AstraZeneca posts drug failures, takes $382m hit
pharmafile | December 20, 2011 | News story | Research and Development, Sales and Marketing | AstraZeneca, depression, ovarian cancer
AstraZeneca has taken a major blow to its late stage pipeline, with one of its key cancer drugs now being halted.
The first drug is its investigational compound olaparib, which will not progress into Phase III development for the maintenance treatment of serous ovarian cancer.
In addition, AstraZeneca also said that a second Phase III study of TC-5214 for patients with major depressive disorder did not meet its primary end point.
As a result the Anglo-Swedish firm will take pre-tax charge of $381.5 million (£245 million) in the fourth quarter.
The decision to discontinue olaparib, a PARP inhibitor, in serous ovarian cancer came after a recent Phase II study showed that it was unlikely to increase overall survival, the best measure of patient benefit in ovarian cancer.
The firm also struggled to find a suitable tablet dose for use in Phase III studies. As a result of these difficulties the drug will now not advance into late stage trials.
The disappointing results from TC-5214 follow recent results of the RENAISSANCE flexible dose trial study 3, which also did not meet its primary endpoint.
AZ said it would continue with the development of the two remaining fixed dose Phase III studies for the drug, and one long-term safety study.
It said: “Regulatory filing targets will be reviewed following full results of the remaining studies which are expected in the first half of 2012.”
The firm added that a potential new drug application filing in the US is planned for the second half of 2012, with a European marketing authorisation application targeted for 2015.
AZ is developing TC-5214 in conjunction with North Carolina, US-based Targacept, after both firms signed a collaborative deal in December 2009.
As a result of the termination of further development of olaparib in serous ovarian cancer, the company is taking a pre-tax impairment charge of $285 million.
AZ added that a further impairment of $96.5 million pre-tax charge would also be taken “based on the lower probability of success for the remaining TC-5214 studies”.
Ben Adams
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