1. Downloaded from – www.singulair.aewww.singulair.ae Use of Montelukast for the Treatment of Seasonal (Spring) Allergic Rhinitis

2. Downloaded from – www.singulair.aewww.singulair.ae Reprinted from Clin Exp Allergy 2002;32:1020-1028. Montelukast for treating seasonal allergic rhinitis: A randomized, double-blind, placebo- controlled trial performed in the spring Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice M-P, Reiss TF for the Montelukast Spring Rhinitis Study Group Slide 1 SGA 2001-W-6473-SS

3. Downloaded from – www.singulair.aewww.singulair.ae Study Objective To examine the effectiveness and tolerability of montelukast for the treatment of patients with seasonal (spring) allergic rhinitis Slide 2 SGA 2001-W-6473-SS Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028.

4. Downloaded from – www.singulair.aewww.singulair.ae Slide 3 SGA 2001-W-6473-SS Study Design Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028. Placebo Montelukast 10 mg once daily (n=348) Loratadine 10 mg once daily (n=602) Placebo (n=352) 3–5 days 0 2 Weeks after randomization Period I Single-blind run-in Period II Double-blind treatment 1

5. Downloaded from – www.singulair.aewww.singulair.ae Study Endpoints Daytime Nasal Symptom Score* Congestion Rhinorrhea Pruritus Sneezing Nighttime Symptom Score* Difficulty falling asleep Nighttime awakenings Congestion on awakening Slide 4 SGA 2001-W-6473-SS * Mean of individual symptom scores Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028. Composite Symptom Score* Other endpoints: Eye symptoms, patient/physician global evaluations, blood eosinophil counts, rhinoconjunctivitis, quality of life, individual symptoms (0 to 3 scale; no symptoms to severe)

6. Downloaded from – www.singulair.aewww.singulair.ae Slide 5 SGA 2001-W-6473-SS MontelukastPlaceboLoratadine Characteristic(n=348)(n=352)(n=602) Age (years) Mean  SD 37  13 36  12 36  13 Range15–7615–81 15–74 Gender (% of patients) Female 676565 Male 333535 Allergic history Mean  SD duration 18  12 18  11 18  12 of allergic rhinitis (years) History of allergic conjunctivitis (% of patients)889087 History of asthma272925 (% of patients) Recent* asthma symptoms8118 (% of patients) Baseline Characteristics of Patients *During the two weeks preceding the study Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028.

7. Downloaded from – www.singulair.aewww.singulair.ae Slide 6 SGA 2001-W-6473-SS Montelukast Reduced Daytime and Nighttime Symptom Scores* *Mean change from baseline; **all p values vs. placebo; ***0–3 scale LS=least squares Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028. 0 –0.2 –0.4 –0.6 Change from baseline (LS mean)*** p  0.001** Placebo (n=352) Daytime nasal symptom score Nighttime symptom score 0 –0.2 –0.4 Montelukast (n=348)Loratadine (n=602) p  0.001** p  0.05**

8. Downloaded from – www.singulair.aewww.singulair.ae Slide 7 SGA 2001-W-6473-SS Montelukast Reduced Daily Composite Symptoms *p  0.001 montelukast and loratadine vs. placebo over 2 weeks of treatment LS=least squares Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028. 0 –0.2 –0.4 –0.6 Change from baseline LS mean (  SE) Week in active treatment Placebo (n=352) Montelukast (n=348)* Loratadine (n=602)* Daily composite symptoms (mean of daytime nasal and nighttime scores) 012

9. Downloaded from – www.singulair.aewww.singulair.ae Slide 8 SGA 2001-W-6473-SS Montelukast Reduced Individual Daytime and Nighttime Symptoms *Ocular tearing, pruritus, redness, puffiness Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028; Malmstrom K et al. Poster presentation at the American Academy of Allergy, Asthma, and Immunology, New Orleans, LA, USA, March 16–21, 2001. Daytime symptoms –Nasal congestion (p<0.03 vs. placebo) –Rhinorrhea (p<0.03 vs. placebo) –Sneezing (p<0.03 vs. placebo) –Nasal pruritus (p<0.03 vs. placebo) Daytime eye symptoms* (p<0.03 vs. placebo) Nighttime symptoms –Difficulty falling asleep (p<0.001 vs. placebo) –Nighttime awakenings (p<0.001 vs. placebo) –Nasal congestion on awakening (p<0.03 vs. placebo)

10. Downloaded from – www.singulair.aewww.singulair.ae Slide 9 SGA 2001-W-6473-SS Montelukast Reduced Eosinophils*— A Systemic Marker of Inflammation *From baseline; **vs. placebo Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028. 1.1 5 0 –5 –10 –15 –20 Median % change from baseline –16.9 0 Placebo (n=352) Montelukast (n=348) Loratadine (n=602) p  0.001**

11. Downloaded from – www.singulair.aewww.singulair.ae Slide 10 SGA 2001-W-6473-SS % of patients: PlaceboMontelukastLoratadine Reason for Discontinuation(n=352)(n=348)(n=602) Lack of efficacy2.31.11.3 Clinical adverse experience0.30.91.5* Protocol deviation0.60.61.2 Loss to follow-up0.30.30.3 Withdrawal of consent0.60.30.2 Other1.10.30.3 Total5.13.44.8 *One patient (0.17%) discontinued because of an adverse experience that started before randomization. Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028. Montelukast and Loratadine Were Both Well Tolerated

12. Downloaded from – www.singulair.aewww.singulair.ae Montelukast 10 mg once daily Reduced a broad range of daytime and nighttime allergy symptoms vs. placebo compared to baseline Reduced peripheral blood eosinophils, a marker of inflammation Was well tolerated May provide therapeutic value in the treatment of concomitant allergic rhinitis and asthma Slide 11 SGA 2001-W-6473-SS Study Conclusions Multicenter, randomized, double-blind, parallel-group study in patients 15–81 years of age with seasonal (spring) allergic rhinitis Adapted from Philip G et al Clin Exp Allergy 2002;32:1020-1028.

13. Downloaded from – www.singulair.aewww.singulair.ae References Slide 13 SGA 2001-W-6473-SS Please see notes page.

14. Downloaded from – www.singulair.aewww.singulair.ae Use of Montelukast for the Treatment of Seasonal (Spring) Allergic Rhinitis Slide 14 SGA 2001-W-6473-SS Before prescribing, please consult the manufacturers’ prescribing information. Merck does not recommend the use of any product in any different manner than as described in the prescribing information. Copyright © 2002 Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. 9-04 SGA 2001-W-6473-SS Printed in USA VISIT US ON THE WORLD WIDE WEB AT http://www.merck.com