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 The two companies also plan to collaborate in developing new
medicines for migraine.
Swiss-based Novartis said on Tuesday the alliance was part of a
drive to build up its portfolio in neuroscience, following other
deals this summer that have expanded the company's presence in pain
relief and multiple sclerosis.
"We're quite pleased with where we are but we are always looking to
continue to grow and build out our pipeline," Vas Narasimhan, global
head of development for Novartis Pharma, told Reuters.
The work with U.S. drugmaker Amgen on Alzheimer's will focus on
finding a medicine that can be given orally, rather than as an
injection, through the development of so-called BACE inhibitor
drugs.
BACE inhibitors 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.
Other companies such as Eli Lilly, Biogen and Roche are developing
injectable antibody drugs to target beta-amyloid, which have shown
some promise in clinical trials.
BACE inhibitors would be more convenient, since they are pills, and
they also offer an opportunity to intervene earlier in the disease
process -- but they are further behind in development and have yet
to prove themselves in clinical trials.
Novartis' experimental compound CNP520, currently in early Phase I/IIa
studies, will be the lead BACE inhibitor molecule. CNP520 is planned
to be included in a prevention study in people with a genetic risk
of developing Alzheimer's, in collaboration with the Banner
Alzheimer's Institute in the United States.
The product is relatively late to the party, since Merck already has
a BACE inhibitor in Phase III development, with data expected in
2017, while AstraZeneca and Eli Lilly started a large Phase II/III
study in December.
But Novartis believes CNP520 has a particularly attractive profile
and could potentially avoid some of the side effects seen with some
other BACE products, such as fluid build-up.
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Under the Alzheimer's deal, Amgen will pay an undisclosed upfront
payment and milestone payments as well as disproportional research
and development costs for a period, followed by a 50/50 cost and
profit share arrangement.
For migraine, the collaboration will focus on Amgen's experimental
drugs AMG 334, currently in Phase III, and AMG 301, in Phase I.
Novartis will have global co-development rights and commercial
rights outside North America and Japan.
Novartis will fund disproportional migraine R&D expenses for a
period and will pay Amgen double-digit percentage royalties on
sales.
The Basel-based drugmaker is probably best known for its cancer
medicines, including leukemia treatment Glivec, as well as its big
new drug hope Entresto for heart failure.
But it also has an important presence in multiple sclerosis (MS)
with Gilenya and the company last month moved to expand its MS
business by buying the remaining rights to ofatumumab from
GlaxoSmithKline.
It also gained access to an experimental neuropathic pain drug in
June by buying U.S.-Australian biotech firm Spinifex
Pharmaceuticals.
(Reporting by Ben Hirschler; Editing by Susan Fenton)
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