Teva reports data from QNASL studies on seasonal and perennial allergic rhinitis

Nov 1 2011

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that data from four late-stage studies examining QNASL™ (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) symptoms, will be presented at the 2011 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Boston, Mass., November 3-8, 2011. Findings from one Phase III clinical study being presented demonstrate the degree of patient satisfaction with QNASL™, while the others support the safety and efficacy profile for the product.

On August 5, 2011, the United States (U.S.) Food and Drug Administration (FDA) accepted for review, the New Drug Application (NDA) filing for QNASL™. The submission was based on a comprehensive clinical development program including results from two Phase III clinical trials designed to evaluate the safety and efficacy of QNASL™ for the treatment of SAR and PAR symptoms. In both trials, QNASL™ demonstrated significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion versus placebo.

"We are pleased to have data accepted for presentation at the ACAAI Annual Meeting that highlight the favorable attributes associated with QNASL," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "These data provide insight into the level of patient satisfaction and ease of use of the device, which are important for patient acceptance and may impact adherence, and reinforce the safety and efficacy profile for QNASL demonstrating the product's potential to provide relief for both nasal and ocular symptoms. We remain committed to the clinical development program for QNASL with the goal of addressing unmet needs amongst the 60 million people suffering from allergic rhinitis in the U.S."

The following QNASL™ data will be presented:

Abstract Title & Poster Number

• P361: Patient Satisfaction and Ease-of-Use of BDP HFA Nasal Aerosol Device in Subjects With Perennial Allergic Rhinitis
• P357: BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis
• P358: BDP HFA Nasal Aerosol 320 μg Once Daily Is Not Associated With HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis
• P359: BDP HFA Nasal Aerosol 320 μg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis
• P362: Long-Term Treatment With BDP HFA Nasal Aerosol 320 μg Once Daily Is Safe and Effective in Subjects With Perennial Allergic Rhinitis

"Despite currently available treatment options for allergic rhinitis, patients continue to be physically and emotionally affected by symptoms and are burdened by the side effects associated with aqueous, 'wet' sprays," said Russell A. Settipane, MD, FACAAI, FAAAAI, FACCP, Allergy and Asthma Center and Asthma Nasal Disease & Allergy Research Center of New England, Providence, R.I. "We are encouraged by the data being presented by Teva at the ACAAI Annual Meeting this year and are looking forward to having a new option available to address the current dissatisfaction patients are experiencing with the 'wet' sprays, such as medicine dripping down the throat."

Currently, the only intranasal corticosteroids available for the treatment of SAR and PAR are products with an aqueous or "wet" spray. In contrast, QNASL ™is delivered as a pressurized, odorless, non-aqueous aerosol solution, or "dry" spray, which is environmentally friendly. The new nasal aerosol delivery system also offers a built-in dose counter.