Key Developments: Eli Lilly and Co (LLY.N)

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Latest Key Developments (Source: Significant Developments)

Eli Lilly and Co's basal insulin peglispro shows superiority to insulin glargine in reducing HbA1c in people with type 2 diabetes
Saturday, 6 Jun 2015 01:45pm EDT 

Eli Lilly and Co:Says that its basal insulin peglispro (BIL) consistently demonstrated superior hemoglobin A1c (HbA1c) reduction in people with type 2 diabetes compared to insulin glargine across three Phase III trials.Says trials compared BIL and insulin glargine in three common type 2 patient populations: those not previously using insulin (IMAGINE-2), those using basal insulin with mealtime insulin (IMAGINE-4) and those currently using a basal insulin (IMAGINE-5).  Full Article

Eli Lilly and Co announces U.S. Food and Drug Administration Approves Humalog 200 units/mL KwikPen
Wednesday, 27 May 2015 08:30am EDT 

Eli Lilly and Co:Says FDA has approved Humalog200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog(insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes.  Full Article

Eli Lilly and Co and Sanford-Burnham announce collaboration to investigate immunological therapies
Thursday, 14 May 2015 06:00am EDT 

Eli Lilly and Co:They will collaborate to discover and develop immunological therapies.Lilly and Sanford-Burnham will investigate potential therapeutics using biotechnology approaches in targeting multiple immune checkpoint modulators for the treatment of immunological diseases such as lupus, Sj√∂gren's Syndrome, inflammatory bowel disease and other autoimmune disorders.Comprehensive research collaboration is driven by Lilly's world-class biotechnology capabilities and expertise in immunology, and Sanford-Burnham's deep expertise in understanding the fundamental cellular pathways regulating immune system focusing on immune checkpoint networks.  Full Article

Eli Lilly and Company and BioNTech AG announce research collaboration on cancer immunotherapies
Monday, 11 May 2015 03:15pm EDT 

Eli Lilly and Company and BioNTech AG:Enters into a research collaboration to discover novel cancer immunotherapies.Companies will seek to use the power of the body's own immune system to attack cancer cells and create possible new treatment options for cancer patients.Leveraging the scientific expertise between the two organizations, Lilly and BioNTech will collaborate to identify and validate novel tumor targets and their corresponding T cell receptors (TCRs) in one or more types of cancer.Says these tumor targets and TCRs may then be engineered and developed into potent and selective cancer therapies.Under the terms of the agreement, BioNTech will receive a $30 million signing fee. For each potential medicine, BioNTech could receive over $300 million in development, regulatory and commercial milestones.Says if successfully commercialized, BioNTech would also be eligible for tiered royalty payments up to double-digits.Says in addition, subject to the terms of the agreement, Lilly will make a $30 million equity investment in BioNTech's subsidiary, Cell & Gene Therapies GmbH, which specializes in the research and development of TCR and chimeric antigen receptor immunotherapeutics.Further financial terms were not disclosed.  Full Article

Eli Lilly and Company declares second-quarter 2015 dividend
Monday, 4 May 2015 02:26pm EDT 

Eli Lilly and Company:Has declared a dividend for the second quarter of 2015 of $0.50 per share on outstanding common stock.The dividend is payable June 10, to shareholders of record at the close of business on May 18.  Full Article

Eli Lilly and Company receives fourth FDA approval for CYRAMZA
Friday, 24 Apr 2015 04:27pm EDT 

Eli Lilly and Company:Receives fourth U.S. Food and Drug Administration approval for CYRAMZA.CYRAMZA is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.Says approval is based on Phase III trial known as RAISE.  Full Article

Eli Lilly and Co Reaffirms FY 2015 outlook
Thursday, 23 Apr 2015 06:25am EDT 

Eli Lilly and Co:Expects FY 2015 EPS to be in the range of $2.21 to $2.31 on a reported basis.Reaffirms FY 2015 non-GAAP EPS in the range of $3.10 to $3.20.Reaffirms FY 2015 revenue of between $19.5 bln and $20.0 bln.FY 2015 EPS of $3.15, revenue of $19.85 bln - Thomson Reuters I/B/E/S.  Full Article

Eli Lilly and Company and Bristol-Myers Squibb Co announces collaboration in north america
Thursday, 16 Apr 2015 12:15pm EDT 

Eli Lilly and Company and Bristol-Myers Squibb Co:Says that it has agreed to transfer rights to Erbitux in North America, including the U.S., Canada, and Puerto Rico, from Bristol-Myers Squibb to Lilly.Rights include, but are not limited to, full commercialization and manufacturing operational responsibilities.The companies' decision comes after a 14-year successful collaboration, which includes Lilly's wholly-owned subsidiary ImClone LLC.Bristol-Myers Squibb and Lilly will work closely to ensure a smooth transition on this important product for patients with certain advanced colorectal and head and neck cancers.  Full Article

OncoMed Pharmaceuticals Inc and Lilly Enter clinical supply agreement to evaluate combination of Demcizumab and Alimta (pemetrexed for injection) in lung cancer
Thursday, 2 Apr 2015 08:30am EDT 

OncoMed Pharmaceuticals Inc:Says it has entered into an agreement with Eli Lilly and Company.Demcizumab, OncoMed's anti-DLL4 antibody, is being tested in combination with Lilly's Alimta (pemetrexed for injection) and carboplatin for the treatment of first-line advanced non-small cell lung cancer (NSCLC).Under terms of this agreement, Lilly will provide clinical supply of Alimta for OncoMed's ongoing Phase 2 DENALI trial.  Full Article

Pfizer Inc and Eli Lilly and Co preparing to resume phase 3 chronic pain program for Tanezumab
Monday, 23 Mar 2015 08:00am EDT 

Pfizer Inc adn Eli Lilly and Co:Says that they are preparing to resume Phase 3 clinical program for Tanezumab.As a result, Pfizer expects to receive $200 mln upfront payment from Lilly in accordance with their collaboration agreement.Says this announcement follows decision by U.S. Food and Drug Administration (FDA) to lift partial clinical hold on tanezumab development program after review of robust body of nonclinical data characterizing sympathetic nervous system response to tanezumab.Says data were submitted to FDA in Feb. 2015.In prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines.Says partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since Dec. 2012 due to adverse changes in the sympathetic nervous system of mature animals.Studies in terminal cancer pain were allowed to proceed.  Full Article

CORRECTED-BRIEF- Eli Lilly and Co says EMPA-REG OUTCOME met its primary endpoint

Aug 20 - Eli Lilly and Co : * Jardiance demonstrated cardiovascular (cv) risk reduction in people with type 2 diabetes at high risk for cv events * Says empa-reg outcome met its primary endpoint * Says empa-reg outcome demonstrated superiority of jardiance, when added to standard of care, in cv risk reduction * Source text for Eikon * Further company coverage

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