Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade AZN now with 
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.

Register
To receive FREE breaking news email alerts for AstraZeneca PLC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
The Reserve Bank of New Zealand on Thursday raised its Official Cash Rate by 25 basis points, to 3.00 percent from 2.75 percent. The decision was in line with expectations, and it marks the second straight month with a rate hike following 24 straight meetings in which the rate was not changed. New Zealand's economic expansion has considerable momentum, with GDP estimated to have grown by 3.5 percent in the year to March. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter. Stocks moved mostly lower during trading on Wednesday, giving back some ground after trending higher over the past several sessions. Selling pressure was relatively subdued, however, limiting the downside for the markets. The major averages all closed in the red, although the tech-heavy Nasdaq underperformed its counterparts by a wide margin.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.