Anoro® Ellipta® approved in Australia for Chronic Obstructive Pulmonary Disease

GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) have proudly announced that the Therapeutic Goods Administration (TGA) has approved Anoro® Ellipta® (umeclidinium/vilanterol) as a maintenance bronchodilator treatment to relieve symptoms in Australian adult patients with chronic obstructive pulmonary disease (COPD) which is also known as “chronic bronchitis,” “smoker’s cough” or emphysema”.

  • Administered using a new dry powder inhaler called Ellipta1

GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) have proudly announced that the Therapeutic Goods Administration (TGA) has approved Anoro® Ellipta® (umeclidinium/vilanterol) as a maintenance bronchodilator treatment to relieve symptoms in Australian adult patients with chronic obstructive pulmonary disease (COPD) which is also known as “chronic bronchitis,” “smoker’s cough” or emphysema”.

Anoro is a combination treatment comprising two bronchodilators (medicines that help make breathing easier), umeclidinium, a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta®.

GSK Associate Medical Director, Dr Navin Singh says the company is committed to bringing new respiratory therapy options to Australian patients.

“There are many Australians living with COPD for whom the disease represents a significant burden. GSK is committed to developing a range of new therapeutic options that provide physicians with treatment choices when considering individual patient needs.”

“We are delighted by the TGA approval 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 Singh.

“We are very pleased that Anoro Ellipta is now approved for use in Australia for the treatment of COPD,” said Rick E Winningham, Chief Executive Officer of Theravance. “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.”

The evidence supporting this approval was based upon results of 11 clinical studies in 7,851 patients with COPD.

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

About COPD
COPD is a term for a group of respiratory disorders including emphysema and chronic bronchitis3. COPD effects approx 5% of Australians over 552.

About Anoro Ellipta1
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.

Following TGA registration GSK’s next focus is to make Anoro Ellipta available to healthcare professionals. Anoro Ellipta is not available on the Pharmaceutical Benefits Scheme (PBS).

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 information1.

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.

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.

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.

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

References:
1. Anoro® Ellipta® Approved Consumer Medicine Information July 2014
2. National Health survey 2007-8; adults. Prevalence in adults stable (AIHW: COPD in Australia p14; p164).
3. Lung Foundation Australia website: http://lungfoundation.com.au/patient-area/lung-diseases/copd/

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 trademarks of the GlaxoSmithKline 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 by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

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

Theravance, Inc., A Royalty Management Company – 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 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 its LABA Collaboration Agreement with GSK (other than RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and VI monotherapy). For more information, please visit Theravance’s web site at www.thrxinc.com.

Theravance forward-looking statements
This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the strategies, plans and objectives of the company following the separation, the timing, manner, amount and planned growth of anticipated potential capital returns to stockholders (including without limitation statements concerning the intention to initiate a cash dividend in the third quarter of 2014, expectations of future cash dividend growth and the potential for future share repurchases), the status and timing of clinical studies, data analysis and communication of results, the potential benefits and mechanisms of action of product candidates, expectations for product candidates through development and commercialization, the timing of seeking regulatory approval of product candidates, and projections of revenue, expenses and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: lower than expected future royalty revenue from respiratory products partnered with GSK, delays or difficulties in commencing or completing clinical studies, the potential that results from clinical or non-clinical studies indicate product candidates are unsafe or ineffective, dependence on third parties to conduct its clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, and risks of collaborating with third parties to discover, develop and commercialize products. Other risks affecting Theravance are described under the heading "Risk Factors" contained in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2014 and the risks discussed in Theravance’s other periodic filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements. (THRX-G)

-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
Senior Vice President and Chief Financial Officer
+1 650-238-9640
investor.relations@thrxinc.com