AstraZeneca PLC failed to win accelerated approval of a cancer
drug in the U.S., dealing a blow to its new drug-development
pipeline, a key plank of its defense in fighting off a $120 billion
approach from Pfizer Inc. last month.
The company said an advisory committee to the U.S. Food and Drug
Administration voted 11 to 2 against accelerated approval of its
experimental ovarian cancer drug olaparib in patients with a
specific mutation of the disease. The FDA isn't obliged to follow
the committee's recommendations, although it often does.
Olaparib is one of a host of new cancer treatments AstraZeneca
is hoping will become the mainstay of its business, reducing its
current reliance on heart, lung and diabetes drugs. It is the first
significant drug-development setback the company has had in the
past six months. The company has demonstrated potentially promising
trial results in a combination of its diabetes drugs and in a new
cancer immunotherapy.
Investor excitement over AstraZeneca's cancer
pipeline--including scientific advances that could potentially
revolutionize treatment of the disease and command high prices--has
supported a significant re-rating of the company's share price in
the past year.
The idea that a Pfizer takeover approach might disrupt and delay
the development of such pipeline drugs was a key reason cited by
AstraZeneca Chief Executive Pascal Soriot for wanting to retain the
company's independence.
Mr. Soriot has also set ambitious new targets for the company to
hit $45 billion in annual sales by 2023, with almost a third coming
from pipeline drugs. Last year, sales were $25.7 billion.
While the news is a setback for AstraZeneca, the number of
patients with that form of ovarian cancer is relatively
small--limiting that specific market for the drug. The company is
now hoping that a further clinical study might prove the drug's
efficacy.
Briggs Morrison, AstraZeneca's global medicines development and
chief medical officer, said "we are disappointed with today's
recommendation, and strongly believe that olaparib has the
potential to provide patients with relapsed BRCA-mutated ovarian
cancer and their doctors with a much-needed treatment option."
He added that the company aims to complete the further study by
the end of next year.
Sanford Bernstein analyst Tim Anderson said in a note to clients
the greatest impact of a potential FDA rejection of the drug was on
investor perception of AstraZeneca's research-and-development
abilities, adding "every bit of slippage at the company probably
does tilt the balance slightly more in favor of a future PFE-AZN
[Pfizer and AstraZeneca] tie-up."
Under U.K. takeover rules, Pfizer cannot return with another
takeover offer before November, unless AstraZeneca invites it back
for talks. Pfizer hasn't ruled out resuming discussions with
AstraZeneca but is also looking at other opportunities for growth
both inside the company and through other potential deals.
Mr. Soriot, meanwhile, is looking for other ways of maximizing
value at AstraZeneca, in addition to his focus on developing its
pipeline drugs. These could potentially include finding partners
for its cancer drugs and exiting noncore areas such as
anti-infectives and neuroscience.
Write to Hester Plumridge at Hester.Plumridge@wsj.com
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