Eli Lilly and Company (LLY - Free Report) announced that two phase III studies evaluating its insulin candidate, Ultra Rapid Lispro (URLi), in type I and type II diabetes patients met the primary efficacy endpoint. The company expects to submit regulatory application based on data from these studies to the FDA in 2019.
A potential approval to URLi is likely to further boost the company’s portfolio. However, there may be patients currently on Humalog switching to the new drug.
Shares of Eli Lilly have rallied 27.9% year to date, comparing favorably with the industry’s increase of 7.5%.
The phase III studies – PRONTO-T1D and PRONTO-T2D – evaluated URLi in combination with either insulin glargine or insulin degludec in adult patients to demonstrate non-inferiority toLilly’s own insulin lispro injection Humalog in reducing blood glucose levels, as measured by reduction in A1C levels from baseline, after 26 weeks. Data showed that both studies met their primary endpoint.
Moreover, URLi demonstrated significant improvement in post-meal glucose control as measured by reduction in glucose excursions at both one and two hours during a meal test. The overall safety and tolerability profile of URLi was similar to Humalog.
URLi is expected to significantly help patients with uncontrolled or high level of blood sugar after a meal offering an opportunity for the candidate to gain market share upon approval.
Lilly has a strong portfolio of diabetic drugs, which includes Trulicity, Humalog and Humulin with blockbuster potential. The company also has Basaglar, Jardiance and Trajenta in its portfolio, which generated total sales of more than $4.5 billion in the first half of 2018.
Nono Nordisk’s (NVO - Free Report) Novolog is a direct competitor of Humalog and is likely to give competition to URLi, if approved.
Zacks Rank & Stocks to Consider
Lilly currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks from the same space are Novartis (NVS - Free Report) and Roche (RHHBY - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Novartis’ earnings per share estimates have increased from $5.15 to $5.17 for 2018 and from $5.47 to $5.55 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 2.07%. The stock is up 2.9% so far this year.
Roche’s earnings per share estimates have moved up from $2.14 to $2.24 for 2018 and from $2.15 to $2.28 for 2019 over the past 60 days.
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