Health Canada approves Tudorza™ Genuair™ as a new treatment for patients living with COPD

Clinical trials show patients received maximal brochodilation from day one in an easy-to-use inhaler

MISSISSAUGA, ON, Oct. 31, 2013 /CNW/ - Almirall Canada announced the Health Canada approval of Tudorza™ Genuair™ (aclidinium bromide) as a long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema,i giving the 750,000 Canadians living with this serious lung diseaseii a new treatment proven to improve breathlessness, lung function, and health-related quality of life.iii

Tudorza™ Genuair™ is an effective, inhaled, long-acting muscarinic receptor antagonist (LAMA), administered via a new multi-dose dry powder inhaler, for the maintenance treatment of patients with COPD.iv The Genuair™ inhaler is a device that is designed with unique features that make it easy for patients to use.v

"COPD is a complex condition to manage, and despite the numerous treatment options available, there remain significant unmet needs in helping patients control their symptoms," says Dr. Ronald Grossman, Respirologist, Credit Valley Hospital and Professor of Medicine at University of Toronto. "The Health Canada approval of Tudorza™ Genuair™ is exciting as it provides physicians with a unique option that offers sustained treatment throughout the entire day, reducing the frequency of night-time and early morning symptoms and ultimately offering patients a better quality of life. Genuair™ is also a novel inhalation device with unique features that may help reduce patient-related dosing errors and ensure proper delivery of medication."

Tudorza™ Genuair™ 400 mcg is recommended twice daily, once in the morning and once in the evening.vi This has proven effective in providing full 24-hour symptom control, which is based on a two-dose strategy - the second dose provides the patient with additional bronchodilation over the second 12 hours of the day.vii

Tudorza™ Genuair™ was developed by Almirall and is being co-promoted in Canada with Forest Laboratories Canada Inc. Almirall SA and Forest Laboratories Inc. have partnered on the commercialization of the product in the U.S.  

"We are very proud to bring Tudorza™ Genuair™ to COPD patients in Canada," says Ed Dybka, General Manager, Almirall Canada. "Canadian patients not only have a new treatment option with proven results in managing COPD symptoms, but we're excited about the innovation behind the Genuair™ inhaler, and believe its ease of use will help patients take their medication correctly and experience improved outcomes."

"We are pleased with the Health Canada approval of Tudorza™ Genuair™," says Greg Engel, General Manager Forest Laboratories Canada Inc. "This announcement marks an important milestone in the partnership between Forest and Almirall, demonstrating our united commitment to offer new options to improve the health of Canadians living with COPD."

About the Data

The Health Canada approval of Tudorza™ Genuair™ is based on results from three randomized, double-blind, placebo-controlled pivotal clinical trials (one of six months duration and two of three months duration), including 1,933 patients with COPD,viii with several trial sites in Canada.

Inhalation of Tudorza™ Genuair™ produced statistically significant improvements in lung function compared to placebo as determined by trough FEV1 (morning pre-dose) and peak FEV1 (evening dose) with maximum bronchodilation being observed.ix

Patients that have been treated with Tudorza™ Genuair™ experienced improvements in breathlessness (assessed using the Transition Dyspnoea Index) and disease-specific health status (assessed using the St. George's Respiratory Questionnaire).x

Tudorza™ Genuair™ also has a good safety profile with the most frequently reported adverse reactions being headache and nasopharyngitis (irritation to the nose and throat). Importantly, the incidence of typical anticholinergic adverse events was low compared to placebo (e.g. dry mouth was <1 per cent).xi

Tudorza™ Genuair™ is not indicated for the relief of an acute deterioration of COPD and should not be used in patients under 18 years of age. The safety and effectiveness of Tudorza™ Genuair™ in patients less than 18 years of age have not been established.

About COPD

Chronic obstructive pulmonary disease refers to two commonly co-existing lung diseases, chronic bronchitis and emphysema, which are characterized by the obstruction of airflow to and from the lungs.xii In Canada, the most common causes of COPD include smoking cigarettes, exposure to second-hand smoke, air pollution (dust or chemicals) and having repeated lung infections as a child.xiii Symptoms of COPD often include a long-lasting cough, shortness of breath, wheezing, fatigue, weight loss (without trying), and the occurrence of many long-lasting lung infections (the flu, acute bronchitis, pneumonia, etc.).xiv

COPD is a progressive disease with worsening of symptoms and in many cases patients experience exacerbations requiring urgent care and hospitalization. Worsening of symptoms and exacerbations is associated with decline in lung function and increase in risk of mortality. COPD is the fourth leading cause of death in Canada.xv It is also the leading cause of hospitalizations in Canada,xvi and has a much higher readmission rate than other chronic illnesses with 18 per cent of COPD patients being readmitted once within the year.xvii It is estimated COPD costs the Canadian health care system at least $1.5 billion a year is COPD hospitalizations alone.xviii

About Tudorza™ Genuair™

Tudorza™ Genuair™ is a long-acting inhaled muscarinic antagonist (sometimes referred to as an anticholinergic). It has a long residence time at M3 receptors and a shorter residence time at M2 receptors. When given by inhalation, Tudorza™ Genuair™ leads to bronchodilation by inhibiting airway smooth muscle contraction.xix Tudorza™ Genuair™ is rapidly hydrolyzed in human plasma to two major inactive metabolites which results in low bioavailability and may reduce the potential for systemic side effects.xx

Tudorza™ Genuair™ is administered to patients using a multi-dose dry powder inhaler. The Genuair™ inhaler was designed with a double feedback system: a colour control window changing from red to green when medication is loaded and ready for use and an audible "click" once medication has been properly inhaled. It also incorporates safety features such as a visible dose indicator to show patients approximately how many doses remain and an end-of-dose lock-out system to prevent use of an empty inhaler.xxi

About Almirall

Almirall is a pharmaceutical company committed to provide valuable medicines from our own R&D, external partnerships, licenses and collaborations. In 2012, Almirall invested over 23 per cent of its sales in R&D. Through seeking innovative medicines we aim to become a relevant player in respiratory and dermatology diseases with also a strong interest in gastroenterology and pain. With more than 3,000 employees in 22 countries, Almirall generated total revenues of 900 million euros in 2012. The company was founded in 1943 and is headquartered in Barcelona, Spain. The stock is traded in the Spanish stock exchange (ticker: ALM). For more information please visit www.almirall.com.

References
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i Tudorza™ Genuair™ (aclidinium bromide inhalation powder) Product Monograph. Almirall Limited. July 26, 2013.
ii The Lung Association. The Challenge of Lung Disease in Canada. Available at: http://www.lung.ca/involved-impliquez/federalelection-electionfederale/background-contexte/index_e.php#s4. Last accessed August 14, 2013.
iii Tudorza™ Genuair™ (aclidinium bromide inhalation powder) Product Monograph. Almirall Limited. July 26, 2013.
iv Ibid.
v Van der Palen, Job, Ginko, Thomas, Kroker, Axel et al. Preference, satisfaction and errors with two dry powder inhalers in patients with COPD. Expert Opin. Drug Deliv. (2013) 10(8).
vi Tudorza™ Genuair™ (aclidinium bromide inhalation powder) Product Monograph. Almirall Limited. July 26, 2013.
vii Kerwin, E., D'Urzo, A., Gelb, A., et al. on behalf of the ACCORD1 1 study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclindium bromide in COPD patients (ACCORD COPD I). COPD - 2012; 9:90-101.
viii Tudorza™ Genuair™ (aclidinium bromide inhalation powder) Product Monograph. Almirall Limited. July 26, 2013.
ix Ibid.
x Ibid.
xi Ibid.
xii The Lung Association. COPD - What is COPD? Available at: http://www.lung.ca/diseases-maladies/copd-mpoc/what-quoi/index_e.php. Last accessed August 21, 2013.
xiii Ibid.
xiv The Lung Association. COPD - Signs & Symptoms? Available at: http://www.lung.ca/diseases-maladies/copd-mpoc/signs-signes/index_e.php. Last accessed September 18, 2013.
xv The Lung Association. The Challenge of Lung Disease in Canada. Available at: http://www.lung.ca/involved-impliquez/federalelection-electionfederale/background-contexte/index_e.php#s4. Last accessed August 14, 2013.
xvi Canadian Institute for Health Information. A Snapshot of Health Care in Canada as Demonstrated by Top 10 List. P.6. Available at: https://secure.cihi.ca/free_products/Top10ReportEN-Web.pdf. Last accessed August 22, 2013.
xvii Benady, S. Canadian Thoracic Society Report - Human Economic Burden of COPD: A Leading Cause of Hospital Admission in Canada. 2010.
xviii Ibid.
xix Tudorza™ Genuair™ (aclidinium bromide inhalation powder) Product Monograph. Almirall Limited. July 26, 2013.
xx Ibid.
xxi Ibid.


SOURCE Almirall

For further information:

Vanessa Principe
Edelman
416-849-8931
vanessa.principe@edelman.com

Rodrigo Delgado 
Almirall Canada
800-957-7679
rodrigo.delgado@almirall.com