Elan Announces Johnson & Johnson Release of Discontinuation of Phase 3 Development of Bapineuzumab Intravenous (IV) In Mild to Moderate Alzheimer’s Disease
Chris Burns, 800-252-3526David Marshall, 353-1-709-4444or353-1-709-4022Jonathan Birt, +44-751-559-7858Jamie Tully, +1-212-687-8080
Elan Corporation, plc (NYSE:ELN) announced today that Johnson & Johnson has issued a press release regarding the discontinuation of Phase 3 development of bapineuzumab IV in mild to moderate Alzheimer’s. The press release can be accessed on or . Additionally, Pfizer Inc. has provided an announcement to the marketplace on the top line results of Phase 3 Study 301. The press release can be accessed on .
“We are tremendously disappointed for patients and their caregivers who are suffering from Alzheimer’s and our employees who have dedicated many years to advancing this technology with the goal of creating a meaningful therapy to combat this challenging disease,” said Kelly Martin, CEO of Elan Corporation, plc. He commented further that, “from a shareholder perspective, we will continue to focus on revenue growth with the advancement of Tysabri, rigorous cost and timeline alignment and – as we have done consistently over the years - a strengthening of our balance sheet and capital structure to provide a unique growth and value investment thesis to the marketplace while continuously reducing overall financial risk.”
Specific details surrounding the anticipated reduction of Janssen AI’s future funding requirements will be determined after discussions with our equity co-investor, Johnson & Johnson and after the complete data set from Study 301 and 302 has been presented at the 16 Congress of the European Federation of Neurological Societies (EFNS) on September 11, 2012, the American Neurological Association (ANA) Annual Meeting on October 8, 2012 and the 5 Clinical Trials on Alzheimer’s Disease (CTAD) on October 29, 2012. In addition to the data from Study 301 and 302, outcomes from the on-going vaccine and bapineuzumab SQ trials are important and will be instructive for a comprehensive evaluation of the immunotherapeutic approach to Alzheimer’s.
Given the discontinuation of the bapinezumab IV clinical development work in mild to moderate Alzheimer’s patients, we anticipate there to be a significant reduction in spending through the end of next year. In addition, Elan will record a non-cash impairment charge of $117.3 million on our equity method investment in Janssen AI in the third quarter of 2012, representing the full carrying value of Elan’s 49.9% proportionate share of the Janssen AI AIP assets.
In September 2009, as a result of its transaction with Johnson & Johnson, Elan acquired a 49.9% interest in Janssen AI. Janssen AI partners with Pfizer, Inc on all operational aspects of the immunotherapeutic platform including bapineuzumab. Elan owns 25% of the AIP asset on a global basis plus certain royalty streams at various revenue levels should any therapy from AIP be commercialized in the future.
Elan is a neuroscience focused biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. For additional information about Elan, please visit .