Breo® Ellipta® (fluticasone furoate/vilanterol) to be PBS listed as reimbursed treatment for asthma and COPD

Affordable treatment options for Australian patients with asthma and chronic obstructive pulmonary disease (COPD) are set to expand with GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) announcing the listing of Breo Ellipta on the Pharmaceutical Benefits Scheme (PBS) from 1st December 2014.

Breo Ellipta is a once-daily combination treatment of an inhaled corticosteroid (ICS) and a long-acting bronchodilator administered using the new Ellipta dry powder inhaler (DPI).1 

Breo Ellipta is registered for the treatment of moderate to severe asthma in patients aged 12 years and older. Breo Ellipta is listed on the PBS for patients who have previously had frequent episodes of asthma while receive treatment with oral corticosteroids or optimal doses of inhaled corticosteroid. 

Breo Ellipta is also listed on the PBS for the symptomatic treatment of COPD where the lung function (FEV1) is less than 50% predicted normal and there is a history of repeated exacerbations (“flare ups”) with significant symptoms despite regular bronchodilator therapy. 

Respiratory specialist and senior scientist Professor Phil Bardin said he welcomed the availability of new options in asthma management. 

“Remembering to take medications is a major problem for many people. I welcome contemporary treatments for asthma that gives healthcare professionals additional options for suitable patients,” said Professor Bardin. 

GSK Medical Director, Dr Andrew Weekes says the listing represents a milestone for the company which is dedicated to improving respiratory health in Australia and continuing the development of new treatments for patients with asthma and COPD. 

“We are delighted with this new listing in Australia. GSK is committed to making medicines available and affordable to our Australian patients. 

“The listing of Breo Ellipta reinforces GSK’s commitment to innovation in respiratory health and we are proud to make this treatment option available for prescribers and their patients,” said Dr Weekes. 

“The Australian PBS reimbursement of Breo Ellipta is yet another important achievement reflecting the strength of our partnership with GSK,” said Michael W. Aguiar, President and Chief Executive Officer of Theravance “We, like GSK, are pleased to make Breo Ellipta available for appropriate patients in Australia.” 

For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit www.gsk.com.au/breo 

About Asthma 
Asthma is a condition of the airways when the muscles become tight (bronchonstriction), swollen and irritated (inflammation). Symptoms include shortness of breath, wheezing, chest tightness and cough.2Asthma affects approximately 1 in 10 Australians.3 

About COPD 
The prevalence of COPD in Australia is difficult to determine because accurate diagnosis requires clinical testing. It is estimated that COPD affects approximately 529,000 Australians (2%).4 

Important Safety Information for Breo Ellipta in Australia 
Breo Ellipta is listed on the PBS for use in patients with asthma and/or COPD. Patients use Breo Ellipta by breathing it into their lungs through their mouth using the Ellipta inhaler.1 

In the management of conditions, healthcare professionals in consultation with their patients consider both the potential risks (eg. side effects) and benefits (eg. effectiveness) of each medicine. Information is available from the Consumer Medicine Information (CMI) and Product Information. A summary of this information is provided below, please review the CMI for further information.

Breo Ellipta should not be used to relieve sudden attack of breathlessness or wheezing. Breo Ellipta should not be used in patients with an allergy to lactose or milk protein or an allergy to any of the ingredients within the medicine.

Breo Ellipta needs to be used with caution (ie. care) in specific patients, including those with: liver disease; heart or blood pressure problems; being or have been treated with tuberculosis (TB) or pneumonia; eye problems (glaucoma or cataracts); weak bones (osteoporosis); diabetes; thyroid problems; seizures; long standing or untreated infections; immune system problems.

Like all medicines, Breo Ellipta can cause side effects, although not everybody gets them. Common side effects include oral thrush, mouth pain or irritation; voice disorder and cough. Some of these side effects can be reduced by rinsing the mouth out with water immediately after using Breo Ellipta. Other side effects include: infection or inflammation of the lungs; infection or inflammation of the nose sinuses; itchy, runny or blocked nose; weakening of the bones; stomach pain; high temperature; joint and back pain.1 

Some medicines may affect how Breo Ellipta works or increase the likelihood of side effects, these include: beta-blockers (used to treat high blood pressure and heart conditions); ketoconazole (used to treat fungal infections); ritonavir (used to treat viral infections); and medicines to treat depression or mood/mental disorders (such as monoamine oxidase inhibitors or tricyclics antidepressants).1 

Additional notes: 
The information contained within this media release does not contain all the available information. It does not take the place of talking to healthcare professionals. Please speak to your healthcare professional for further information about asthma, COPD or Breo Ellipta. 

Professor Phil Bardin has served on advisory boards and been involved in clinical trials sponsored by GSK for which compensation was received. In relation to this GSK media announcement, no compensation was provided to Professor Phil Bardin, and the opinions expressed are his own. Professor Phil Bardin has been briefed by GSK on the approved use of this product. 

For a copy of the Consumer Medicine Information, please visit: www.gsk.com.au/breo 

References: 
1. Breo Ellipta Consumer Medicine Information. Version 3 dated 29 May 2014 
2. Australian Centre for Asthma Monitoring 2011. Asthma in Australia 2011. AIHW Asthma Series no. 4. Cat. no. ACM 22. Canberra: AIHW. 
3. National Health survey 2007-8; adults. Prevalence in adults stable (AIHW: Asthma in Australia 2011; COPD in Australia p14; p164) 
4. Australian Institute of Health and Welfare Report. Australia’s Health 2014. p138 


If you are an Australian healthcare professional please visit www.health.gsk.com for more information on Breo Ellipta. 

You can follow GSK on Twitter for more Australian updates @GSK_AU

For full product information, information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC.


Breo and Ellipta are registered trademarks of the GSK group of companies.


GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life. For further information please visit www.gsk.com 

Theravance, Inc. – is focused on maximizing the potential value of the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, with the intention of providing capital returns to stockholders. Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement with GSK, Theravance is eligible to receive the associated royalty revenues from RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, "FF/VI"), ANORO® ELLIPTA®(umeclidinium bromide/vilanterol, "UMEC/VI") and if approved and commercialized, VI monotherapy. Theravance is also entitled to a 15% economic interest in any future payments made by GSK under agreements entered into prior to the spin-off of Theravance Biopharma, and since assigned to Theravance Respiratory Company, LLC, relating to the combination of UMEC/VI/FF and the Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program, as monotherapy and in combination with other therapeutically active components, such as an inhaled corticosteroid, and any other product or combination of products that may be discovered and developed in the future under these agreements with GSK (other than RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and VI monotherapy). For more information, please visit Theravance's website at www.thrxinc.com. 


ENDS 

This media release has been issued by Palin Communications on behalf of GSK. 


GSK Australia Enquiries or interview requests contact: 
Martin Palin 
0418 419 258 / 02 9412 2255 
martin@palin.com.au 

Ishtar Schneider 
0422 944 023 / 02 9412 2255 
Ishtar@palin.com.au 

Theravance, Inc. Enquiries contact: 
Michael W. Aguiar 
President and Chief Executive Officer +1 650-238-9640 
investor.relations@thrxinc.com