Eli Lilly and Company
) recently announced that it will be developing diabetes
candidate, LY2605541, on its own. The company said that its
diabetes alliance with Boehringer Ingelheim International will be
amended with Eli Lilly re-assuming sole worldwide development and
commercialization rights to LY2605541.
The terms regarding the other candidates/products covered by
the diabetes alliance remain unchanged. The diabetes alliance,
announced in Jan 2011, covers marketed product, Tradjenta
(linagliptin), and pipeline candidates - empagliflozin and
LY2605541 is currently in late-stage development. Eli Lilly
said that it intends to initiate additional studies with the
candidate in 2013 and 2014. Phase III results could be out in
2014 - positive results would allow the company to submit
marketing applications in 2014.
Meanwhile, Eli Lilly and Boehringer Ingelheim 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.
While the occurrence of adverse events was similar to placebo,
the occurrence of genital infections was higher in the
empagliflozin arm. The companies intend to seek approval for
empagliflozin in the US, Europe and Japan this year.
Other SGLT-2 Inhibitors in Development
We note that Eli Lilly and Boehringer Ingelheim are not the
only companies looking to develop a SGLT-2 inhibitor.
) oral SGLT2 inhibitor, Forxiga gained EU approval in Nov 2012.
However, Forxiga is yet to gain approval in the US. The
companies, which received a complete response letter from the FDA
for Forxiga, intend to resubmit their marketing application in
mid-2013. Another SGLT2 inhibitor currently under FDA review is
Johnson & Johnson's
) canagliflozin (proposed trade name: Invokana).
Neutral on Eli Lilly
We currently have a Neutral recommendation on Eli Lilly, which
carries a Zacks #3 Rank (Hold). The company recently provided its
financial guidance for 2013 and commented on its 2012 guidance as
well. Although Eli Lilly's 2013 revenue guidance was in line with
expectations, the earnings guidance was above expectations. Share
buybacks and cost control should help the company achieve its
2013 guidance despite the presence of generic competition for key
Large-cap pharma companies that currently look more attractive
). Both carry a Zacks #2 Rank (Buy).
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