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SEPRACORE REPORTS NET INCOME OF $11.3 MIL FOR 2ND QTR 2006.

Biotech Financial Reports • Sept 1, 2006 •
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Sepracor Inc. (Nasdaq: SEPR), Marlborough, Mass., has announced its consolidated financial results for the second quarter of 2006. For the three months ended June 30, 2006, Sepracor's consolidated revenues were $264.4 million, of which revenues from pharmaceutical product sales were $256.4 million (XOPENEX(R) brand levalbuterol franchise revenues were $117.3 million and LUNESTA(TM) brand eszopiclone revenues were $139.1 million). Net income for the second quarter of 2006 was approximately $11.3 million, or $0.10 per diluted share. Reported results for the second quarter of 2006 included charges of $10.6 million, or $0.09 per diluted share, for stock-based compensation due to Sepracor's adoption in January 2006 of Statement of Financial Accounting Standards or SFAS No. 123R. These consolidated results compare with consolidated revenues of $185.1 million, of which revenues from pharmaceutical product sales were $166.7 million ($83.2 million for sales of XOPENEX(R) brand levalbuterol and $83.5 million for sales of LUNESTA), and a net loss of $7.4 million, or $0.07 per share, for the three months ended June 30, 2005.

For the six months ended June 30, 2006, Sepracor's consolidated revenues were $550.1 million, of which revenues from pharmaceutical product sales were $533.9 million (XOPENEX franchise revenues were $256.7 million and LUNESTA revenues were $277.2 million). Net income for the first six months of 2006 was approximately $21.5 million, or $0.19 per diluted share. Reported results for the first six months of 2006 included charges of $20.4 million, or $0.18 per diluted share, for stock-based compensation due to Sepracor's adoption of SFAS No. 123R. These consolidated results compare with consolidated revenues of $304.1 million, of which revenues from pharmaceutical product sales were $273.4 million ($189.9 million for sales of XOPENEX franchise products and $83.5 million for sales of LUNESTA), and a net loss of $30.0 million, or $0.29 per share, for the six months ended June 30, 2005.

As of June 30, 2006, Sepracor had approximately $944.5 million in cash and short- and long-term investments.

Commercial Operations

LUNESTA brand eszopiclone - During the second quarter of 2006, Sepracor announced the publication of results of a study in which LUNESTA was administered to patients with insomnia and co-existing major depressive disorder. The Phase IIIB/IV, 545-patient study was published in the June issue of Biological Psychiatry.

Data from LUNESTA Phase IIIB/IV studies were also presented at the American Psychiatric Association annual meeting and the SLEEP 2006 20th Anniversary Meeting of the Associated Professional Sleep Societies in May and June. The presentations included results from the following studies conducted by Sepracor:

-- The second long-term, placebo-controlled study examining the safety and efficacy of LUNESTA for six months of nightly use in patients with primary insomnia;

-- A study in which LUNESTA was administered to patients with insomnia and co-existing major depressive disorder;

-- A study in which LUNESTA was administered to patients with insomnia and co-existing rheumatoid arthritis;

-- A study in which LUNESTA was administered to patients with insomnia and co-existing perimenopause/menopause symptoms; and

-- The Regimen of Eszopiclone Sleep Satisfaction Trial (RESST), a patient satisfaction study.

In addition, Sepracor completed two driving studies of similar design (randomized, double-blind, placebo-controlled crossover studies) for LUNESTA. In July 2006, the results of a study which looked at the effects of a single evening dose of 3 mg LUNESTA on next-day driving ability and psychomotor/memory function in healthy volunteers compared to placebo were presented at the Collegium Internationale Neuro-Psychopharmacologicum 25th Biennial Congress. The primary objective of this study was to assess next-day, on-the-road brake reaction time (BRT) in subjects administered either LUNESTA 3 mg or placebo the evening before. The study was conducted in 31 healthy adult volunteers. In this study, there was no statistically significant difference in the primary endpoint of on-the-road BRT following nighttime administration of LUNESTA 3 mg compared with placebo. BRT is a test sensitive to the effects psychotropic drugs (drugs that act on the central nervous system) and provides results consistent with laboratory measures of psychomotor performance.

During the second quarter of 2006, Sepracor completed a second driving study that examined the effects of a single evening dose of 3 mg LUNESTA on next-day driving ability and psychomotor/memory function in patients with primary insomnia compared to placebo. Preliminary analysis of the results of the second driving study confirm the next-day, on-the-road BRT results of the first driving study.

The results of the above-mentioned driving studies are consistent with and supportive of the multiple other studies assessing next-day residual effects that are discussed in some detail in the current LUNESTA prescribing information.

Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. The recommended dosing for LUNESTA to improve sleep onset and/or maintenance is 2 mg or 3 mg for adult patients (ages 18 to 64). In older adult patients (ages 65 and older), 2 mg is recommended for improving sleep onset and/or maintenance, while the 1 mg dose is recommended for improving sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

XOPENEX(R) brand levalbuterol HCl Inhalation Solution - Marketed through Sepracor's sales force, XOPENEX Inhalation Solution is a short-acting bronchodilator indicated for the treatment or prevention of bronchospasm in patients 6 years of age and older with reversible obstructive airway disease, such as asthma. XOPENEX is available for use in a nebulizer, which is a machine that converts liquid medication into a fine mist that is inhaled through a mask, at 0.31 mg and 0.63 mg dosage strengths for routine treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12 years of age and older. Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. According to the American Lung Association, approximately 26 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects approximately 8.6 million children in the U.S. under the age of 18 . XOPENEX HFA(TM) (levalbuterol tartrate) MDI - XOPENEX HFA is a hydrofluoroalkane (HFA) metered-dose inhaler (MDI), which is a portable, hand-held device consisting of a pressurized canister containing medication and a mouthpiece through which the medication is inhaled. Indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease, XOPENEX HFA complements the XOPENEX Inhalation Solution product line and provides patients with a portable means of administering XOPENEX.

Approximately 95 percent of short-acting beta-agonist inhalers sold in 2005 contained chlorofluorocarbon (CFC) propellants, according to IMS Health information. Under provisions in the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement that requires the phase-out of substances that deplete the ozone layer, MDIs containing CFC propellants qualify for removal from the marketplace. In March 2005, the U.S. Food and Drug Administration (FDA) issued its final rule for removal of the essential use exemption for albuterol, which currently permits use of CFC-containing albuterol inhalers despite environmental concerns. Under the rule, all production and sales of albuterol CFC MDIs in the U.S. are required to cease by the end of 2008. The XOPENEX MDI uses an HFA propellant and does not contain CFCs. Currently, the U.S. short-acting bronchodilator MDI market potential, at XOPENEX HFA branded prices, is approximately $2.9 billion.

Sepracor Pipeline Progress

Arformoterol New Drug Application Under FDA Review

A New Drug Application (NDA) for arformoterol tartrate inhalation solution remains under review at the FDA. The NDA for arformoterol tartrate was submitted to the FDA in December 2005 and was accepted for filing by the FDA in February 2006. Arformoterol tartrate is a long-acting beta-agonist formulation, submitted for approval for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Arformoterol, a single isomer of formoterol, is the first long-acting bronchodilator to be developed in an inhalation solution for use with a nebulizer; other long-acting bronchodilators currently available are formulated in dry-powder inhalers.

The Prescription Drug User Fee Act (PDUFA) date for arformoterol is October 12, 2006. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission.

Sepracor completed more than 100 preclinical and 16 clinical studies of arformoterol involving more than 2,000 patients. Among the clinical studies conducted were two 12-week pivotal studies, each with more than 700 patients, as well as a large-scale, 12-month safety study. In Phase III studies, patients treated with arformoterol demonstrated a statistically significant improvement in FEV(1), which is a test of lung function, versus those patients administered placebo.


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