The Lancet recently published data on Eli Lilly and Company (LLY) and Boehringer Ingelheim Pharmaceuticals, Inc.’s Tradjenta, from a 24-week, double-blind, parallel-group, multinational, phase III study (n=241).
The published data showed a significant reduction in blood glucose levels (HbA1c) of elderly type II diabetes patients on Tradjenta compared to patients on placebo. Moreover, Tradjenta’s overall safety and tolerability profile was similar to placebo.
Tradjenta, a once-daily 5-mg tablet, is currently approved for use along with diet and exercise to improve glycemic control in adults with type II diabetes. Eli Lilly and Boehringer are also evaluating Tradjenta in a phase IIIb study 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.
We are pleased with Eli Lilly’s efforts to strengthen its diabetes franchise. Eli Lilly and Boehringer Ingelheim are currently seeking U.S. and EU approval for another type II diabetes candidate, empagliflozin. 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.
We note that Eli Lilly is not the only company looking to develop a SGLT-2 inhibitor. In fact, Johnson & Johnson (JNJ) gained FDA approval for its SGLT-2 inhibitor, Invokana, earlier this year.
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 U.S. 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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