Healthcare Industry News: OMNARIS
News Release - January 28, 2008
Sepracor Acquires Exclusive U.S. Rights to Nycomed's ALVESCO(R) HFA and OMNARIS(TM) AQ Products as Well as Ciclesonide PipelineCiclesonide is the active ingredient in ALVESCO HFA Inhalation Aerosol for asthma and OMNARIS AQ Nasal Spray for allergic rhinitis
ALVESCO HFA and OMNARIS AQ are FDA-approved and scheduled for launch in 2008
Agreement expands Sepracor's pipeline by inclusion of OMNARIS HFA, ALVESCO inhalation solution and ALVESCO in combination with a long-acting beta-agonist
The U.S. market for inhaled corticosteroids is estimated at approximately $1.2 billion(1)
The U.S. market for nasal corticosteroids is estimated at approximately $2.4 billion(2)
MARLBOROUGH, Mass. & ZURICH, Switzerland--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) and Nycomed today 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 programs 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 U.S. 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 Håkan Björklund, 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.
About Ciclesonide, ALVESCO HFA and OMNARIS AQ
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.
Inhaled corticosteroids are well accepted as first-line asthma and allergic rhinitis therapy. They inhibit the activity of pro-inflammatory cells and promote the endogenous production of anti-inflammatory substances. With regular use of these corticosteroids, the inflammation in the lungs and airways that underlies asthma is attenuated.
In clinical trials, ALVESCO HFA was generally well tolerated. The most common adverse reactions (>3%) were headache, nasopharyngitis, sinusitis, pharyngolarynegeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in the extremities and back pain.
Treatment with orally inhaled corticosteroids may lead to signs or symptoms of hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function and/or suppression of growth in children. Glaucoma, increased intraocular pressure and cataracts have been reported following the administration of inhaled corticosteroids.
ALVESCO (ciclesonide) HFA Inhalation Aerosol is an orally inhaled corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. ALVESCO is not indicated for the relief of acute bronchospasm.
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. Ciclesonide nasal spray was shown to have a favorable safety profile. The most frequently reported adverse events seen with ciclesonide nasal spray were headache, epistaxis, nasopharyngitis, ear pain, and pharyngolaryngeal pain. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.
Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa causing sneezing, itching, nasal congestion and discharge. Seasonal allergic rhinitis is caused by substances that trigger allergies and is sometimes referred to as “hay fever.” Perennial allergic rhinitis is a chronic condition caused by triggers such as pet dander and dust. The result of poorly controlled allergies can result in impairments in day-to-day activities as well as a reduction in a patient’s quality of life. According to the American Academy of Allergy, Asthma, and Immunology, more than 40 million Americans are currently estimated to suffer with allergic diseases, and allergies are the sixth leading cause of chronic disease in the United States.
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. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol and BROVANA® brand arformoterol tartrate Inhalation Solution. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.
The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from the company’s own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region, Nycomed has a presence in about 50 markets worldwide.
Privately owned, the combined group had annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).
For more information visit www.nycomed.com.
Sepracor Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the development, commercialization and distribution of products containing ciclesonide; the expected launch of OMNARIS AQ during the 2008 spring allergy season and plans to launch ALVESCO HFA in the second half of 2008; the supply of finished product by Nycomed; Sepracor’s future pipeline; and future payments by Sepracor to Nycomed. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the clinical benefits, efficacy and safety of products containing ciclesonide; the timing and success of the development of products containing ciclesonide; unexpected delays in commercial introduction and the commercial success of products containing ciclesonide; Nycomed's ability to supply or obtain from third parties Sepracor's requirements for products or components covered by the agreement with Nycomed; the success of Sepracor's alliance with Nycomed; the scope of Nycomed’s and/or Sepracor’s patents and the patents of others; the ability of Sepracor and Nycomed to attract and retain qualified personnel; and certain other factors that may affect future operating results that are detailed in Sepracor’s quarterly report on Form 10-Q for the quarter ended September 30, 2007 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.
1. IMS Health, moving average total for inhaled corticosteroids as of November 2007.
2. IMS Health, moving average total for nasal corticosteroids as of November 2007.
OMNARIS is a trademark and Alvesco is a registered trademark of Nycomed GmbH. Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc.
For a copy of this release or any recent release, visit Sepracor’s web site at www.sepracor.com.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.