Alnylam’s shares plunge by 42% after deaths in clinical trials
pharmafile | October 6, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Alnylam, Shares, clinical trials, deaths, failure, market value, phase III, revusiran
Alnylam Pharmaceuticals’ shares lost close to half of their value as it was forced to end a trial of its late-stage experimental drug because it was causing more deaths compared with the placebo. The treatment, revusiran, was being tested to treat a condition named hereditary ATTR amyloidosis with cardiomyopathy, which can potentially cause nerve and heart damage.
The decision to halt the trial was made after reports of new or worsening nerve damage in another study of the drug. Alnylam was forced to consult with an independent committee overseeing to trial to make an assessment. The committee returned with the verdict that the benefits of the drug were far outweighed by the potential risks. After this decision was taken, subsequent study found that more people who had taken revusiran had died than those taking a placebo.
“Patient safety comes first. We have stopped all dosing and are actively monitoring patients across revusiran studies to ensure their safety. We will also continue to evaluate ENDEAVOUR (the Phase III trial) data to understand the potential cause of these findings,” commented John Maraganore, Ph.D., the Chief Executive Officer at Alnylam.
Independent analysts had predicted that sales of the drug could potentially reach more than $1 billion in sales by 2023. The failure of drug in the Phase III trial and, more particularly, the manner of its failure is represented in the depth to which Alnylam’s shares have fallen, with their $6.03 billion market value having since fallen by 42%.
18 people died in the course of the trial but Alnylam has, as yet, refused to disclose how many of these individuals were taking revusiran.
Ben Hargreaves
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