Schering-Plough Announces Two European Filings
KENILWORTH, N.J., Aug. 26 /PRNewswire-FirstCall/ — Schering-Plough Corporation, (NYSE: SGP), today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company’s Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older. The company also announced today that the EMEA has validated the MAA for nomegestrol acetate (2.5 mg) / 17 beta-estradiol (1.5mg), a combined oral contraceptive (COC) containing a unique combination of a natural estrogen identical to the estrogen produced by a woman’s own body and a selective progestin.
Mometasone furoate/formoterol fumarate combines mometasone furoate, the active ingredient of the inhaled corticosteroid, ASMANEX(R), with formoterol fumarate, the active ingredient of the long-acting beta2-agonist, FORADIL(R), administered via a single metered-dose inhaler.
Marketing approval from the EMEA is being sought for nomegestrol acetate/17 beta-estradiol as an oral treatment for women to prevent pregnancy.
Both applications will follow the Centralized Procedure.
“These two regulatory milestones are important steps toward advancing our late-stage pipeline and meeting patient needs. If approved by the EMEA, the mometasone furoate/formoterol fumarate combination would represent an important additional treatment option for physicians and their patients and further strengthen Schering-Plough’s portfolio of respiratory products,” said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. “Schering-Plough is also committed to providing women a variety of birth control options to meet diverse lifestyle needs and choices.”
About the Investigational Mometasone Furoate and Formoterol Fumarate Combination
Schering-Plough has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol fumarate fixed-dose combination. In the United States, a New Drug Application (NDA) for the fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older is currently under review by the U.S. Food and Drug Administration (FDA).
Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and chronic obstructive pulmonary disease (COPD) medications, in terms of dollar sales.(1) The fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma in patients younger than 12 years of age and for use in COPD is currently in Phase III development.
About Nomegestrol Acetate/17 beta-estradiol
Nomegestrol acetate/17 beta-estradiol is a combined oral contraceptive in a monophasic dosing regimen. The progestin (nomegestrol acetate) is derived from, and structurally similar to, the naturally occurring steroid hormone progesterone, while 17 beta-estradiol, a natural estrogen is identical to the endogenous estrogen a woman’s body produces on its own. If approved, this unique monophasic combination of a progestin and natural estrogen can offer women effective pregnancy prevention.
In clinical trials with nomegestrol acetate/17 beta-estradiol, commonly reported in-treatment adverse events included acne, weight increase, headache and irregular withdrawal bleeding.
Nomegestrol acetate/17 beta-estradiol is licensed from Theramex, S.A.M., an affiliate of Merck KGaA, Darmstadt, Germany. Theramex has retained rights for marketing and distribution of the product in certain countries. In Europe, the filing was made by Merck Serono, the division for innovative pharmaceuticals of Merck KGaA, Darmstadt, Germany. In the U.S., Schering-Plough is working with the FDA and anticipates filing nomegestrol acetate/17 beta-estradiol in 2010.
Asthma is a chronic lung disease characterised by inflammation of the air passages, resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.(2) Asthma symptoms can be triggered by allergens or irritants and can include difficulty breathing, wheezing, coughing, shortness of breath and tightness in the chest.(2)
There are approximately 30 million people living with asthma in Europe, with as many as six million suffering from severe symptoms. With asthma affecting as many as 300 million people worldwide, it is now one of the world’s most common long-term conditions and its prevalence is estimated to increase by a further 100 million by 2025. It is also estimated that asthma accounts for about 1 in every 250 deaths worldwide, many of which are preventable.(3) There is no cure for asthma, but asthma can be managed with proper treatment.(2)
Important Information about ASMANEX(R) TWISTHALER(R) in the U.S.
ASMANEX(R) TWISTHALER(R) (mometasone furoate inhalation powder) is approved in the U.S. for the maintenance treatment of asthma in patients 4 years of age and older. ASMANEX TWISTHALER will not relieve sudden asthma symptoms and is not for children under the age of 4.
ASMANEX TWISTHALER is available in two dose strengths in the U.S., 110 mcg for children between 4 and 11 years old, and 220 mcg for patients 12 and older.
ASMANEX has not been demonstrated to be effective in treating asthma symptoms caused by specific asthma triggers.
Important Safety Information for ASMANEX(R) TWISTHALER(R)
ASMANEX(R) TWISTHALER(R) 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 greater than or equal to 12 years old include headache, allergic rhinitis, sore throat, and upper respiratory infection.
Please see additional important product information for ASMANEX TWISTHALER.
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.
Important Information About FORADIL(R) AEROLIZER(R) in the U.S.
FORADIL(R) AEROLIZER(R) 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.
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 is not marketed by Schering-Plough in the European Union.
Important Safety Information for FORADIL(R) AEROLIZER(R) in the U.S.
FORADIL(R) 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 asthma clinical trials, the most common adverse events reported with FORADIL AEROLIZER were viral infection, bronchitis, and chest infection.
In COPD clinical trials, the most common adverse events reported with FORADIL AEROLIZER were upper respiratory infection, back pain, and sore throat.
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 for FORADIL AEROLIZER.
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 and consumer products as well as to animal health 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 Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for investigational mometasone furoate/formoterol fumarate MDI and nomegestrol acetate/17 beta-estradiol. 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 the regulatory process for approval of investigational mometasone furoate/formoterol fumarate MDI and nomegestrol acetate/17 beta-estradiol, 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 second quarter 2009 10-Q, filed July 24, 2009.
1. IMS Midas data, 2003-2008.
2. “Asthma Facts and Figures.” Asthma and Allergy Foundation of America, 2005. Available at: http://www.aafa.org/display.cfm?id=8&sub=42.
3. Masoli, Matthew, “Global Burden of Asthma.” Medical Research Institute of New Zealand, December 2003.
SOURCE Schering-Plough Corporation