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eli lilly & co (LLY) Key Developments

Boehringer Ingelheim and Eli Lilly and Company Presents Results from 52-Week Phase Iii Study of Investigational Empagliflozin/Linagliptin Combination Tablet in Adults with Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Company presented results from a 52-week Phase III study that demonstrated sustained efficacy of the investigational empagliflozin/linagliptin combination tablet in adults with type 2 diabetes (T2D) already taking metformin and in those who were previously untreated. Results from the study, presented during the 50(th) Annual Meeting of the European Association for the Study of Diabetes (EASD), also confirmed the safety profile of the combination tablet.

AstraZeneca plc and Eli Lilly and Co. Reach Deal on BACE Inhibitor AZD3293 for Alzheimer's Disease

AstraZeneca plc and Eli Lilly and Co. announced that they reached a deal to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme or BACE inhibitor currently in development as a potential treatment for Alzheimer's disease. As per the terms of the deal, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50 million in the first half of 2015. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer's disease. Lilly will lead clinical development, working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of AZD3293.

Eli Lilly and Company Announces CYRAMZA Phase III Second-Line Colorectal Cancer Trial

Eli Lilly and Company announced that the RAISE trial, a Phase III study of ramucirumab in combination with chemotherapy in patients with metastatic colorectal cancer, met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting. RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI. The study also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared to the placebo plus FOLFIRI arm. The most common grade >/=3 adverse events occurring at a higher rate on the ramucirumab-plus-FOLFIRI arm compared to the control arm were neutropenia, fatigue, hypertension, and diarrhea. Despite advances in treating colorectal cancer in recent years, the mortality rate remains significant. It is the fourth leading cause of cancer death worldwide and the second leading cause of cancer death in the U.S. Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. VEGF Receptor 2 is an important mediator in the VEGF pathway In an in vivo animal model, ramucirumab inhibited angiogenesis. Angiogenesis is a process by which new blood vessels form to supply blood to normal healthy tissues as well as tumors, enabling the cancer to grow.

Eli Lilly and Company Demonstrates Basal Insulin Peglispro HbA1c Superiority Against Lantus(R) in Phase III Trials in Patients with Type 1 Diabetes

Eli Lilly and Company announced that the company's basal insulin peglispro (BIL) demonstrated a statistically significant lower hemoglobin A1c (HbA1c) compared with insulin glargine (Lantus(R)) at 26 weeks and 52 weeks, respectively, in the IMAGINE-1 and IMAGINE-3 Phase III clinical trials in patients with type 1 diabetes. Patients in these trials were also taking mealtime insulin. Notably, patients in IMAGINE-1 continued treatment beyond 26 weeks, and the HbA1c superiority for BIL was maintained at 52 and 78 weeks. The Phase III trials needed for submission are now complete. The trials, in both type 1 and type 2 diabetes, showed consistent superiority of HbA1c for BIL against comparators. Lilly is on track to file a submission with regulators by the end of the first quarter in 2015. The primary efficacy endpoint of non-inferior HbA1c at the primary study endpoint compared with insulin glargine was met in both the IMAGINE-1 and IMAGINE-3 trials, and superiority was demonstrated. In addition, significantly more patients taking BIL versus those taking insulin glargine achieved an HbA1c of less than 7%, a target for glycemic control established by the American Diabetes Association. Both trials also showed the rate of nocturnal hypoglycemia was significantly lower in patients taking BIL than in those taking insulin glargine. In both trials -- in which patients were taking both mealtime and basal insulin -- there was a statistically significant increase in the rate of total hypoglycemia for patients taking BIL compared with those taking insulin glargine due to a higher rate of daytime hypoglycemic events. In the open-label IMAGINE-1 trial, patients taking BIL reported a statistically significant higher rate of severe hypoglycemic events. However, in the larger, blinded IMAGINE-3 trial the rate of severe hypoglycemic events for treatment with BIL was numerically lower compared with insulin glargine, but was not statistically significant. Additionally, both trials showed a statistically significant difference in weight. Patients taking BIL experienced weight loss--even with lower HbA1c--compared with weight gain in patients taking insulin glargine. Results of these two trials also showed patients taking BIL experienced changes in lipid parameters, including a small but statistically significant increase in triglycerides in both trials. In IMAGINE-3, there were small but statistically significant reductions and increases, respectively, in HDL (high-density lipoprotein) cholesterol and LDL (low-density lipoprotein) cholesterol in patients taking BIL compared with those taking insulin glargine. In addition, IMAGINE-3 showed patients taking BIL experienced small but statistically significant increases in systolic and diastolic blood pressure compared to insulin glargine (less than 2 mmHg mean difference at 52 weeks). Statistically significant differences in HDL and LDL cholesterol and blood pressure were not observed in IMAGINE-1. There were no major adverse cardiac events (MACE) in IMAGINE-1, and in IMAGINE-3, the MACE+ (cardiovascular death, non-fatal stroke, non-fatal MI and hospitalization due to unstable angina) event rate was lower for patients taking BIL compared with those taking insulin glargine. In both trials, treatment with BIL was associated with a statistically significant higher incidence of patients with greater than three times the upper limit of normal range in the liver enzyme ALT (alanine aminotransferase) compared with patients taking insulin glargine. No cases of severe liver injury (Hy's Law) occurred in either of the trials. In a subset of patients whose liver fat was measured using MRI imaging, BIL-treated patients had a statistically significant increase in liver fat compared to insulin glargine. In both trials, there were significantly more injection site reactions observed in patients taking BIL compared to those taking insulin glargine. Phase III Clinical Trial Program: Additionally, the IMAGINE-7 trial--a flexible dosing study of BIL in patients with type 1 diabetes--and the IMAGINE-6 trial, evaluating BIL compared to NPH insulin in patients with type 2 diabetes, have both completed. IMAGINE-7 showed there was no statistically significant difference in HbA1c between BIL dosed at the same time every day versus BIL dosed at variable times. IMAGINE-6 met its primary efficacy endpoint of non-inferior reduction in HbA1c compared with NPH insulin at 26 weeks and also demonstrated HbA1c superiority of BIL compared to NPH insulin. There were no new safety signals in either trial and the adverse events were similar to those seen in the other IMAGINE trials. The core Phase III clinical trial program of BIL -- consisting of seven IMAGINE trials in patients with type 1 and type 2 diabetes -- is now complete, and superiority in HbA1c for BIL was seen in all six of the Phase III trials that were conducted against active comparators. An analysis across all clinical trials in patients with type 1 and type 2 diabetes showed that the rates of major adverse cardiovascular events among patients taking BIL and those taking insulin glargine or NPH insulin were similar, with an observed hazard ratio below 1 and the upper limit of the 95% confidence interval below 1.4. Data Disclosure and Regulatory Submission Plans: Detailed study results for all Phase III trials are expected to be disclosed in 2015. Lilly plans to submit BIL for regulatory review to the U.S. Food and Drug Administration and the European Medicines Agency by the end of first quarter of 2015.

Louisiana Court Orders Takeda to Pay $6 Billion over Diabetes Drug

Upholding a jury verdict, a U.S. district court in Louisiana has ordered Takeda Pharmaceutical Co. to pay some $6 billion in punitive damages for concealing cancer risks of its diabetes drug Actos. But the ruling, on September 3, 2014 is not yet final as the U.S. District Court for the Western District of Louisiana has not reached a conclusion on the major Japanese drug maker's motion for a reexamination or its petition for a substantial reduction in the amount of the damages. The court is expected to issue a ruling on the motion in the coming weeks. The Louisiana court also upheld a separate jury verdict that ordered Eli Lilly and Co., which sold Actos in partnership with Takeda, to pay $3 billion in damages.


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