Eli Lilly and Company ( LLY )
suffered yet another pipeline setback recently with Alimta failing
to achieve the primary endpoint (overall survival) in the phase III
The study was conducted in patients suffering from nonsquamous
non-small cell lung cancer (NSCLC). Patients were randomized to
receive Alimta plus Roche's ( RHHBY
) Avastin and carboplatin induction followed by maintenance therapy
with the Alimta-Avastin combination or paclitaxel plus Avastin and
carboplatin followed by maintenance therapy with Avastin.
Results showed that median overall survival in the Alimta arm
was 12.6 months compared to 13.4 months in the paclitaxel arm. The
Alimta arm, however, showed a statistically significant improvement
in progression-free survival (6.0 months versus 5.6 months).
This is the latest in a series of pipeline setbacks faced by Eli
Lilly over the past few weeks. The company had recently announced
that it is shelving its plans for the phase III development of its
schizophrenia candidate, pomaglumetad methionil (mGlu2/3).
Eli Lilly's decision to discontinue phase III development of the
candidate was based on an independently conducted futility
analysis, which indicated that the candidate would fail to achieve
its primary endpoint in the HBBN study.
The announcement regarding the discontinuation of phase III
development of pomaglumetad methionil came shortly after Eli Lilly
and Daiichi Sankyo Company, Limited presented data on Effient
(prasugrel) from a head-to-head phase III study -- TRILOGY ACS
(TaRgeted platelet Inhibition to cLarify the Optimal strateGy to
medicallY manage acute coronary syndromes).
Results showed that Prasugrel plus aspirin failed to achieve
statistical significance compared to Sanofi's ( SNY )
Plavix (clopidogrel) plus aspirin in the study that was conducted
in patients with unstable angina (UA) or non-ST elevation
myocardial infarction (NSTEMI), who did not undergo an
The study results were disappointing as positive data would have
allowed Eli Lilly to seek approval for expanding Effient's label.
Effient is currently approved by the US Food and Drug
Administration (FDA) for the reduction of the rate of thrombotic
cardiovascular events in patients with acute coronary syndrome
(ACS) who are to be managed with an artery-opening procedure.
Meanwhile, in August, Eli Lilly reported top-line results on its
phase III Alzheimer's candidate, solanezumab. Results showed that
solanezumab failed to meet its primary endpoints in both the phase
III EXPEDITION studies. However, the candidate demonstrated
promising potential in slowing cognitive decline.
Neutral on Eli Lilly
We currently have a Neutral recommendation on Eli Lilly. The
biggest near-term challenge for the company will be to replace the
revenues lost to generic competition now that Zyprexa has lost US
and EU exclusivity.
We expect the top- and bottom-line to remain under pressure as
the contraction in Zyprexa sales more than offsets growth in
Cymbalta, diabetes and new product sales. The pipeline setbacks are
also disappointing and will make it all the more challenging for
the company to replace revenues.
On the other hand, 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. Eli Lilly currently carries a Zacks #2 Rank
(short-term Buy rating).
LILLY ELI & CO (LLY): Free Stock Analysis
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