April 16, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
French drugmaker Ipsen has been having a rocky Thursday, after an announcement that its experimental prostate cancer drug tasquinimod had flopped during a Phase III trial sent shares of it and its Swedish partner on the drug, Active Biotech, sharply downward.
“Efficacy results together with preliminary safety data do not support positive benefit risk balance in this population,” said the companies in a statement. “Therefore the companies have decided to discontinue all studies in prostate cancer. Full results will be presented at an upcoming scientific conference.”
Tasquinimod had shown promise in earlier trials and analysts had already begun building the drug’s success into their business prediction models for the business. But news that it will now be the next Medivation, Inc. drug Xtandi or Johnson & Johnson ‘s Zytiga send shares of Active plummeting 60 percent, and Ipsen down 10 percent.
Maxim Jacobs, analyst at Edison Investment Research, said today that the disappointment was unexpected, but that the drug may eventually show success in treating multiple scelerosis.
“The failure of Tasquinimod in prostate cancer is certainly disappointing. Investors though shouldn’t forget that the results of the Phase III CONCERTO study of Laquinimod for multiple sclerosis is coming next year. As an oral medication for MS, even mild efficacy could lead to meaningful sales.”
“The data at hand is unambiguous and cannot motivate further development of tasquinimod in this patient population,” said Tomas Leanderson, chief executive of Active Biotech.
The companies said they are working with regulators to transition patients involved in the study to more appropriate therapies. They also said they will work with trial investigators, ethics committees and the relevant regulatory authorities to provide them with updated and current information in compliance with local regulations.
“We are disappointed for prostate cancer patients. Ipsen remains strongly committed to oncology,” said Marc de Garidel, chairman and CEO of Ipsen. “We are grateful to the clinicians, caregivers, patients and their families who were involved in this study.”
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
