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Feb 3, 2014

Top 10 Clinical Trial Failures of 2013

Which drugs tanked during testing last year?

Top 10 Clinical Trial Failures of 2013

Five of the trial failures on this list were for cancer indications. [© Ljupco Smokovski - Fotolia.com]

  • #5. Tabalumab

    Sponsor: Eli Lilly

    Indication: Rheumatoid arthritis (RA)

    Type of drug: Anti-BAFF (B cell activating factor) monoclonal antibody

    How it failed: The company said tabalumab showed a lack of efficacy in the Phase III FLEX-V study, which was investigating the compound for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors.

    Date of failure announcement: February 7

    Cost of development write-off attributed to the drug: “Approximately” $60 million in costs related to the discontinuation of the rheumatoid arthritis program.4

  • #4. Fostamatinib (R788)

    Sponsors: AstraZeneca and Rigel

    Indication: Rheumatoid arthritis

    Type of drug: Oral spleen tyrosine kinase inhibitor

    How it failed: Fostamatinib with methotrexate (MTX) did not show statistically significant improvement compared to placebo in ACR20 response rates at 24 weeks in patients given 100 mg twice-daily for four weeks followed by 150 mg once daily, in Phase III OSKIRA-3 trial of patients inadequately responding to MTX and a single TNF-alpha antagonist. However, the drug did show statistically significant improvements in ACR20 response rates at 24 weeks in the 100 mg twice-daily group.

    Date of failure announcement: June 4

    Cost of development write-off attributed to the drug: AZ recorded a $136 million pre-tax impairment charge to R&D expense in second quarter of 2013 toward intangible assets relating to fostamatinib, which was excluded from core financial measures. AZ was solely responsible for all costs and expenses incurred by both parties up to December 4, 2013.5 Following release of topline results, AstraZeneca said it will not proceed with regulatory filings, and returned its rights to the compound to Rigel.6,7

  • #3. Preladenant

    Sponsor: Merck & Co.

    Indication: Parkinson’s disease

    Type of drug: Adenosine A2A receptor antagonist

    How it failed: Company said initial review of data from three separate Phase III trials to assess safety and efficacy did not provide evidence of efficacy for preladenant compared with placebo. Two of the studies assessed preladenant when added to levodopa therapy in patients with moderate-to-severe PD; the third assessed preladenant as monotherapy in early PD. Citing its review, Merck discontinued the extension phases of the studies and said it no longer plans to pursue regulatory filings for the drug candidate.

    Date of failure announcement: May 23

    Cost of development write-off attributed to the drug: Approximately $181 million impairment charge in the second quarter of 2013, following discontinuation of the clinical development program.

  • #2. Darapladib

    Sponsor: GlaxoSmithKline

    Indication: Chronic coronary heart disease (CHD) in adults

    Type of drug: Oral inhibitor of lipoprotein-associated phospholipase A2 (Lp-PLA2)

    How it failed: Did not meet primary endpoint of time to first occurrence of any major adverse cardiovascular event (MACE) from the composite of myocardial infarction (heart attack), stroke, and cardiovascular death (relative risk reduction of 6%; p=0.199) in Phase III STABILITY (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) trial.8

    Date of failure announcement: November 12

    Cost of development write-off attributed to the drug: No writedown announced, though one analyst has estimated GSK will take a £150 million (about $246.3 million) writedown9 pending formal announcement expected with release of Q4 and full-year 2013 results; next steps unknown pending completion of a second Phase III study of darapladib in acute coronary syndrome, called SOLID-TIMI 52.

  • #1. Iniparib (BSI-201; SAR240550)

    Sponsor: Sanofi

    Indications: Newly diagnosed, metastatic (stage IV) squamous non-small-cell lung cancer; platinum-resistant ovarian cancer

    Type of drug: Benzamide (4-iodo-3-nitrobenzamide) structurally related to nicotinamide

    How it failed: Did not meet its primary endpoint of achieving improvement in overall survival when added to gemcitabine/carboplatin chemotherapy compared to patients who received gemcitabine/carboplatin alone in Phase III ECLIPSE trial, which also found no clinically meaningful differences in the main safety parameters between the two arms. Company also said topline results of a Phase II study of iniparib in platinum-resistant ovarian cancer do not support further development of iniparib in this patient population.

    Date of failure announcement: June 3

    Cost of development write-off attributed to the drug: €384 million ($525 million) impairment loss on intangible assets charged in the first half of 2013, related to discontinuation of internal R&D programs for iniparib in non-small-cell lung cancer and ovarian cancer.



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