QVAR® Versus Fluticasone in a Real-World Study Highlights the Importance of Inhaled Corticosteroid (ICS) Choice in Achieving Asthma Control

HORSHAM, Pa., Sept. 8 /PRNewswire/ -- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced the publication of results from a real-life observational study of the General Practice Research Database (GPRD), which revealed that asthma patients treated with QVAR® (beclomethasone dipropionate HFA), either as initial therapy or with an increase (step up) in dose, had a similar or better chance of achieving asthma control as patients who were treated with fluticasone propionate (Flovent®). Asthma control was achieved in the QVAR population at lower doses of drug versus those in the Flovent population. These results were published in the September issue of the Journal of Allergy and Clinical Immunology (JACI) and are available at www.jacionline.org/inpress.

"The results of Teva's most recent study using the GPRD database reinforce the effectiveness of ICS monotherapy in achieving asthma control for most patients who either initiate ICS therapy or who are already on an ICS and need a step up in dose," said Paul Dorinsky, MD, Vice President, Teva Global Respiratory Research and Development. "In fact, over 85% of the study patients achieved the primary measure of asthma control as defined by the study. The GPRD findings are timely given the recent FDA guidance advocating limited use of products containing long-acting beta-agonists (LABAs), including LABA-plus-ICS combination products, while recommending more aggressive treatment with monotherapy ICS agents. We are also encouraged that patients in the initiation population of the study treated with QVAR achieved better asthma control at lower prescribed doses of drug, as a key goal of asthma management is to use the lowest dose needed to achieve overall asthma control and prevent exacerbations. In the step up population, patients receiving QVAR had a similar chance of achieving asthma control at lower prescribed doses than with Flovent. In both populations, the rate of exacerbations was not significantly different between the QVAR and Flovent patient groups."

Historically, the choice of ICS has been driven by a number of criteria, including cost and convenience. Less emphasis has been placed on therapeutic index, as no randomized controlled trials have consistently demonstrated clinically meaningful differences in outcomes among available ICS options.  The present study using the GPRD database is a rigorously conducted, real-world observational study that compared the clinical effectiveness of QVAR and Flovent^®, two ICS agents that have different formulations and product attributes. This highlights the importance and potential value/relevance of real-world, retrospective studies in evaluating therapeutic options within a class of drugs.

"Retrospective studies like the GPRD study provide real-life evidence that indicates there may be clinically meaningful differences in asthma outcomes, depending on which ICS agent is used," said David Price, Primary Care Respiratory Society professor of primary care respiratory medicine, University of Aberdeen Center of Academic Care and lead investigator of the study. "QVAR's smaller particle size combined with its delivery system allows it to be distributed throughout the entire lung, where it reaches and treats the inflammation in the large and small airways associated with asthma. The benefits demonstrated by QVAR in this study may be associated with the product's ability to treat both the large and small airways."

As governments, patients and physicians continue their search for medicines that are efficacious, safe and cost-effective, the GPRD findings have important implications as to how QVAR and Flovent^® could be implemented in clinical practice moving forward.

About the Study

The objective of this retrospective, observational study was to compare asthma-related outcomes over 1 year as recorded in a primary care database for patients aged 5-60 years receiving a first prescription (initiation population) or dose increase (step-up population) of hydrofluoroalkane HFA-beclomethasone (QVAR®) or fluticasone (HFA or CFC formulation) delivered by metered-dose inhaler (MDI). Patients in both the initiation and step-up groups were selected using a matched cohort analysis that matched patients based on baseline disease severity, therapy, and demographic characteristics. Co-primary outcomes were asthma control (a composite measure comprising no unplanned visit or hospitalization for asthma, oral corticosteroids, or antibiotics for lower respiratory infection) and exacerbation rate.

About GPRD

The General Practice Research Database (GPRD) is a large, well-maintained database, administered as a not-for-profit by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency that contains deidentified longitudinal medical records from approximately 500 primary care practices in the UK. Patient records in the GPRD total 13 million; and active records number 3.6 million, equivalent to 5.5% of the UK population. The demographic characteristics of patients included in the GPRD are considered broadly representative.

The GPRD is the largest and most comprehensive source of data of its kind and is used worldwide for research by the pharmaceutical industry, clinical research organizations, regulators, government departments and leading academic institutions.

About Asthma

Asthma is a chronic (long-term) disease of inflammation of both the large and small airways of the lung, characterized by symptoms of wheezing and coughing. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and even death.

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^® does not replace fast-acting (rescue) inhalers for sudden symptoms.

If you are switching from an oral corticosteroid to QVAR^®, follow your doctor's instructions to avoid health risks when you stop using oral corticosteroids.

Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult growth is unknown.

In clinical studies, common side effects included headache and pharyngitis.

Do not stop taking QVAR^® abruptly without talking to your doctor.

QVAR^® is a registered trademark of IVAX LLC, a member of the TEVA Group.

For full Prescribing Information, please click here: http://www.qvar.com/Document/PrescribingInformation.pdf.

About Teva

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), 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®, Protonix® and Yaz®, 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 (including the acquisition of ratiopharm), 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").

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