Both companies have drugs in development that use antibodies to target the build-up of plaque in patients’ brains. Lilly argues its treatment, solanezumab, doesn’t infringe a patent held by J&J’s Janssen Alzheimer Immunotherapy Research & Development LLC, according to court documents.
“An effective treatment for Alzheimer’s Disease (AD) has been elusive, despite massive efforts to find one,” Indianapolis-based Lilly said in the documents. The trial, which started yesterday, “could dictate whether Lilly’s treatment for AD is available to patients in the U.K. before the expiry of the patent in November 2018, or possibly longer.”
Drug companies are vying to find the first working treatment for a condition that is expected to affect 65 million people worldwide by 2030, causing loss of memory, mood changes, dementia and brain damage. There have been 101 clinical trial failures since 1998, according to the Pharmaceutical Research & Manufacturers of America.
“The patent is valid and the claimant is not entitled to a declaration of non-infringement,” Janssen said in court documents from the trial.
Lilly’s U.K. media relations team didn’t immediately respond to a phone call seeking comment. Greg Panico, a U.S. spokesman for Janssen, declined to immediately comment.
Janssen’s drug bapineuzumab cost more than $500 million to research and ended up “a costly failure,” Lilly’s lawyer Andrew Waugh told the court yesterday, citing clinical trial results. Lilly is proceeding with its treatment, he said. “One of the reasons it hasn’t failed is because it works by a different mechanism to that which is described in the patent.”
Derica Rice, Lilly’s chief financial officer, said in an April earnings call the company would hold another pivotal trial for solanezumab this year.
While solanezumab failed to meet the main goal of two large studies, an analysis of the data from that research found it did slow progression in people with milder stages of Alzheimer’s. The new study, looking only at those patients, will start by the third quarter of 2013, Lilly said in December.
Sanofi Chief Executive Officer Chris Viehbacher said earlier this month the French drugmaker won’t pursue an Alzheimer’s treatment because the science isn’t advanced enough to justify the cost.
The first Alzheimer’s drugs, if successful, would lead to a market worth $20 billion, Barbara Ryan, a former Deutsche Bank analyst estimated last year.
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