• pCODR conditionally recommends the reimbursement of VENCLEXTA for the treatment of patients with CLL who have received at least one prior therapy and who have failed a BCRiⁱ
• VENCLEXTA is the first and only approved BCL-2 inhibitor in Canada
• A need exists for CLL patients who have failed novel oral therapiesⁱⁱ

 

Montreal, QC, March 6, 2018 – AbbVie, a global research and development-based biopharmaceutical company, today announced that the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee conditionally recommends the reimbursement of VENCLEXTA^TM for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a BCRi. This recommendation is a positive step towards patients living with CLL accessing a medication that serves an unmet medical need.

 

VENCLEXTA is a first-in-class, oral, once-daily medicine. It selectively inhibits the BCL-2 protein, which is responsible for helping cancer cells survive in the blood.

 

“Lymphoma Canada understands the high relapse rate of CLL that necessitates a variety of treatment options. The positive recommendation of VENCLEXTA provides Canadians living with CLL with hope for the future, which is an important determinant as one battles this disease,” says Robin Markowitz, CEO, Lymphoma Canada. “Lymphoma Canada is confident that the pan-Canadian Oncology Drug Review

Expert Review Committee’s decision to recommend VENCLEXTA for reimbursement will provide patients with comfort to know that they have additional treatment options.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodⁱⁱⁱ, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,200 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.^iv The 17p deletion is a genetic mutation that is found in 3 to 10 percent of people with previously untreated CLL and up to 50 percent of relapsed or refractory cases.^v Despite the development of new therapies for relapse/refractory (R/R) CLL, there remains a need for salvage therapies for patients that have failed treatment because they have relapsed, are refractory or simply intolerant or unsuitable to the toxicity profile of these newer agents. ⁱⁱ

 

“The first thing I understood during my initial consultation with my Hematologist about my leukaemia is that it was chronic. Since my diagnosis in 2010, I have relapsed twice, but I have always been fortunate that the right treatment was available to me at the right time,” explains Mark Silverstein of Aurora, ON. “This last relapse was no different, and the treatment I had been excited about for several years was made available only a couple of months prior to my second relapse. Now with VENCLEXTA, Canadians

 

living with CLL have another treatment option. I have chosen my own way over the last seven years – by educating myself on my disease, maintaining a healthy partnership with my Hematologist, by removing fear from my choices, and finally to consistently remain intellectually, emotionally, and spiritually open to a journey with no assurances how it will all turn out.”

 

VENCLEXTA previously received a Notice of Compliance with Conditions (NOC/c) by Health Canada on September 27, 2016. The therapy has been approved for previously treated chronic lymphocytic leukemia (CLL) patients, who have either a genetic mutation, known as 17p deletion, or no other available treatment options. Under NOC/c policy, AbbVie will provide Health Canada with data from additional studies to confirm the clinical benefit of VENCLEXTA.^vi

 

“For people living with CLL, the goal of treatment is to delay progression of the disease and improve quality of life. Therefore, providing Canadians access to an approved treatment option is essential. The entire team at AbbVie Canada applauds and celebrates the pan-Canadian Oncology Drug Review recommendation for VENCLEXTA,” said Stéphane Lassignardie, General Manager of Abbvie Canada. “This recommendation reinforces AbbVie’s growing position in hematologic oncology.”

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases.

 

VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and by AbbVie outside of the U.S.

 

About AbbVie Care

Canadians prescribed VENCLEXTA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

-30-

Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

 

ⁱ pCODR Expert Review Committee (pERC) Final Recommendation https://www.cadth.ca/sites/default/files/pcodr/pcodr_venetoclax_venclexta_cll_fn_rec.pdf

ⁱⁱJain P. et al. Long-Term Outcomes for Patients With Chronic Lymphocytic Leukemia Who Discontinue Ibrutinib.

Cancer. 2017 Jun 15;123(12):2268-2273.

ⁱⁱⁱ Lymphoma Canada. Chronic lymphocytic leukemia. Available at http://www.lymphoma.ca/lymphoma/lymphoma-101/types-lymphoma/cll

^iv Canadian Cancer Statistics, 2015 http://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic- lymphocytic-cll/statistics/?region=on

^v Schnaiter A. et al. 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach.

Hematol Oncol Clin N Am. 2013;27:289–301.

^vi VENCLEXTA product monograph, AbbVie Corporation, September 27, 2016

• Nova Scotia joins Alberta, Ontario, Quebec, Manitoba, British Columbia, and Yukon to offer DUODOPA

 

MONTREAL, QC, February 22, 2018 – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that Canadians diagnosed with advanced Parkinson’s Disease living in Nova Scotia now have public access to DUODOPA. Parkinson’s disease is a progressive degenerative brain disorder with no cure.

 

DUODOPA is used to treat patients with advanced Parkinson’s disease who have severe and disabling motor symptoms that cannot be well controlled with available oral treatments. It is a levodopa and carbidopa medication combination delivered in the form of a gel through an intestinal pump.

 

Ryan Underhill, Managing Director for Parkinson Canada in Nova Scotia said, “We hear from people with Parkinson’s and their families every day. Having public access to effective treatment options gives them a sense of hope. We see firsthand how very challenging this disease is for individuals managing their unique symptoms through all stages of disease progression.”

 

Over 25 people are diagnosed with Parkinson’s every day in Canada¹. Between 2011 – 2031, the number of Canadians diagnosed with Parkinson’s is expected to double to more than 163,700².

Stéphane Lassignardie, General Manager of AbbVie Canada added, “We are thrilled that Nova Scotians now have access to DUODOPA. We continue to work with the healthcare community and the government to bring our medications to different communities. Our mission is to continue to advance scientific innovation in therapeutic areas where there are limited or no treatment options available to patients.”

 

About DUODOPA

 

DUODOPA® (levodopa/carbidopa intestinal gel) is a gel containing two medications delivered directly into the small intestine that is used to treat patients with advanced Parkinson’s disease who are responsive to levodopa treatment. DUODOPA is for use in patients who have severe and disabling motor symptoms of Parkinson’s disease that cannot be well controlled with available combinations of medications for Parkinson’s disease and for whom the benefits of this treatment may outweigh the risks associated with the insertion and long-term use of the percutaneous endoscopy gastrostomy- jejunostomy (PEG-J) tube required for administration. The symptoms of Parkinson’s disease include tremor, feeling rigid, slow movements, and balance problems.

 

DUODOPA® was approved in recognition of a high unmet need for effective therapies and no satisfactory alternatives. DUODOPA is approved in 34 countries and is used by more than 8,500 patients worldwide. Any medicines can have side effects. Like all medicines, DUODOPA® or the procedure of the PEG-J tube can cause serious side effects. DUODOPA® is contraindicated in patients with narrow-angle glaucoma, severe liver and renal insufficiency, severe heart failure, severe cardiac arrhythmia, suspicious, undiagnosed skin lesions or a history of melanoma, acute stroke and in patients taking non- selective MAO inhibitors and selective MAO type A inhibitors. DUODOPA® is also contraindicated in patients with clinical or laboratory evidence of uncompensated cardiovascular, cerebrovascular, endocrine, hematologic or pulmonary disease (including bronchial asthma)_.

 

For further information, please consult the DUODOPA Product Monograph at www.abbvie.ca

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

 

Media:

Eileen Murphy AbbVie Canada (514) 832-7788

eileen.murphy@abbvie.com

 

 

¹ Neurological Health Charities Canada (NHCC), Health Canada, Public Health Agency of Canada (PHAC), Canadian Institute of Health Research (CIHR). MAPPING CONNECTIONS: An Understanding of Neurological Conditions in Canada. Sept. 2014. pg.66.

² POHEM-Neurological, Statistics Canada and Public Health Agency of Canada. Table 3-5: Projected prevalence, by select neurological condition, Canada, 2011, 2016, 2021, 2026, and 2031, Microsimulation Project. Ibid.,

• Hidradenitis suppurativa (HS) is a painful, chronic inflammatory skin disease
• HUMIRA® (Adalimumab) is the first and only Health Canada-approved therapy for the treatment of adults living with
• HUMIRA® (adalimumab) now reimbursed for HS in Manitoba, Saskatchewan, New Brunswick and Ontario

 

MONTREAL, QC, February 21, 2018 – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that Canadians diagnosed with hidradentis suppurativea (HS) living in Manitoba, Saskatchewan, New Brunswick and Ontario now have public access to HUMIRA® (adalimumab).

 

HS is a chronic, systemic, immune-mediated skin disease which affects between 1 to 3% of the global population however the diagnosis is often delayed or the condition is misdiagnosed with the true prevalence unknown.¹ HS is known to produce lesions in the skin that are inflamed (swollen), recurrent and chronic (lasting for an extended period of time). HS can have both a psychological and physical impact.

 

In general, HS has a greater impact on the quality of life of affected individuals compared to other dermatological conditions. ² The average Canadian HS patient will see five doctors with over 17 visits spanning eight years before being diagnosed. HS is associated with intense pain, decreased mobility, and the deep-seated lesions (nodules or abscesses) may be accompanied by unpleasant odor and purulent drainage. The lesions are present under the arms, groin, and perianal area with the breasts being affected in female individuals. With time, healed lesions form scars which are sometimes extensive.³

 

Dr Afsaneh Alavi, dermatologist and Founder and past President of the Canadian Hidradenitis Suppurativa Foundation said, “We applaud the decisions of Manitoba, Saskatchewan, New Brunswick and Ontario to cover the first and only Health Canada approved treatment option for people living with HS. Having seen first-hand how HS impacts every aspect of a person’s life; nobody should have to endure this painful disease when effective treatment is available.”

 

“This is great news for HS patients living in Manitoba, Saskatchewan, New Brunswick and Ontario,” says Kathryn Andrews-Clay, Executive Director of the Canadian Skin Patient Alliance. “Our recent report on the lived experiences of HS patients highlights the need for an effective treatment to help improve their quality of life. We hope that the rest of the country will quickly follow Manitoba, Saskatchewan and Ontario’s leadership.”

 

Stéphane Lassignardie, General Manager of AbbVie Canada added, “We are motivated and encouraged for people living with HS in Manitoba, Saskatchewan, New Brunswick and Ontario. Enabling access to a much needed medication is extremely important for AbbVie in our mission to treat unmet medical needs. We are committed to partnering with payers across our country to ensure every Canadian with HS has equal access to our medication. “

 

 

About HUMIRA

 

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

 

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 14 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.

 

1

1

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects. Before initiation of, during and after treatment with HUMIRA, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph available at www.abbvie.ca.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

Important Safety Information⁴

 

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be

 

started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

 

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

 

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

 

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

 

HUMIRA is given by injection under the skin.

 

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

 

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph¹ at www.abbvie.ca

 

 

References

 

1 The Canadian Hidradenitis Suppurativa Foundation – www.hs-foundationcanada.org

2 Wolkenstein P, et al. J Am Acad Dermatol. 2007;56(4):621-623.

3 The Canadian Hidradenitis Suppurativa Foundation – www.hs-foundationcanada.org

⁴ HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. (December 5, 2017).

 

 

###

 

Media:

Eileen Murphy AbbVie Canada (514) 832-7788

eileen.murphy@abbvie.com

• MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment^*1
• MAVIRET previously received a Notice of Compliance from Health Canada on August 16, 2017
• MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

 

MONTREAL, QC, February 6, 2018 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that the CADTH Canadian Drug Expert Committee (CDEC) issued a positive recommendation for MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6)². MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,^* who make up a large portion of HCV patients in Canada.

 

The recommendation states that glecaprevir/pibrentasvir be reimbursed for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis, including patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors, if specific conditions are met.³

 

“Continued efforts are fundamental to the ultimate goal of eliminating hepatitis C, which is a serious and complex disease in Canada. It is vital that as many patients as possible are able to achieve a virologic cure, as quickly as possible, and we hope that patients throughout Canada will be able to benefit from

this latest treatment, which has the potential to cure most HCV patients in eight weeks,” states Dr. Samuel Lee, Hepatologist and Professor, Cumming School of Medicine, University of Calgary.

 

Approximately 300,000 Canadians are infected with hepatitis C.⁴ In 2012 alone, more than 10,000 new cases of hepatitis C were reported, but 40 percent of patients are estimated to be living unaware of their disease.⁵ GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.^4,6 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years⁷ of infection. Additionally, HCV is common among people with severe chronic kidney disease (CKD), and some of these patients previously did not have a direct-acting antiviral (DAA)- based treatment option.⁸

 

“Our goal is to see Canada meet its commitment to the World Health Organization’s Global Strategy on Viral Hepatitis by eliminating hepatitis C by 2030. This is within our reach, but we need a coordinated

 

national response with a comprehensive action plan to prevent, screen, diagnose and treat Canadians living with hepatitis C,” says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation and Toronto-based hepatologist. “The Canadian Liver Foundation recommends screening for hepatitis C

based on risk factors, plus a one-time test for all Canadians born 1945 – 1975⁹. Furthermore, treatment eligibility restrictions that currently exist need to be removed, so that physicians and their patients have affordable and equitable access to all available treatment options, regardless of background, disease severity or the province in which they live.”

 

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

 

“AbbVie is deeply committed to curing Canadians of hepatitis C. We strongly believe in providing patient and doctor choice when selecting the appropriate medication,” explains Stéphane Lassignardie, General Manager, AbbVie Canada. “The CADTH positive recommendation reinforces our belief that there is a need for innovative therapies like MAVIRET in order to reach the goal set out by the World Health Organization to eliminate HCV by 2030 in Canada and across the world.”

 

About MAVIRET™

MAVIRET™ is approved in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).² MAVIRET is a new, pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.²

 

MAVIRET is an 8-week, pan-genotypic virologic cure^** for use in patients without cirrhosis and who are new to treatment,^*1 such patients comprising the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) and those with genotype 3 infection.² It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.²

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

 

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].

**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR₁₂) are considered cured of hepatitis C.

 

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at

 

www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

 

Media:

Muriel Haraoui AbbVie Canada (514) 717-3764

muriel.haraoui@abbvie.com

 

 

 

¹ Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

² MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017.

³ CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed February 2018. ⁴Messina, JP et al. “Global distribution and prevalence of hepatitis C virus genotypes.” Hepatology, 2015; 61: 77–87. Supporting information http://onlinelibrary.wiley.com/wol1/doi/10.1002/hep.27259/full. Accessed January 2018.

⁵ Hepatitis C: Get the Facts. Government of Canada. https://www.canada.ca/en/public-health/services/publications/diseases- conditions/poster-hepatitis-c-get-facts.html. Accessed February 2018.

⁶ Wyles, D et al. SURVEYOR-II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis. Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, US on November 11-15, 2016.

⁷ Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 2018.

⁸ Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10. ⁹ The Canadian Liver Foundation, press release: https://www.newswire.ca/news-releases/not-getting-the-message-too-many- canadians-born-between-1945-1975-unaware-of-their-increased-risk-of-undiagnosed-hepatitis-c-587783871.html. Accessed February 2018.

• 80% of patients with plaque psoriasis may develop nail psoriasis in their lifetime
• Over 50% of moderate to severe psoriasis patients suffer from nail disease
• Psoriasis patients with nail involvement are three times more likely to have or develop psoriatic arthritis

 

MONTREAL, QC, October 25, 2017 – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that Health Canada has approved the inclusion of nail psoriasis data in the HUMIRA Product Monograph. HUMIRA is approved for use in adult patients with chronic moderate to severe plaque psoriasis. This label update for HUMIRA stemmed from the results of the Nail Psoriasis Pivotal Trial M13- 674; a trial specifically evaluating two primary endpoints of nail psoriasis.

 

According to the Canadian Guidelines for the Management of Plaque Psoriasis (Source: Canadian Psoriasis Guidelines Committee, June 2009) Canadian nail psoriasis is among the most challenging manifestations of psoriasis, in part due to the nature of drug delivery around and beneath the nail plate. HUMIRA is the first biologic with data incorporated into its Product Monograph that was obtained from a clinical trial specifically designed with two primary endpoints to evaluate nail psoriasis.

 

Dr Kim Papp, Dermatologist with Probity Medical Research in Waterloo, Ontario said: “Psoriasis involving the finger nails may cause pain – imagine what your fingers feel like when they are caught in a car door. And psoriasis involving the finger nails can result in significant impairment: inability to grasp or hold objects, impossible to pick up small items.“

 

Stéphane Lassignardie, General Manager, AbbVie Canada added: “While researching nail psoriasis we learnt that patients experienced professional restrictions and missed more work days. At AbbVie, we are committed to our dermatology portfolio and finding solutions for unmet medical needs.“

 

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

 

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 14 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.

 

1

1

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects. Before initiation of, during and after treatment with HUMIRA, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph available at www.abbvie.ca.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

Important Safety Information¹

 

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

 

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

 

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of

1 HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. (July 28, 2017).

 

HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

 

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

 

HUMIRA is given by injection under the skin.

 

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

 

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph¹ at www.abbvie.ca

 

1 HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. (July 28, 2017).

 

 

###

Media:

Eileen Murphy AbbVie Canada (514) 832-7788

eileen.murphy@abbvie.com

• HUMIRA® (adalimumab) now reimbursed in British Columbia, Ontario, New Brunswick, Newfoundland and Labrador, Saskatchewan and
• Also covered by the federal Non-Insured Health Benefits (NIHB)

 

MONTREAL, CANADA, AUGUST 29, 2017 – AbbVie today announced that HUMIRA® (adalimumab) will now be reimbursed in British Columbia, Ontario, New Brunswick, Newfoundland and Labrador, Saskatchewan and Yukon for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP), or who are intolerant to such therapies. It is also now covered by the federal Non-Insured Health Benefits (NIHB) program, which provides coverage to nearly one million status First Nations and Inuit peoples.

 

Ulcerative colitis is a chronic disease of the colon, marked by inflammation and ulceration of the colon mucosa, or innermost lining. Canada has among the highest reported prevalence and incidence of Inflammatory Bowel Disease (IBD) in the world. There are approximately 104,000 Canadians living with UC and approximately 4,500 new cases of UC are diagnosed every year¹.

 

“This is great news because it improves public access to another treatment option for Canadians with ulcerative colitis,” says Dr. Brian Bressler, Clinical Associate Professor of Medicine, Division of Gastroenterology, University of British Columbia. “In British Columbia in particular, this means HUMIRA is the only sub-cutaneous option covered by the government and having that treatment option is critical for patients.”

 

“Ulcerative colitis is a chronic and challenging disease to manage and patients need medications that work,” explains Gail Attara, Chief Executive Officer, Gastrointestinal Society. “Ensuring coverage of these vital biologic medications for patients across the country is essential.”

 

“The longstanding and extensive experience of HUMIRA® in Canada across numerous indications makes it an important option for those living with ulcerative colitis,” says General Manager, Stéphane

 

1The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and Recommendations, Crohn’s and Colitis Foundation of Canada. http://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/ccfc-ibd-impact-report-2012.pdf

 

Lassignardie, AbbVie Canada. “AbbVie is also committed to developing new advanced innovative therapies in immunology in order to address unmet medical needs.”

 

HUMIRA® is also approved in Canada in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), psoriasis (Ps), hidradenitis suppurativa (HS), uveitis (Uv), as well as in children 2 years of age and older for the treatment of polyarticular juvenile idiopathic arthritis (JIA) and in pediatric patients with Crohn’s disease (CD) 13 to 17 of age, ≥ 40kg.

 

About HUMIRA

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 13 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.

 

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects². Before initiation of, during and after treatment with HUMIRA; patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph² available at www.abbvie.ca.

 

About AbbVie Care

Canadians prescribed HUMIRA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond.

For more information, call 1-866-8-HUMIRA (486472) or consult www.abbviecare.ca.

 

Important Safety Information²

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a

 

region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

 

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

 

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

 

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

 

HUMIRA is given by injection under the skin.

 

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

 

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph³ at www.abbvie.ca.

 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us

at www.abbvie.ca or follow us on Twitter at @abbviecanada.

 

 

# # #

 

Media inquiries

Stephanie Weinstein stephanie.weinstein@abbvie.com 514-832-7268

Fifteen winners selected after record number of applications received

 

Toronto, ON – August 8, 2017 – Following a demanding selection process, Crohn’s and Colitis Canada is proud to announce it has selected 15 post-secondary students to be awarded AbbVie IBD Scholarships. The 15 students, hailing from colleges and universities across the country, all live with the challenges of inflammatory bowel disease (IBD), but still strive to earn a higher education. The scholarships of up to

$5,000 to be used by each student for his or her tuition consist of ten annual scholarships and five additional scholarships awarded this year in celebration of Canada 150.

 

“We received a record number of scholarship applications in 2017, with each student sharing heartfelt stories of courage and determination,” said Mina Mawani, President and CEO, Crohn’s and Colitis Canada. “Every student receiving the AbbVie IBD Scholarship has worked hard to excel academically while overcoming the difficulties caused by their disease.”

 

Canada has one of the highest rates of inflammatory bowel disease in the world, with nearly a quarter of a million people affected. Crohn’s disease and ulcerative colitis, the two main forms of IBD, cause inflammation of the intestinal tract, resulting in ulcers, severe pain, fatigue, internal bleeding, and an unpredictable and urgent need to use the washroom. People with IBD are often diagnosed at a young age, which can make the already challenging task of completing post-secondary education all the more stressful.

 

“The AbbVie IBD Scholarship is designed to assist post-secondary students at a critical time in their lives by encouraging them to pursue their studies while living with these chronic diseases,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “Dealing with the everyday stress of school can be challenging enough. When you factor in the pain and stigma felt by many people living with Crohn’s and colitis, it can be overwhelming.”

 

Since 2012, the AbbVie IBD Scholarship has supported nearly 60 Canadian students in navigating post- secondary education while living with Crohn’s or colitis by awarding scholarships that total in excess of

$250,000. Scholarship recipients are not only academically ambitious, but also actively engaged in their communities, supporting others living with IBD and raising awareness. To that end, each recipient will be sharing their story in their community and online.

 

2017 AbbVie IBD Scholarship Recipients

 

• Adrian Bulfon – Schulich School of Medicine and Dentistry, Western University
• Alexandra Cohen – McGill University
• Shira Gertsman – University of Ottawa
• Hjordis Hentschel – University of Lethbridge

 

• Leslie Hernandez – National Theatre School
• Timothy Ireland – University of Winnipeg
• Aleksandra Kacinska – Ryerson University
• Najla Kanaan – Wilfred Laurier University
• Gillian McKirdy – City University in Canada
• Emma Neary – Queen’s University
• Elliot Pitter – Dalhousie University
• Brandon Schupp – University of Toronto
• Joseph Shaw – Dalhousie University
• Veronica Slade – University of Regina
• Aaron Slobodin – Quest University Canada

 

To read more about the 2017 AbbVie IBD Scholarship recipients, visit: http://crohnsandcolitis.ca/Support-for-You/IBD-Scholarships/Recipients.

 

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About the AbbVie IBD Scholarship

Now in its sixth year, the AbbVie IBD Scholarship Program recognizes outstanding students across Canada who are living with Crohn’s disease or ulcerative colitis. Each winner is awarded an educational grant of up to $5,000 CAD. The scholarship is available to students of any age who are enrolled in a Canadian post-secondary educational institution in 2017. Visit http://crohnsandcolitis.ca/Support-for- You/IBD-Scholarships for more information.

 

 

About Crohn’s and Colitis Canada

Crohn’s and Colitis Canada is the only national, volunteer-based charity focused on finding the cures for Crohn’s disease and ulcerative colitis and improving the lives of children and adults affected by these diseases. We are one of the top two health charity funders of Crohn’s and colitis research in the world, investing over $100 million in research to date. We are transforming the lives of people affected by Crohn’s and colitis (the two main forms of inflammatory bowel disease) through research, patient programs, advocacy and awareness. Visit crohnsandcolitis.ca for more information. Follow us on Twitter, Facebook or Instagram at @getgutsycanada.

 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca or follow us on Twitter at @abbviecanada.

 

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For more information, or to arrange interviews, please contact:

 

Adam Bornstein

Smithcom Ltd. adam.bornstein@smithcom.ca 905.505.2540

 

Rasheed Clarke

Crohn’s and Colitis Canada rclarke@crohnsandcolitis.ca 416-920-5035 ext. 215

(Toronto, ON – June 7, 2017) – ABC Life Literacy Canada (ABC) is proud to announce the second year of ABC Health Matters, a health literacy program developed to help Canadians increase their confidence when talking about and making decisions regarding health issues with family, friends, and health care professionals. With the support of AbbVie Corporation and McKesson Canada, and through delivery partner University Health Network (UHN), ABC Health Matters will reach patient groups with this health care provider-led program. The ambition of ABC Health Matters is to create a healthier and more confident Canada by increasing the health literacy of all Canadians.

 

“ABC is pleased to launch the second year of ABC Health Matters to help Canadians build their confidence and knowledge to navigate the health care system,” said Mack Rogers, Executive Director, ABC Life Literacy Canada. “With the support of AbbVie, McKesson, and delivery partner UHN, we are helping learners to be more comfortable talking about their health and to become advocates for

themselves and their family to make informed decisions about their health care for an improved quality of life.”

 

An alarming 60 percent of adults and 88 percent of seniors have low health literacy (Public Health Agency of Canada). Our ability to thrive—as individuals, families, communities, and as a country—relies on good health, yet those with low health literacy are more likely to be sick, ill, or injured and have difficulty understanding and following a treatment plan. ABC Health Matters targets adults who struggle to manage their health and arms them with the knowledge to better access health care to live a more healthy life.

 

The program was piloted across Ontario last year to adult literacy programs with very positive results. Learners reported an increase in confidence to manage their own health and the health of those they care for and an increase in knowledge of their rights and responsibilities as a patient. Ninety-three percent of participants indicated they intended to be more proactive about their health and intend to ask more questions of their health care professionals going forward.

 

“We are very excited to continue our partnership with ABC and evolve our workshops to be leveraged in hospitals. We strongly believe that improving health literacy is vital to a healthier Canada.

It is through supporting such initiatives as ABC Health Matters that we are taking a step forward in making a positive impact in healthcare sustainability,” said Stéphane Lassignardie, General Manager, AbbVie.

 

ABC Health Matters program includes two workbooks, which are delivered in two, two-hour workshops. The workbooks can also be downloaded for free from our website for use at home by learners. The first workbook includes information such as how to talk about your health with your family and with your health care provider and includes practice activities and helpful sample scripts. The second workbook

 

includes information specific to the Ontario health care system and UHN network with details about services from your local pharmacist and doctor, Telehealth, and how to create a medical history card.

 

“Increasing the health literacy of patients makes them full partners in their care. ABC Health Matters is an innovative example that demonstrates how pharmacists can be a key resource in health literacy and how active participation can increase positive outcomes and improve adherence for individuals, families and communities. McKesson Canada is proud to continue to partner with ABC Health Matters to support this important initiative,” said Paula Keays, President, McKesson Canada.

 

ABC Health Matters will be delivered at three UHN locations across Toronto in workshops held during May and June. Led by McKesson pharmacist volunteers and the UHN health care team, the program will reach 150 patient-learners as well as learners across Canada accessing the program through self-led delivery. To register for a workshop or download the program workbooks for free, visit ABCHealthMatters.ca.

 

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About ABC Life Literacy Canada

ABC Life Literacy Canada is a non-profit organization that inspires Canadians to increase their literacy and essential skills. We mobilize business, government and communities to support lifelong learning and achieve our goals through leadership in programs, communications and partnerships. We envision a Canada where everyone has the skills they need to live a fully engaged life. For the latest news and information on adult literacy please visit www.abclifeliteracy.ca. Follow us on Twitter (@abclifeliteracy). For more information about ABC Health Matters visit ABCHealthMatters.ca.

 

About AbbVie Corporation

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 29,000 people worldwide and markets medicines in more than 170 countries. For more information: www.abbvie.ca on Twitter at @abbviecanada.

 

About McKesson Canada

Founded more than 100 years ago, McKesson Canada is dedicated to delivering vital medicines, supplies and information technologies that enable the healthcare industry to provide patients better, safer care. Our solutions empower pharmacies, manufacturers, hospitals and other healthcare institutions by enabling them to get closer to the millions of patients they serve every single day, while contributing to the quality and safety of care in Canada. For more information, visit www.mckesson.ca.

 

For more information, please contact:

Milena Stanoeva

Marketing and Communications Coordinator ABC Life Literacy Canada

416-218-0010 x122

mstanoeva@abclifeliteracy.ca