Eli Lilly and Company (LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. recently announced that they have commenced a phase IIIb study with Tradjenta (linagliptin) in type II diabetes patients with prevalent albuminuria who are currently receiving standard treatment for diabetic nephropathy.
The 24-week, multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study, MARINA (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin), will evaluate the glycemic efficacy and safety of once-daily Tradjenta (5 mg). The study is slated to complete in 2014.
Tradjenta is currently approved for use in type II diabetes patients along with diet and exercise.
We are pleased with Eli Lilly’s efforts to strengthen its diabetes franchise. Earlier this year, Eli Lilly and Boehringer Ingelheim had announced positive top-line results on empagliflozin from four phase III trials. Empagliflozin (10 and 25 mg taken once daily), a sodium glucose co-transporter-2 (SGLT-2) inhibitor, was found to be more effective in lowering blood sugar levels compared to placebo. Eli Lilly and Boehringer Ingelheim recently submitted a new drug application for empagliflozin in the US.
Eli Lilly currently carries a Zacks Rank #3 (Hold). The biggest near-term challenge for Eli Lilly will be to replace the revenues that will be lost to generic competition now that Zyprexa has lost US and EU exclusivity. The generic threat will continue to pose challenges for Eli Lilly with Cymbalta slated to lose patent protection in late 2013 and Evista in 2014.
On the flip side, the Animal Health business and the diabetes franchise should provide some downside support. We are also pleased to see Eli Lilly pursuing small acquisitions and in-licensing deals to boost its pipeline.
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