Eli Lilly, AstraZeneca Progress With Alzheimer's Drug

LONDON—AstraZeneca PLC said Monday that the Alzheimer's drug it is codeveloping with Eli Lilly & Co. has received fast-track designation from the U.S. Food and Drug Administration, a status designed to speed up the development of promising new medicines.

The drug, dubbed AZD3293, is part of a hot new class of Alzheimer's drugs called BACE inhibitors which act to prevent the formation of a substance known as amyloid, whose build up in the brain is thought to be the main cause of the degenerative disease.

The FDA awards fast-track status to drugs it believes could fulfill an unmet need in a serious condition. It means AstraZeneca will have increased access to officials at the agency while developing the drug, to minimize delays.

Earlier this year AstraZeneca and Lilly said they would progress the drug to the final stage of testing in patients with early stage Alzheimer's.

They also plan to start testing the drug in patients with mild Alzheimer's in a separate trial.

BACE inhibitors are the latest glimmer of hope in a field littered by failures, but they could stumble in later-stage development. Eli Lilly scrapped a BACE inhibitor, LY2886721, in 2013 over concerns that the drug could affect liver function.

Research recently released by the trade group Pharmaceutical Research & Manufacturers of America showed there were 123 Alzheimer's drug failures between 1998 and 2014, and just four medicines approved.

The high level of risk involved in Alzheimer's research partly drove Astra's decision to collaborate with Lilly, which has a longer history of developing drugs for the disease. The pair struck a risk-and-reward sharing deal in 2014 that handed Lilly the leading role in designing and running the clinical trials for the drug, previously developed solely by Astra.

The two will share the costs of development, and, if the drug is successful, future revenues, equally. Lilly also agreed to a series of payments to AstraZeneca as the drug progresses through various milestones.

The deal forms part of AstraZeneca Chief Executive Pascal Soriot's "externalization" strategy to fully or partly offload research programs that fall outside its core areas of expertise.

The high failure rate of research in Alzheimer's disease has led to other partnerships in the industry: last year Novartis AG struck a deal with Amgen Inc.

An estimated 5.3 million Americans suffer from the disease, according to the Alzheimer's Association, a nonprofit organization. Current treatments can help manage symptoms, but there is no cure.

The market for Alzheimer's drugs stood at $4.9 billion in 2013 and is expected to reach $13.3 billion by 2023, according to GlobalData, a research and consulting firm.

Write to Denise Roland at [e-mail]

(END) Dow Jones Newswires

August 22, 2016 08:35 ET (12:35 GMT)

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