AERIUS Now Approved For Use In Intermittent And Persistent Allergic Rhinitis

Schering-Plough Corporation today announced the launch of two multinational clinical trials, and an important label change for AERIUS (desloratadine) in the European Union (EU).  The ACCEPT (AERIUS Control: Clinical and Epidemiological Profile of Tablets) trials will evaluate the efficacy, impact on quality of life, productivity, and pharmacoeconomics of AERIUS in patients with persistent allergic rhinitis (PER) (symptoms lasting four days or more per week and more than four weeks per year) or intermittent allergic rhinitis (IAR) (symptoms lasting less than four days per week or less than four weeks per year).  The trials will be conducted in collaboration with the Global Allergy and Asthma European Network (GA2LEN), a clinical research network of leading European research teams from 16 countries. 

            "The ACCEPT trials are the first multinational studies to involve many of our GA2LEN sites," said Paul Van Cauwenberge, Vice-Chancellor, Ghent University, Belgium and Coordinator of GA2LEN.  "This is a unique collaboration between researchers and industry.  We are pleased to be involved and look forward to expanding our knowledge of managing allergic rhinitis and building an important research partnership with Schering-Plough."             The launch of these trials coincides with the publication of the updated "Allergic Rhinitis and its Impact on Asthma" (ARIA) guidelines, developed by the World Health Organization. 

            Allergic rhinitis has traditionally been classified as seasonal or perennial based on the time of exposure and the nature of the allergen (outdoor or indoor).  According to the updated ARIA guidelines, allergic rhinitis also can be classified as intermittent (IAR) or persistent (PER), based on the duration of the condition rather than the exposure to a seasonal or perennial allergen.  The ACCEPT trials are among the first studies to evaluate an antihistamine based on the ARIA guidelines' classification of allergic rhinitis.

            The ACCEPT trials will involve more than 1,300 patients at nearly 100 sites in 13 countries, and are estimated to be completed in the spring of 2007.              "The ACCEPT trials are landmark studies which will help harmonize standards in the diagnosis and treatment of allergic rhinitis throughout Europe," said Torsten Zuberbier, MD Professor of Dermatology and Allergy, University of Berlin, and lead investigator on the ACCEPT studies.  "These studies will examine practical use of the new ARIA guidelines and evaluate the impact of treatment with desloratadine for patients with intermittent allergic rhinitis or persistent allergic rhinitis."

            The European Medicines Agency (EMEA) has adopted changes to the European Union (EU) label for AERIUS.  AERIUS is now approved for use in IAR and PER and the terms have been added to the Posology and method of administration section (4.2) and the Pharmacodynamic properties section (5.1) of the AERIUS Summary of Product Characteristics (SPC). 

            "Many patients are affected by both seasonal and perennial allergens.  The updated ARIA guidelines and the additional classifications of allergic rhinitis will help physicians more accurately assess and treat their patients' symptoms," said David Price, MD Professor, University of Aberdeen. 

About Allergic Rhinitis

As many as 94 million people across Europe are affected by allergic rhinitis (or hay fever) each year. 1   Symptoms may include sneezing, congestion, runny nose, and itchy or watery eyes.2 

            Symptoms of allergic rhinitis 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 more serious conditions, such as asthma.

            Survey data show that symptoms are most severe in the morning, and about two-thirds of respondents reported that morning suffering affects the rest of the day.3  Mornings can be an especially difficult time for all allergy sufferers in terms of allergic triggers because pollen concentrations are usually highest between 5 a.m. and 10 a.m.  In addition, if a pet is sleeping in the bed, exposure to their dander during the night may account for the increased prevalence and severity of morning allergy symptoms.  People with allergies also should shower before going to bed to rinse off any pollen or pet dander that may have collected in their hair or on their body during the day.

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

About AERIUS®

            According to the new classification of the labeling, AERIUS Tablets and AERIUS Syrup is now approved to treat symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis), in patients 12 years of age and older and patients 1 year of age and older, respectively.

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), or hives of unknown cause. AERIUS is available in two convenient forms.  In the European Union, AERIUS Tablets are available for adults and adolescents 12 years of age and older and AERIUS Syrup is available for children as young as 1 year of age.4

Research shows AERIUS provides powerful morning symptom relief.  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.5  AERIUS, which has a 27-hour half-life, offers demonstrated efficacy at the end of the dosing interval.

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache. In infants and toddlers aged 6 to 23 months who received AERIUS Syrup, the most frequent adverse events reported in excess of placebo were diarrhoea, fever and insomnia.  

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 AERIUS and the potential market for AERIUS.  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 2006 10-Q.

# # # References: 
1. http://www.wrongdiagnosis.com/p/pollen_allergy/stats-country.htm.  Statistics for Northern, Western, Central, Eastern, Southwestern, Southern and Southeastern Europe combined.
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. AERIUS (summary of product characteristics)  Schering Corporation.
5. 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.

http://www.schering-plough.com