Navigation Links
Lilly Discontinues One of Three Phase 3 Rheumatoid Arthritis Registration Studies for Tabalumab
Date:12/13/2012

Lilly will continue to develop additional treatment options for patients with autoimmune diseases."

The decision to stop the FLEX-M study is expected to result in a fourth-quarter charge in the range of $20 million to $35 million (pre-tax), or approximately $0.02 per share (after-tax). The company's previously issued financial guidance for 2012 remains unchanged.

About the FLEX-M Study

The FLEX-M study (study BCDM) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of tabalumab in patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate therapy. This pivotal registration study includes the assessment of the effect of tabalumab on structural progression.   

About BAFF and Tabalumab 

BAFF (B cell activating factor) is a cytokine that promotes B cell survival, proliferation and activation. In the presence of excess BAFF, B cells, including autoreactive B cells, are not appropriately eliminated by the immune system and may therefore contribute to the development of RA by producing autoantibodies and proinflammatory cytokines and "helping" autoreactive T cells. BAFF exists in both membrane-bound and soluble forms.

Tabalumab is a human immunoglobulin G subclass 4 (IgG4) monoclonal antibody (MAb) that inhibits both membrane-bound and soluble B cell activating factor (BAFF). Tabalumab is currently in Phase 3 development as a potential treatment for rheumatoid arthritis and systemic lupus erythematosus.

About Lilly's Autoimmune Pipeline

Tabalumab is one of three potential new medicines in late-stage clinical development for a variety of autoimmune conditions. The others are ixekizumab, an anti-IL-17 monoclonal antibody, for psoriasis and psoriatic arthritis, and baricitinib, a JAK1 and JAK2 inhibitor being developed in collaboration with Incyte Corporation, for RA, psoriasi
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Lilly Provides Update on Next Steps for Solanezumab
2. Lilly to Expand Indianapolis Insulin Manufacturing Operations
3. Lilly Names Melissa Barnes Chief Ethics and Compliance Officer and Senior Vice President; Announces Retirement of Anne Nobles
4. Lilly Celebrates 18th Consecutive Year as One of Working Mothers 100 Best Companies
5. Boehringer Ingelheim and Lilly introduce the My Well Planner Lifestyle Improvement Program for Adults with Type 2 Diabetes
6. Lilly Announces Results From Lung Cancer Study
7. Lilly Announces Retirement of Robert Armitage, Names Michael Harrington Senior Vice President and General Counsel
8. Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on Efficacy Results
9. U.S. Court of Appeals Upholds Validity of Lillys Alimta Compound Patent
10. Lilly Revises 2012 Reported Guidance to Reflect Income from Early Payment of Amylin Obligations
11. Lilly Announces Study Results Regarding Postmenopausal Women with Back Pain Caused by Vertebral Fractures
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... LAWRENCEVILLE, N.J. , Sept. 17, 2014 /PRNewswire-USNewswire/ ... that details how to implement GS1 Standards to ... (DSCSA), and enhance patient safety and security in ... Applying GS1 Standards to U.S. Pharmaceutical Supply ... Chain Security Act , was developed in ...
(Date:9/17/2014)... Sept. 17, 2014 Isis Pharmaceuticals, Inc. ... has earned a $4 million milestone payment from ... with the initiation of a Phase 3 study ... (MDR), gram-negative bacterial infections.  The Phase 3 study ... the efficacy and safety of plazomicin compared to ...
(Date:9/17/2014)... FRANCISCO , Sept. 17, 2014 Sutro ... bispecific antibodies, and the biopharmaceutical division of Merck KGaA, ... EMD Serono in the United States ... a collaboration and license agreement to develop antibody drug ... to a cytotoxic drug. The antibody is thought to ...
Breaking Medicine Technology:New Healthcare Industry Guideline Delineates How to Implement GS1 Standards to Support Requirements of the 2013 Drug Supply Chain Security Act 2New Healthcare Industry Guideline Delineates How to Implement GS1 Standards to Support Requirements of the 2013 Drug Supply Chain Security Act 3New Healthcare Industry Guideline Delineates How to Implement GS1 Standards to Support Requirements of the 2013 Drug Supply Chain Security Act 4Isis Pharmaceuticals Earns $4 Million from Achaogen for the Initiation of a Phase 3 Study of Plazomicin 2Isis Pharmaceuticals Earns $4 Million from Achaogen for the Initiation of a Phase 3 Study of Plazomicin 3Sutro Biopharma and Merck KGaA of Darmstadt, Germany, to Partner on Development of Antibody Drug Conjugates 2Sutro Biopharma and Merck KGaA of Darmstadt, Germany, to Partner on Development of Antibody Drug Conjugates 3Sutro Biopharma and Merck KGaA of Darmstadt, Germany, to Partner on Development of Antibody Drug Conjugates 4
... The Board of Directors of Stereotaxis, Inc. (NASDAQ: ... that it reaffirmed the Company,s plans for both the launch ... Odyssey ™  platform into standard labs. "At ... commercial strategies put forth for the launch of Epoch, as ...
... 2011 Reportlinker.com announces that a new market ... Pharmaceutical Manufacturers - India ... This register contains information about 1327 ... includes the following details of the manufacturers: ...
Cached Medicine Technology:Stereotaxis' Board of Directors Reaffirms Commercialization Plans for Epoch™ and Odyssey™ Product Platforms 2Stereotaxis' Board of Directors Reaffirms Commercialization Plans for Epoch™ and Odyssey™ Product Platforms 3
(Date:9/17/2014)... 2014 In Pretrial Order #139 (Scheduling ... discovery conferences would be beneficial in this [MDL].” Accordingly, ... “At the end of December,” the order further provides, ... additional conferences. , “The plain import of this ... still much to be discussed as these cases progress ...
(Date:9/17/2014)... Dennis Thompson HealthDay ... -- Exposure in the womb to household chemicals known ... developing asthma, Columbia University researchers reported in a new ... risk of developing asthma between age 5 and 11 ... levels of two phthalates (pronounced thal-ates), the researchers found. ...
(Date:9/17/2014)... Scripps Research Institute (TSRI) have devised a new ... against vancomycin-resistant strains of MRSA and other disease-causing ... have not one but two distinct mechanisms of ... resistance quickly. , "This is the prototype of ... clinical use a generation or maybe even two ...
(Date:9/17/2014)... York, New York (PRWEB) September 17, 2014 ... filings involving the Conserve line of metal-on-metal hip ... now underway in U.S. District Court, Northern District ... an updated Case List issued by the U.S. ... 2014, at least 397 product liability claims have ...
(Date:9/17/2014)... Toledo, Ohio (PRWEB) September 17, 2014 ... hearing for today, September 17, 2014, to consider: , ... Testosterone Replacement Therapy (TRT), and, 2. ... of TRT. , With the TRT litigation ongoing, an ... FDA on the dangers of testosterone replacement therapy. Among ...
Breaking Medicine News(10 mins):Health News:Transvaginal Mesh Lawsuit News: New Order in C.R. Bard MDL Sets Schedule of Conferences for September to December, the Rottenstein Law Group LLP Reports 2Health News:Prenatal Exposure to Chemicals in Plastics Linked to Asthma Risk in Kids 2Health News:Prenatal Exposure to Chemicals in Plastics Linked to Asthma Risk in Kids 3Health News:Prenatal Exposure to Chemicals in Plastics Linked to Asthma Risk in Kids 4Health News:Scripps Research Institute chemists modify antibiotic to vanquish resistant bacteria 2Health News:Scripps Research Institute chemists modify antibiotic to vanquish resistant bacteria 3Health News:Wright Hip Lawsuit News: Nearly 400 Filings Reported in Federal Wright Conserve Hip Replacement Litigation, Bernstein Liebhard LLP Reports 2Health News:Wright Hip Lawsuit News: Nearly 400 Filings Reported in Federal Wright Conserve Hip Replacement Litigation, Bernstein Liebhard LLP Reports 3Health News:FDA Advisory Committee Holds Hearing on Testosterone Safety 2
... From June Dairy Month through,the State Fair, summer ... June 1, Minnesotans will be able get details about ... mouse. ExploreDairy.com is a,one-stop resource for all the latest ... hardworking dairy farm families., ExploreDairy.com is designed to ...
... 29 The following is a,statement by Matthew L. ... Health Organization,s World No Tobacco Day, to be celebrated,May ... of the global,tobacco epidemic and the urgent need for ... save lives., This year,s theme -- Tobacco-Free Youth: ...
... May 29 The Academy of General,Dentistry (AGD) expresses ... reauthorize the Dental Health Improvement Act (S,3067) for another ... and Benjamin Cardin (D-MD). The intent of the Act ... shortage of dental health,professionals., "Last week was a ...
... Leaders of Indiana and Purdue universities Thursday ... Translational Sciences Institute (CTSI), a medical research initiative ... business and government to swiftly transform discoveries into ... National Institutes of Health has awarded a five-year ...
... The Musculoskeletal Transplant,Foundation (MTF) will provide military hospitals ... joint repair for injured servicemen and,women., Military ... obtaining,tissue used for cartilage transplantation and meniscus grafts ... types of tissue are in high,demand for U.S. ...
... NY) The National Institutes of Health has ... University and Montefiore Medical Center one of its ... million over five years. The grant will support ... Research (ICTR), whose overarching goal is to collaboratively ...
Cached Medicine News:Health News:ExploreDairy.com Debuts With Information on Minnesota Dairy Events, People and Products 2Health News:World No Tobacco Day Sounds Urgent Call for Nations to Fight Tobacco Use, Save Lives 2Health News:World No Tobacco Day Sounds Urgent Call for Nations to Fight Tobacco Use, Save Lives 3Health News:AGD Thanks Senators for Introducing Bill to Reauthorize the Dental Health Improvement Act 2Health News:NIH awards Einstein College of Medicine & Montefiore Medical Center $22M grant 2Health News:NIH awards Einstein College of Medicine & Montefiore Medical Center $22M grant 3
Hemagglutination slide test for the qualitative detection and quantitative determination of antibodies to streptococcal extracellular antigens in serum, plasma, or whole blood....
Color-enhanced slide agglutination test for the rapid qualitative and semi-quantitative detection of antistreptolysin O....
Hemagglutination slide test for the qualitative and quantitative detection of Rheumatoid Factor in serum or synovial fluid....
Hemagglutination slide test for the qualitative and quantitative detection of infectious mononucleosis heterophile antibodies in serum or plasma....
Medicine Products: