; and leukemia drug Blincyto, which was up 26% to $244 million. Amgen CEO Robert Bradway cited the four products in affirming his confidence in the company’s ability to grow over the next several years, adding that Blincyto is on the verge of approval into an earlier treatment line and that the company will share data later this month that demonstrate Tezspire’s potential to treat chronic obstructive pulmonary disease.

AcquisitionPhase 3Drug Approval

100 Deals associated with Etanercept

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KEGG	Wiki	ATC	Drug Bank
D00742	Etanercept	L04AB01	DB00005

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	NO	Pfizer Europe MA EEIG	02 Feb 2000
Ankylosing Spondylitis	IS	Pfizer Europe MA EEIG	02 Feb 2000
Ankylosing Spondylitis	LI	Pfizer Europe MA EEIG	02 Feb 2000
Ankylosing Spondylitis	EU	Pfizer Europe MA EEIG	02 Feb 2000
Arthritis, Psoriatic	IS	Pfizer Europe MA EEIG	02 Feb 2000
Arthritis, Psoriatic	EU	Pfizer Europe MA EEIG	02 Feb 2000
Arthritis, Psoriatic	LI	Pfizer Europe MA EEIG	02 Feb 2000
Arthritis, Psoriatic	NO	Pfizer Europe MA EEIG	02 Feb 2000
Axial Spondyloarthritis	IS	Pfizer Europe MA EEIG	02 Feb 2000
Axial Spondyloarthritis	EU	Pfizer Europe MA EEIG	02 Feb 2000
Axial Spondyloarthritis	LI	Pfizer Europe MA EEIG	02 Feb 2000
Axial Spondyloarthritis	NO	Pfizer Europe MA EEIG	02 Feb 2000
Enthesitis-Related Arthritis	LI	Pfizer Europe MA EEIG	02 Feb 2000
Enthesitis-Related Arthritis	EU	Pfizer Europe MA EEIG	02 Feb 2000
Enthesitis-Related Arthritis	NO	Pfizer Europe MA EEIG	02 Feb 2000
Plaque psoriasis	LI	Pfizer Europe MA EEIG	02 Feb 2000
Plaque psoriasis	EU	Pfizer Europe MA EEIG	02 Feb 2000
Plaque psoriasis	NO	Pfizer Europe MA EEIG	02 Feb 2000
Plaque psoriasis	IS	Pfizer Europe MA EEIG	02 Feb 2000
Rheumatoid Arthritis	US	Immunex Corp.	02 Nov 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Pauciarticular Chronic Arthritis	Phase 3	PL	Pfizer Inc.	10 Oct 2011
Juvenile Pauciarticular Chronic Arthritis	Phase 3	CO	Pfizer Inc.	10 Oct 2011
Juvenile Pauciarticular Chronic Arthritis	Phase 3	LV	Pfizer Inc.	10 Oct 2011
Psoriasis	Phase 3	RO	Wyeth AB	01 Jun 2006
Ankylosing Spondylitis	Phase 3	-	Wyeth AB	01 Mar 2002
Rheumatoid Arthritis	Phase 1	-	Amgen, Inc.	01 Oct 2005
Inflammation	Phase 1	-	Amgen, Inc.	01 Oct 2004
Psoriasis	Preclinical	AT	Wyeth AB	01 Jun 2006
Plaque psoriasis	Preclinical	-	Amgen, Inc.	08 Sep 2004
Systemic onset juvenile chronic arthritis	Discovery	-	Amgen, Inc.	04 Jun 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01258738 (EMBARK, Pubmed \| Arthritis Rheumatol) Manual	Phase 3	Non-radiographic axial spondyloarthritis	185	etanercept	ulgwdbbtbw(lprwghbupd) = wbzwjueuuk mvklrptgzz (xdzejnwpvl ) View more	Positive	01 Jan 2018
				Placebo	ulgwdbbtbw(lprwghbupd) = mrthnvxbja mvklrptgzz (xdzejnwpvl ) View more
NCT02378506 (Pubmed) Manual	Phase 3	Rheumatoid Arthritis	187	etanercept	(nlnfybnrsc) = iprsdcwmlb obntqfxwkn (xfachdokbl ) View more	Positive	01 Jan 2019
NCT01313208 (DMARD, Pubmed) Manual	Phase 4	Rheumatoid Arthritis	210	etanercept	(hlkiooevpw) = tdxwrigqhl wcklnxlssk (vsssrxytts ) View more	Positive	05 Mar 2015
				Placebo	(hlkiooevpw) = aakberzmsz wcklnxlssk (vsssrxytts ) View more
Pubmed \| Scand J Rheumatol Manual	Not Applicable	Non-radiographic axial spondyloarthritis	80	Etanercept	(mwxhujlulp): difference = 0.3 (95% CI, 0.6 - 3.1) View more	Positive	11 May 2022
				Placebo
FDA Manual	Not Applicable	Plaque psoriasis	211	Placebo	zoseyibaqp(fxodtnzckg) = lsuljvkpnn hrwmdtfcgd (defepxwmvi ) View more	Positive	18 Oct 2023
				Enbrel 0.8 mg/kg	zoseyibaqp(fxodtnzckg) = jiknnpylcu hrwmdtfcgd (defepxwmvi ) View more
NCT00844142 (Pubmed \| Ther Adv Musculoskelet Dis) Manual	Phase 2	Axial Spondyloarthritis	19	etanercept	(wcopepuzih) = ybifyhydjy clilppdjzx (bhoaddpbng ) View more	Positive	29 Jan 2021
NCT01313221 (REFINE, Pubmed \| J Eur Acad Dermatol Venereol) Manual	Phase 3	Plaque psoriasis	282	etanercept	(gsibjxiroh): difference = 16.2 (95% CI, -3.5 to 35.8) View more	Positive	01 Feb 2015
				as-needed topical therapy+etanercept
NCT01068353 (STEADI-09, Pubmed \| Ann Neurol) Manual	Phase 2	Alzheimer Disease	41	Etanercept	(oqoxhazivz) = wovmhdwgoy acimvosozb (lcgjgrmbqa )	Positive	26 May 2015
				Placebo	(oqoxhazivz) = ccsoavtpfq acimvosozb (lcgjgrmbqa )
NCT01421069 \| NCT00962741 (CLIPPER2, Pubmed) Manual	Phase 3	Enthesitis-Related Arthritis \| Juvenile Pauciarticular Chronic Arthritis \| Arthritis, Psoriatic	127	etanercept	(qopzfrodnp) = Most frequently reported TEAEs [n (%), events per 100 patient-years] were headache [28 (22%), 5.3], arthralgia [24 (19%), 4.6], and pyrexia [20 (16%), 3.8]. zqdnsxsrte (hznyrufoxg )	Positive	23 May 2019
NCT02986139 (Pubmed \| Rheumatol Ther) Manual	Phase 3	Arthritis, Psoriatic \| Rheumatoid Arthritis	111	Etanercept (prior formulation)	(tfhfagccxi) = jpvlkkmpvn ckncghrsew (qdewwaimkg )	Positive	01 Jun 2019
				Etanercept (Phosphate-Free Etanercept Formulation)	(tfhfagccxi) = ncinmaclll ckncghrsew (qdewwaimkg )

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