Sepracor Presents OMNARISâ„¢ HFA Nasal Aerosol Large-Scale Phase II Study Data at American Academy of Allergy Asthma and Immunol

Sepracor Presents OMNARISâ„¢ HFA Nasal Aerosol Large-Scale Phase II Study Data at American Academy of Allergy Asthma and Immunology (AAAAI)

  • Ciclesonide is a corticosteroid with a unique activation mechanism and is a prodrug activated by intracellular esterases following oral or nasal inhalation
  • In a large-scale Phase II study, ciclesonide delivered in an aerosol nasal formulation utilizing hydrofluoroalkane (HFA) met its primary and secondary endpoints
  • Initiation of Phase III studies is planned for OMNARIS HFA in the second half of 2008
  • OMNARISâ„¢ (ciclesonide) aqueous (AQ) Nasal Spray is on track to be launched in April 2008
  • The U.S. market for nasal corticosteroids is estimated at approximately $2.3 billion

2008 AAAAI Annual Meeting

MARLBOROUGH, Mass. -- Sepracor Inc. announced today that data from a large-scale Phase II study of ciclesonide HFA metered-dose inhaler (MDI), a nasal aerosol formulation, for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients, were presented at the AAAAI 2008 annual meeting held in Philadelphia, PA. In this study, all doses of ciclesonide HFA (75 mcg, 150 mcg and 300 mcg once-daily) met the primary efficacy endpoint and demonstrated a statistically significant reduction in 24-hour total nasal symptom scores (TNSS) versus placebo. The study also met its secondary endpoint of instantaneous TNSS improvement versus placebo. There were no clinically meaningful differences in the incidences of adverse events (epistaxis, nasal discomfort and headache) between each of the ciclesonide HFA treatment groups and placebo.

“We are encouraged by these study results and plan to initiate Phase III studies during the second half of this year,” said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. “Currently, a nasal HFA MDI formulation that delivers medication for the treatment of allergies is not available. We are excited about the prospect of this late-stage candidate and believe that patients may benefit from this new delivery system. Patients who currently use available aqueous solutions may experience run-off of medication down the back of the throat and forward nasal drip. An HFA formulation may therefore contribute to improved patient comfort and increased compliance.”

Ciclesonide HFA contains the active ingredient ciclesonide, a unique corticosteroid that is activated after administration into des-ciclesonide, which has potent anti-inflammatory activity and a high affinity for glucocorticoid receptors.

Ciclesonide is the active ingredient in both ciclesonide HFA and OMNARIS AQ Nasal Spray, a product approved by the U.S. Food and Drug Administration that is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergies. OMNARIS AQ is on track to be launched in April 2008. Intranasal corticosteroids are well accepted as first-line therapy for the treatment of allergic rhinitis.

About the Data

Poster 206 Effectiveness of Ciclesonide Nasal Aerosol in Adult and Adolescent Patients With SAR

513 adult and adolescent patients at least 12 years of age with a history of SAR were randomized in a double-blind manner to receive ciclesonide HFA nasal aerosol 75 mcg, 150 mcg, or 300 mcg or placebo once-daily for up to two weeks.
Efficacy was assessed by patient-reported average morning and evening reflective and instantaneous TNSS and patient-reported morning instantaneous TNSS. The TNSS assesses the common allergy symptoms of nasal congestion, itching, sneezing, and runny nose. The safety and tolerability of ciclesonide were also assessed in the trial.
All ciclesonide HFA doses demonstrated a statistically significantly greater reduction from baseline in 24-hour reflective TNSS versus placebo (0.64 [p = 0.011] for the 75 mcg group; 0.89 [p < 0.001] for the 150 mcg group; and 0.80 [p = 0.001] for the 300 mcg group versus placebo) on days 1 to 14.
Twenty-four hour average morning and evening instantaneous TNSS and patient-reported morning instantaneous TNSS were similarly improved for all ciclesonide treatment groups (p ≤ 0.003) versus placebo.
The incidence of treatment-related adverse events was low and was similar among all treatment groups: headache = 3.1% for placebo versus <6.5% for the ciclesonide groups; nasal discomfort (including nasal burning/stinging) = 2.3% for placebo versus <1.5% for the ciclesonide groups; and epistaxis 0% for placebo versus <0.8% for the ciclesonide groups.
About Allergic Rhinitis

Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa causing sneezing, itching, nasal congestion and discharge.2A Some patients with allergic rhinitis have systemic symptoms, including weakness, malaise, irritability, fatigue, difficulty concentrating and decreased appetite.2B

Allergic rhinitis is the most common allergic disease in the U.S. affecting about 40 million people, specifically 10 to 30 percent of adults and up to 40 percent of children.3 It is associated with direct costs of about $4.5 billion annually and indirect costs that reflect approximately four million days of lost time and productivity at work and school.4

Seasonal allergic rhinitis is caused by substances typically outdoors (i.e., pollen) that set off allergies and is sometimes referred to as “hay fever.” Symptoms may vary in occurrence and intensity during the day or from season to season. Symptoms are often worse in the morning even when the exposure occurred on the previous day.2C

Perennial allergic rhinitis is a chronic condition caused by triggers such as pet dander and dust. Symptoms of perennial allergic rhinitis are very similar to those of seasonal allergic rhinitis, although perennial is persistent and chronic.2C

About Ciclesonide

Ciclesonide is a corticosteroid with a unique activation mechanism. It is a prodrug that is activated by intracellular esterases following oral or nasal inhalation.

OMNARIS (ciclesonide) AQ Nasal Spray is the intranasal formulation of ciclesonide for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older, and with perennial allergic rhinitis in adults and adolescents 12 years of age and older. Intranasal corticosteroids are well accepted as first-line therapy for the treatment of allergic rhinitis, and they work by reducing inflammation - the major underlying cause of the clinical symptoms. Ciclesonide nasal spray was shown to have a favorable safety profile. The most frequently reported adverse events seen with ciclesonide nasal spray were headache, epistaxis, nasopharyngitis, ear pain, and pharyngolaryngeal pain. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.

About Sepracor

Sepracor Inc. 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 unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol and BROVANA® brand arformoterol tartrate Inhalation Solution. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.

Forward-Looking Statement

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the development, commercialization and distribution of products containing ciclesonide; the planning of Phase III studies of OMNARIS HFA for the second half of 2008; and the expected launch of OMNARIS AQ in April 2008. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the clinical benefits, efficacy and safety of products containing ciclesonide; the timing and success of the development of products containing ciclesonide; unexpected delays in commercial introduction and the commercial success of products containing ciclesonide; the ability of Nycomed GmbH to supply or obtain from third parties Sepracor's requirements for products or components covered by Sepracor’s exclusive distribution and development agreement with Nycomed; the success of Sepracor's alliance with Nycomed; the scope of Nycomed’s and/or Sepracor’s patents and the patents of others; the ability of Sepracor and Nycomed to attract and retain qualified personnel; and certain other factors that may affect future operating results that are detailed in Sepracor’s annual report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission.

In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.

References

1IMS Health, moving average total for nasal corticosteroids as of December 2007.

2A American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. Available from: http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 2. Page 1.

2B American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. Available from: http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 2. Page 10.

2C American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report.

http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 2. Page 12.

3 American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. Available from: http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 1. Page 1.

4 Round table discussion. The health and economic impact of rhinitis. Am J Main Care 1997; 3: S8-18. Page S11. Figure 1.

Omnaris is a trademark of Nycomed GmbH. Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc.

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