Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today reported that asthma treatment reslizumab demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations (CAE) in two pivotal Phase III studies.
In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo (50% and 60% respectively). Reslizumab also demonstrated a positive effect on lung function and asthma control in the Phase III program. The combination of an effect on clinically important exacerbations and on improvements and preservation of lung function suggest that reslizumab may be a uniquely differentiated treatment for patients with moderate to severe asthma with elevated levels of blood eosinophils.
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“The consistent results from these duplicate Phase III trials demonstrating substantial reductions in asthma exacerbations are impressive, ” said Professor Mario Castro, Washington University School of Medicine, Division of Pulmonary and Critical Care Medicine and lead investigator. “They support the potential of targeted anti-IL-5 therapy with reslizumab in patients with moderate-severe persistent asthma and elevated blood eosinophils who are at risk for asthma exacerbations and are uncontrolled by standard asthma therapies.”
“These pivotal Phase III study results are striking. Asthma that is inadequately controlled by current standard of care therapy continues to present a serious problem for patients, physicians and healthcare systems. The success of these studies gives us confidence that we may have a valuable potential new treatment option for asthma patients, with elevated levels of blood eosinophils, who are at risk of exacerbation, ” said Teva President of Global R&D and Chief Scientific Officer Dr. Michael Hayden. “We plan to submit applications for approval in the US, Europe and other regions as soon as possible.”
Teva estimates that the market for severe asthma biotech drugs could exceed $7.5 billion a year in the US and Europe alone.
- Reslizumab unequivocal in meeting primary end point in both studies – cuts frequency of clinical asthma exacerbations by at least half (50% and 60% respectively)
- Positive results pave the way for reslizumab regulatory submissions planned for the first half of 2015 (initially US, followed by EU and other regions), pending full analysis of the data
- Reslizumab’s combination of exacerbation reduction and lung function improvement may constitute a significant differentiator in this segment (data to be presented at European Respiratory Society Congress, Sept 6-10)
- Over 10% of population suffer from asthma, a significant number are inadequately controlled: A major challenge and a significant opportunity for an effective, targeted, therapeutic option