Schering-Plough Assumes Exclusive Worldwide Marketing Rights for Mometasone Furoate/Formoterol Combination for Asthma and COPD
KENILWORTH, N.J., May 19 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced changes to its global collaboration with Novartis for the development and commercialization of fixed-dose combination therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The changes will result in Schering-Plough assuming exclusive worldwide rights to develop and commercialize a fixed-dose combination of its inhaled corticosteroid ASMANEX(R) (mometasone furoate inhalation powder), and Novartis' long-acting beta2-adrenergic receptor agonist, FORADIL(R) (formoterol fumarate). Also as a result, Novartis will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of Schering-Plough's inhaled corticosteroid mometasone furoate with its investigational beta2-agonist QAB149 (indacaterol).
"Schering-Plough has a long history in developing therapies for treating respiratory diseases. This strategic action will allow us to focus our efforts within the asthma and COPD market," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "The investigational fixed-dose combination of ASMANEX and FORADIL, both of which are currently approved and marketed as individual products, is in Phase III development for the treatment of asthma and COPD. Schering-Plough anticipates filing the mometasone furoate/formoterol combination for the treatment of asthma with the Food and Drug Administration in the first half of 2009," added Koestler.
This is the latest development in a successful long-term relationship between Novartis and Schering-Plough which dates back to 2002. The collaboration was expanded in August 2006 to include the joint development and commercialization of a fixed-dose combination of indacaterol and mometasone furoate. The collaboration has completed the mometasone furoate/formoterol combination's phase II (asthma, COPD) and phase III (asthma) development, while phase III (COPD) continues. Meanwhile, the indacaterol/mometasone combination is in phase II development (asthma, COPD).
Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and COPD medications, in terms of dollar sales.(1)
Under the revised agreements, Schering-Plough will assume the remaining development and commercialization costs of the mometasone furoate/formoterol fixed-combination product which will utilize a meter-dose inhaler device while Novartis will assume the remaining development and future commercialization costs of the indacaterol/mometasone furoate combination including the Schering-Plough TWISTHALER(R) multi-dose dry powder inhaler device. There will be a royalty sharing arrangement based on sales. Schering-Plough will recognize sales worldwide for mometasone furoate/formoterol upon commercialization. In addition, Schering-Plough will receive royalties and other compensation for Novartis' use of the Schering-Plough TWISTHALER device.
This transaction is subject to approval in accordance with the Hart-Scott-Rodino Act.
Background on Schering-Plough and Novartis respiratory collaborations
In October 2002, Schering-Plough and Novartis announced an agreement giving Schering-Plough exclusive U.S. distribution and marketing rights to Novartis' FORADIL AEROLIZER(R). In April 2003, the two companies 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.
In August 2006, Schering-Plough and Novartis announced an agreement for the joint worldwide development and commercialization of a fixed-dose combination treatment containing Schering-Plough's mometasone furoate and Novartis' indacaterol. Indacaterol is currently under regulatory review in the U.S. and European Union.
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.(2) 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.(3)
COPD, the world's fourth most common 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.
ASMANEX is approved for the maintenance treatment of asthma in patients 4 years of age and older. ASMANEX will not relieve sudden asthma symptoms and is not for children less than 4 years of age.
In the U.S., it is available in two dose strengths, 110 mcg for children between 4 and 11 years old, and 220 mcg for patients 12 and older.
Important Safety Information
ASMANEX is not a rescue inhaler and should not be used to treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma symptoms.
ASMANEX should not be used to treat acute asthma episodes (including status asthmaticus) where extra measures are required.
ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone or any of the ingredients in ASMANEX. There have been cases of hypersensitivity, allergic reactions, facial swelling, hives, and throat tightness reported.
Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX.
It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider as the dosage of ASMANEX should be reduced slowly.
If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.
Avoid coming in contact with measles, chicken pox virus, tuberculosis, or any other infections before or while using ASMANEX. Contact your health care provider immediately if you or your child have been exposed.
Patients who use inhaled steroids, including ASMANEX, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.
Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms.
ASMANEX may increase the risk of some eye problems such as cataracts, glaucoma, and increased intraocular pressure. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
Use ASMANEX as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.
The most common side effects with ASMANEX in patients 4-11 years old include fever, allergic rhinitis, abdominal pain, vomiting, urinary tract infection, and bruise.
The most common side effects with ASMANEX in patients 12 years of age and older include headache, allergic rhinitis, sore throat, and upper respiratory infection.
About FORADIL AEROLIZER
FORADIL AEROLIZER is for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. FORADIL AEROLIZER is for the maintenance treatment of asthma in those 5 years and older when taken on a long-term, twice-daily basis. FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.
FORADIL AEROLIZER is not indicated for patients whose asthma can be managed by occasional use of fast-acting rescue inhalers.
FORADIL AEROLIZER is also for the acute prevention of exercise-induced bronchospasm (EIB) in those 5 years of age and older when administered on an occasional, as-needed basis at least 15 minutes before exercise.
Important Safety Information
FORADIL belongs to a class of medications known as long-acting beta2-adrenergic agonists or LABAs. In patients with asthma, LABAs may increase the chance of asthma related death. Therefore, FORADIL should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.
In COPD clinical trials, the most common adverse events reported with FORADIL AEROLIZER were upper respiratory infection, back pain, and sore throat.
In asthma clinical trials, the most common adverse events reported with FORADIL AEROLIZER were viral infection, bronchitis, and chest infection.
FORADIL capsules should only be inhaled orally using the AEROLIZER inhaler. The capsules should not be swallowed.
FORADIL AEROLIZER should not be used to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Do not use more than one capsule twice daily. FORADIL AEROLIZER should be used with caution in patients with cardiovascular disorders. FORADIL AEROLIZER is not a substitute for inhaled or oral corticosteroids and, in the treatment of asthma, they should not be stopped or reduced at the time FORADIL AEROLIZER is initiated.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see additional important product information.
About Schering-Plough Corporation
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is 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 Part II, Item 1A "Risk Factors" in the Company's first quarter 2009 10-Q, filed May 1, 2009.
|SOURCE Schering-Plough Corporation|
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