Canadian cystic fibrosis patients can now lead more independent lives

New dry powder tobramycin formulation and the easy-to-use, pocket-sized, portable device will treat lung infections due to Pseudomonas aeruginosa (Pa) and reduce treatment burden

MONTRÉAL, April 5 /CNW/ - Novartis Canada announced today that it has received Health Canada Notice of Compliance (NOC) for TOBI® Podhaler®, a fast and convenient inhaled therapy1 for cystic fibrosis (CF) patients aged six and over. Canadian CF patients will be the first in the world to have access to TOBI® Podhaler®. The TOBI® Podhaler® offers a new dry-powder formulation of tobramycin delivered in a convenient and portable breath-activated inhaler for treating Pseudomonas aeruginosa (Pa) infections in CF patients.

"It is anticipated that the introduction of portable therapy for Pa infections will be a tremendous advance for CF patients, and may have a significant, positive impact on quality of life and treatment success," says Dr. Felix Ratjen, Paediatric Respirologist. "By eliminating the need for a nebulizer and regular disinfection of the equipment, it is anticipated that the risk of bacterial contamination will be greatly reduced while patient compliance will likely improve. Ultimately, this will lead to more effective treatment and help CF patients live more active, normal lives."

Pseudomonas aeruginosa infection is one of the most common pulmonary pathogens for Canadians with CF.2  As a CF patient ages, they are more likely to develop a Pa infection.3 By the age of 25 years, more than 70 per cent of CF patients will develop a lung infection due to Pa.4 This common respiratory pathogen is one of the main drivers of morbidity and mortality in CF.5

Due to the complexity of current anti-Pa treatment, most patients do not fully adhere to their therapy.6,7,8 Although disinfection and cleaning are suggested every time a nebulizer is used, it is estimated that only 30 per cent of patients comply, and  some never clean their nebulizer.9 TOBI® Podhaler® is a dry formulation with a disposable inhaler device which can be replaced weekly and potentially reduce the risk of bacterial contamination.10

In addition, data shows that patients using TOBI® Podhaler® completed their tobramycin treatment in five to six minutes, a reduction of 72 per cent11 in the time traditionally required to administer nebulized tobramycin. By improving the delivery of tobramycin and reducing treatment administration times, the TOBI® Podhaler® has the potential to help patients lead more independent lives.

Unique formulation and delivery system

TOBI® Podhaler® has a unique dry powder formulation, developed using novel PulmoSphere® technology to produce particles that are light and porous for deep delivery into the lung. This means treatment can be given with a portable, patient-friendly device, in contrast to current treatment options which are administered with a nebulizer.

By eliminating the use of a nebulizer, TOBI® Podhaler® does not require additional time for assembly and disinfection of the delivery device. In addition, TOBI® Podhaler® removes the need for refrigeration and a power source for the delivery device. A study found that patients treated with TOBI® Podhaler® had significantly higher treatment satisfaction than those treated with TOBI®.12

In addition, TOBI® Podhaler® was generally well tolerated during clinical trials. The most frequent reactions associated with TOBI® Podhaler® during the first treatment cycle were: cough, dysphonia, productive cough and oropharyngeal pain. The frequency of these adverse reactions decreased over the study duration.

About cystic fibrosis

CF is the most common, fatal genetic disease affecting Canadian children and young adults and currently there is no cure.13 In Canada there are an estimated 3,800 people living with CF, with 1,200 in Québec.14 CF is a multi-organ disease, primarily affecting the lungs and digestive system. A build-up of thick mucus in the lungs causes severe breathing problems. It may be difficult to clear bacteria from the lungs, leading to cycles of infection and inflammation, which damage the delicate lung tissues.15  For additional information, visit www.cysticfibrosis.ca.

Disclaimer

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "to file", "may", "should", "potential", "promise", "plans", "will", or similar expressions, or by express or implied discussions regarding potential new indications or labeling for TOBI® Podhaler® or regarding potential future revenues from TOBI® Podhaler®. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with TOBI® Podhaler® to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that TOBI® Podhaler® will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that TOBI® Podhaler® will achieve any particular levels of revenue in the future. In particular, management's expectations regarding TOBI® Podhaler® could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Pharmaceuticals Canada Inc.

Novartis Pharmaceuticals Canada Inc. provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas.  In 2009, the Company invested close to $110 million in research and development and conducted hundreds of clinical trials across the country seeking new treatments in Ophthalmology, Respiratory, Neurosciences (including MS), Immunology and Infectious diseases, Cardiovascular, Oncology (including Hematology) and organ transplantation. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca.

* is a registered trademark.

References
_____________________________________________
1 Geller DE, Flume PA, Brockhaus F, et al. Treatment convenience and satisfaction of tobramycin inhalation powder (TIP™) versus TOBI® in cystic fibrosis (CF) patients. Poster and abstract presented at 33rd European Cystic Fibrosis Congress, 17 June 2010.

2 Canadian Cystic Fibrosis Patient Data Registry Report. 2008. Page 23. Figure 17. www.cysticfibrosis.ca/assets/files/pdf/CPDR_ReportE.pdf. Accessed March 8, 2011.

3 IBID. Page 24. www.cysticfibrosis.ca/assets/files/pdf/CPDR_ReportE.pdf

4 Cystic Fibrosis Foundation. Patient Registry, Annual Data Report. 2008.

5 Pelicic V, Nassif X. Impact of genome sequences on mutational analysis of fungal and bacterial pathogens. In: Hacker J, Dobrindt U. Pathogenomics.  Genome analysis of pathogenic microbes. Weinheim, German: Wiley VCH; 2006: 69-82.

6 Modi A, Lim CS, et al. A multi-method assessment of treatment adherence for children with cystic fibrosis. J Cyst Fibros 2006; 5:177-85.

7 Latchford G, Duff A, et al. Adherence to nebulised antibiotics in cystic fibrosis. Patient Educ Couns 2009; 75:141-44.

8 Briesacher BA, Quittner AL, et al. Adherence to tobramycin inhaled solution and health care utilization. Am J Resp Crit Care Med 2009; 179:A1183.

9 Melani AS, Sestini P, Aiolfi S, et al. GENebu Project: home nebulizer use and maintenance in Italy. Eur Respir J 2001; 18: 758-63.

10 IBID

11 Geller DE, Flume PA, Brockhaus F, et al. Treatment convenience and satisfaction of tobramycin inhalation powder (TIP™) versus TOBI® in cystic fibrosis (CF) patients. Poster and abstract presented at 33rd European Cystic Fibrosis Congress, 17 June 2010.

12 IBID

13 Canadian Cystic Fibrosis Patient Data Registry Report. 2008. Page 2. www.cysticfibrosis.ca/assets/files/pdf/CPDR_ReportE.pdf . Accessed March 8, 2011.

14 Cystic Fibrosis Québec.  www.aqfk.qc.ca/cystic-fibrosis/what-is-cf-- Accessed March 9, 2011.

15 http://www.cysticfibrosis.ca/en/aboutCysticFibrosis/index.php.  Accessed March 2, 2011.


SOURCE Novartis Pharmaceuticals Canada Inc.

For further information:

Lise Huneault,
External Communications Manager
Novartis Pharma Canada Inc.
Tel 514-631-6775 ext 1203
lise.huneault@novartis.com
          Kerry Collings
Argyle Communications
Tel  416-968-7311 ext 227
kcollings@argylecommunications.com

 


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