SDET, Subsidiary of SDT Holdings, Announces Plan to Build Battery Factory in Quebec

MONTREAL, Feb. 06, 2018 (GLOBE NEWSWIRE) — Via OTC PR Wire — SDT Holdings, Inc. / Wuhan General Group (China), Inc. (OTC PINK:WUHN) (the “Company”).

The proposed state-of-the-art, large-capacity battery facility intends to leverage the newly electric mining equipment market forecasted to reach $56 billion by 2022.

Strategic Development of Electrification Technology (SDET) is a Quebec-based enterprise that specializes in the research and development, prototyping, benchmarking and piloting of industrial batteries. The company also produces low-cost, high-performance battery cells designed for a wide range of heavy-duty industrial electric equipment. These cells are known to have exceptional autonomy and ultra-rapid recharge capabilities, without any degradation or loss of lifecycle.

The Company announced today that it plans to build a R&D laboratory and battery factory, subject to the receipt of mandatory governmental permits along with the solidification of required debt and equity financing. “We are currently in discussion with partners and city officials,” stated Ramy Kamaneh, CEO of SDT Holdings, Inc.

The key companies profiled to use the batteries produced in the new factory include Caterpillar Inc., Komatsu Ltd., Sandvik, Joy Global Inc., Hitachi Construction Machinery Co. Ltd., Atlas Copco and AB Volvo.

The Company anticipates the construction to begin no later than the second quarter of this fiscal year. Phase One is estimated to take five months to complete and Phase Two, nine months. Once fully operational, the facility is projected to be a home base for 25 new permanent jobs with the expectation that more jobs will be created as production ramps up.

About the new factory announcement, Ramy Kamaneh states, “By building a cutting-edge battery factory along the Quebec mining region, which is in direct proximity to lithium, graphite and other primary materials needed to build the battery, we put ourselves in an advantageous supply situation, while reducing our costs significantly. By providing batteries to the mining industry both nationally and internationally, forecast numbers show that we are poised to earn substantial additional revenues in the years to come.”

About

SDT Holdings, Inc. is a Montreal-based industrial technology holding company that focuses on the development, production and commercialization of its four subsidiaries, specialized in these areas: mining electrification, cryptocurrencies / blockchain, industrial batteries, internet of things and artificial intelligence for the industrial market. Dedicated to supplying quality, innovative technologies and battery solutions, SDT Holdings services the transport, mining, agricultural, industrial and earthmoving industries.

SDT Holdings, Inc
Publicly traded company (OTC Pink:WUHN)
Website: www.sdtholdings.com
For further information contact:
Phone: (514) 928-7368
E-mail: info@sdtholdings.com

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that would cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

 

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AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™ – an oral therapy for the treatment of patients with hepatitis C

  • 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.

SDT Holdings, Inc./ Wuhan General Group (China), Inc. (OTC PINK: WUHN) Announces Corporate Update

MONTREAL, Jan. 26, 2018 (GLOBE NEWSWIRE) — Via OTC PR Wire — SDT Holdings, Inc. / Wuhan General Group (China), Inc. (OTC PINK:WUHN) (the “Company”).

The Parent Company announces the following updates and developments:

  • Former officers and board of directors have stepped down from their position in the company while simultaneously appointing Ramy Kamaneh as the new President and CEO of Wuhan General Group (China), Inc.
  • The custodianship has been discharged and return control to Wuhan General Group Board of Directors.
  • Appointed lawyer firm BOOTH UDALL FULLER to expedite further transactions.
  • OTC filings and corporate profile, FINRA, State of Nevada name change all in progress.
  • Corporate website in development.
  • Currently interviewing auditors for compliance and up listing to a higher market place.
  • SDT Holdings, Inc. is finalizing the RTO transaction with Wuhan General Group (China), Inc.

The Company will be announcing in next week’s corporate updates and developments (letter of intent, joint ventures, partnerships, acquisitions, contracts …) regarding its subsidiaries.

“We have engaged the right resources in getting the Company current in a timely fashion as well as other related transactions. Also, would like to thank all my team for their effort to build this great future Nasdaq company as well as for all the interest and support from our current and prospective investors,” stated Ramy Kamaneh, CEO of SDT Holdings, Inc.

About

SDT Holdings, Inc. is a Montreal-based industrial technology holding company that focuses on the development, production and commercialization of its 4 subsidiaries: Mining Electrification, Cryptocurrencies/blockchain, Industrial Batteries, Internet of Things and Artificial Intelligence for the industrial market. We are dedicated to supplying quality, innovative technologies and battery solutions for the Transport, Mining, Agricultural, Industrial and Earthmoving Industries.

SDT Holdings, Inc.
Publicly traded company (USOTC Pink: WUHN)
Website: www.sdtholdings.com
For further information contact:
Phone: (514) 928-7368
E-mail: info@sdtholdings.com

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that would cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

 

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SDT Holdings, Inc. / Wuhan General Group (China), Inc. (OTC PINK: WUHN) Announces First Corporate Press Release

MONTREAL, Jan. 23, 2018 (GLOBE NEWSWIRE) — Via OTC PR Wire — SDT Holdings, Inc. / Wuhan General Group (China), Inc. (OTC PINK:WUHN) (the “Company”).

SDT Holdings, Inc. is a Montreal-based industrial technology parent company that focuses on the development, production and commercialization of its subsidiaries: Mining Electrification, Cryptocurrencies/blockchain, Industrial Batteries and Internet of Things / Artificial Intelligence for the industrial market. We are dedicated to supplying quality, innovative technologies and battery solutions for the Transport, Mining, Agricultural, Industrial and Earthmoving Industries.

The Company will be announcing in the coming days a sequence of corporate updates and developments (joint ventures, acquisitions, contracts …) regarding the parent company as well as its subsidiaries. Let this be the start in establishing trust and transparency with our current and prospective investors.

“We have spent a lot of time and resources in getting the Company reinstated with the state of Nevada as well as other transactions and we couldn’t be more excited for what’s to come. 2018 will be a great year for us and our shareholders,” stated Ramy Kamaneh, CEO of SDT Holdings, Inc.

Communication
In addition, the Company would like to take the opportunity to inform shareholders that it will be using its twitter account for weekly update and press release for its major announcements. Please sign up to our newsletter on your coming soon webpage or e-mail at info@sdtholdings.com. We welcome shareholder questions.

About
SDT Holdings, Inc. is a Montreal-based industrial technology holding company that focuses on the development, production and commercialization of its 4 subsidiaries: Mining Electrification, Cryptocurrencies/blockchain, Industrial Batteries, Internet of Things and Artificial Intelligence for the industrial market. We are dedicated to supplying quality, innovative technologies and battery solutions for the Transport, Mining, Agricultural, Industrial and Earthmoving Industries.

SDT Holdings, Inc
Publicly traded company (OTC Pink: WUHN)
Website: www.sdtholdings.com
For further information contact:
Phone: (514) 928-7368
E-mail: info@sdtholdings.com

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that would cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

Nail psoriasis data now part of HUMIRA® label

  • 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

More Canadians have access to HUMIRA® (adalimumab) for the treatment of Ulcerative Colitis (UC)

  • 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

Vireo Health to Participate in $3.8 million NIH Study on Medical Marijuana, Pain and Opioid Use

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AbbVie’s MAVIRET™ Approved by Health Canada for the Treatment of Chronic Hepatitis C in All Major Genotypes

  • MAVIRET is the first and only 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment*1
  • The approval is supported by a 97 percent (n=639/657) cure** rate across GT1-6 patients without cirrhosis and who are new to treatment2
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

 

MONTREAL, QC, August 17, 2017 – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that Health Canada has granted approval 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). 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.

 

“Despite recent advances in HCV treatment, physicians still face challenges treating patients with less common genotypes and those with other complicating health conditions,” said Dr. Morris Sherman, MD, FRCPC, Chairperson, Canadian Liver Foundation. “In order to eliminate hepatitis C in Canada, we need to identify all those living with the virus and have effective treatment options for everyone. This new therapy provides another tool for physicians to expand treatment to a greater number of patients while at the same time shortening the duration which may lead to cost savings for the health care system.”

 

MAVIRET is also approved for use in 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), those GT1 patients not previously cured with certain direct-acting antiviral (DAA) treatment, and those with GT3 chronic HCV infection.2 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.2

 

“With the approval of MAVIRET, we are proud to bring the hope of a new cure to people living with hepatitis C in Canada, reflecting AbbVie’s dedication to addressing critical unmet needs for patients,” said Stéphane Lassignardie, General Manager, AbbVie Canada. “MAVIRET is designed to deliver a virologic cure for most HCV patients including those with specific treatment challenges. AbbVie will continue to work with local health authorities and stakeholders across Canada to get our treatment to as many patients as possible.”

 

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).

 

Approximately 300,000 Canadians are infected with hepatitis C.3 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.4 GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.3,5 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to

30 percent within 20 years6 of infection. Additionally, HCV is common among people with severe CKD, and some of these patients previously did not have a DAA-based treatment option.7

 

With 8 weeks of treatment, 97 percent (n= 639/657) of GT1-6 patients without cirrhosis and who were new to treatment achieved a virologic cure.1 These high cure rates were achieved in patients with varied patient and viral characteristics and including those with CKD.2 Additionally, 97.5 percent (n=274/281) of patients with compensated cirrhosis achieved a virologic cure with the recommended duration of treatment, including patients with CKD.2 In registrational studies for MAVIRET, less than 0.1 percent of patients permanently discontinued treatment due to adverse reactions.2 The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.2

 

“In an extensive clinical trial program, patients achieved high cure rates with MAVIRET regardless of genotype, fibrosis score, viral load, and even in patients with resistant virus strains and those with chronic kidney disease,” said Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist, Director of the Toronto Liver Centre. “In clinical practice, MAVIRET has the potential to simplify treatment decisions for physicians, offering, in one therapy, a cure for the majority of HCV patients and cutting out pre-testing before treatment initiation.”

 

MAVIRET combines two new, potent direct-acting antivirals that target and inhibit proteins essential for the replication of the hepatitis C virus.2 The presence of most genotypes or baseline mutations that are commonly associated with resistance have been shown to have no relevant impact on efficacy. 2

 

Canadians prescribed MAVIRET will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature patient support program designed to provide a wide range of services including reimbursement assistance, education and ongoing disease management support. AbbVie Care will support people living with HCV throughout their treatment journey to achieve high cure rates in the real world.

 

Approval of MAVIRET followed Health Canada’s Priority Review process, which is granted to new medicines intended for patients with a life-threatening disease where there is no existing treatment with the same profile or where the new product represents a significant improvement in the benefit/risk profile over existing products.8 AbbVie’s investigational, pan-genotypic regimen was also recently approved by the European Commission and the U.S. Food and Drug Administration.

 

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,* such patients comprising the majority of people living with HCV.1 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-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.

 

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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 Messina, JP et al. “The global distribution of HCV genotypes.” Hepatology, 2015; 61: 77–87. Supporting information hep27259- sup-0001-suppinfo.pdf. Accessed August, 2017.

4 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 August, 2017.

5 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.

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

7 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10. 8 Priority Review of Drug Submissions. Government of Canada. https://www.canada.ca/en/health-canada/services/drugs- health-products/drug-products/fact-sheets/priority-review-drug-submissions-therapeutic-products.html. Accessed August, 2017.

Introducing the 2017 AbbVie IBD Scholarship Recipients

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.

 

xxx

 

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

AbbVie IBD Scholarship expands in celebration of Canada 150

Toronto, ON – June 28, 2017 – In celebration of Canada 150, Crohn’s and Colitis Canada and AbbVie announced today that five additional AbbVie IBD Scholarships of up to $5,000 will be awarded to students who live with Crohn’s disease or ulcerative colitis for the upcoming school year, bringing the total number of scholarships offered to 15.

 

“Canada has one of the highest rates of inflammatory bowel disease (IBD) in the world, with most cases diagnosed in individuals between the ages of 15 and 30,” said Mina Mawani, President and CEO of Crohn’s and Colitis Canada. “As one in 150 Canadians live with Crohn’s disease or ulcerative colitis, Canada 150 is an important opportunity to raise awareness of these chronic diseases, and these scholarships benefit young Canadians during a difficult time in their lives.”

 

“This year, Crohn’s and Colitis Canada received a record number of scholarship applications at just under

  1. The recipients of the scholarship will be determined by the selection committee,” said Kate Lee, Vice President, Research and Patient Programs.

 

“We are extremely proud of our longstanding partnership with Crohn’s and Colitis Canada on the AbbVie IBD Scholarship Program,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “Since 2012, the AbbVie IBD Scholarship has supported nearly 60 Canadian students navigating post-secondary education while living with a chronic disease and we are pleased to extend our support to even more youth this year in celebration of Canada 150.”

 

Past recipients of the AbbVie IBD Scholarship credit the program for helping them focus on their studies while offering a platform to share their advice and experience with other students living with Crohn’s or colitis. Rachel Meehan received the scholarship in 2016 while completing her master’s degree from the University of Guelph. “During my undergrad, I took on too much at once and didn’t appropriately manage the symptoms of my Crohn’s disease,” said Meehan. “Receiving the AbbVie IBD Scholarship meant one less thing to worry about when I returned to school for my master’s degree.”

 

The five additional recipients will be selected from applications received during the initial call for applications, which closed on June 1, 2017.

 

 

 

 

 

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About the AbbVie IBD Scholarship

In its sixth year, the annual AbbVie IBD Scholarship Program will recognize 15 individuals 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 ibdscholarship.ca 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

 

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

 

Corey Michaels

Smithcom Ltd. corey.michaels@smithcom.ca 416-894-4704

 

Rasheed Clarke

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