Sepracor Inc. announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Xopenex HFA (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 US"

"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 HN Corrigan, MD, 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 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 paediatric 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 per cent 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 US.

Currently, the U.S. short-acting bronchodilator MDI market potential at branded prices, assuming parity pricing to branded Proventil 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 paediatricians in the US, according to IMS Health information.