13th Jan 2020 08:27
(Alliance News) - AstraZeneca PLC said Monday it has ended its phase III Strength trial for Epanova, which could result in a USD100 million impairment.
The decision to discontinue the trial was based on a recommendation by an independent monitoring committee which said Epanova is "unlikely to demonstrate a benefit to patients" with mixed dyslipidaemia who are at increased risk of cardiovascular disease.
Mene Pangalos, Astra's executive vice president of BioPharmaceuticals R&D, said: "It was important to assess the potential benefit of Epanova in mixed dyslipidaemia. We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline."
Astra said it is reviewing the ongoing value of the USD533 million Epanova asset.
"Any impairment will be treated as a non-core item in the fourth quarter of 2019. A write down of up to USD100 million relating to inventories is also anticipated to impact the core earnings in the fourth quarter of 2019," Astra added.
Separately, the FTSE 100-listed pharma firm said its Lynparza treatment has been granted priority review by the US Food & Drug Administration to treat advanced ovarian cancer.
AstraZeneca co-develops and co-commercialises Lynparza together with Merck & Co Inc.
Astra and peer Merck said a supplemental new drug application for Lynparza in combination with bevacizumab has been granted the review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab.
The decision to accept the review was based on results from phase III of the Paolo-1 trial. The trial showed Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% based on a hazard ratio of 0.59.
Lynparza is currently approved for the treatment of advanced ovarian cancer, metastatic breast cancer and metastatic pancreatic cancer.
Shares in Astra were up 0.2% in early trading in London on Monday morning at 7,662.00 pence each. Merck closed 0.2% higher in New York on Friday at USD89.53, but the shares have lost 0.1% in after-hours trade to USD89.45.
By Paul McGowan; [email protected]
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