Firm gains two approved products, the API, ciclesonide, and three line-extension programs.

Nycomed granted Sepracor exclusive U.S. licenses to ciclesonide and two approved products containing this API. The company stands to make up to $430 million from this deal. Sepracor points out that this acquisition will complement its respiratory portfolio.

Sepracor adds two products to its portfolio: Alvesco HFA inhalation aerosol MDI (metered-dose inhaler) and Omnaris AQ nasal spray. Alvesco HFA is indicated for use in asthma patients and is expected to launch in the second half of 2008. Omnaris AQ for the treatment of allergic rhinitis has also received FDA approval and will be released in the spring, according to Sepracor.

Additionally, the company obtained development, marketing, and commercialization rights to ciclesonide, a corticosteroid that reportedly has a unique mechanism of action. Sepracor will continue development programs with Omnaris HFA MDI, a Phase II candidate; Alvesco in combination with a long-acting beta-agonist, an early clinical candidate; and Alvesco inhalation solution, a preclinical candidate.

Nycomed will receive $150 million upfront. Additionally, the firm may become entitled to subsequent payments of up to $280 million upon accomplishment of various development and sales milestones. Nycomed will also receive compensation for providing finished product and royalties on sales of ciclesonide products.

Nycomed retains all rights outside the U.S. to ciclesonide and certain line-extension and other products that Sepracor develops under this agreement.

Alvesco HFA and Omnaris AQ contain ciclesonide, which is activated into des-ciclesonide after administration. It has potent anti-inflammatory activity and a high affinity for glucocorticoid receptors. Alvesco HFA has reportedly been approved in 45 countries and introduced in 30. It has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response, according to the companies. Omnaris AQ is sanctioned for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children six years and older and with perennial allergic rhinitis in adults and adolescents 12 years and older.

Sepracor currently markets Xopenex® for the treatment of bronchospasm and Brovana as a maintenance treatment of bronchoconstriction in patients with COPD.

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