Anoro® Ellipta® (umeclidinium/vilanterol) to be reimbursed in Australia for Chronic Obstructive Pulmonary Disease

- Administered using a new dry powder inhaler called Ellipta1
- Listed on the Pharmaceutical Benefits Scheme (PBS) from 1st December
2014

GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) have welcomed news that Anoro Ellipta (umeclidinium/vilanterol) will be reimbursed via the Australian Pharmaceutical Benefits Scheme (PBS) as a long-term once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) which is also known as chronic bronchitis, “smoker’s cough” or emphysema. 

The reimbursement will be effective from December 1st 2014. 

Anoro is a once-daily combination treatment comprising two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta. 

Senior respiratory physician and clinical researcher Professor Peter Frith from Repatriation General Hospital said he welcomed the improved access to new treatments that results from PBS reimbursement.

“I certainly welcome better access to effective treatment options in COPD that can alleviate symptoms and improve quality of life. Combined drugs of this nature promise to add significantly to patient well-being,” said Professor Frith. 

GSK Medical Director, Dr Andrew Weekes says the reimbursement of Anoro Ellipta underscores GSK’s commitment to providing new COPD treatment options for respiratory patients in Australia. 

“GSK is committed to developing and launching new therapeutic options that provide physicians with choice when considering individual patient needs in COPD. We are delighted by the Australian PBS listing of Anoro Ellipta which provides a new alternative for COPD patients for whom dual bronchodilator treatment in a single inhaler may be appropriate,” said Dr Weekes. 

Michael W. Aguiar, President and Chief Executive Officer of Theravance said he felt pleased to see Anoro Ellipta being reimbursed in Australia for the treatment of COPD. 

“We believe this will be an important treatment option for appropriate patients with COPD and is a further positive outcome from the collaboration between Theravance and GSK to bring to market new respiratory medicines that meet patient needs.” 

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

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%).2 

About Anoro Ellipta 
Anoro Ellipta is registered for use in patients with COPD. Patients use Anoro Ellipta by breathing it into their lungs through their mouth using the Ellipta inhaler1

Anoro Ellipta is available on the Pharmaceutical Benefits Scheme (PBS) from 1st December 2014. 

Healthcare professionals together with their patients consider both the potential risks (eg. side effects) and benefits (eg. effectiveness) of medicines when managing a condition. Information regarding Anoro Ellipta is available from the Consumer Medicine Information (CMI). A summary of this information is provided below, please review the CMI for further information. 

Anoro Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. Anoro Ellipta should not be used in patients with an intolerance to lactose or allergy to milk or any of the other ingredients within the medicine1. Do not use Anoro Ellipta to treat asthma. 

Anoro Ellipta needs to be used with care in specific patients, including those with heart or blood pressure problems, eye problems (specifically, narrow-angle glaucoma), enlarged prostate gland or difficulty passing urine or with a blockage in the bladder1

Common side effects with using this medicine may include: cough, sore throat with or without runny nose, constipation, dry mouth, urinary tract infection, and infection of the upper airways1

Some medicines may affect how Anoro Ellipta works including medicines called beta blockers (to treat high blood pressure or other heart problems) and ketoconazole (to treat fungal infections)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 COPD or Anoro Ellipta. 

Professor Peter Frith has served on advisory boards sponsored by GSK for which an honorarium was received. In relation to this GSK media announcement, no honorarium was provided to Professor Peter Frith, and the opinions expressed are his own. Professor Peter Frith has been briefed by GSK on the approved use of this product. 

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


References: 
1. Anoro® Ellipta® Approved Product information July 2014 
2. 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 Anoro® 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. 

Anoro 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. 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