7th Feb 2014 09:24
LONDON (Alliance News) - Biopharmaceutical company Shire PLC Friday saw its shares fall after it said it would abandon clinical development of Vyvanse for the potential treatment of major depressive disorder after it failed late-stage trials.
In a statement, the company said that two pivotal Phase III investigational studies evaluating the efficacy and safety of Vyvanse Capsules as an adjunctive treatment for major depressive disorder in adults who inadequately responded to antidepressant monotherapy with a selective serotonin reuptake inhibitor or Serotonin?norepinephrine reuptake inhibitor, did not meet their primary efficacy endpoints.
Vyvanse is a prescription medicine currently approved for the treatment of Attention-Deficit/Hyperactivity Disorder in the US, Canada, Australia, several European countries and Brazil.
The company also still intends to file an application with the US Food and Drug Administration for its approval as a binge eating disorder treatment later this year.
"While this news in major depressive disorder is disappointing for patients and Shire, we will later in the year be filing with the FDA for a new indication for Vyvanse in Binge Eating Disorder in adults, and Vyvanse is an effective and leading treatment for ADHD," said Shire Chief Executive Flemming Ornskov.
The failed trails did show that the safety profile for Vyvanse in the two studies appeared to be generally consistent with the known profile established in studies in adults with ADHD.
Berenberg said the primary endpoint target in the major depressive disorder studies had been missed by a wide margin. It had previously assumed a 33% chance of success for Vyvanse in this indication and had assumed the company would have received royalties on sales.
Now that the major depressive disorder indication is removed from the bank's forecasts, its 2018 earnings per share forecast for Shire falls 3%, and, more importantly, Berenberg is no longer no longer forecasting double-digit earnings growth through to 2018. It said it now expects EPS growth of 9%, not 10%.
Shire shares were down 1.2% at 3,105 pence Friday morning, one of the biggest declines on the FTSE 100.
By Steve McGrath; [email protected]; @SteveMcGrath1
Copyright © 2014 Alliance News Limited. All Rights Reserved.
Related Shares:
Shire