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Press Release

SCOTLAND APPROVES NEW TOBI® PODHALER® (tobramycin inhalation powder) DEVICE FOR THE TREATMENT OF CHRONIC PULMONARY INFECTION IN CYSTIC FIBROSIS PATIENTS

Novartis Pharmaceuticals Limited
Posted on: 12 Jun 12

Frimley, UK, 11 June 2012 – The Scottish Medicines Consortium (SMC) has today recommended the use of Novartis’ TOBI® Podhaler® (tobramycin inhalation powder) for the suppressive treatment of chronic pulmonary infection due to Pseudomonas aeruginosa (Pa) in adults and children aged 6 years and older with cystic fibrosis (CF).1,2

The decision is positive news for CF patients in Scotland, who now have the opportunity to benefit from a new, quick and convenient treatment to suppress their chronic Pa lung infections.1,3 The decision also provides healthcare professionals and CF specialists with robust guidelines when managing chronic Pa infections.

“The positive SMC guidance, based on robust clinical data, is promising news for people affected by CF. The time saved using tobramycin inhalation powder compared to nebulised tobramycin is significant and can help reduce the time burden of treatment, allowing them to fit all their treatments more easily into their day.” Dr Gordon MacGregor, West of Scotland Adult CF Unit.

Currently, there are more than 700 people living with CF in Scotland (and over 9,000 in the UK).4,5 The majority of CF deaths result from loss of lung function linked to inflammation due to chronic bacterial infection, principally Pa.6,7,8 Approximately 60% of CF patients acquire Pa by age 23.9

The Podhaler® is a novel drug delivery system with patented technology that delivers tobramycin inhalation powder via a hand-held, portable inhaler.1,3 Significantly, those using the new drug-delivery device completed their treatment in just five to six minutes, twice a day. This is considerably faster than tobramycin nebuliser solution, which takes approximately 20 minutes to take, twice a day; decreasing treatment time by 72% compared with the existing nebulised TOBI® (tobramycin nebuliser solution).3

In addition to the time saving, the dry powder formulation means the likelihood of bacterial growth in the device is low, as the new hand-held, plastic inhaler can be wiped clean with a dry cloth.10 This is an advance in CF medication as research shows that over 60% of people with CF fail to clean their nebulisers as directed, and around two thirds of nebulisers are contaminated with bacteria.11

Clinical trial data show that the new drug-device combination has similar efficacy to tobramycin nebuliser solution (300mg/5ml), offering the clinical benefits of improved lung function and reduced hospitalisations, compared to placebo.3,7 It also has the advantage of greater convenience and patient satisfaction compared to nebulised tobramycin.3

In addition, the SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tobramycin inhalation powder, making this new treatment option accessible to CF patients.2

Sue Webb, CEO Novartis Pharmaceuticals UK, says “We are delighted with this positive decision by the Scottish Medicines Consortium Our aim is to make tobramycin inhalation powder more accessible to cystic fibrosis patients, providing them with a more rapid and patient-friendly treatment regimen.“

TOBI® Podhaler® (tobramycin inhalation powder) was granted a marketing authorisation for an orphan medicinal product for human use on 20 July 2011 by the European Commission. The device was launched in the UK in September 2011.

SMC approval was based on the Novartis submission of data demonstrating non-inferiority to tobramycin inhalation solution (via a nebuliser) measured by relative change in FEV1 % predicted over three treatment cycles in a phase III, open-label, randomised study.3

The new tobramycin inhalation powder is a novel dry powder, which has been produced using patented PulmoSphere® technology and delivers light, porous tobramycin particles that require little effort to be inhaled deep into the lungs and is the first licensed treatment to be formulated using this technology.1,10 It has a recommended dosage of four capsules (4 x 28 mg = 112 mg tobramycin), administered twice daily for 28 days (alternating cycles of 28 days on treatment followed by 28 days off treatment).1 The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.1 The new plastic inhaler is light-weight, portable and, unlike a nebuliser, has no need for an external power source or batteries, and the tobramycin dry powder capsules do not require refrigeration.1,10

The majority of adverse reactions reported with tobramycin inhalation powder were mild to moderate,3 and the incidence of serious adverse events was shown to be similar between tobramycin inhalation powder and tobramycin nebuliser solution. The safety of tobramycin inhalation powder has been studied in two separate clinical trials.3,7 The most commonly reported adverse events in the main safety study, where tobramycin inhalation powder was compared to tobramycin nebuliser solution, were cough, lung disorder, productive cough, fever, shortness of breath, mouth and throat pain and change in voice.1,3

For full Product Characteristics, please visit http://www.medicines.org.uk

Cystic fibrosis (CF) is one of the UK's most common life-threatening inherited diseases.5,8 Over two million people in the UK carry the faulty gene that causes cystic fibrosis - around one in 25 of the population.5 CF affects the internal organs, especially the lungs and digestive system, by clogging them with thick sticky mucus. This makes it hard to breathe and digest food.5

The majority of CF deaths result from loss of lung function linked to inflammation due to chronic bacterial infection, principally Pseudomonas aeruginosa (Pa).6,7,8 Pa is the most common respiratory infection in CF patients over the age of 7 years old.9 Around half of the CF population can expect to live over 38 years, although improvements in treatments mean a baby born today with CF could expect to live even longer.5

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group's continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 124,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.co.uk

References
1. TOBI Podhaler Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/19020/spc/ Accessed May 2012
2. SMC Submission / SMC announcement on Monday 11 June 2012. ‘tobramycin 28mg inhalation powder, hard capsules (TOBI Podhaler®), Scottish Medicines Consortium’ www.scottishmedicines.org.uk Accessed June 2012
3. Konstan MW, et al. J Cyst Fib 2011; 10: 54-61
4. The Butterfly Trust: http://thebutterflytrust.org.uk/id2.html Accessed May 2012
5. Cystic Fibrosis Trust: http://www.cftrust.org.uk/aboutcf/whatiscf/ Accessed May 2012
6. LiPuma JJ, et al. Clin Microbiol Rev 2010; 23 (2): 299-323
7. Konstan MW, et al. Ped Pulm 2011; 46: 230-238
8. VanDevanter DR, et al. Respiratory Research 2010; 11: 137-144
9. UK CF Registry Annual Data Report 2010. http://www.cftrust.org.uk/aboutcf/publications/cfregistryreports/UK_CF_Registry_-_Annual_Data_Report_2010.pdf/ Accessed May 2012
10. Geller DE, et al. J Aer Med and Pulm Drug Deliv 2011; 24: 1-8 http://www.liebertonline.com/doi/pdf/10.1089/jamp.2010.0855. Accessed May 2012
11. Blau H, et al. Child Care, Health Dev. 2007; 33 (4): 491-495

Novartis Media Relations

Novartis UK Press Office
T : 01276 698691
Pressoffice-uk.phgbfr@novartis.com

Gemma Rickwood, Packer Forbes
T: 0207 036 8550
gemma@packerforbes.com

For more information:
http://www.novartis.co.uk

Editor's Details

Gemma Rickwood, Packer Forbes
Packer Forbes
http://www.novartis.co.uk
0207 036 8550
gemma@packerforbes.com

Last updated on: 12/06/2012

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