) recently announced encouraging data from two phase III studies
(EDITION I and EDITION II) evaluating its new insulin candidate,
U300. Detailed data from both the studies are expected by the end
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The multi-center and open label EDITION I (n = 807) study
compared the safety and efficacy of U300 and Lantus, another
diabetes drug at Sanofi, in patients with type II diabetes using
basal and mealtime insulin. U300 demonstrated similar blood sugar
control with fewer night-time low blood sugar events as compared
Top-line data from the EDITION II study (n = 811) assessed the
safety and efficacy of U300 versus Lantus in patients with type
II diabetes using basal and oral antidiabetic treatments. Data
from the study revealed that U300 was similar in efficacy to
Lantus in terms of blood sugar reduction. However, fewer patients
experienced night-time low blood sugar events with U300 as
compared to Lantus.
Lantus, which generated sales of €1.3 billion in the first
quarter of 2013, is one of the top-selling drugs at Sanofi. U300
on approval is expected to further strengthen Sanofi's product
portfolio. Although Sanofi holds a strong position in the
diabetes market, we note that the market is highly crowded with
Eli Lilly and Company
Sanofi carries a Zacks Rank #3 (Hold). We remain concerned about
generic erosion confronting most of Sanofi's key drugs including
Plavix, Avapro, Lovenox, Taxotere, Eloxatin and Xatral. The
genericization of Avapro and Plavix is expected to negatively
impact Sanofi's business net income by around €800 million in the
first half of 2013.
Sanofi is looking to combat headwinds by containing operating
costs. Additionally, new product launches should make significant
revenue contributions in the upcoming quarters.
Companies that currently look attractive include Novo Nordisk,
carrying a Zacks Rank #2 (Buy).