Real-World Study Comparing QVAR™ to fluticasone highlights the
importance of Inhaled Corticosteroid (ICS) choice in achieving Asthma Control

- Study reveals that patients started with QVAR^TM were significantly more likely to achieve asthma control at lower doses than with fluticasone

LONDON, ON, Oct. 27 /CNW Telbec/ - Graceway Pharmaceuticals, the Canadian marketers of ^PrQVAR™ (beclomethasone dipropionate) Inhalation Aerosol, HFA, announced the publication of results from a real-life observational study of the General Practise Research Database (GPRD) published in the September issue of the Journal of Allergy and Clinical Immunology (JACI). The study, looking at more than 2000 asthma sufferers treated with QVAR™ or fluticasone in the United Kingdom for one year, revealed that those treated with QVAR™ either as initial therapy or with an increase or step-up in dose had a similar or better chance of achieving asthma control than patients who were treated with fluticasone. Asthma control was achieved in the QVAR™ population at lower doses of drug versus those in the fluticasone population. The full article is available at www.jacionline.org/inpress.

"We are pleased that these real-world results reinforce the guideline recommendations on the management of persistent asthma, that is, prescribing inhaled corticosteroid (ICS) monotherapy as a first line therapy to patients and then step-up in dose if necessary to achieve asthma control," said Erin Craven, General Manager and Vice-President of Graceway Pharmaceuticals. "Over 80% of the study patients achieved the primary measure of asthma control as defined by the study." "We were also encouraged that patients in the initiation population of the study treated with lower doses of QVAR™ achieved similar or greater control of their asthma, and this may impact the quality of life of individuals living with this condition."

The present study using the GPRD database is a rigorously conducted, real-world observational study that compared the clinical effectiveness of QVAR™ and fluticasone, 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.

About the Study

The study was designed to compare the effectiveness of QVAR™ and fluticasone, both inhaled corticosteroids, among patients taken from the General Practice Research Database (GPRD), administered as a not-for-profit database by the UK Medicines and Healthcare products Regulatory Agency.  This database is a valuable source of long-term observational data.   

Selection of patients in both the initiation and step-up groups was conducted using a retrospective matched cohort analysis based on criteria that included disease severity, therapy, and demographic characteristics. In addition, co-primary outcomes of asthma control defined as a "composite measure comprising no unplanned visit or hospitalization for asthma, use of oral corticosteroids or antibiotics for lower respiratory infection, and asthma exacerbation rate."¹ The demographic characteristics of patients included in the GPRD are considered broadly representative.

According to the study's findings, patients achieving the primary measure of asthma control were 86.0% and 82.9% in the QVAR™ and fluticasone cohorts, respectively. The study also showed patients started on QVAR® were significantly more likely to achieve asthma control at lower doses compared to fluticasone. Control at lower doses may reduce the risk of systemic effects, including adrenal suppression.  

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 fluticasone could be implemented in clinical practice moving forward.

"What is so interesting and unique about this GPRD study is that we looked at asthma sufferers in the real world, not simply as subjects in a clinical trial and the results confirmed the effectiveness of ICS in asthma and suggested that there maybe clinically meaningful differences for some patients in asthma outcomes depending on whether the individual uses QVAR or fluticasone," said David Price, Primary Care Respiratory Society professor at the University of Aberdeen Center of Academic Care and lead investigator of the study.

Previously conducted randomized controlled trials have not consistently demonstrated clinically meaningful differences in outcomes among available ICS therapy. The study, using the GPRD database, demonstrates that when two ICS agents, QVAR™ and fluticasone, with different formulations and product attributes are compared there is a clear clinical effectiveness demonstrated by QVAR™. This highlights the importance and potential value and relevance of real-world, retrospective studies in evaluating therapeutic options within a class of drugs.

About Asthma

According to the Public Health Agency, Canada has one of the highest incidences of asthma in the world. Nearly 3 million people suffer from the disease in this country.

Asthma is a chronic inflammatory disease of both the large and small airways of the lung, characterized by symptoms of wheezing (a whistling sound when you breathe), coughing, chest tightness, and shortness of breath. Asthma has no set pattern and its symptoms can vary. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and in more serious cases even death. ²

About QVAR™

QVAR™ is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. It is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR™ may reduce or eliminate the need for systemic corticosteroids. QVAR™ is not a bronchodilator and is not indicated for the relief of acute bronchospasm. To view the QVAR™ product monograph, including prescribing information, common side-effects and safety information, please visit www.gracewaypharma.ca

About Graceway Pharmaceuticals

Graceway Pharmaceuticals Canada ("Graceway Canada"), headquartered in London, Ontario is a wholly-owned subsidiary of Graceway Pharmaceuticals, LLC, based in Bristol, Tennessee. Graceway is a pharmaceutical company focused on acquiring, in-licensing and developing branded prescription pharmaceutical products. Graceway initially acquired the imiquimod franchise as part of its acquisition of 3M's (NYSE:MMM) branded pharmaceutical business in the United States, Puerto Rico, Canada and Latin America. Graceway has also recently completed acquisitions of other molecules or compounds from, among other companies, Pfizer, Inc. (NYSE:PFE) and Gilead Sciences, Inc. (NASDAQ:GILD).

Current prescription products marketed by Graceway Canada include, among others, Zyclara™ (imiquimod 3.75%) Aldara™(imiquimod 5%) Cream, QVAR™ (beclomethasone dipropionate metered dose aerosol) and other products in women's health and cardiology.

For more information on Graceway's products, please visit www.gracewaypharma.ca.   *QVAR™ is a trademark of Graceway Pharmaceuticals Canada.

The real-life observational study of the General Practice Research Database (GPRD) was sponsored by TEVA Pharmaceuticals.

References: Product Monograph, 2010.

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¹ Neil Barnes Elliot Israel Nicolas Roche Alison Chisholm Linda Kemp Journal of Allergy and Clinical Immunology ² Canada

For further information:

For additional information or to arrange a telephone interview with Professor Price and/or Erin Craven, please contact:

Daniela Pizzuto
energi PR
1-888-764-6322 ext. 235
[email protected]om