Breo™Ellipta® (fluticasone furoate/vilanterol trifenatate) approved in Australia for Asthma and COPD

GSK Australia and Theravance, Inc. (NASDAQ: THRX) have proudly announced today that the Therapeutic Goods Administration (TGA) has approved Breo Ellipta for the treatment of patients with asthma or chronic obstructive pulmonary disease (COPD) in Australia1.

  • New combination of an inhaled corticosteroid and a long-acting bronchodilator1
  • Administered using a new dry powder inhaler called Ellipta1

GSK Australia and Theravance, Inc. (NASDAQ: THRX) have proudly announced today that the Therapeutic Goods Administration (TGA) has approved Breo Ellipta for the treatment of patients with asthma or chronic obstructive pulmonary disease (COPD) in Australia1.

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

GSK Medical Director Dr Andrew Yeates says the company had been focused for many years on the development of new treatments for patients with asthma or COPD. Both of these conditions can have a significant impact on patient lives.

“We are delighted that Breo Ellipta is now approved in Australia. GSK is committed to supporting innovation in respiratory medicine and making medicines available to our Australian patients. Building on GSK’s strong respiratory heritage, we are proud that healthcare professionals in Australia have the option of prescribing this medicine when managing patients with asthma or COPD,” said Dr Yeates.

“The Australian approval of Breo Ellipta is yet another important achievement and is testament to our successful partnership with GSK in respiratory disease,” said Rick E Winningham, Chief Executive Officer of Theravance. “We are delighted that TGA has approved Breo Ellipta for the treatment of asthma and COPD, providing another treatment option for these patient populations.”

About asthma and COPD
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.2 Asthma affects approximately 1 in 10 Australians.3

COPD is an umbrella term for a group of disorders including: emphysema and chronic bronchitis.4 Symptoms include shortness of breath, cough, chest infections and coughing up mucus. COPD affects approximately 5% of Australians over the age of 55.2

About Breo Ellipta1
Breo Ellipta is registered for use in patients with asthma or COPD. Patients use Breo Ellipta by breathing it into their lungs through their mouth using the Ellipta inhaler.1

Following TGA registration, GSK's next focus will be to make Breo Ellipta available to healthcare professionals. Breo Ellipta is not available on Pharmaceutical Benefits Scheme (PBS).

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.1

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.1

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.1

Like all medicines, Breo Ellipta can cause side effects, although not everybody gets them. Common side effects 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. For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit: www.gsk.com.au.


References:
1. Breo™ Ellipta® Product information 17 April 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. Lung Foundation Australia website: http://lungfoundation.com.au/patient-area/lung-diseases/copd/

For full consumer medicines information, please visit: http://www.gsk.com.au/breo

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. AUS/FFT/0005/14 Date of Approval: 17/04/2014.

Breo and Ellipta® are registered trade marks 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 by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Theravance – is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance's key programs include: RELVAR®/BREO® ELLIPTA® (FF/VI), ANORO ELLIPTA (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist) GSK961081, each partnered with GlaxoSmithKline plc (GSK), and its Long-Acting Muscarinic Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance’s web site at www.theravance.com.

THERAVANCE® and the Theravance logo are registered trademarks of Theravance, Inc.

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 status and timing of clinical studies, data analysis and communication of results, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the timing of seeking regulatory approval of our product candidates, statements concerning the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights and statements concerning expectations for product candidates through development and commercialization 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 its 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 delays or difficulties in commencing or completing clinical studies, the potential that results of clinical or non-clinical studies indicate product candidates are unsafe or ineffective, our dependence on third parties in the conduct of our clinical studies, delays or failure to achieve regulatory approvals for product candidates, risks of relying on third-party manufacturers for the supply of our product and product candidates and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Theravance's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 3, 2014 and the risks discussed in our 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)

This media release as 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
+1 650-808-4100
investor.relations@theravance.com