Sepracor Inc. and Nycomed announced an exclusive development, marketing and commercialization agreement for ciclesonide in the United States. Ciclesonide, Nycomed's proprietary corticosteroid, has a unique activation mechanism and is the active ingredient in Alvesco HFA (hydrofluoroalkane) Inhalation Aerosol MDI (metered-dose inhaler) for the treatment of asthma and in Omnaris AQ Nasal Spray for the treatment of allergic rhinitis. The broad ciclesonide franchise complements Sepracor's respiratory portfolio and further leverages the company's commercial infrastructure with both Omnaris AQ and Alvesco HFA projected to be launched in 2008.
Sepracor expects to launch Omnaris AQ during the 2008 spring allergy season and Alvesco HFA in the second half of 2008. Sepracor has obtained development rights to several line extensions, which have the potential to broaden the ciclesonide and current Sepracor respiratory franchises. These programmes include Omnaris HFA MDI, a phase II candidate; Alvesco inhalation solution, a preclinical candidate; and Alvesco in combination with a long-acting beta-agonist, an early clinical candidate. Nycomed will receive an upfront payment of $150 million and may become entitled to receive subsequent payments of up to $280 million over the life of the agreement upon accomplishment of various development and sales milestones. Nycomed will also receive compensation for providing finished product, and royalties on sales of ciclesonide products.
"We are delighted with this agreement, as Omnaris AQ and Alvesco HFA represent two new and exciting products for our 1,600-person sales force to launch in 2008. We are also pleased with the additional development assets that form part of this ciclesonide franchise," said Adrian Adams, president and chief executive officer of Sepracor. "The ciclesonide franchise adds further strength to our growing pipeline and is commercially synergistic with our Xopenex and Brovana franchises. I am particularly pleased that our core strategy of fully leveraging our existing products, growing our research and development pipeline and successfully delivering value-enhancing business development successes is being implemented as planned."
Nycomed retains all rights to ciclesonide outside the United States and has partnered the product with Teijin Pharmaceuticals in Japan where Alvesco HFA was launched in June 2007. Nycomed has retained rights outside the US to certain line extensions and additional products developed by Sepracor under this agreement.
"We were looking for a strategic partner both able to commercialise the products and further develop them. With Sepracor we have found that ideal partner," said Hakan Bjorklund, Nycomed's CEO. "This agreement clearly leverages the potential of ciclesonide that we believe to be one of the most innovative corticosteroids available to patients," he added.
Alvesco HFA and Omnaris AQ both contain 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. Ciclesonide and des-ciclesonide have negligible bioavailability due to low gastrointestinal absorption and first pass metabolism. In large, well-controlled clinical trials, once-daily dosing with Omnaris AQ demonstrated significant improvements in the Total Nasal Symptom Scores compared to placebo, with this effect maintained for up to one year in a long-term, daily administration study with no evidence of tolerance (loss of effect over time). Alvesco HFA, in large, well-controlled clinical trials demonstrated significant improvements in asthma control measured as morning pre-dose FEV1, which is a test of lung function, morning peak expiratory flow and reduced need for rescue albuterol compared to placebo. Additionally, patients with more severe asthma previously maintained on oral corticosteroids were able to significantly reduce their oral prednisone use.
Ciclesonide is Nycomed's proprietary corticosteroid with a unique activation mechanism. It is a prodrug that is activated by intracellular esterases following oral or nasal inhalation.
Alvesco (ciclesonide) HFA Inhalation Aerosol is a next generation inhaled corticosteroid that reduces inflammatory processes and is indicated for use in patients with asthma. Alvesco HFA has been approved in 45 countries including the U.S. and introduced in 30, with more launches expected in 2008. Alvesco HFA is based on the active ingredient, ciclesonide. Alvesco HFA has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response.
Omnaris (ciclesonide) AQ 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.
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.
Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.