Eli Lilly and Company
) received a boost recently with its phase III oncology
candidate, necitumumab, achieving the primary endpoint in a study
(SQUIRE) conducted in patients with stage IV metastatic squamous
non-small cell lung cancer (NSCLC). Shares were up 2.6% on the
Results showed that patients receiving first-line treatment
with necitumumab plus Gemzar and cisplatin achieved higher
overall survival (OS) compared to patients on chemotherapy.
Common adverse events included rash and hypomagnesemia. Serious
adverse events included thromboembolism (blood clots).
Eli Lilly intends to present these results at a medical
meeting next year and is looking to file for regulatory approval
by the end of 2014. The company has full global development and
commercialization rights to necitumumab. Earlier, Eli Lilly had a
) for necitumumab in North America and Japan - however,
Bristol-Myers terminated the collaboration in late 2012.
The approval of necitumumab would be a major positive for Eli
Lilly - in its press release, Eli Lilly mentioned that non-small
cell lung cancer accounts for 85% of all lung cancer cases. About
30% of these patients suffer from squamous cell cancer.
However, we remain concerned about the occurrence of
thromboembolism in the study. We remind investors that in early
2011, enrolment in another phase III study on necitumumab was
stopped due to safety concerns related to thromboembolism in new
or recently enrolled patients.
Eli Lilly currently carries a Zacks Rank #3 (Hold). The
biggest near-term challenge for Eli Lilly will be to replace the
revenues lost due to the Zyprexa genericization. The generic
threat will continue to pose challenges for Eli Lilly with
Cymbalta slated to lose patent protection in late 2013 and Evista
in 2014. On the other hand, the Animal Health business and the
diabetes franchise should provide some downside support.
Currently, companies like
) look well-positioned. Both are Zacks Rank #1 (Strong Buy)
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