Schering-Plough Corporation Announces Global Agreement With Novartis AG To Develop Once-Daily Combination Therapy For Asthma And COPD
Schering-Plough's once daily inhaled corticosteroid mometasone, the active ingredient in ASMANEX® and Novartis' once daily beta2-agonist indacaterol (QAB149) will be combined in a single inhalation device. The combined product, with once-daily dosing, has the potential to offer patient benefits including enhanced disease control and convenience.
"Today's announcement represents another action we are taking to strengthen our respiratory franchise and increase our value to health care providers and patients," said Fred Hassan, Schering-Plough chairman and CEO. "This agreement brings together proven and promising therapeutic agents for asthma and COPD, as well as the strong technological and marketing expertise of two global pharmaceutical companies," he added. ASMANEX® is the only inhaled asthma controller therapy approved in the United States for once-daily initiation and management of asthma in patients previously treated with bronchodilators alone or inhaled corticosteroids.
"Asthma and COPD patients often have to use more than one treatment and are looking for new, effective and easier ways to control their symptoms," said Robert J. Spiegel, M.D., Chief Medical Officer and senior vice president, Schering-Plough Research Institute. "The combination of mometasone and indacaterol has the potential to enhance current therapy and help improve the quality of life for patients."
Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the fastest-growing segment of the worldwide asthma market. Under the agreement, the parties will share development costs, and there will be no initial payments by either party. The companies will co-promote the combination therapy worldwide.
The development plans for the combination therapy are foreseen to include using Schering-Plough's TWISTHALER® delivery device among other inhalers. The TWISTHALER is an easy-to-use, inhalation-driven device that operates without a propellant, thus eliminating the need for hand-breath coordination. The TWISTHALER device, recipient of the DuPont Award for innovation in packaging, includes a numeric dose counter that provides patients with a visual indication of the remaining doses. Schering-Plough will receive royalties and other compensation for the TWISTHALER device if the combination therapy is commercialized in this device.
The joint development and commercialization of mometasone and indacaterol is the latest example of the long-term collaboration between the two companies. In April 2003, Schering-Plough and Novartis announced an agreement for the joint worldwide development and marketing of a new combination treatment of the active ingredients in Schering-Plough's ASMANEX and Novartis' Foradil® (formoterol fumarate). This combination therapy is entering Phase III development for the treatment of asthma and COPD.
About asthma and COPD
Asthma is a chronic inflammatory lung disease that affects 300 million people worldwide, with an estimated 15 million suffering from a severe form of the disease.(1) Their health and quality of daily life are often severely affected, and more than 180,000 people die from asthma each year throughout the world.(2)
COPD, the world's fourth largest cause of death, is an irreversible and chronic obstruction of the airways, which is caused primarily by smoking. It is estimated that the disease is prevalent in 4 percent of the population in the USA, Europe and Japan, and that at least one in 15 smokers suffers from COPD. COPD progresses slowly and eventually leads to a largely irreversible loss of lung function.
The worldwide respiratory market for therapies to treat asthma and COPD was estimated at approximately $15 billion in 2005 and is expected to grow to $22 billion by 2015.(3)
About ASMANEX
ASMANEX is an inhaled corticosteroid used as first-line maintenance treatment of asthma. ASMANEX is approved for once-daily dosing in the evening and became available nationwide in the United States in August 2005. Clinical studies have shown ASMANEX to provide significant improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings, and significant improvements in daytime symptoms such as coughing and wheezing.
Indications
ASMANEX® TWISTHALER® 220 mcg (mometasone furoate inhalation powder) is for the maintenance treatment of asthma for patients 12 years of age and older. ASMANEX TWISTHALER is also for asthma patients who are taking oral steroids where it may reduce or eliminate the need for oral steroids. ASMANEX TWISTHALER will not relieve sudden asthma symptoms.
Important safety information: * The most common side effects with ASMANEX TWISTHALER include headache, allergic rhinitis, sore throat, and upper respiratory infection. * ASMANEX TWISTHALER therapy should not be used to treat acute asthma episodes where extra measures are required. * Be careful while adjusting to a switch from an oral steroid to the inhaled steroid Asmanex, as you may be less able to heal after surgery, infection or serious injury. * Use ASMANEX as directed by your health care provider, since its ability to work in your lungs depends on regular use. If your asthma symptoms do not improve, or seem worse, contact your health care provider. * Avoid coming into contact with the measles or chickenpox virus. Contact your health care provider immediately if you are exposed; * If you are at an increased risk for decreased bone mineral density, the use of corticosteroids may increase your risk. Your health care provider should monitor your condition and, if needed, provide treatment. * Long-term use of inhaled corticosteroids, such as Asmanex, may increase the risk of some eye problems such as cataracts or glaucoma.
About Schering-Plough Respiratory Products Schering-Plough has been a leader in the U.S. respiratory arena for more than 50 years, beginning with such products as CHLOR-TRIMETON and CORICIDIN, first introduced as prescription products in the late 1940s and now well-established over-the-counter (OTC) brands. Respiratory products include PROVENTIL HFA, the first HFA-propelled albuterol MDI, and the first non-sedating antihistamine CLARITIN (loratadine). Today, NASONEX (mometasone furoate monohydrate) and the CLARINEX (desloratadine) family of nonsedating prescription antihistamines (marketed in Europe under the trade names AERIUS(TM) and NEOCLARITYN(TM)) provide physicians and patients with a variety of treatment options. Schering-Plough continues to make available in the U.S. FORADIL AEROLIZER, a long-acting beta2 agonist for asthma and chronic obstructive pulmonary disease.
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the development and potential market for combination products including ASMANEX and the TWISTHALER device. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward- looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A Risk Factors, in the Company's second quarter 10-Q.
References: 1. The Global Initiative for Asthma: The Global Burden of Asthma Report 2004. 2. World Health Organization 3. Market evaluation based on IMS data.
Source: Schering-Plough Corporation