Health Canada approves tadalafil to help patients with serious,
life-threatening lung disease

    
    Adcirca(TM) is the first once-a-day PDE-5 inhibitor oral therapy for the
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    treatment of pulmonary arterial hypertension
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TORONTO , Feb. 3 /CNW/ - Adcirca(TM) (tadalafil) is now available in Canada for the treatment of pulmonary arterial hypertension (PAH). Adcirca represents an important new and convenient option for the estimated 2,000 to 10,000 Canadians with this rare but progressive and serious disorder. Characterized by an elevation of pressure in the pulmonary (lung) arteries, PAH can lead to shortness of breath, fatigue, heart failure and often leads to death within four years of diagnosis.(1)

Adcirca, recently approved by Health Canada , is a vasodilator which means it relaxes or opens blood vessels. It is the first oral once-a-day phosphodiesterase-5 (PDE-5) inhibitor for the treatment of PAH. Adcirca offers significant improvement in exercise capacity, and is shown to consistently improve certain aspects of health-related quality of life for patients with PAH, such as climbing stairs, doing laundry or even dressing.(2)

"The once-a-day oral dosing of Adcirca is both effective and well tolerated, which is extremely important for these patients," said Dr. Sanjay Mehta , Professor of Medicine and Director of the Southwest Ontario PH Clinic in London , Ontario, and Medical Director, Pulmonary Hypertension Association of Canada . "As a physician who treats this serious and life-threatening disease, I am confident that the convenience of this new oral treatment will help to promote compliance among patients, thus making a difference in their health-related quality of life."

As PAH worsens, symptoms may limit all physical activity, making it increasingly difficult to keep up with everyday responsibilities, such as bathing, dressing, walking for a period of time, climbing stairs or doing laundry, among others. Studies show that Adcirca also improves the time to clinical worsening. Although there is no cure for PAH, improved time to clinical worsening may allow patients to maintain a healthy lifestyle for a longer period of time, and may extend the time before more expensive and complicated treatment is needed for patients.(3),(4)

"Pulmonary arterial hypertension is a life-threatening lung disease that is not often diagnosed until it is at an already advanced stage, making everyday tasks - like getting out of bed - a struggle," said Darren Bell , President, Pulmonary Hypertension Association of Canada . "While there is no cure for PAH, having access to new treatments like Adcirca is critical in helping to delay disease progression and improve aspects of a patient's health-related quality of life."

PHIRST-1 Clinical Trial

The pivotal Phase 3 randomized, double-blind, 16-week placebo-controlled clinical trial (PHIRST-1) followed 405 patients with PAH. In order to assess the response to therapy, scoring systems and clinical endpoints used in PAH clinical trials such as the six-minute walk test (6MWT) were implemented.(2) The object of this test is to walk as far as possible in six minutes.(5) PHIRST-1 patients taking Adcirca 40 mg (administered as two 20 mg tablets) once daily achieved a significant mean 33 metre improvement in the six-minute walk distance compared to the placebo group.(2)

In addition, PHIRST-1 patients taking Adcirca 40 mg experienced a prolonged time to clinical worsening (defined as death, lung or heart-lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening World Health Organization functional class) compared to the placebo group (five per cent for tadalafil 40 mg, versus 16 per cent with placebo).(2) Moreover, the incidence of clinical worsening was reduced in the 40 mg tadalafil group (p=0.038; relative risk 68 per cent less than placebo).(2)

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is a serious and life-threatening condition for which there are approved treatments, but no cure. This disease affects people of all genders, races, and ages, but it is more prevalent among women in their child bearing years (mean age 36).(1) Symptoms include persistent shortness of breath, chest pain, fatigue, dizzy spells and swelling of the ankles and legs.(1) If left untreated, PAH often progresses, with devastating effects including heart failure and death.(1)

Treatment options target the prostacyclin, endothelin, or nitric oxide pathways that are involved in the pathobiology of PAH.(6) Tadalafil, a phosphodiesterase type 5 (PDE-5) inhibitor, increases cyclic guanosine monophosphate (cGMP), the final mediator in the nitric oxide pathway.(7)

Scoring systems and clinical endpoints used in PAH clinical trials include (but are not limited to) the 6MWT, Borg Dyspnea Score, WHO functional class, SF-36, EQ-5D and time to clinical worsening.

About Adcirca

Adcirca, manufactured and marketed in Canada by Eli Lilly Canada , is a prescription medicine used to treat PAH, a life-threatening disease that constricts the pulmonary vasculature and reduces the flow of blood through the lungs. The use of Adcirca in patients using any form of nitrate medication is contraindicated.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis , Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada , headquartered in Toronto , Ontario, employs more than 500 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca.

    
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    References:
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    (1) British Columbia Pulmonary Arterial Hypertension Society website.
        Available at: http://www.bcphs.org/facts.html
    (2) Galie, N., et al. "Tadalafil therapy for pulmonary arterial
        hypertension" manuscript. Registration Trial Number: NCT00125918.
    (3) ADCIRCA Patient Information. Last accessed: July 16, 2009.
    (4) ADCIRCA Prescribing Information. Last accessed: July 16, 2009.
    (5) Your Lung Health.org website. Available at:
        http://www.yourlunghealth.org/testing/6min_walk/index.cfm
    (6) McLaughlin, VV et. al. "ACCF/AHA 2009 expert consensus document on
        pulmonary hypertension," 2009
    (7) Sandner, P et al. "PDE5 inhibitors beyond erectile dysfunction"
        abstract., 2007
    

For further information: Jennifer Gordon, Eli Lilly Canada Inc., [phone]; Jennifer Runza, MS&L, [phone]