Schering-Plough Corporation announced the European Commission (EC) has approved AERINAZE (desloratadine 2.5 mg/pseudoephedrine 120 mg) Modified-Release Tablets for the relief of symptoms of seasonal allergic rhinitis, when accompanied by nasal congestion, in patients 12 years of age and older. The EC approval results in Marketing Authorization with unified labeling that will be valid in the current European Union (EU) 27 member states as well as in Iceland and Norway.

"For patients with seasonal allergy symptoms including nasal congestion, the combination of an antihistamine and decongestant like AERINAZE provides safe and effective relief," said Claus Bachert, MD, PhD, Professor of Medicine, University of Ghent, Ghent, Belgium.

The new antihistamine with decongestant formulation uses a bi-layer tablet delivery system, which controls the release of the pseudoephedrine component for consistent delivery. The recommended twice-daily dosing of AERINAZE will help patients control their nasal and non-nasal symptoms, including stuffiness/congestion, sneezing, runny or itchy nose, itching of the ears or palate, itchy and watery eyes, or redness of the eyes, in the morning and throughout the day.

The EC approved AERINAZE based on results from two, 2-week multicenter, randomized parallel group clinical trials involving 1,248 patients 12 to 78 years of age with seasonal allergic rhinitis, 414 of whom received AERINAZE tablets. In both trials, the antihistaminic efficacy of AERINAZE, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than that of pseudoephedrine alone during the treatment period. In addition, the decongestant efficacy of AERINAZE was significantly greater than that of desloratadine alone during the treatment period, based on nasal stuffiness/congestion scores. The study data show that AERINAZE effectively treats nasal congestion, in addition to relieving other nasal and non-nasal symptoms of seasonal allergic rhinitis.

The most commonly reported adverse events for AERINAZE were insomnia, dry mouth, and headache.

AERINAZE should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired.

Schering-Plough markets desloratadine under the brand names AERIUS®, AZOMYR® and NEOCLARITYN® in Europe and as CLARINEX® in the United States. These brands build upon Schering-Plough's heritage as a leader in discovery and development.

About Allergic Rhinitis

Allergic rhinitis affects approximately 24.4 percent of Europeans.1 Symptoms, which may include sneezing, nasal congestion, itchy and runny nose, and itchy, redness and/or watery eyes,2 can have an impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and other respiratory conditions, such as asthma.2

Survey data show that symptoms are most severe in the morning.3 The survey also showed that even though allergies are frequently a self-diagnosed condition, patients rely on medical experts to help properly manage their symptoms.3

According to the World Allergy Organization (WAO), approximately $20 billion is spent globally each year on allergic rhinitis, including medications, time off work, and physician consultations.4

About AERINAZE

AERINAZE (desloratadine 2.5 mg/ pseudoephedrine 120 mg) Modified-Release Tablets provide 12-hour relief of symptoms of seasonal allergic rhinitis, when accompanied by nasal congestion, in patients 12 years of age and older.5

Due to its pseudoephedrine component, AERINAZE Modified-Release Tablets are contraindicated in patients who are hypersensitive to desloratadine, loratadine, pseudoephedrine or to any of the other ingredients of the product, in patients who are receiving heart or blood pressure medicine, in patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, urinary tract blockage, high blood pressure, heart or blood vessel disease, a history of stroke, an overactive thyroid, or in patients who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen (14) days.5 Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver, bladder or kidney problems; a previous history of brochospasm or enlarged prostate should check with their healthcare provider before taking AERINAZE.5 Care should be used if AERINAZE is taken with other antihistamines or decongestants because combined effects on the cardiovascular system may be harmful.5 The most frequently reported adverse events for AERINAZE were insomnia, dry mouth and headache.5

About AERIUS

AERIUS (desloratadine) is a nonsedating prescription antihistamine for the treatment of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria (CIU) - hives of unknown cause.6 AERIUS Tablets is approved to treat symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis) and CIU in patients 12 years of age and older. AERIUS Orodispersible Tablets 2.5 mg and 5 mg are approved to treat these symptoms in patients 6 years of age and older. AERIUS Syrup and AERIUS Oral Solution are both approved to treat these symptoms in patients 1 year of age and older.6

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache.6 In clinical trials in a pediatric population (children aged 6 months through 11 years), the overall incidence of adverse events in children 2 through 11 years of age was similar for the AERIUS syrup and placebo groups.6 In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhea, fever and insomnia.6

Research shows AERIUS provides powerful morning symptom relief. 6 In a study of 346 people with moderate-to-severe seasonal allergic rhinitis, patients receiving AERIUS experienced significant improvement in morning scores versus placebo for both nasal and non-nasal symptoms.7 AERIUS offers demonstrated efficacy at the end of the dosing interval.

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 approximately 33,500 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 Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for AERINAZE. 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 and a discussion of risks and uncertainties that may impact 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 2007 10-Q.

Schering-Plough Corporation.

References:

1. Dahl R, Anderson PS, Chiavto T, Valovirta E, de Monchy J. National prevalence of respiratory allergic disorders. Resp Med 2004; 98: 398-403.

2. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket Guide. 2001.

3. "Understanding the Dynamics Surrounding Allergy Suffering and Treatment" Forbes Consulting Group. 2005.

4. Allergy Facts. World Allergy Organization. http://www.worldallergy.org/media/globalstatistics.shtml >. Accessed March 5, 2007.

5. AERINAZE (summary of product characteristics). Schering Corporation.

6. AERIUS [NEOCLARITYN] (summary of product characteristics). Schering Corporation.

7. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group. Efficacy and tolerability of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest. 2001; 21:25-32.