Teva Respiratory Announces Positive Results From Phase III Trial of BDP HFA Nasal Aerosol in Seasonal Allergic Rhinitis

"Dry" Nasal Spray Met Primary and Secondary Endpoints

HORSHAM, Pa., July 28 /PRNewswire/ -- Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

"The outcomes of the Phase III SAR trial validate the potential of BDP HFA as a treatment option for patients trying to manage their nasal allergies," said Mark Salyer, General Manager of Teva's Respiratory Division. "The goal of this development program is to address the unmet clinical need among the 60 million Americans affected with allergic rhinitis who are looking for a solution that delivers a 'dry' experience to avoid the 'wet feeling' and postnasal drip associated with the nasal spray formulations that are available today."

Currently, the intranasal spray (INS) market is composed only of aqueous or "wet feeling" products; however, prior to the U.S. Food and Drug Administration's (FDA) decision to phase out metered dose inhalers (MDIs) that contain chlorofluorocarbons (CFCs), the nasal market also included aerosol or "dry formulation" sprays. Teva's Nasal Aerosol utilizes an HFA propellant. Future studies will further examine the safety and efficacy profile of this product.

Based on results from the Phase I study that evaluated the pharmacokinetics, safety and tolerability of BDP HFA, the systemic exposure following administration of the treatment (up to 320 mcg/day) was approximately 27 percent of orally inhaled BDP HFA, which is marketed by Teva as the asthma treatment QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol. Based on these results, the established QVAR® safety data may provide further supportive evidence for the development of this "dry" nasal formulation for the treatment of allergic rhinitis.

Study Design and Results

The Phase III SAR trial was designed as a randomized, double-blind, placebo-controlled, parallel-group, clinical study to assess the efficacy and safety of BDP HFA Nasal Aerosol in the treatment of SAR in subjects 12 years of age and older. Over a two-week treatment period during the Mountain Cedar pollen season, 340 patients at four different sites in the U.S. were randomized to 320 mcg of BDP HFA propellant or placebo as a nasal aerosol daily. To measure efficacy in comparison to placebo, the study used the standard reflective Total Nasal Symptom Score (TNSS) for primary endpoints and instantaneous TNSS and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) for secondary endpoints.

The pivotal trial primary and secondary end points both met statistical significance with Teva's HFA Nasal Aerosol, which demonstrated clinical efficacy in patients with SAR versus placebo. The product was also generally well tolerated and comparable to placebo. The most common adverse events reported were nasal discomfort, headache, epistaxis (nosebleed), nausea and urticaria (hives).

About Allergic Rhinitis

Allergic rhinitis (AR) is a chronic inflammatory disease characterized by sneezing, nasal itch, rhinorrhea, and nasal congestion as symptoms, in addition to allergic conjunctivitis in many subjects. For many AR patients, a stuffy nose may be the most irritating symptom; however, a recent survey reported almost half (46%) of parents of children with allergic rhinitis reported severe symptoms such as headache and ear and facial pain. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. While AR itself is not life-threatening (unless accompanied by severe asthma or anaphylaxis), morbidity associated with the condition can be significant. The presence of AR commonly exacerbates asthma, and may increase the risk of asthma attacks, emergency visits and hospitalizations.

In the U.S., the prevalence of AR has increased during the past three decades; it is recently estimated at 20% in the general adult population and closer to 40% in children. Of the estimated 60 million Americans affected with AR, approximately 20% have SAR, 40% have perennial allergic rhinitis (PAR), and 40% have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $2.7 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities, such as asthma and sinusitis, further increase AR-related treatment costs.

About QVAR®

QVAR® is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR® is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR® may reduce or eliminate the need for systemic corticosteroids.

Important Safety Information

QVAR® is not a bronchodilator and is not indicated for relief of acute bronchospasm. Common side effects associated with the use of QVAR® and placebo in clinical trials include, but are not limited to, headache (12% and 9%, respectively) and pharyngitis (8% and 4%, respectively). Caution: Adrenal insufficiency may occur when transferring patients from systemic steroids (see WARNINGS, Prescribing Information). A reduction in growth velocity in growing children and teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment.

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About Teva Respiratory

Teva Respiratory is the U.S.-based respiratory subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel® and Protonix®, the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone® (including potential generic and oral competition for Copaxone®), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").


SOURCE Teva Respiratory, a subsidiary of Teva Pharmaceutical Industries Ltd.