FDA accepts Teva's NDA for BDP Nasal HFA to treat allergic rhinitis

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA), a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Teva's NDA was submitted to the FDA on May 24, 2011.

“We are encouraged by the positive safety and efficacy results from both the Phase III trials evaluating BDP Nasal HFA in seasonal and perennial allergic rhinitis”

The submission is based on a comprehensive clinical development program including results from two Phase III clinical trials assessing the safety and efficacy of BDP Nasal HFA in the treatment of SAR and PAR. In both trials, BDP Nasal HFA demonstrated significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion versus placebo. BDP Nasal HFA was generally well tolerated and the safety profile was similar to that of placebo.

"BDP Nasal HFA has demonstrated promising results in the treatment of both SAR and PAR, and we remain committed to addressing unmet needs and dissatisfaction with currently available treatments among the 60 million patients in the U.S. who suffer from allergic rhinitis," said Professor Yitzhak Peterburg, Teva's Group Vice President, Global Branded Products.

Currently, the only intranasal corticosteroids available for the treatment of SAR and PAR are products with an aqueous or "wet" spray. In contrast, BDP Nasal HFA is delivered as a pressurized, non-aqueous aerosol solution, or "dry" spray, propelled by HFA, which is environmentally friendly. Recent survey results have found that some nasal allergy patients who used an intranasal corticosteroid spray in the last year reported dripping in the throat as a moderately or extremely bothersome side effect. Patients reported being less satisfied with current nasal sprays when they experienced discomfort from the spray or when they felt the medication drip down the back of their throats. Healthcare providers and specialists also reported patient dissatisfaction with current nasal sprays due to the bothersome side effects associated with these treatments.

"We are encouraged by the positive safety and efficacy results from both the Phase III trials evaluating BDP Nasal HFA in seasonal and perennial allergic rhinitis," said Eli O. Meltzer, M.D., Allergy & Asthma Medical Group & Research Center, San Diego, CA. "The new nasal aerosol delivery system which propels an odorless, non-aqueous spray also offers a built-in dose counter."

Source Teva Pharmaceutical Industries Ltd.

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