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AstraZeneca Begins Olaparib Phase III Trial; Reverses $285 Mln Charge

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9/4/2013 2:50 AM ET

AstraZeneca PLC (AZN.L,AZN: Quote) Wednesday said it enrolled the first patient in the Phase III SOLO, or Study of OLaparib in Ovarian cancer, programme. Olaparib, an innovative oral poly ADP ribose polymerase inhibitor is being investigated for the treatment of BRCA mutated ovarian cancer in SOLO. The clinical development is designed to study the benefit, progression free survival, of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the first line setting, SOLO 1, and relapsed setting, SOLO 2.

A pre-tax impairment charge of $285 million, which was incurred in December 2011 after deciding not to progress olaparib into phase III, will be reversed in the third quarter of 2013, following the start of the programme. This reversal will be excluded from the core earning per share, the company said.

The SOLO 1 study is being conducted in collaboration with the Gynecologic Oncology Group and the SOLO 2 study with the European Network of Gynaecological Oncological Trial Groups. Both trials are randomised, double blind, placebo controlled studies that utilise the tablet formulation of olaparib at a dose of 300mg twice daily.

Separately, Myriad Genetics, Inc. (MYGN) said it is expanding its collaboration agreement with AstraZeneca to provide companion diagnostics for the olaparib Phase 3 clinical development program. Pursuant to the agreement, Myriad will build out a new laboratory within its Salt Lake City facility in accordance with U.S. Food and Drug Administration regulations for companion diagnostic devices.

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by RTT Staff Writer

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