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June 16, 2014
18:19 EDTLLYEli Lilly reports results from Phase 3 trials of Dulaglutide
Eli Lilly and Company released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia. Dulaglutide is an investigational glucagon-like peptide-1 receptor agonist being studied for the treatment of type 2 diabetes. Results were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco. "Many patients with type 2 diabetes reach a point when oral medicines alone may no longer be effective enough. In these cases, many healthcare professionals choose to intensify treatment with an injectable medicine," said Francesco Giorgino, MD, professor of endocrinology and metabolism, University of Bari, Italy. "Data from these two studies comparing once-weekly dulaglutide with insulin glargine, in combination with other diabetes treatments, provide important information about a GLP-1 receptor agonist that, if approved, may be appropriate for patients with type 2 diabetes." Results from the AWARD-2 trial, which evaluated the safety and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated patients reached target HbA1c levels of less than 7 percent. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels. Both doses of dulaglutide were associated with sustained weight loss, while insulin glargine showed weight gain. Results from the AWARD-4 trial the first Phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin showed that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7%, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30% less total insulin dose. Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with relative weight benefit compared to the basal/bolus therapy of insulin glargine and mealtime insulin lispro. Hypoglycemia rates were lower in dulaglutide 1.5 mg-treated patients compared to insulin glargine in both studies. In AWARD-2, the 0.75 mg dose also had a lower rate of hypoglycemia compared to insulin glargine. Adverse events were similar for dulaglutide-treated patients in both studies. The most frequently reported events were gastrointestinal-related, including nausea, diarrhea and vomiting. Nausea, which was mostly mild to moderate, was the most commonly reported event. These findings are consistent with prior studies of once-weekly dulaglutide.
News For LLY From The Last 14 Days
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October 21, 2014
08:32 EDTLLYFDA accepted NDA for empagliflozin plus
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07:15 EDTLLYFDA to hold workshop on breast cancer drug development
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October 17, 2014
10:51 EDTLLYOptions with increasing implied volatility
Options with increasing implied volatility: COV DISH HLT QEP GREK BKW BYI LLY DTV TIBX
October 16, 2014
14:36 EDTLLYLilly to close Guayama facility, will take 16c charge in Q4
Eli Lilly announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. All of the approximately 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina, Puerto Rico, location. As a result of this action, the company expects to record a charge of approximately $170M or approximately 16c per share, after tax, in Q414. While Lilly will initiate efforts to sell the Guayama site, the company will continue to invest in two manufacturing plants at Carolina. In November 2013, Lilly announced a $200M investment to increase capacity in its Carolina-based insulin active ingredient manufacturing plant. In July, Lilly announced an additional $40M in investments to increase capabilities at its Carolina-based drug product site as part of a rebalancing of Lilly's oral solid dosage network.
October 14, 2014
07:15 EDTLLYBiotech Industry Organization to hold a summit
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October 10, 2014
10:03 EDTLLYEli Lilly olaratumab granted orphan designation as soft tissue sarcoma treatment
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October 8, 2014
10:55 EDTLLYLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
06:11 EDTLLYNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.

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