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 The British drugmaker is running a lung cancer trial known as
ATLANTIC that is due to produce results by the end of this year and
could, in theory, support a submission seeking accelerated U.S.
approval in the first half of 2016.
However, this option is now looking less likely since Bristol-Myers
Squibb's Opdivo and Merck's Keytruda have already won U.S. Food and
Drug Administration (FDA) clearance in lung cancer, reducing the
chances of durvalamb gaining rapid approval.
"The landscape has changed because competing products received
approval far faster than could have been expected a bit more than a
year ago," AstraZeneca Chief Executive Pascal Soriot told reporters
in a post-results conference call.
Roche also has a competing product, atezolizumab, that it plans to
file for approval in lung cancer in the first quarter of 2016.
As a result the chances of an accelerated FDA approval based on
ATLANTIC have decreased, since there is a reduced unmet medical
need. All four drugs work in a similar way to boost the immune
system's ability to detect and fight tumour cells.
Durvalumab is AstraZeneca's most important pipeline product and the
company said last year, during its bid defense against a takeover
attempt by Pfizer, that the medicine could eventually generate
annual sales of $6.5 billion, making it a key component of an
overall $45 billion sales forecast for 2023.
While ATLANTIC is looking at durvalumab's use on its own in a subset
of late-stage lung cancer patients, Soriot said the drug's real
promise lay in combining it with other products to help a much wider
range of patients.
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"Our long-range forecast for 2023 remains the same. In fact, we now
have a little bit more for oncology sales and a little bit less for
diabetes in our forecasts," he said.
"Getting accelerated approval with our monotherapy was never part of
our base plan or our long-range forecasts. We still want to pursue
the accelerated approval, but as an upside."
Soriot also said AstraZeneca was considering a marketing partnership
deal for its gout drug lesinurad, which was recommended for approval
by an FDA advisory panel last month.
"Partnering the gout portfolio is clearly a very strong option that
we are considering," he said. "We have to wait for lesinurad's
approval and then, based on that, we will pursue discussions with
potential partners."
(Editing by Greg Mahlich)
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