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Title: GSK Receives Positive Opinion From CHMP on Seretide (Salmeterol/Fluticasone Propionate) Dosing for Initial Maintenance Therapy

"GSK Receives Positive Opinion From CHMP on Seretide (Salmeterol/Fluticasone Propionate) Dosing for Initial Maintenance Therapy"

LONDON, UK -- May 3, 2006 -- GlaxoSmithKline (GSK) announced today that it has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on dosing of Seretide™ (salmeterol/fluticasone propionate) for initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is essential. Dose recommendations have been agreed between GSK and the CHMP, which are designed to help clinicians to prescribe Seretide appropriately as an initial maintenance therapy. This is the first step towards obtaining updated national marketing authorisations. Once this amendment has been adopted by the European Commission, clinicians will have guidance in terms of the patient population which will benefit most from Seretide therapy at the most appropriate starting dose. Kate Knobil MD, VP Respiratory Clinical Development, GSK said: "We are delighted that the CHMP have issued a positive opinion accepting proposed wording for the Seretide label to include initial maintenance therapy use in appropriate asthma patients. This means that if the CHMP opinion is approved Seretide will be the only ICS/LABA combination with guidance on use as an initial maintenance therapy." The opinion provided by the CHMP is in line with current GINA guidelines, which state that therapy should be initiated on the basis of the severity of a patient's asthma. For patients presenting with moderate persistent asthma, the daily controller medications recommended are inhaled corticosteroids (ICS) plus long acting beta2 agonists (LABA).1 Disease information Asthma is a disease characterised by recurrent attacks of breathlessness, coughing, wheezing and tightness in the chest, which vary in severity and frequency from person to person so that one sufferer may have symptoms from hour to hour, another from day to day.2 Asthma affects all age groups but often starts in childhood and can change in one individual over their life time.3 Asthma has two major components -- smooth muscle dysfunction and airway inflammation, which cause the airways to narrow and reduce the flow of air in and out of the lungs. Whilst asthma cannot be cured, it can be controlled. Asthma attacks (or exacerbations) are episodic, but airway inflammation is chronically present requiring long-term management. For many patients with asthma this means taking preventative medication every day (eg: anti-inflammatory drugs) to control the underlying inflammation and prevent symptoms and attacks. If symptoms occur, short-term medications (inhaled short-acting beta2-agonists) are used to relieve them. Medication is not the only way to control asthma. It is also important to avoid asthma triggers -- stimuli that irritate and inflame the airways. Product Information Seretide is an inhaled combination treatment for asthma, containing salmeterol and fluticasone propionate. Fluticasone propionate is an anti-inflammatory agent that controls airway inflammation, which is the underlying cause of asthma. Salmeterol is a long acting bronchodilator which acts for up to 12 hours to reduce asthma symptoms (chest tightness, wheezing, cough) Seretide, combines these two well established asthma treatments in one inhaler. Seretide is approved in Europe, under the mutual recognition procedures, for use in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonistin. REFERENCES: 1. Global Initiative For Asthma, Global Strategy for Asthma Management and Prevention. NIH Publication No. 02-3659. Issued January 1995 (updated 2002). Management Section (Chapter 7) Updated 2005 from 2004 document. www.ginasthma.org. 2. BMA Complete Family Health Encyclopedia. Dorling Kindersley p138 3. World Health Organisation. Bronchial Asthma Fact Sheet No 206. Revised January 2000 SOURCE: GlaxoSmithKline

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