) recently announced disappointing late-stage results on
intravenous (IV) bapineuzumab. Bapineuzumab is being developed
under Pfizer and
Johnson & Johnson
) Janssen Alzheimer Immunotherapy R&D LLC's Alzheimer's
Immunotherapy Program (AIP). Pfizer and Janssen AI are partners in
) has a 49.9% interest in Janssen AI following its September 2009
transaction with Johnson & Johnson.
Pfizer said that bapineuzumab failed to meet the co-primary
endpoints in a phase III study (Study 301) being conducted in
mild-to-moderate Alzheimer's disease patients who do not carry the
ApoE4 (apolipoprotein E epsilon 4) genotype.
This is the second set of disappointing data to be presented on
bapineuzumab over the last few weeks. On July 23, Pfizer had
announced that bapineuzumab failed to meet its co-primary endpoints
in a phase III study (Study 302) that was conducted in patients
with mild-to-moderate Alzheimer's disease who carry the ApoE4
genotype. Results showed that bapineuzumab failed to achieve the
co-primary endpoints namely change in cognitive and functional
performance compared to placebo.
With bapineuzumab failing in two phase III studies, the Joint
Steering Committee for the AIP decided to discontinue other studies
being conducted with the candidate in mild-to-moderate Alzheimer's
These include two phase III studies (Study 3001 and Study 3002)
being conducted by Pfizer as well as follow-on extension studies.
The companies have communicated their decision to discontinue the
studies to the regulatory authorities as well as clinical
Bapineuzumab has always been a high risk-return candidate for
the companies involved in its development. Expectations regarding
this candidate's chances of success have always been pretty low.
While disappointing, the discontinuation of IV bapineuzumab is not
The successful development of therapies for the treatment of
Alzheimer's is challenging and we note that several companies have
failed in developing treatments for Alzheimer's. In fact, Pfizer
has faced failure before in this field - the company had a
collaboration agreement with
) for an Alzheimer's candidate, which was subsequently
Another company that is working on the development of an
Alzheimer's candidate is
). Lilly's solanezumab (LY2062430) is in two phase III studies,
EXPEDITION and EXPEDITION 2, with results likely to be reported
later this year.
The Alzheimer's disease market represents huge commercial
potential and a successfully developed product could generate
billions of dollars in sales once launched.
We currently have Neutral recommendations on Pfizer and Johnson
& Johnson, both of which carry a Zacks #3 Rank (short-term
'Hold' rating). We, however, have an Underperform recommendation on
Elan, which carries a Zacks #5 Rank (short-term 'Strong Sell'
rating). We expect Elan shares to be significantly impacted by the
discontinuation of bapineuzumab IV.
ELAN CP PLC ADR (ELN): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
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PFIZER INC (PFE): Free Stock Analysis Report
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