1. Managing COPD Nephron Pharmaceuticals Corporation Sponsored by Masters 14 August 2010

2. nephron pharmaceuticals corporation Presenter details Michael McGowan Regional manager and Director of International Sales and Affairs mmcgowan@nephronpharm.com Marie Moran Territory Manager, nationwide and International Sales mmoran@nephronpharm.com www.nephronpharm.comwww.masters-uk.com Sponsored by Masters2

3. nephron pharmaceuticals corporation Overview Understanding COPD and associated conditions Causes and prevalence of COPD Treatment options Pharmacist’s role in managing COPD Advocacy/patient groups Sponsored by Masters3

4. nephron pharmaceuticals corporation What is COPD? COPD - Chronic Obstructive Pulmonary Disease is a progressive lung disease. Airways become narrower, resulting in difficulties with breathing. Symptoms are treatable but the condition is irreversible and progressively worsens over time, unlike asthma where symptoms come and go. Sponsored by Masters4

5. nephron pharmaceuticals corporation Causes of COPD Most cases of COPD are caused by long-term exposure to lung irritants that damage the lungs and airways, i.e. chemical fumes and organic dust such as grain, cotton, wood, or mining dust. However, in the US the most common irritant is cigarette smoke. In most patients, symptoms begin to show after the age of 40 years. On rare occasions, a genetic condition called alpha-1 antitrypsin may play a role in development of COPD. Patients have low levels of alpha-1 antitrypsin (AAT) — a protein made in the liver. Sponsored by Masters5

6. nephron pharmaceuticals corporation Warning symptoms ■ An annual increase/decrease in the amount of sputum (phlegm) ■ A change in the color of the sputum to brown, yellow or green ■ The presence of blood in the sputum ■ An unusual increase in the severity of breathlessness ■ Swelling in the ankles ■ Unusual increase or decrease in weight ■ Need to increase the number of pillows to sleep comfortably ■ Increasing lack of energy and tiredness Sponsored by Masters6

7. nephron pharmaceuticals corporation Umbrella of COPD ■ Chronic Bronchitis ■ Emphysema Sponsored by Masters7

8. nephron pharmaceuticals corporation Chronic bronchitis Chronic bronchitis is an inflammation of the bronchi. Clinically defined as a persistent cough that produces sputum and mucus for at least three months in two consecutive years. Tobacco smoke is the main cause. Sponsored by Masters8

9. nephron pharmaceuticals corporation Emphysema Characterized by damage to the alveoli. Consequently, the body does not get the oxygen it needs, making it hard to catch breath, development of a persistent cough and trouble breathing during exercise. Tobacco smoke is most common cause. Sponsored by Masters9

10. nephron pharmaceuticals corporation Prevalence of COPD The World Health Organization estimates that 80 million people worldwide have moderate to chronic COPD. In 2005, more than 3 million died of COPD, equating to 5% of all deaths globally. Almost 90% of COPD deaths occur in low and middle-income countries. Sponsored by Masters10

11. nephron pharmaceuticals corporation COPD rates rising In the US, COPD is the 4 th leading cause of death. Estimated to become 3 rd leading cause of death worldwide by 2030. Affects men and women equally, owing to increased tobacco use among women in higher-income countries and greater exposure to indoor air pollution (biomass fuel) in low-income countries. Sponsored by Masters11

12. nephron pharmaceuticals corporation Economic burden In 2007, the US spent $42.6 billion on COPD healthcare costs and loss of productivity. About 24 million Americans have COPD, according to the American Lung Association. However, only about half have been diagnosed with the condition. Sponsored by Masters12

13. nephron pharmaceuticals corporation Treatment options Current pharmacotherapies cannot cure COPD Pharmacotherapies can help control the condition - Bronchodilators (β-agonists & Anticholinergics) - Inhaled corticosteroids - Oxygen therapy Sponsored by Masters13

14. nephron pharmaceuticals corporation Bronchodilators ■ Bronchodilators open the airways and are an important part of COPD pharmacotherapy. ■ Bronchodilators relax the smooth muscles that line the walls of the breathing tubes, making the airway wider and easier for air to move through. ■ Can be administered as tablets, liquids, or inhalation Sponsored by Masters14

15. nephron pharmaceuticals corporation Bronchodilator classes Two main classes of Bronchodilators: Beta- Agonists and Anticholinergics ■ Beta- Agonists □ Relax the muscles surrounding the airways □ Two types: short-acting and long-acting beta agonists (SABAs and LABAs) Sponsored by Masters15

16. nephron pharmaceuticals corporation SABAs SABAs – Short-acting β agonist Example of SABA = Albuterol (a rescue remedy in breathlessness) First beta receptor agonist to be marketed Usually administered through a nebulizer, but can be given orally as an inhalant or intravenously Onset of action within 5 minutes Provides relief for up to 6 hours Common side-effects: palpitations, chest pain, rapid heart rate, tremors or nervousness Sponsored by Masters16

17. nephron pharmaceuticals corporation LABAs LABAs – long Acting β agonist) Example of LABAs = Salmeterol and Formoterol Physical effects are similar to SABAs but effects can last up to 12 hours FDA has given LABAs a black box warning following concerns that they can increase severity of asthma exacerbations and even risk of fatal asthma. Sponsored by Masters17

18. nephron pharmaceuticals corporation Alpha and beta receptor Drug that has a dual affinity for alpha and beta receptors = Racepinephrine Racemic mixture of the enantiomorphs of epinephrine Stimulates alpha properties, acting as a vasoconstrictor to help reduce mucosal and submucosal oedema Also stimulates Beta properties that act as bronchodilators, resulting in the enlargement of airways and facilitating secretion removal Administered via inhalation as nebuliser therapy Onset of pharmacological action is immediate Sponsored by Masters18

19. nephron pharmaceuticals corporation Anticholinergics Blocks the chemical produced by our bodies that normally causes the airway to contract Decreases mucous secretions Combined with Albuterol or Metaproterenol for management of COPD. More effective than beta agonist alone. Example = Ipratropium Bromide Usually administered by inhalation Onset within 15 minutes, therefore not recommended for emergency use Half-life of about 6 hours Sponsored by Masters19

20. nephron pharmaceuticals corporation Corticosteroids For moderate to severe COPD that cannot be controlled by conventional pharmacotherapy Do not prevent lung decline over time, but can help reduce symptoms and reduce frequency of flare-ups Drug is delivered by inhalation to the lungs, therefore usually fewer side-effects than oral treatment However, high doses can affect other parts of the body and worsen conditions such as osteoporosis Examples of Inhalation products = Budesonide, Fluticasone, Triamcinolone, Flunisolide, Beclomethasone Sponsored by Masters20

21. nephron pharmaceuticals corporation Oxygen therapy For severe COPD and low levels of oxygen in the blood stream Supplemental oxygen can: - improve sleep and mood - increase mental alertness and stamina - allow the body to carry out normal functions - prevent heart failure in people with severe lung disease However, high doses for prolonged period can be toxic Surgery may be considered as a last resort Sponsored by Masters21

22. nephron pharmaceuticals corporation Pharmacist’s role in managing COPD Pharmacists play a crucial role in helping to prevent and manage COPD: - diagnosis - providing accurate and up-to-date information on COPD - encouraging healthier lifestyle, i.e. smoking cessation options, diet, exercise - Helping with compliance of prescribed medication and help improve the technique when using inhaled medication - Annual immunization against influenza. Influenza can lead to exacerbations and respiratory failure. - Pharmacists can form support teams with other healthcare professionals Sponsored by Masters22

23. nephron pharmaceuticals corporation Useful links http://www.aarc.org – American Association of Respiratory Care http://emphysemafoundation.org – Emphysema Foundation http://www.nlm.nih.gov – Medline http://www.nhlbi.nih.gov/health/public/lung/copd/index.htm – National Heart and Lung Institute of US http://www.nhlbi.nih.gov/health/public/lung/copd/index.htm – National Heart and Lung Institute of US http://www.alpha1.org – Alpha1 National Association http://www.nlhep.org – National Lung Foundation USA http://www.breathingbetterlivingwell.com – patient support material http://www.olivija.com/SmokeNoMore http://www.copdadvocate.com – patient support http://www.copdadvocate.com http://www.phrma.org - listing of free medication http://www.phrma.org http://www.thekitchenlink.com – for people with special dietary requirements http://www.thekitchenlink.com Sponsored by Masters23

24. nephron pharmaceuticals corporation More information This is a snapshot of managing COPD, but we would be delighted to send you more detailed information Contact Mike at mmcgowan@nephronpharm.com or Marie at mmoran@nephronpharm.com www.nephronpharm.com www.masters-uk.com Sponsored by Masters24

25. Thank you! Nephron Pharmaceuticals Corporation Sponsored by Masters 14 August 2010