Daily Archives: October 12, 2019

SAN FRANCISCO, Oct. 7, 2019 /PRNewswire/ -- Nektar Therapeutics(NASDAQ: NKTR) today announced the initiation of two Phase 1b studies of NKTR-358 (LY3471851*), a novel T regulatory (Treg) cell stimulator, one in patients with psoriasis and one in patients with atopic dermatitis. NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune regulating Treg cells. NKTR-358 works by targeting the interleukin-2 receptor complex to stimulate the proliferation and suppressive functional activity of Treg cells. Nektar entered into a strategic collaboration with Eli Lilly and Company in 2017 to develop and commercialize NKTR-358. The two Phase 1b studies are Lilly-sponsored studies.

"Dysfunctions in Treg cell biology are implicated in the breakdown of immune self-tolerance, which is one of the underlying mechanisms involved in autoimmune and inflammatory diseases such as lupus, atopic dermatitis and psoriasis," said Brian Kotzin, M.D., Senior Vice President, Clinical Development and NKTR-358 Program Lead at Nektar Therapeutics. "NKTR-358 has demonstrated that it can drive expansion of Tregs, which we believe could help to regulate and control pathogenic T cells and restore normal self-tolerance mechanisms. We are excited to start these clinical studies to explore NKTR-358 for the treatment of psoriasis and atopic dermatitis, two common inflammatory diseases."

Earlier this year, Nektar presented initial results of a first-in-human Phase 1a single-ascending dose study of NKTR-358 in healthy volunteers at the Annual European Congress of Rheumatology (EULAR). The data showed that NKTR-358 was well-tolerated and led to a marked and selective dose-dependent expansion of T regulatory cells with no measurable effect on conventional CD4+ and CD8+ T cells. Nektar plans to present additional data from the single-ascending dose study at the 2019 Annual Meeting of the American College of Rheumatology in November 2019.

Atopic dermatitis (AD), also known as eczema, is a chronic, inflammatory skin disease which results in widespread rashes and patches of itchy skin, which can become thickened, cracked, raw or leak fluid when scratched. About 6.6 million adults report moderate-to-severe symptoms of AD1. AD is commonly associated with an individual or family history of asthma, hay fever, food allergy and/or other allergic diseases.

Psoriasis is an immune-mediated skin disease that causes raised, red, scaly patches to appear on the skin typically affecting the outsides of the elbows, knees or scalp. According to the World Psoriasis Day consortium, 125 million people worldwide2 to 3 percent of the total populationhave psoriasis2.

NKTR-358 is also being evaluated in a double-blind, randomized, placebo-controlled Phase 1b study in adults with systemic lupus erythematosus (SLE). The study will evaluate the safety, tolerability, pharmacokinetics and immunological effects of multiple ascending doses of NKTR-358 in approximately 50 adults with SLE. For more information, please visit clinicaltrials.gov and search NCT03556007.

About the Phase 1b Study in Psoriasis

The Phase 1b study is a double-blind, randomized, placebo-controlled multiple-dose study of NKTR-358 and will evaluate the safety, tolerability and pharmacokinetics of NKTR-358 in approximately 40 adults with plaque psoriasis. Exploratory objectives include assessment of disease activity and biomarkers.

About the Phase 1b Study in Atopic Dermatitis

The Phase 1b study is a double-blind, randomized, placebo-controlled multiple-dose study of NKTR-358 and will evaluate the safety, tolerability and pharmacokinetics of NKTR-358 in approximately 40 adults with atopic dermatitis. Exploratory objectives include assessment of disease activity and biomarkers. For additional information visit clinicaltrials.gov and search NCT04081350.

About NKTR-358 (LY3471851)

Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. NKTR-358 is a potential first-in-class resolution therapeutic that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance.

NKTR-358 is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.

About Nektar Therapeutics

Nektar Therapeutics is a research-based, development-stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, autoimmune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: "believe," "design," "could," "plan," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the expected benefits of NKTR-358, the ability to obtain useful data from clinical studies of NKTR-358, and the future clinical development plans for NKTR-358. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) NKTR-358 is in early-stage clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety and efficacy findings in clinical studies notwithstanding positive findings in prior studies; (ii) clinical study outcomes of NKTR-358 remain very unpredictable and it is possible that a given clinical study could fail due to efficacy, safety or other important clinical findings, wherein any failure of a clinical trial for NKTR-358 in particular indication could prevent further development for all indications; (iii) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, and competitive factors; (iv) scientific discovery of new therapeutics is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-358) is therefore highly uncertain and unpredictable; (v) patents may not issue from our patent applications for NKTR-358, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2019. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors:Vivian Wu of Nektar Therapeutics628-895-0661

For Media:Jodi Sievers of Nektar Therapeutics415-482-5593

Dan Budwick of 1AB973-271-6085dan@1abmedia.com

*NKTR-358 is referred to as LY3471851 under Lilly-sponsored studies.

1 Fuxench, Zelma C. Chiesa, et al. "Atopic Dermatitis in America Study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population." Journal of Investigative Dermatology 139.3 (2019): 583-590.2 National Psoriasis Foundation, https://www.psoriasis.org accessed September 4, 2019.

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SOURCE Nektar Therapeutics

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Nektar Therapeutics Announces Initiation of Two Clinical Studies of Novel T Regulatory Cell Stimulator NKTR-358 (LY3471851) in Patients with Psoriasis...

Research from Taltz, Olumiant and mirikizumab highlight the impact Lilly's medicines may have for patients around the world

INDIANAPOLIS, Oct. 8, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that it will present new data for Taltz (ixekizumab), Olumiant (baricitinib) and mirikizumab at the 28th annual European Academy of Dermatology and Venereology (EADV) Congress taking place Oct. 9-13 in Madrid, Spain. The research being highlighted at this year's meeting reinforces Lilly's commitment to developing treatments for individuals living with dermatological conditions such as psoriasis, psoriatic arthritis, atopic dermatitis and alopecia areata.

"Lilly is proud to showcase data from our dermatology portfolio at EADV this year. Our scientific expertise in dermatology has helped increase the number of available treatment options for patients around the world living with skin-related diseases," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We aspire to raise expectations as to how these diseases are treated so people can live their lives without compromise."

Lilly will present findings from a Phase 3 trial of Taltz for pediatric patients with moderate to severe psoriasis as a late-breaking oral presentation at this year's meeting. The company also will be sharing results from a patient survey evaluating treatment expectations and burden of disease for patients living with psoriasis.

For baricitinib, Lilly will present a late-breaking presentation of the BREEZE-AD7 clinical trial. BREEZE-AD7 is an investigational study measuring the efficacy and safety of baricitinib in combination with topical corticosteroids for the treatment of moderate to severe atopic dermatitis (AD) in adults. Lilly and Incyte Corporation (NASDAQ: INCY) are partners in the clinical development of baricitinib. Further, Lilly will present data findings from a real-world study assessing how elements of an individual's quality of life (both functional and emotional) may be impacted by AD.

Posters to be shared around Lilly's investigational compound, mirikizumab, include research from a study measuring patient outcomes and health-related elements of quality of life for individuals with moderate to severe psoriasis.

Studies, along with the times and locations for the data sessions, are highlighted below.

Taltz Data

Oral Presentations

Thursday, October 10

Saturday, October 12

Poster Presentations

Baricitinib Data

Oral Presentations

Saturday, October 12

Poster Presentations

Mirikizumab Data

Poster Presentations

INDICATIONS AND USAGE FOR TALTZTaltz is approved for the treatment of adults with adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.

IMPORTANT SAFETY INFORMATION FOR TALTZ

CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS InfectionsTaltz may increase the risk of infection. In clinical trials of patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of patients with psoriatic arthritis and ankylosing spondylitis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

HypersensitivitySerious hypersensitivity reactions, including angioedema and urticaria (each 0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel DiseaseDuring Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn's disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn's disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

ImmunizationsPrior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONSMost common adverse reactions (1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea and tinea infections. Overall, the safety profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 23AUG2019

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patientsOLUMIANT (baricitinib) 2 mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS

WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

WARNINGS AND PRECAUTIONS

SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS: Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES: Neutropenia Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Lymphopenia Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Liver Enzyme Elevations Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases to 5x and 10x upper limit of normal were observed for both ALT and AST in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Lipid Elevations Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

VACCINATIONS: Avoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

ADVERSE REACTIONSAdverse reactions (1%) include: upper respiratory tract infections (16.3%, 14.7%, 11.7%), nausea (2.7%, 2.8%, 1.6%), herpes simplex (0.8%, 1.8%, 0.7%) and herpes zoster (1.0%, 1.4%, 0.4%) for Olumiant 2 mg, baricitinib 4 mg, and placebo, respectively.

USE IN SPECIFIC POPULATIONSPREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with moderate or severe renal impairment.

Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

BA HCP ISI 01JUN2018

About Taltz Taltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.1

About OLUMIANT OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.2 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.3 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.2 OLUMIANT is approved in more than 60 countries.

About Mirikizumab Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis and Crohn's disease.

About Moderate to Severe Plaque Psoriasis Psoriasis is a chronic, immune disease that affects the skin.4 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate to severe plaque psoriasis.4,5 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.4 Patients with plaque psoriasis often have other serious health conditions, such as diabetes and heart disease and experience negative impact on their quality of life.4

About Atopic DermatitisAtopic dermatitis (AD), a serious form of atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.6 AD is a heterogeneous disease both clinically and biologically, but may be characterized by chronic baseline symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.7,8 AD affects approximately 1-3 percent of adults worldwide.9

Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.10 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.11

About BREEZE-AD7The BREEZE-AD7 clinical trial is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of baricitinib in combination with topical corticosteroids in adult patients with moderate to severe atopic dermatitis. Two doses were evaluated separately such that the primary objective of the study could be met if one or both doses achieved the primary endpoint. The primary endpoint evaluated significant improvement in disease activity as determined by the proportion of patients on baricitinib achieving clear (0) or almost clear skin (1) with a greater than or equal to 2-point improvement as measured by the validated 5-point Investigator's Global Assessment for AD (vIGA) scale at 16 weeks of treatment. BREEZE-AD7 is the third of five Phase 3 studies that make up the BREEZE-AD program. Lilly previously announced results for BREEZE-AD1 and BREEZE-AD2 earlier this year.

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab), OLUMIANT (baricitinib), and mirikizumab, and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that mirikizumab will receive regulatory approval, that Taltz or OLUMIANT will receive additional regulatory approvals, or that any will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

_______________________________1 Taltz Prescribing Information, 2019.2 Olumiant Prescribing Information, 2018.3 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.4 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed September, 2019.5 Skin conditions by the numbers. American Academy of Dermatology website. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed September, 2019.6 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.7 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.8 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.9 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.10 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.11 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

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SOURCE Eli Lilly and Company

Company Codes: NASDAQ-NMS:INCY, NYSE:LLY

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Lilly to Unveil New Data for the Treatments of Complex Dermatological Conditions at the 28th Annual European Academy of Dermatology and Venereology...

Eli Lilly (LLY) announced positive results from its phase 4 study treating patients with severe plaque psoriasis. This was a head to head study and it might make a better case on why patients would want to be treated with Taltz over other treatments that are currently available on the market. There are several competitors that Eli Lilly will have to deal with, but this head to head study is a step in the right direction. Sales of Taltz are continuing to grow by a large percentage year over year. I think that the company will do really good in the long run if it keeps releasing positive results for Taltz, like what was achieved for this head to head study.

The phase 4 study is known as IXORA-R. This study was a head to head study between Taltz and Tremfya. There were a total of 1,027 patients with moderate to severe plaque psoriasis. The primary endpoint is the proportion of patients achieving skin clearance as measured by PASI 100 at week 12. One thing to note is that this study was a unique one. That's because it was the first of a kind study to pit an IL-17A inhibitor (Taltz) against a Johnson & Johnson (JNJ) with its IL-23/p19 inhibitor (Tremfya) using the PASI 100 score as a primary endpoint. PASI 100 indicates percentage of patients who achieve a 100% skin clearance from baseline to week 12. It was noted that Taltz had met the primary endpoint of this study. This was where Taltz had achieved superiority against Tremfya in that patients with plaque psoriasis achieved complete skin clearance (PASI 100) at week 12. Specifically, there were 41.3% of patients with PASI 100 at week 12 treated with Taltz compared to only 24.9% of those given Tremfya. This was a statistically significant improvement in favor of Taltz with a p-value of p<0.001. What makes this study so successful is not just the fact that the primary endpoint was met. Of course, that is always a positive for any study of this caliber. However, it is the fact that Taltz worked so well in a short period of time. Not only did more patients achieve skin clearance when treated with Taltz, but there were many who had a 50% improvement in skin clearance after only 1 week of treatment. That's great, but why is this good for this patient population? This is especially important in patients with plaque psoriasis. That's because these patients experience peeling and itching of the skin. As you can imagine, the quicker a treatment works, the faster the patient experiences relief from their disease. This, in turn, has a big impact on quality of life. The thing is that data from this study is not coming to an end. There will be additional results revealed yet again at the 24-week mark in 2020.

This was definitely a good head to head study in favor of Eli Lilly with Taltz. Sales of Taltz have been doing quite well actually this year. In both Q1 and Q2 of 2019 combined, sales of Taltz reached $607 million. To put it another way, sales of the drug in Q2 of 2019 alone ended up being $353.8 million, which was an increase of 61% year over year. Taltz is putting up good numbers, however, another drug from Novartis (NVS) known as Cosentyx has achieved an even massive number in terms of sales in plaque psoriasis and several other autoimmune disorders. Cosentyx was said to have generated $1.6 billion in the first half of 2019. I think it is important to point out that Cosentyx had first-mover advantage compared to some other drugs. Tremfya has also been doing pretty good as well growing year over year but is lagging slightly behind Cosentyx. However, that makes sense considering Taltz has only received a few regulatory approvals thus far. Tremfya posted Q2 2019 worldwide sales of $235 million. The point here is that the space is getting crowded, so there is a risk for Taltz. Still, the latest head to head study might possibly give the drug an edge over its competitors. Lastly, you also have AbbVie (ABBV) with its latest entrant into the plaque psoriasis space with Skyrizi. Skyrizi has done quite well as a start just for plaque psoriasis alone. AbbVie has been able to generate $48 million in sales with this drug in just two months of it being on the market. AbbVie believes that sales could reach as much as $250 million in global sales for 2019.

Eli Lilly doing so well with Taltz in a head to head study versus Tremfya in plaque psoriasis is very good news. It sets up Taltz to do well in terms of sales against this drug for this particular indication. The bigger issue at hand is Novartis with Cosentyx, which has seen its drug generate $1.6 billion in the first half of 2019 alone. This a major competitor where Eli Lilly might have trouble to go against. The good thing at least is that Taltz continues to grow revenues by at least 61% year over year. As long as it can maintain that type of growth year over year, I believe it will do well in the long term. Plus, as I highlighted above, Cosentyx has first-mover advantage compared to these other drugs. Eli Lilly definitely has a shot to compete well with about 4 indications already approved for Taltz. That's why I believe Eli Lilly will do well in the long run.

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.

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Eli Lilly Shows Its Strength With Taltz In Positive Head To Head Study - Seeking Alpha

DUBLIN, Oct. 11, 2019 /PRNewswire/ -- The "TNF Alpha Inhibitors Market By Drug Class (Adalimumab, Certolizumab Pegol, Etanercept, Golimumab, Infliximab), By Pipeline Analysis (Phase I, Phase II, Phase III), By Regions - Global Forecast up to 2025" report has been added to ResearchAndMarkets.com's offering.

Overview of the Global TNF Alpha Inhibitors Market Research:

The author's market research report predicts that the global TNF alpha inhibitors market will grow at a CAGR of 3.6% during the forecast period 2019-2025.

TNF inhibitors, also known as TNF blockers, anti-TNF drugs, and biologic therapies, are a cluster of medications used to treat inflammatory conditions, including rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease (Crohn's and ulcerative colitis), and psoriasis. The drugs decrease inflammation and can stop disease development by targeting an inflammation-causing substance, tumor necrosis factor (TNF).

The market is witnessing the loss of patents in Europe for various blockbuster drugs, resulting in the emergence of biosimilars. In April 2019, Eticovo - a biosimilar from Samsung Bioepis to Amgen's Enbrel (etanercept), received FDA approval. In November 2018, FDA approved Hyrimoz developed by Sandoz, a biosimilar to AbbVie's blockbuster drug Humira, which will be launched in the US market by 2023. Currently, only five approved TNF inhibitors, i.e., adalimumab, certolizumab, etanercept, golimumab, and infliximab, control the market. The wide application of these drugs for numerous autoimmune diseases ensures constant growth of the market during the forecast period 2019-2025.

According to the author analysis, North America accounted for the largest share of the global TNF alpha inhibitors market in 2018 and will retain a high position during the forecast period. North America is followed by Europe, with a market share of more than 20% in 2018.

In 2018, the adalimumab segment accounted for the largest share and is expected to grow at a mid-single-digit CAGR during the forecast period. Increased clinical efficacy and high preference by physicians for the treatment of severe rheumatic diseases made the segment the largest shareholder in 2018. Golimumab is expected to grow at a high CAGR during the forecast period 2019-2025.

Many companies are making huge investments to develop products and enter the market as soon as biologics lose their patents. Among various TNF alpha inhibitors, adalimumab has the highest number of ongoing clinical trials, followed by certolizumab pegol.

Global TNF Alpha Inhibitors Market Research Competitive Analysis: The market is growing at a steady rate, i.e., at a CAGR of 3.6% during the forecast period 2019-2025. New drug launches, product approvals, strategic partnerships, and collaborations are among the significant strategies adopted by market leaders to maintain their leadership position. For instance, in July 2019, the US FDA approved HADLIMA by Samsung Bioepis, a biosimilar referencing HUMIRA, to treat juvenile idiopathic arthritis, adult Crohn's disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, rheumatoid arthritis, and plaque psoriasis. In March 2019, the US FDA approved Cimzia injection to treat non-radiographic axial spondyloarthritis (nr-axSpA) in adults, with detached signs of swelling making it the first-ever FDA approved treatment fulfilling the unmet needs for nr-axSpA; and in May 2018, the drug was approved for the treatment of moderate-to-severe plaque psoriasis.

The rising incidence of chronic autoimmune diseases has led to the increasing launch of biosimilars globally. In May 2019, Fresenius Kabi launched biosimilar adalimumab IDACIO in Germany. In May 2019, Janssen launched Simponi Autoinjector in Japan, and the drugs are distributed by Mitsubishi Tanabe. In addition, other leading vendors are focusing on hugely investing in R&D activities to develop new drugs to obtain a high share in the market.

Key Competitive Facts:

Key Topics Covered:

1 Industry Outlook1.1 Industry Overview 1.1.1 Global Driver for Pharmaceutical Demand 1.1.2 R&D Pipeline in Pharmaceutical Industry 1.1.3 Top Pharma Drugs by Sales ($Million) 1.2 Industry Trends 1.3 Total Addressable Market 1.4 Trends of the Immunotherapy Drugs Market

2 Report Outline2.1 Report Scope 2.2 Report Summary 2.3 Research Methodology 2.4 Report Assumptions

3 Market Snapshot3.1 Market Definition - Infoholic Research 3.2 Segmented Addressable Market (SAM) 3.3 Trends of the TNF Alpha Inhibitors Market 3.4 Related Markets 3.4.1 Oncology Drugs 3.4.2 Biologics 3.4.3 Biosimilars

4 Market Outlook4.1 Market Segmentation 4.2 PEST Analysis 4.3 Porter 5(Five) Forces

5 Market Characteristics5.1 DRO - Global TNF Alpha Inhibitors Market Dynamics 5.1.1 Drivers 5.1.1.1 Increasing prevalence of chronic autoimmune disease 5.1.1.2 Constant research to develop target-based biologics 5.1.2 Opportunities 5.1.2.1 Continuous development of biosimilars 5.1.2.2 Increasing opportunities in the emerging market 5.1.3 Restraints 5.1.3.1 Complex drug development process 5.1.3.2 Patent expiry 5.2 DRO - Impact Analysis 5.3 Key Stakeholders

6 Product: Market Size and Analysis6.1 Overview 6.2 Adalimumab 6.3 Certolizumab Pegol 6.4 Etanercept 6.5 Golimumab 6.6 Infliximab

7 Pipeline Analysis: Market Size and Analysis7.1 Overview 7.2 Phase I 7.3 Phase II 7.4 Phase III

8 Regions: Market Size and Analysis8.1 Overview 8.2 North America 8.3 Europe 8.4 Asia Pacific 8.5 Rest of the World 8.5.2 Mexico 8.5.3 Brazil 8.5.4 Middle East and Africa

9 Competitive Landscape

10 Vendors Profile10.1 AbbVie Inc. 10.1.1 Overview 10.1.2 Geographic Revenue 10.1.3 Business Focus 10.1.4 SWOT Analysis 10.1.5 Business Strategies 10.2 Novartis AG 10.3 Amgen Inc. 10.4 Johnson & Johnson 10.5 Celgene Corporation

11 Companies to Watch For11.1 Apogenix 11.1.1 Overview 11.2 Celltrion Healthcare 11.3 Samsung Bioepis Co. Ltd. 11.4 3SBio Inc. 11.5 Shanghai CP Guojian Pharmaceutical Co. Ltd.

For more information about this report visit https://www.researchandmarkets.com/r/cl7qzh

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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View original content:http://www.prnewswire.com/news-releases/tnf-alpha-inhibitors-market-expected-to-grow-by-3-6-during-the-forecast-period-2019-2025--300937080.html

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TNF Alpha Inhibitors Market Expected to Grow by 3.6% During the Forecast Period, 2019-2025 - P&T Community

PLC's () Gerry Brandon tells Proactive London's Andrew Scott they've signed multi-year agreements with two Top 10 global cosmetic companies for recurring LabskinAI services.

He adds that the LabskinAI teams have also completed an artificially intelligent virtual psoriasis skin model.

''Once we have the major corporates online everyone else follows through ... like dominos falling''.

''We've ticked all the boxes today for pretty much the institutions and now we're in a position where we can look at acquiring infrastructure to accommodate rather than organically grow - because we can't organically grow fast enough''.

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"Watershed moment" for Integumen with multi-year deals and new psoriasis skin model - Proactive Investors UK

Interleukin (IL)-41, also known as Meteorin-like, is expressed in the synovial tissue of patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), and osteoarthritis (OA), and is present and inducible in the enthesis, according to study results published in Clinical Immunology.

The study included data from patients who were treatment-naive. Researchers extracted synovial fluid and measured IL-41 levels using enzyme-linked immunosorbent assay; results from the synovial fluid had <10% reproducibility error. Cell cultures and receptor analysis by flow cytometry were performed to achieve appropriate samples. Researchers also obtained patient demographics.

Study results indicated that IL-41 was detectable in synovial fluid samples in patients with PsA, RA and OA, although it was significantly higher in PsA and RA compared with OA (median, 7722 pg/mL; P =.0011 and 8325 pg/mL; P =.0003 vs 5044 pg/mL, respectively). Researchers also obtained levels of IL-41 in synovial fluid from patients with gout; it was higher compared with IL-41 in patients with OA, but statistical significance was not achieved.

Researchers investigated the production of IL-41 in healthy enthesis samples and noted that although minimal IL-41 was produced from enthesis mononuclear cells, entheseal stromal cells produced a significant amount of IL-41 in comparison. Synovial fibroblasts also showed similar levels of IL-41 compared with entheseal stromal cells.

In addition, the researchers assessed whether IL-41 could be induced by disease relevant mediators, including tumor necrosis factor (TNF), IL-17A, and IL-17F. Results showed that when used alone, TNF, IL-17A, and IL-17F did not induce an increase in IL-41, but TNF with IL-17A or IL-17F led to a significant increase in IL-41 production. Study investigators observed similar results with synovial fibroblasts.

Overall, IL-41 was significantly elevated in the synovium and was induced from enthesis stromal cells in patients with PsA.

The precise role of IL-41 in PsA immunopathogenesis requires further study, the researchers concluded.

Reference

Bridgewood C, Russell T, Weedon H, et al. The novel cytokine Metrnl/IL-41 is elevated in psoriatic arthritis synovium and inducible from both entheseal and synovial fibroblasts. J Clin Immunol. 2019;208:108253.

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IL-41 Levels Elevated in Synovium of Patients With Psoriatic Arthritis - Rheumatology Advisor

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Novartis data show Cosentyx treatment results in rapid and sustained resolution of signs and symptoms of psoriatic arthritis in patients with and wit...