Teva Pharmaceutical Industries Ltd (ADR) (NYSE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for reslizumab, the company’s investigational humanized monoclonal antibody (mAb) which targets interleukin-5 (IL-5), for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.
“Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “The reslizumab BLA filing acceptance represents a significant milestone for Teva as we work toward serving a specific asthma patient population that is defined by elevated blood eosinophil levels and inadequately controlled symptoms despite standard of care therapy. In clinical trials, patients treated with reslizumab showed significant reductions in the rate of asthma exacerbations and significant improvement in lung function. If approved, we believe reslizumab will serve as an important new targeted treatment option to achieve better asthma control for patients with eosinophil-mediated disease.”
The BLA for reslizumab includes data from Teva’s Phase III BREATH clinical trial program. The program consisted of four separate placebo-controlled Phase III trials involving more than 1,700 adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies. Results from these studies demonstrated that reslizumab, in comparison to placebo, reduced asthma exacerbation rates by at least half and provided significant improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy. Common adverse events in the reslizumab treatment group were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. Two anaphylactic reactions were reported and resolved following medical treatment at the study site.
Results from the reslizumab BREATH program were recently presented at the American Thoracic Society 2015 Annual Meeting and the American Academy of Allergy, Asthma and Immunology 2015 Annual Meeting, in addition to being published in The Lancet Respiratory Medicine. The BLA for reslizumab has been accepted for filing by theFDA for standard review, with FDA Regulatory Action expected in March 2016. (Original Source)
Shares of Teva Pharmaceutical closed last Friday at $61.63 . TEVA has a 1-year high of $68.75 and a 1-year low of $47.36. The stock’s 50-day moving average is $60.74 and its 200-day moving average is $59.03.
On the ratings front, Teva Pharmaceutical has been the subject of a number of recent research reports. In a report issued on June 4, Deutsche Bank analyst Gregg Gilbert maintained a Buy rating on TEVA, with a price target of $73, which implies an upside of 18.4% from current levels. Separately, on April 30, Oppenheimer’s Akiva Felt maintained a Buy rating on the stock and has a price target of $77.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Gregg Gilbert and Akiva Felt have a total average return of 21.2% and 35.1% respectively. Gilbert has a success rate of 81.6% and is ranked #185 out of 3624 analysts, while Felt has a success rate of 68.8% and is ranked #25.
The street is mostly Bullish on TEVA stock. Out of 8 analysts who cover the stock, 7 suggest a Buy rating and one recommend to Hold the stock. The 12-month average price target assigned to the stock is $73.00, which represents a potential upside of 18.4% from where the stock is currently trading.
Teva Pharmaceutical Industries Ltd develops, produces and markets generic, branded & OTC medicines. Some of its products are Copaxone, Azilect & Provigil.