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ANORO ELLIPTA approved for COPD treatment in Canada Approved as a new once-daily dual bronchodilator for the treatment of COPD in Canada Mississauga, ON - January 9 , 2014 - GlaxoSmithKline Inc. and Therava

Key Takeaway: ANORO ELLIPTA approved for COPD treatment in Canada Approved as a new once-daily dual bronchodilator for the treatment of COPD in Canada Mississauga, ON - January 9, 2014 - GlaxoSmithKline Inc. and Theravance Inc. today announced that ANORO ELLIPTA was approved in Canada on Dec

Full Press Release Details

ANORO ELLIPTA approved for COPD treatment in Canada
Approved as a new once-daily dual bronchodilator for the treatment of COPD in Canada
Mississauga, ON - January 9, 2014 - GlaxoSmithKline Inc. and Theravance Inc. today announced that ANORO ELLIPTA was approved in Canada on December 23, 2013, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
ANORO ELLIPTA (umeclidinium/vilanterol) dry powder for inhalation is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA).
ANORO ELLIPTA combines two bronchodilators in a single inhaler for the maintenance treatment of COPD. It contains umeclidinium bromide (UMEC), a LAMA and vilanterol trifenatate (VI), a LABA. The approved dosage of ANORO ELLIPTA in Canada is 62.5/25mcg.
Paul Lirette, President, GSK Canada said: "The market authorization of Anoro Ellipta in Canada provides an important treatment option for appropriate patients with COPD. It is a new once-daily combination product that enables patients to receive two bronchodilators in a single daily inhalation."
"We are delighted that ANORO ELLIPTA has achieved market authorization in Canada for the treatment of COPD," said Rick E Winningham, Chief Executive Officer of Theravance. "This is an important step forward for Theravance and GSK, and reinforces our long-standing commitment to work together for patients with respiratory disease."
The phase III pivotal programme for ANORO ELLIPTA included seven clinical studies with almost 6,000 patients with COPD.
Chronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterised by obstruction to airflow that interferes with normal breathing.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.
ANORO ELLIPTA (UMEC/VI) is a new once-daily LAMA/LABA dual bronchodilator approved in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. ANORO ELLIPTA is not indicated for the relief of acute deterioration of COPD, for the treatment of acute episodes of bronchospasm or for the treatment of asthma. ANORO contains 62.5 micrograms UMEC and 25 micrograms VI, in a single inhaler, the ELLIPTA .
Important Safety Information
The following is important safety information for ANORO ELLIPTA .
Indications and Clinical Use:
ANORO ELLIPTA (umeclidinium/vilanterol) is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
ANORO ELLIPTA is not indicated for the relief of acute deterioration of COPD or for the treatment of asthma.
Most Serious Warnings and Precautions
Asthma-related death: Long-acting beta2-adrenergic agonists (LABA) may increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to patients' usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including vilanterol, one of the active ingredients in ANORO ELLIPTA . The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established.
Other Warnings and Precautions:
Adverse reactions reported at a frequency of 1% and greater than placebo include: pharyngitis, sinusitis, lower respiratory tract infection, diarrhea, constipation, pain in extremity, muscle spasms, neck pain and chest pain.
Dosing Considerations:
For More Information:
Please consult the product monograph at www.gsk.ca/ for complete safety information. The product monograph is also available by calling 1-800-387-7374.
ANORO and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
GlaxoSmithKline - 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.ca.
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. 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 , the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE are registered trademarks of Theravance, Inc.
For more information, please contact:
Communications Manager
GlaxoSmithKline Inc.
Theravance Inc. Enquiries
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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 1, 2013 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.
Last updated: Dec 23, 2013