Eli Lilly, AstraZeneca Get Fast-Track Designation for Alzheimer's Drug--Update
22 August 2016 - 10:12PM
Dow Jones News
By Denise Roland
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 Denise.Roland@wsj.com
(END) Dow Jones Newswires
August 22, 2016 07:57 ET (11:57 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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