Life Science News

  • Timing of elimination of the hepatitis C virus (HCV) in Canada's provinces indicates 70% of provinces could reach the World Health Organization's (WHO) HCV elimination target of 2030, however three of Canada's provinces — two of them the most populous in the country — are off track to achieve this hepatitis C elimination goal. 1
  • Timely elimination would save 170 lives and $122.6 million in direct medical costs in these three provinces by 2030. 1
  • The Progress Report developed by Action Hepatitis Canada outlines key metrics on which to evaluate HCV elimination progress in Canada , specific to each province. 2
  • In Canada , there are five priority populations and one age-cohort that carry the largest burden of HCV and are recognized as being affected the most by the virus.

ABBVie (NYSE: ABBV) supports a wide range of efforts to help elevate and prioritize hepatitis C virus (HCV) elimination. With a recent publication indicating 70% of Canada's provinces are on track to reach HCV elimination by the World Health Organization's (WHO) initial proposed target of 2030 1 it is important to turn our attention on those affected by the virus and acknowledge that infection with chronic HCV is a global public health concern.

The Impact of Inaction: Timing of Hepatitis C Elimination in Canada. (CNW Group/AbbVie Canada)

In 2016, Canada was one of the 194 countries that committed to support the World Health Organization's (WHO) goal of eliminating viral hepatitis as a public health threat by 2030. With the remarkable progress in HCV therapy, offering the ability to cure patients, this goal seemed possible.

"With the decline in treatment across Canada , it is particularly critical we continue to monitor treatment levels to assess Canada's progress to HCV elimination," said Jordan J Feld, MD MPH, Interim Director, Toronto Centre for Liver Disease, University Health Network, University of Toronto . "We need to continue to pursue novel approaches to case finding and linkage to care, as well as work closely with identified priority populations to ensure that they are able to seek prevention and treatment services without facing stigma and other barriers in the health care system. At the policy level, we need to improve our data sharing abilities across the country to ensure we can track our progress toward elimination."

Populations Most Affected by HCV in Canada 3

  • Indigenous people
  • People with experience in the prison system
  • People born between 1945 and 1975
  • Immigrants and newcomers
  • Gay, bisexual, men who have sex with men (gbMSM)
  • People who inject or use drugs

" Canada has made great strides toward the elimination of hepatitis C. However, there is a lot more work to be done, and the tactics that got us to this point will not necessarily get us to elimination," said Jennifer van Gennip , Executive Director, Action Hepatitis Canada. "Our mandate is to hold the federal and provincial governments accountable to provide the policies and resourced plans to achieve our goal, with focused efforts on priority populations within Canada ."

A look at national treatment data from January 2019 to November 2020 4 confirmed the decreasing trend in treatment levels nationally - a year-over-year decline of 31% in total treatment levels between 2019 and 2020. The report notes that this drop could be due to the disruptions to the healthcare system caused by the COVID-19 pandemic but could also reflect the saturation of treatment among those already linked to care and the difficulties with finding and engaging with individuals and populations not well served by our various healthcare systems. 1

"Everyone has a part to play in eliminating viral hepatitis as it will take more than medicine to achieve this goal," said Tracey Ramsay , Vice-president and General Manager, AbbVie Canada. "AbbVie is committed to partnering with stakeholders to implement sustainable solutions that allow more patients to be screened, linked to care, and treated in a timely manner, especially for those vulnerable patient populations that have lost access to our healthcare system as a result of the pandemic."

Given the available evidence, Canada's momentum towards timely HCV elimination may be jeopardized if diagnosis and treatment are not maintained at appropriate levels. Improved HCV surveillance to build frameworks and innovative approaches to prevention, testing, linkage to care and treatment to achieve this goal is required.

About Hepatitis C

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have the disease. 5 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada . 6 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Twitter , Instagram and LinkedIn.


1 Timing of elimination of hepatitis C virus in Canada's provinces. https://canlivj.utpjournals.press/doi/full/10.3138/canlivj-2022-0003 . Accessed November 2022.


2 Action Hepatitis Canada. Progress Toward Viral Hepatitis Elimination in Canada. 2021 Report. https://www.actionhepatitiscanada.ca/uploads/8/3/3/9/83398604/ahc_progress_report_2021.pdf . Accessed November 2022.


3 Action Hepatitis Canada. Priority Populations. https://www.actionhepatitiscanada.ca/priority-populations.html . Accessed November 2022.


4 IQVIA GPM National Audit for HCV/Direct Acting Antivirals Market, January 2019–November 2020.


5 Canadian Liver Foundation. https://www.liver.ca/hepatitis-c-warning/ . Accessed November 2022.


6 Canadian Liver Foundation. https://www.liver.ca/how-you-help/advocate/ . Accessed November 2022.

AbbVie logo (CNW Group/AbbVie Canada)

SOURCE AbbVie Canada

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2022/24/c4530.html

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
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 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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Kite and Daiichi Sankyo Announce Changes to YESCARTA® CAR T-Cell Therapy Licensing Agreement in Japan

Daiichi Sankyo to Transfer Yescarta Marketing Authorization in Japan to Gilead Sciences K.K. –

Kite Cell Therapy Business Unit at Gilead Sciences K.K. Will Manage the Sales and Promotion Activities in Japan After the Marketing Authorization Transfer –

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Aptose to Hold Clinical Update and Data Review of AML Drug Tuspetinib on Sunday, December 11th

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that the company's management team will provide a corporate update on Sunday, December 11, 2022, at 10:00 AM EST 9:00 CST, in conjunction with poster presentations at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, being held in New Orleans, LA. The webcast event will include a comprehensive review of current clinical data for Aptose's lead compound tuspetinib, formerly HM43239, a myeloid kinase inhibitor, as well as an update on luxeptinib, Aptose's oral, dual lymphoid and myeloid kinase inhibitor.

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The Gummy Project Enters State of Texas with Purchase Order from 5-star Luxury Hotel Located in Austin, Texas

The Gummy Project Enters State of Texas with Purchase Order from 5-star Luxury Hotel Located in Austin, Texas

  • Purchase Order from 5-star luxury hotel in Austin, Texas marks the achievement of another milestone in The Gummy Project's ongoing highly strategic multi-channel sales strategy
  • The Peachy Bees and Watermelon Sharks are expected to be for sale in each of the hotel's guest room private bars

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order for its Peachy Bees and Watermelon Sharks from a 5-star luxury hotel located in Austin, Texas (the "Luxury Hotel").

"Entering an additional US state and having our gummies for sale at this Luxury Hotel is another significant achievement for the Company as we continue to expand in both Canada and the US," said Charlie Lamb, President and CEO of GUMY.

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New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer

Late-Breaking TROPiCS-02 Analysis Shows that Trodelvy Demonstrates Consistent Efficacy Across Trop-2 Expression Levels –

Trop-2 is Highly Expressed in 90% of Breast Cancers

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AbbVie Launches Strategic Collaboration with HotSpot Therapeutics to Further Expand Immunology Pipeline

  • Collaboration leverages HotSpot's Smart Allostery™ drug discovery platform for the development of the first and only small molecule IRF5 (interferon regulatory factor 5) inhibitor for the potential treatment of autoimmune diseases
  • HotSpot to receive an upfront cash payment of $40 million with potential for further milestones and royalties

ABBVie (NYSE: ABBV) and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, today announced an exclusive worldwide collaboration and option to license agreement for HotSpot's discovery-stage IRF5 program for the treatment of autoimmune diseases.

"This collaboration with HotSpot has the potential to deliver an entirely new target class of modulators to patients with serious autoimmune diseases, such as systemic lupus erythematosus, and will help to further strengthen our robust immunology pipeline," said Jonathon Sedgwick , Ph.D., vice president and global head of discovery research, AbbVie.  "HotSpot's drug discovery platform has been able to identify molecules that bind to IRF5 in a predictable, reproducible manner potentially enabling effective drugging of what has been considered an undruggable target."

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The Gummy Project Officially Launches in U.S. Market with Ecommerce Site and Nationwide Shipping

The Gummy Project Officially Launches in U.S. Market with Ecommerce Site and Nationwide Shipping

  • U.S. customers can now purchase Watermelon Sharks and Peachy Bees at www.shopgummies.com.
  • Product is shipped nationwide across the U.S. within 5-7 days.

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce the official launch of its U.S. ecommerce site at www.shopgummies.com.

"We are excited to officially launch our products into the U.S. market, which is a major milestone for the company," said Charlie Lamb, CEO at GUMY. "We are now ready to ship product to all 50 states, which represents a tremendous growth opportunity for the Company beyond the existing Canadian market."

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