AstraZeneca share price: Company fails to win backing for ovarian cancer drug

on Jun 26, 2014
Updated: Jun 1, 2022
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iNVEZZ.com, Thursday, June 26: AstraZeneca Plc (LON:AZN) has failed to convince an advisory panel of the US Food and Drug Administration (FDA) of the benefits of its ovarian cancer treatment olaparib, with the panel requesting more data for the drug.

AstraZeneca’s share price has added about 0.5 percent in London so far this morning.
**FDA advisory panel recommendation**
AstraZeneca announced in a statement today that the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted that current clinical evidence did not support an accelerated approval for use of olaparib as a maintenance therapy for relapsed ovarian cancer in which tumours have responded completely or partially to platinum-based chemotherapy.

Reuters reported that the panel had voted that the Anglo-Swedish company should complete a second trial to confirm the results seen in a smaller study which were not robust enough to convince the committee that they could be reproduced.
“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,” AstraZeneca’s chief medical officer Briggs Morrison said in the company statement.

The advisory panel’s recommendation came after an FDA staff report questioned the benefit of olaparib pointing to the very small group of patients included in the trial, as well as to an ‘underperforming’ control arm. (AstraZeneca share price: FDA report questions benefit of ovarian cancer drug)

AstraZeneca noted that it would evaluate the advisory committee’s recommendation and would also continue with a late-stage trial on olaparib, expected to be completed by the end of next year.
Oncology treatments are one of AstraZeneca’s key growth areas and were also at the centre of the drugmaker’s defence against Pfizer Inc’s (NYSE:PFE) takeover attempt.

**Merger with Pfizer not dead, analysts say**

Earlier this week, The New York Times’ Dealbook quoted analysts at BNP Paribas as pointing out that a potential tie-up with Pfizer might not be dead despite AstraZeneca’s repeated rejections.
The analysts said that a sweetened offer equal to about £75 billion would still make ‘economic sense’. Last month, AstraZeneca’s board snubbed Pfizer’s final £69 billion bid, arguing that it substantially undervalued the company.
“It will be interesting to see if Astra’s shareholders can put enough pressure on the management to resume talks first,” BNP analysts Kokou Agbo-Bloua and Antoine Porcheret noted in a research report, as quoted by Dealbook.
Under UK takeover rules, Pfizer cannot make another offer until November. The US pharma group, however, can return with a fresh proposal in August if approached by AstraZeneca’s board.
The Anglo-Swedish company’s biggest investor BlackRock Inc (NYSE:BLK), which also happens to be one of Pfizer’s top five shareholders, has already signalled that it wants fresh negotiations to see if the offer could be improved as early as this summer. (AstraZeneca share price: Top shareholder pushes for resumption of Pfizer talks)
**As of 09:38 BST, buy AstraZeneca shares at 4366.50p.**
**As of 09:38 BST, sell AstraZeneca shares at 4365.50p.**

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