) recently announced highly-awaited top-line results on Alzheimer's
disease candidate, bapineuzumab. Pfizer said that bapineuzumab
failed to meet its co-primary endpoints in a phase III study (Study
302) being conducted by
Johnson & Johnson's
) Janssen Alzheimer Immunotherapy R&D LLC.
Study 302 was being conducted in patients with mild-to-moderate
Alzheimer's disease who carry the ApoE4 (apolipoprotein E epsilon
4) genotype. Results showed that bapineuzumab failed to achieve the
co-primary endpoints namely change in cognitive and functional
performance compared to placebo.
Pfizer and Janssen have communicated these results to regulatory
authorities and trial investigators so that patients participating
in the study are informed. With bapineuzumab failing to show
efficacy, patients participating in the follow-on extension study
will be taken off the candidate. However, follow-up data will be
Ongoing Studies Will Continue
As far as the other studies being conducted with bapineuzumab
are concerned, these studies will continue. Bapineuzumab is being
evaluated in three additional placebo-controlled phase III studies
- Study 301, Study 3001 and Study 3002. While Study 301 is being
conducted by Janssen in North America in non ApoE4 carriers, the
remaining two studies are being conducted by Pfizer outside North
America. The Pfizer studies are also being conducted in ApoE4
carriers and non-carriers.
Pfizer and Janssen intend to speed up the interim analysis of
the Pfizer-conducted Study 3001 (ApoE4 carriers). Meanwhile,
top-line data from Study 301 (non-carriers) should be out later
Data from both Study 302 and Study 301 will be presented in
September at the European Federation of Neurological Societies
meeting in Stockholm.
Bapineuzumab is being developed under Janssen'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.
Bapineuzumab has always been a high risk-return candidate for
the companies involved in its development. While disappointed with
the phase III results, bapineuzumab's failure did not come as a
major surprise as chances of success were pretty low.
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, Johnson
& Johnson and Elan Corp. All three companies carry a Zacks #3
Rank (short-term Hold rating). Elan shares were down in pre-market
ELAN CP PLC ADR (ELN): Free Stock Analysis
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