Sepracor Inc announced the results of a large-scale, 707-patient phase-III study of Omnaris (ciclesonide) HFA, an aerosol nasal formulation of ciclesonide, for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients. In this study, Omnaris HFA met its primary efficacy endpoint by demonstrating a statistically significant reduction in the 24-hour reflective total nasal symptom score (TNSS), which assesses the common allergy symptoms of nasal congestion, itching, sneezing and runny nose, versus placebo. In addition, Omnaris HFA statistically significantly met its key secondary endpoints of improvement in the 24-hour instantaneous TNSS and the 24-hour reflective total ocular symptom score (TOSS) versus placebo. Ocular symptoms, which can include itching, tearing and redness of the eyes, can be particularly troublesome and are present in a large number of patients with SAR.

"We are very excited about these preliminary phase-III results since Omnaris HFA is a differentiated asset with the potential to become a significant growth product for Sepracor. We are developing Omnaris in a novel, HFA metered-dose device that we believe is a first-in-class delivery system for the treatment of allergic rhinitis," said Adrian Adams, president and chief executive officer of Sepracor. "This late-stage clinical candidate represents another planned step forward in our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline towards creating shareholder value over time."

Omnaris HFA and Omnaris Nasal Spray both represent a potential improvement in delivery systems that may be able to reduce post-nasal drip and back-of-the-throat run-off associated with some intranasal aqueous-based corticosteroids for the treatment of allergic rhinitis. The HFA device is designed to deliver a fine, dry mist of medication, administered by a metered-dose device, to a patient's nose. The Allergies in America Survey, published in 2006, reports that approximately 33 per cent of respondents find 'dripping down the throat' to be moderately or extremely bothersome, and approximately 25 per cent of respondents have discontinued use of a nasal allergy prescription due to bothersome side effects.

Ciclesonide is the active ingredient in Omnaris HFA as well as Omnaris Nasal Spray, which is a product approved by the US Food and Drug Administration (FDA) that is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. Sepracor launched Omnaris Nasal Spray in April 2008. Intranasal corticosteroids, such as Omnaris Nasal Spray, are well accepted as first-line therapy for the treatment of allergic rhinitis. Ciclesonide is developed, marketed and commercialized by Sepracor in the US under an exclusive distribution agreement with Nycomed GmbH.

"We are encouraged by these study results and plan to initiate a phase-III perennial allergic rhinitis study this year," said Mark H N Corrigan, executive vice president, Research and Development at Sepracor. "HFA formulations that deliver medication for the treatment of nasal allergies are currently not available. We are excited about the potential for Omnaris HFA and believe that patients may benefit from this new delivery system. When chlorofluorocarbon (CFC) nasal sprays for allergic rhinitis were available, they constituted an important treatment option for patients and physicians, and an HFA formulation could therefore contribute to improved patient comfort and increased compliance."

In accordance with the provisions of the Montreal Protocol on Substances that Deplete the Ozone Layer, and codified by the United States Congress into law in Title VI of the Clean Air Act, the production, importation, and consumption of CFCs used in aerosol-spray propellants in products for the treatment of allergic rhinitis in the US were banned as of January 1, 1996.

Sepracor is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving large and growing markets and unmet medical needs.