Lilly's Study On Higher Doses Of Trulicity Meets Endpoint

Eli Lilly and Company’s (NYSE:LLY) phase III study evaluating higher doses of its GLP-1 receptor agonist, Trulicity, demonstrated superiority in A1C (a measure of blood glucose) reduction in type II diabetes patients compared to Trulicity doses already available

Data from AWARD-11 phase III study showed that 3.0 mg and 4.5 mg doses of Trulicity significantly reduced A1C from baseline compared to once-weekly Trulicity 1.5 mg after 36 weeks, thereby meeting the study’s primary efficacy endpoint of superiority. The study also demonstrated superiority in weight loss, its secondary efficacy endpoint.

The study will continue for 52 weeks and Lilly plans to file for regulatory approval of the higher doses by late 2019.

Lilly’s shares have declined 3.8% this year so far compared with the industry’s increase of 3.3%.

Trulicity is a key drug in Lilly’s diabetes portfolio. In the first quarter of 2019, Trulicity generated revenues of $879.7 million, up 30% year over year driven by higher demand in the United States and higher volumes in ex-U.S. markets, which offset the impact of lower realized prices.

However, Trulicity is facing stiff competition from Novo Nordisk’s (NYSE:NVO) Ozempic/semaglutide, launched in 2018. In fact, Lilly is seeing pricing pressure across all its diabetes products, which creates uncertainty around the franchise’s long-term growth prospects. A number of competitors are entering the diabetes space. For example, with the approval of Merck (NYSE:MRK) /Pfizer’s (NYSE:PFE) Steglatro and its combinations, competition in the SGLT2 inhibitors class is expected to increase. The class includes Lilly’s key diabetes medicine, Jardiance.

Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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