FDA Approves Sepracor's XOPENEX HFA Metered-Dose Inhaler

MARLBOROUGH, Mass., March 11 /PRNewswire-FirstCall/ -- Sepracor Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for XOPENEX HFA(TM) (levalbuterol tartrate) Inhalation Aerosol, a hydrofluoroalkane (HFA) metered- dose inhaler (MDI) for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease. Reversible obstructive airway disease includes respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD).

'We are extremely pleased that the XOPENEX HFA MDI received first-cycle approval from the FDA,' said W. James O'Shea, President and Chief Operating Officer at Sepracor. 'We are working diligently to resolve outstanding manufacturing issues and complete process validation work. It remains our target to launch XOPENEX HFA around the end of the year, during the peak asthma season. Upon launch, Sepracor's sales force, which includes approximately 1,250 sales professionals, will promote the XOPENEX HFA MDI to primary care doctors, specialists including allergists and pulmonologists, and hospitals in the U.S.'

'We are very excited about the XOPENEX HFA MDI approval as this is the second FDA approval of a Sepracor NDA in the past three months. This is the shortest FDA approval time for an HFA MDI to date and, we believe, a reflection of the quality of our MDI program and NDA,' said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. 'We expect that the XOPENEX HFA MDI will make XOPENEX available to the large number of adult and children asthmatics who prefer the convenience of an MDI as part of their therapy. This product will also allow those patients who are currently benefiting from therapy with XOPENEX(R) brand levalbuterol HCl Inhalation Solution administered by nebulization, to continue to use XOPENEX when therapy with a hand-held device is appropriate.'

The MDI development program included approximately 1,870 pediatric and adult subjects and 54 studies (preclinical and clinical). In 2003, Sepracor completed its Phase III studies of XOPENEX HFA. In each of the three, large- scale, pivotal Phase III trials that Sepracor conducted, the XOPENEX HFA MDI was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma. In the primary airway function measure, FEV1 (a test of lung function that measures the amount of air forcefully exhaled in one second), the XOPENEX HFA MDI produced statistically and clinically significant improvements relative to placebo.

Sepracor's XOPENEX MDI utilizes state-of-the-art HFA technology and does not contain a chlorofluorocarbon (CFC) propellant. MDIs are portable, hand- held devices consisting of a pressurized canister containing medication and a mouthpiece through which the medicine is inhaled. Each canister provides 200 actuations (or inhalations). Sepracor and 3M Drug Delivery Systems Division are collaborating under an agreement that includes scale-up, manufacturing and supply of the XOPENEX HFA. The collaboration combines Sepracor's short-acting beta-agonist, XOPENEX, and 3M's expertise in manufacturing MDIs, the device most commonly used by patients for the treatment of asthma and COPD.

Sepracor currently markets XOPENEX Inhalation Solution through the company's 1,250-person 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. XOPENEX Inhalation Solution is available for use in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for 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. XOPENEX Inhalation Solution revenues for the twelve months ended December 31, 2004 were approximately $319.8 million.

Approximately 90 percent of the short-acting beta-agonist inhalers sold in 2004 contained 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 would be subject to eventual removal from the marketplace. In June 2004, the FDA issued a proposed rule for the removal of the essential use exemption for albuterol, which currently permits the use of CFC-containing albuterol inhalers despite environmental concerns. Removal of this essential use exemption would prevent albuterol products containing CFC propellants, including MDIs, from being marketed in the U.S.

Currently, the U.S. short-acting bronchodilator MDI market potential at branded prices, assuming parity pricing to branded PROVENTIL(R) HFA, is approximately $1.8 billion.

Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. According to the 2002 National Health Interview Survey conducted by the Centers for Disease Control and Prevention, nearly 31 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects nearly 9 million children in the U.S. under the age of 18. Short-acting beta- agonists are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information.

Safety Information

XOPENEX HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol or any other component of XOPENEX HFA. XOPENEX HFA and other beta-agonists can produce paradoxical bronchospasm, which may be life threatening. If additional adrenergic drugs, including other short-acting sympathomimetic aerosol bronchodilators or epinephrine, are to be administered with XOPENEX HFA by any route, they should be used with caution to avoid deleterious cardiovascular effects. Due to the cardiovascular side effects associated with beta-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias and hypertension), diabetes, hyperthyroidism, or convulsive disorders. Also, see the complete prescribing information regarding potential drug interactions with beta-blockers, diuretics, digoxin, or MAOI and tricyclic antidepressants.

Please visit http://www.sepracor.com/ to access the FDA-approved labeling text, which will be posted prior to the conference call on Monday, March 14, 2005.

Sepracor will host a conference call and live webcast on Monday, March 14, 2005 beginning at 8:30 a.m. ET. To participate via telephone, dial (612) 326- 1028. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at http://www.sepracor.com/ and access the For Investors section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A replay of the call will be accessible by telephone after 12:00 p.m. ET and will be available for approximately one week. To replay the call, dial [phone], access code 773967. A replay of the webcast will be archived on the Sepracor web site in the For Investors section.

About Sepracor

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company's commercialization efforts are carried out by its U.S.-based, 1,250-person, primary care and specialty-oriented sales force. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the successful development, manufacture and commercial launch of, and the safety, efficacy and potential benefits of the XOPENEX HFA MDI and the company's other pharmaceuticals under development, and expectations with respect to collaborative agreements. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected delays in scale-up, manufacture and commercial introduction; the ability of Sepracor and 3M to collaborate successfully; Sepracor's ability to fund and the results of further clinical trials with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor's patents and the patents of others; the commercial success of Sepracor's products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor's licensees and other collaboration partners; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2004 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.

Xopenex HFA is a trademark and Xopenex is a registered trademark of Sepracor Inc. 3M is a trademark of 3M Company. Proventil is a registered trademark of Schering Corporation.

For a copy of this release or any recent release, visit http://www.prnewswire.com/comp/780960.html or http://www.sepracor.com/.

Contact: David P. Southwell Executive Vice President Chief Financial Officer Jonae R. Barnes Vice President Investor Relations Sepracor Inc. [phone]