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OMNARIS(TM) Nasal Spray Now Available By Prescription for Patients With Seasonal and Perennial Allergies

Posted on: Thursday, 17 April 2008, 09:01 CDT

Sepracor Inc. (Nasdaq: SEPR) today announced that OMNARIS™ (ciclesonide) Nasal Spray is now available by prescription in pharmacies nationwide. OMNARIS Nasal Spray is indicated 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.

"We believe that OMNARIS Nasal Spray is a strategically seamless fit with our proprietary portfolio of respiratory products," said Adrian Adams, President and Chief Executive Officer of Sepracor. "Our commercial organization has had significant experience in promoting respiratory products to primary care physicians and respiratory specialists across the U.S. We believe that this experience, combined with well-established relationships with allergists, pulmonologists and primary care physicians, and our increased sales force capacity, provide a strong platform from which to launch this product."

OMNARIS Nasal Spray contains the active ingredient ciclesonide, a unique corticosteroid that is activated into des-ciclesonide after administration, which has potent anti-inflammatory activity and a high affinity for glucocorticoid receptors. In large, well-controlled clinical trials, once-daily dosing with OMNARIS Nasal Spray demonstrated significant improvements in Total Nasal Symptom Scores compared to placebo, with this effect maintained with dosing for up to one year in a long-term, safety study. Intranasal corticosteroids are well-accepted as first-line therapy for the treatment of allergic rhinitis.

"When assessing products available in the marketplace to treat patients for allergic rhinitis, prescribing physicians are always searching for treatments that are going to be safe and effective, and easy for patients to use," said Dr. Sandra Gawchik, Asthma & Allergy Associates, Upland, Pa. "When prescribing physicians are considering OMNARIS, which is a new nasal corticosteroid, there are important features that stand out in the product's profile. OMNARIS has low volume, it is administered once daily, and there's no fragrance or alcohol that may irritate a patient's nasal passages."

About Allergic Rhinitis

Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa causing sneezing, itching, nasal congestion and discharge.3A Some patients with allergic rhinitis have systemic symptoms, including weakness, malaise, irritability, fatigue, difficulty concentrating and decreased appetite.3B

Allergic rhinitis is the most common allergic disease in the U.S. affecting approximately 40 million people, specifically 10 to 30 percent of adults and up to 40 percent of children.1 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.3C

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.3C

About Ciclesonide

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

OMNARIS (ciclesonide) 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.

For additional information about OMNARIS, please visit www.omnaris.com.

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, BROVANA® brand arformoterol tartrate Inhalation Solution and OMNARIS brand ciclesonide Nasal Spray. 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 launch of OMNARIS Nasal Spray and the safety, efficacy, potential benefits, possible uses and commercial success of OMNARIS Nasal Spray. 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; unexpected delays in commercial introduction and the commercial success of OMNARIS Nasal Spray; changes in the use and/or label of OMNARIS Nasal Spray; 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/A 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

1 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.

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

3A 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.

3B 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.

3C 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.

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.

For a copy of this release or any recent release,

visit Sepracor's web site at www.sepracor.com.

Source: Business Wire

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