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Pfizer, Inc. (PFE - Analyst Report) 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 (JNJ - Analyst Report) 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 analyzed.
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 this summer.
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 AIP and Elan Corporation (ELN - Snapshot Report) 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 Medivation (MDVN - Analyst Report) for an Alzheimer’s candidate, which was subsequently discontinued.
Another company that is working on the development of an Alzheimer’s candidate is Eli Lilly (LLY - Analyst Report). 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 trading.