Judge orders a halt to Alzheimer's spat as Eli Lilly chooses sides in dispute

Paul Aisen

A California judge has stepped between two top research institutions fighting over a vast Alzheimer's disease R&D program with ties to Big Pharma, ordering the study's new managers to hand it back for the time being. The ruling came the same day Eli Lilly publicly sided with USC and Paul Aisen, the former UC San Diego researcher who has played a central role in the continued development of the Phase III drug solanezumab, in the dispute.

In a preliminary injunction, a superior court judge has demanded USC, which poached Aisen and some of the program's key researchers from UC San Diego in June, to take its hands off of the initiative until a related lawsuit from UCSD is resolved. That means returning to UCSD all data and systems related to the Alzheimer's Disease Cooperative Study (ADCS), a National Institutes of Health-partnered initiative that has run 30 trials on potential new drugs since its foundation in 1991.

UCSD has managed ADCS since its inception, appointing the high-profile researcher Aisen to oversee the program in 2007. But USC lured Aisen away last month with the promise of a $500,000 salary, bringing with him 8 top Alzheimer's researchers in what UCSD claims was an effort to wrest control of ADCS and get in line for the high-dollar grants attached to the program. In its lawsuit, UCSD claimed Aisen and his colleagues transferred loads of data from ADCS onto an Amazon hosting account of their own, repeatedly refusing to disclose the password to school officials.

The court's latest ruling puts a stop to that, mandating Aisen and company return every bit of ADCS data and technology now in their possession to restore "status quo" while the broader suit unfolds, at the same time appointing a third-party "special master" to oversee the transition. The court believes UCSD "has demonstrated a likelihood of succeeding" in the lawsuit, establishing that it "currently is, and shall continue, to incur and suffer irreparable injury" unless USC relinquishes its data.

The lawsuit, uncommon in academia, has broad implications for Alzheimer's R&D in general, as ADCS is currently running or recruiting 6 clinical trials involving thousands of patients. And the intramural squabble has now cost UCSD one of its banner partners, as Eli Lilly ($LLY), whose ongoing trial of the Alzheimer's treatment solanezumab is under ADCS management, has changed its mind.

In a statement released Tuesday, Lilly said that it is ending its relationship with UCSD, trasferring its allegiance to the rebel group at USC under Aisen. Aisen has had close ties to Lilly for years. According to a recent Bloomberg piece, he teared up over signs of efficacy in the late-stage data that Lilly had gathered from two failed Phase III studies of solanezumab, helping to persuade the company to launch a new, and massively expensive, late-stage program for the drug against early-stage Alzheimer's. Aisen has also been directly involved in solanezumab R&D, helping Lilly make a controversial case for the amyloid beta drug.

"After a thorough evaluation of the on-going situation, Lilly has determined that it is in the best interest of the A4 study and its participants to end UCSD's management of the study. The A4 study will continue uninterrupted as the company initiates discussions with the University of Southern California about transitioning management and oversight of the study, while the company will simultaneously work with UCSD on a transition plan," Lilly said in a statement.

- read the injunction (PDF)
- here's Lilly's statement

John Carroll contributed to this report.

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