* Novartis pursues NHS pact to accelerate heart drug
* Swiss drugmaker bought inclisiran for nearly $10 bln
* Deal calls for speedy NICE review, broad 2021 adoption
By John Miller
ZURICH, Jan 13 (Reuters) - Novartis and Britain's
National Health Service (NHS) on Monday announced a pact that
will clear the way for accelerated review by the country's
health watchdog NICE for heart drug inclisiran, which could make
it broadly available as soon as 2021.
Novartis hopes the NHS deal will boost sales of
cholesterol-lowering inclisiran, which the Swiss drugmaker
bought in a deal announced last year for nearly $10 billion and
predicts will be a top seller.
Inclisiran was submitted to U.S. regulators last year, and
Novartis expects a European submission in coming weeks.
The pact also calls for a UK clinical trial, based on
proprietary NHS data, to identify patients at risk of heart
disease for whom conventional treatment has not worked, as well
as a collaboration on manufacture of cutting-edge drugs like
inclisiran, which targets "bad cholesterol", a culprit behind
heart attacks and strokes.
Heart disease or hardening of the arteries is a big killer
in Britain and the NHS has made fighting cardiovascular
disorders one of its long-term priorities.
"If licensed, it will allow the drug to be put through the
NICE approval process at the earliest opportunity possible,
making it available to NHS patients much earlier," Britain's
Department of Health and Social Care (DHSC) said, in response to
Reuters questions.
Should inclisiran win U.K. approval, as expected, the deal
calls for the NHS to pay for it as an add-on therapy for those
patients whose cholesterol levels do not respond adequately to
statins, at a significantly reduced price.
The DHSC did not release the agreed price, citing commercial
confidentiality. It also declined to comment on whether Novartis
would be required to make inclisiran in Britain.
British health minister Matt Hancock said: "This
collaboration has the potential to save 30,000 lives over the
next ten years."
RIVAL DRUGS
Novartis bought inclisiran with its $9.7 billion acquisition
of The Medicines Co., announced in late November, to expand a
cardiovascular medicines portfolio that already includes heart
failure drug Entresto, a billion-dollar-per-year seller.
Novartis Chief Executive Vas Narasimhan has predicted
inclisiran will become one of Novartis's most-lucrative
medicines but has warned of "a few years of slow ramp" before
sales take off.
Narasimhan has said inclisiran's price tag would be in the
"cost-effective range" to compete with rival medicines, Amgen's
Repatha and Praluent from Regeneron and Sanofi
.
They list at some $5,800 annually in the United States,
following price cuts undertaken to boost slumping sales. [https://reut.rs/2NiOj72
] [https://reut.rs/2FKb0Nt
]
Inclisiran is a twice-yearly injection, while Repatha and
Praluent are injected every two weeks.
(Reporting by John Miller. Editing by Jane Merriman)