Fostair(R) Launched In The UK For The Regular Treatment Of Adults With Asthma

Main Category: Respiratory / Asthma
Article Date: 16 Jan 2008 - 1:00 PDT

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Fostair, the first and only metered-dose inhaler combining belcometasone dipropionate (inhaled corticosteroid, ICS) and formoterol fumarate dihydrate (long-acting beta2 agonist, LABA) is launched in the UK for the regular treatment of adults with asthma requiring treatment with a combination of ICS and LABA.1 Fostair offers comparable efficacy to commonly used strengths of the only other combination inhalers available SeretideTM and Symbicort®,2, 3 has a speed of onset of bronchodilation of within 5 minutes,3 and is the only formoterol containing combination available in the familiar metered-dose inhaler (MDI).4

It is at least 20% less expensive than comparable strengths of Seretide and Symbicort 5 and research suggests that if all dose-comparable eligible patients, both existing and new, had been treated with Fostair the NHS would have saved over £40 million in one year,5 the equivalent to employing an extra 3,600 Grade E Nurses across the UK.6

Efficacy has been shown in two separate phase III head-to-head, randomised, doubleblind studies comparing Fostair with both Symbicort (budesonide / formoterol) and Seretide (salmeterol / fluticasone). In these studies Fostair demonstrated comparable morning Peak Expiratory Flow (PEF) with the other combinations.2, 3 The second study showed that patients treated with Fostair had a statistically significantly faster improvement in lung function (FEV1) compared to patients treated with Seretide. 3

"The arrival of Fostair will offer an important new treatment alternative to UK clinicians. It combines two effective asthma treatments, belcometasone dipropionate and formoterol with which we are very familiar. I am sure its introduction as another choice of combination inhaler will be welcomed" said Professor Neil Barnes, Consultant in Respiratory Medicine at the London Chest Hospital, Barts and the London NHS Trust, London.

About £500,000,000 is spent each year on fixed combination inhalers.5 Last year the National Institute for Health and Clinical Excellence (NICE) published its Final Appraisal Determination on inhaled corticosteroids in the treatment of adults which recommends the use of the least expensive ICS / LABA combination for patients with chronic asthma.7 The NICE guidance is expected to be issued to the NHS in the first quarter of 2008.

Fostair combines, belcometasone dipropionate, a widely used inhaled corticosteroid (ICS), and fomoterol a long acting beta-2-receptor agonist (LABA) with a rapid onset of action. Fostair is delivered via a familiar, 120 actuation metered-dose inhaler and has a dose regimen also familiar to most adults with asthma.1

Fostair is licensed for the regular treatment of adult asthma (18 years of age and over) where ICS and LABA is appropriate1:

- Patients not adequately controlled with ICSs and 'as needed' inhaled short-acting beta2 agonists
- Patients already adequately controlled on both ICSs and LABAs
- Not indicated for the treatment of acute asthma attacks

The side effect profile of Fostair has been shown to be consistent with that of a combination ICS and LABA.1 In the head-to-head studies with other combination inhalers, no differences were observed between treatments in frequency of adverse events.2, 5

There are approximately 5.2 million adult patients with asthma in the UK, with 640,000 being treated with fixed dose combination inhalers. It is estimated that each year 128,000 new patients will be suitable for treatment with a combination inhaler.4

About Trinity-Chiesi

Trinity-Chiesi Pharmaceuticals Limited is on the threshold of an exciting new era of expansion. Backed up by a wealth of experience and expertise, we have our sights set on becoming world leaders in respiratory medicine, with Modulite® technology pioneering our CFC-free inhalers. We are already initiating our 5-year programme. Between now and 2010, Trinity-Chiesi aims to move from being a company with a reputation for providing quality, cost-effective, modifiedrelease preparations, to one also known for its patient-focussed, innovative, respiratory medicines.

References:

1. Fostair Summary of Product Characteristics. Trinity-Chiesi Pharmaceuticals Ltd.

2. Papi A, Paggiaro PL, Nicolini G, et al. Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur Respir J.2007; 29: 682-689

3 . Papi A, Paggiaro P, Nicolini G, et al. ICAT SE study group. Beclomethasone/formoterol versus fluticasone/salmeterol inhaled combination in moderate to severe asthma. Allergy 2007;62 (10): 1182-1188

4. MIMS Dec 2007

5. Data on file, Trinity Chiesi Pharmaceuticals Ltd

6. http://www.nursing-pay.com/pay9.shtml

7. National Institute for Health and Clinical Excellence (NICE), final appraisal determination (FAD) on corticosteroids for the treatment of chronic asthma in adults http://www.nice.org.uk/guidance/index.jsp?action=folder&o=36931, Accessed December 2007

Seretide™ is a trademark of GlaxoSmithKline UK Limited.
Symbicort® is a registered trademark of AstraZeneca UK Limited.

Trinity-Chiesi Pharmaceuticals Limited

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