Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) announced that it has successfully filed a Marketing Authorization Application (MAA) with theEuropean Medicines Agency (EMA) for reslizumab. Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal antibody (mAb) for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.
“Uncontrolled asthma remains a serious challenge for patients and healthcare professionals despite the availability of standard of care treatment,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “There is a tremendous need for targeted new medicines. Clinical trials have shown that reslizumab significantly reduced the rate of asthma exacerbations and improved lung function in a specific group of patients with elevated eosinophil levels. This group of patients’ asthma was poorly controlled despite being on a standard treatment regimen. The successful filing of the MAA for reslizumab means that this patient population, which often experiences the most severe symptoms, is now one step closer to a new targeted treatment option in Europe.”
The MAA for reslizumab includes data from Teva’s Phase III BREATH clinical trial program. The program consisted of four separate placebo-controlled Phase III trials specifically designed to include a targeted population of 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, compared to placebo, reduced asthma exacerbation rates by at least half (50-60 percent) and provided significant improvement in lung function, quality of life and other secondary measures of asthma control as add-on 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.
“Through the development of novel molecules and inhaler devices, Teva is committed to delivering innovations in asthma care that help patients achieve improved asthma outcomes and quality of life,” said Rob Koremans, MD President and CEO of Teva Global Specialty Medicines. “We are delighted with this successful filing for reslizumab, which, if approved, will broaden and strengthen our respiratory offering and provide a much-needed new treatment for an underserved patient group.”
A final decision from the EMA on reslizumab is anticipated in the second half of 2016. A Biologics License Application (BLA) for reslizumab was also accepted by the U.S. Food and Drug Administration (FDA) in June 2015, with FDA Regulatory Action expected in March 2016. (Original Source)
Shares of Teva Pharmaceutical Industries closed yesterday at $72 . TEVA has a 1-year high of $72.15 and a 1-year low of $47.36. The stock’s 50-day moving average is $61.55 and its 200-day moving average is $60.20.
On the ratings front, Teva Pharmaceutical has been the subject of a number of recent research reports. In a report released today, BMO analyst David Maris upgraded TEVA to Buy, with a price target of $80, which represents a potential upside of 11.1% from where the stock is currently trading. Separately, yesterday, Standpoint Research’s Ronnie Moas reiterated a Buy rating on the stock and has a price target of $84.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Maris and Ronnie Moas have a total average return of 26.7% and 8.0% respectively. Maris has a success rate of 62.5% and is ranked #978 out of 3717 analysts, while Moas has a success rate of 70.5% and is ranked #27.
The street is mostly Bullish on TEVA stock. Out of 8 analysts who cover the stock, 7 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $73.00, which represents a slight upside potential from current levels.
Teva Pharmaceutical Industries Ltd develops, produces and markets generic, branded & OTC medicines. Some of its products are Copaxone, Azilect & Provigil.