LONDON Feb 6 AstraZeneca is moving an
experimental Alzheimer's drug into late-stage development,
taking on U.S. rival Merck & Co which announced plans to
start similar final-stage research in December.
Britain's second-biggest drugmaker revealed its plan to move
AZD3293 into the last phase of testing needed for registration
as it announced full-year results on Thursday.
Both the AstraZeneca and Merck medicines work by blocking an
enzyme called beta secretase that is involved in production of
beta-amyloid, a protein that creates brain plaques considered a
major cause of Alzheimer's disease.
Such oral drugs are known as BACE inhibitors and are viewed
as a promising new approach to fighting the memory-robbing
BACE inhibitor drugs have taken centre stage after an
injectable class of medicines targeting beta-amyloid plaque
failed or fell short in trials conducted by Pfizer and
Not all experts accept that reducing beta-amyloid is the key
to defeating Alzheimer's, however, and the safety of the new
BACE drugs has also been a subject of concern after Lilly pulled
the plug on its product due to liver toxicity.
Mene Pangalos, AstraZeneca's head of innovative medicines
and early development, told analysts there had been no signs of
similar problems with his company's product. AZD3293 also had a
clean profile in terms of potential heart problems, he added.
"We have a very potent molecule, not dissimilar to Merck's
molecule," he added.
AstraZeneca is integrating Phase II and Phase III trials for
its drug, which Pangalos said could either lead to a second
pivotal Phase III study or, if the data was strong enough, an
immediate filing for regulatory approval.
ISI analyst Mark Schoenebaum said Merck was probably some
six months ahead of AstraZeneca in the BACE race, with the first
Phase III data from the U.S. company's programme likely to
emerge in around 2017.
Dementia - of which Alzheimer's disease is the most common
form - already affects 44 million people worldwide and this is
set to reach 135 million by 2050, according to Alzheimer's
Disease International, a non-profit campaign group.
Unlike heart disease and cancer, no major advancements have
been seen in Alzheimer's drug research since the first treatment
was approved in 1993 by U.S. regulators.
Current Alzheimer's drugs, including generic forms of
Pfizer's Aricept (donepezil), can minimally and briefly help
memory and ability to perform daily functions, but do not slow