eli lilly & co (LLY) Key Developments
Eli Lilly (US) Expands its Manufacturing and Development Facility Capacities with the Help of Novast Laboratories
Mar 6 14
Eli Lilly (US) will be expanding its manufacturing and development facility capacities with the help of Novast Laboratories. The two parties are building a 260,000-square-foot facility in Nantong, Jiangsu, China, which will manufacture sustained-release and containment-solid oral-dosage branded generics. The facility, to which Novast is investing USD 60 million to USD 70 million, is expected to be completed in 2015.
U.S. Food and Drug Administration Issues Complete Response Letter for Empagliflozin
Mar 5 14
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin. The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application. Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with type 2 diabetes and submitting a response to the complete response letter as soon as possible. Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.
Eli Lilly and Company Announces Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes
Feb 25 14
Eli Lilly and Company announced positive top-line results of the sixth AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) trial for once-weekly dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a treatment for type 2 diabetes. In the AWARD-6 study, once-weekly dulaglutide 1.5 mg achieved the primary endpoint of non-inferiority to once-daily liraglutide 1.8 mg, as measured by the reduction of hemoglobin A1c (HbA1c) from baseline at 26 weeks. Adverse events were similar for patients in both treatment groups. The most frequently reported events were gastrointestinal-related. These findings are consistent with prior studies of once-weekly dulaglutide. Once-weekly dulaglutide has been submitted to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies. All previous five AWARD trials (1-5) included demonstrated superiority in reduction of HbA1c at the 1.5 mg dose against placebo and active comparators. Lilly plans to present detailed data from the AWARD-6 (dulaglutide vs. liraglutide), AWARD-2 (dulaglutide vs. insulin glargine), and AWARD-4 (dulaglutide vs. insulin glargine; both in combination with insulin lispro) studies at scientific meetings later this year.
Eli Lilly and Company Revises Earnings Guidance for the Year 2014
Feb 24 14
Eli Lilly and Company revised earnings guidance for the year 2014. The company now expects earnings to come in between $2.72 to $2.80 per share in 2014, down from its previous guidance range between $2.77 and $2.85.
Eli Lilly and Company Announces Ramucirumab Phase III Lung Cancer Trial Meets Primary Endpoint of Overall Survival
Feb 19 14
Eli Lilly and Company announced that the REVEL trial, a global Phase III study of ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC), showed a statistically significant improvement in the primary endpoint of overall survival in the ramucirumab-plus-docetaxel arm compared to the control arm of placebo plus docetaxel. REVEL also showed a statistically significant improvement in progression-free survival in the ramucirumab arm compared to the control arm. The global, randomized, double-blind REVEL trial compared ramucirumab and docetaxel to placebo and docetaxel in NSCLC patients whose disease has progressed after failure of prior platinum-based chemotherapy for locally advanced or metastatic disease. The study included nonsquamous and squamous NSCLC patients. The most common (>5% incidence) Grade >3 adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm were decreased white blood cell count (neutropenia/leukopenia), febrile neutropenia, fatigue/asthenia and hypertension.