-- Veklury is Now Recommended by the WHO for Use in Both Non-Severe COVID-19 Patients at the Highest Risk of Hospitalization and Patients with Severe COVID-19 --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced updates to the World Health Organization's (WHO) Therapeutics and COVID-19: living guideline , which now conditionally recommends Veklury ® (remdesivir) for the treatment of patients with severe COVID-19 and continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization.
The WHO conditional recommendation for Veklury's use in the treatment of patients with severe COVID-19 is mainly driven by the final results of the WHO-sponsored SOLIDARITY study, which showed a statistically significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline, compared to standard of care (RR: 0.83; 95% CI: 0.75–0.93). Additionally, SOLIDARITY showed a statistically significant 13% lower relative risk of mortality with Veklury treatment for those patients hospitalized on supplemental oxygen and not requiring mechanical ventilation, compared with standard of care (RR: 0.87; 95% CI: 0.76–0.99). In the study, Veklury had no significant effect on patients with COVID-19 who were already being ventilated. These findings complement results from the National Institute of Allergy and Infectious Diseases' double-blind placebo-controlled ACTT-1 trial, in which a mortality reduction was seen in Veklury-treated patients on low flow oxygen at baseline, as compared to placebo, in a post-hoc subgroup analysis (HR: 0.30; 95% CI: 0.14–0.64). Veklury did not demonstrate a mortality benefit in the overall population or other baseline oxygen subgroups in either ACTT-1 or SOLIDARITY.
"When the full results of SOLIDARITY were published in May 2022, it showed that Veklury reduced mortality and progression to ventilation for those patients who were oxygenated and not ventilated. These findings are consistent with other studies, such as ACTT-1," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "The WHO guideline plays an important part in informing COVID-19 treatment in many parts of the world. We are pleased this guideline update reflects the critical role that Veklury plays in helping to reduce disease progression or death from COVID-19. Veklury and generic remdesivir have been made available to more than 11 million patients around the world, and it's the only antiviral treatment recommended by the WHO for both patients at high risk of progression not requiring oxygen and those requiring supplemental oxygen."
In the WHO guideline, patients with severe COVID-19 are defined as those with oxygen saturation less than 90% on room air, signs of pneumonia and/or signs of severe respiratory distress; it does not include critically ill patients on mechanical ventilation. Numerous credible national and international organizations, including the U.S. National Institutes of Health (NIH) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), recommend Veklury for the treatment of COVID-19 across a broad spectrum of disease severity, including both non-severe COVID-19 patients at high risk of hospitalization and patients with severe COVID-19.
"The WHO's latest COVID-19 guideline update will help further expand access for remdesivir to those with more significant disease who are in need of effective treatment options," said Dr. Elizabeth Sapey, BSc, MBBS, PhD, FRCP, Professor of Acute and Respiratory Medicine at the Institute of Inflammation and Ageing, University of Birmingham. "With this new recommendation, the WHO guideline now better reflects the full body of evidence supporting remdesivir's role in COVID-19 treatment and aligns more closely with recommendations in most major guidelines and protocols."
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research. Remdesivir has an established safety profile and minimal drug interactions in diverse populations. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury was approved by the FDA in October 2020, for adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. In January 2022, the FDA approved a sNDA to expand the indication to non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. This allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days. In April 2022, Veklury was approved by the FDA for the treatment of pediatric patients over 28 days old and weighing at least 3 kg who are hospitalized or not hospitalized and at high risk of progression to severe COVID-19, including hospitalization or death. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.
Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Due to Veklury's mechanism of action, it has a high barrier to resistance. In vitro laboratory testing in multiple independent studies show that Veklury continues to demonstrate durable activity against SARS-CoV2 as it evolves, including the Delta variant and Omicron variants BA.4 and BA.5. As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead's existing commitment to enabling broad patient access to remdesivir.
U.S. Indication for Veklury
Veklury ® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (at least 28 days old and weighing at least 3 kg) with positive results of SARS-CoV-2 viral testing, who are:
For more information, please see the U.S. full Prescribing Information available at www.gilead.com .
U.S. Important Safety Information for Veklury
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury; the risk that physicians may not see the benefits of prescribing Veklury for the treatment of severely ill patients with COVID-19; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Veklury is available at www.gilead.com .
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220915005509/en/
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Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform
This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.
Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.
Justin Beck, Chief Visionary Officer ("CVO") for Contakt World, said, "National health equity leader Daniel E. Dawes teaches us that you can't fix problems you don't understand via data. The systemic omission or destruction of racial and ethnic data in public health and healthcare systems mean that disparities often aren't addressed politically - sometimes by design."
He added, "We learned about this on Episode 2 of Contakt World: Truth in Health on iHeartRadio entitled 'COVID The Great Revealer' in my exclusive interview with Daniel E. Dawes, and through Daniel's book published by Johns Hopkins University Press: The Political Determinants of Health. We learned about the oppression of data again, particularly among American Indian and Alaska Natives, speaking with Abigail Echo-Hawk, Chief Research Officer at Seattle Indian Health Board and Director of the Urban Indian Health Institute, on Episode 8 of Contakt World: Truth in Health entitled 'General Disparities? Or Data Genocide?'"
A long-term initiative of the leading institution Satcher Health Leadership Institute at Morehouse School of Medicine ("SHLI"), Health Equity Tracker ("HET") was designed to improve collection and transparency for key demographic data so we can address disparities in healthcare and ultimately improve outcomes for the most vulnerable among us who have suffered from 150+ years systemic inequities. HETP was designed through SHLI's Health Equity Task Force, which involved thought leadership from leaders all over the country in health equity, public health, healthcare, pandemic response, epidemiology, members of Congress in the United States, and Contakt World's co-founder and board member Robin Coleman, a publisher for Johns Hopkins University Press. Funding from Google.org, Gilead Sciences, Annie E. Casey Foundation, and CDC Foundation enabled the project in its formative stages.
"Since the launch of our Health Equity Task Force, Contakt World has been a critical partner in propelling actionable solutions and thought leadership into action," said Daniel E. Dawes. "Now that the HET is operational, Smart Health RM can help collect de-identified data from public health agencies and healthcare where gaps exist as a data partner for Health Equity Tracker. Engagency can also help to identify underserved populations and drive them to their local health department or provider, leveraging Contakt World's agency partnership with Unified Partnerships via iHeartMedia."
"Health agencies, organizations like National Association of County and City Health Officials ("NACCHO"), and public health professionals prioritize health equity in all they do. We hope our data partnership with HET continues to distinguish Contakt World, much like our innovation around communications and community engagement does," added CVO Beck.
Contakt World will soon launch vaccine hesitancy ads targeting unvaccinated populations in hard-to-reach areas for SHLI in a project that included funding from Google.org and Gilead Sciences. Beck finished by saying "I want to emphasize that our long-term view as a ‘phygital' world involves integration of advertising, calls to action, and our SaaS solutions. I believe we can transform the way health agencies and providers connect with their communities, which could improve health outcomes, especially for the hard to reach who suffer from disparities."
Contakt World Contact Zayn Kalyan Interim CEO and Director Direct: 778-938-3367
For more information, please visit the Company's website at www.contakt.world.
Contakt World Investor Contact Lucas A. Zimmerman Senior Vice President - MZ North America Direct: 949-259-4987 contakt@mzgroup.us www.mzgroup.us
Certain information set forth in this press release contains statements that reflect "forward-looking information", as such term is defined under Canadian securities laws ("forward-looking statements"). These forward-looking statements are often identified by words such as "intends", "anticipates", "expects", "believes", "plans", "likely" or similar words. Specifically, this news release includes forward-looking statements regarding: the Company's partnership with SHLI; the HET program's intention and implementation; the planned integration of Smart Health RM and Engagency into the HET program; Contakt's intention to launch vaccine hesitancy ads for SHLI; the Company's long-term view and future business plans. The forward-looking statements reflect the Contakt World's management's expectations, estimates, or projections concerning future results or events, based on the opinions, assumptions and estimates considered reasonable by management at the date the statements are made. Although Contakt World believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements involve risks and uncertainties and undue reliance should not be placed on forward-looking statements, as unknown or unpredictable factors could cause actual results to be materially different from those reflected in the forward-looking statements. The forward-looking statements may also be affected by risks and uncertainties in the business of Contakt World, including those described in the Company's public filings available on www.SEDAR.com. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change, except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
The Canadian Securities Exchange (CSE) has not reviewed, approved or disapproved the content of this news release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92368
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Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform
Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.
Justin Beck, Chief Visionary Officer ("CVO") for Contakt World, said, "National health equity leader Daniel E. Dawes teaches us that you can't fix problems you don't understand via data. The systemic omission or destruction of racial and ethnic data in public health and healthcare systems mean that disparities often aren't addressed politically - sometimes by design."
He added, "We learned about this on Episode 2 of Contakt World: Truth in Health on iHeartRadio entitled 'COVID The Great Revealer' in my exclusive interview with Daniel E. Dawes, and through Daniel's book published by Johns Hopkins University Press: The Political Determinants of Health. We learned about the oppression of data again, particularly among American Indian and Alaska Natives, speaking with Abigail Echo-Hawk, Chief Research Officer at Seattle Indian Health Board and Director of the Urban Indian Health Institute, on Episode 8 of Contakt World: Truth in Health entitled 'General Disparities? Or Data Genocide?'"
A long-term initiative of the leading institution Satcher Health Leadership Institute at Morehouse School of Medicine ("SHLI"), Health Equity Tracker ("HET") was designed to improve collection and transparency for key demographic data so we can address disparities in healthcare and ultimately improve outcomes for the most vulnerable among us who have suffered from 150+ years systemic inequities. HETP was designed through SHLI's Health Equity Task Force, which involved thought leadership from leaders all over the country in health equity, public health, healthcare, pandemic response, epidemiology, members of Congress in the United States, and Contakt World's co-founder and board member Robin Coleman, a publisher for Johns Hopkins University Press. Funding from Google.org, Gilead Sciences, Annie E. Casey Foundation, and CDC Foundation enabled the project in its formative stages.
"Since the launch of our Health Equity Task Force, Contakt World has been a critical partner in propelling actionable solutions and thought leadership into action," said Daniel E. Dawes. "Now that the HET is operational, Smart Health RM can help collect de-identified data from public health agencies and healthcare where gaps exist as a data partner for Health Equity Tracker. Engagency can also help to identify underserved populations and drive them to their local health department or provider, leveraging Contakt World's agency partnership with Unified Partnerships via iHeartMedia."
"Health agencies, organizations like National Association of County and City Health Officials ("NACCHO"), and public health professionals prioritize health equity in all they do. We hope our data partnership with HET continues to distinguish Contakt World, much like our innovation around communications and community engagement does," added CVO Beck.
"Since the launch of our Health Equity Task Force, Contakt World has been a critical partner in propelling actionable solutions and thought leadership into action," said Daniel E. Dawes. "Now that the HET is operational, Smart Health RM can help collect de-identified data from public health agencies and healthcare where gaps exist as a data partner for Health Equity Tracker. Engagency can also help to identify underserved populations and drive them to their local health department or provider, leveraging Contakt World's agency partnership with Unified Partnerships via iHeartMedia."
Contakt World Contact Zayn Kalyan Interim CEO and Director Direct: 778-938-3367
For more information, please visit the Company's website at www.contakt.world.
Contakt World Investor Contact Lucas A. Zimmerman Senior Vice President - MZ North America Direct: 949-259-4987 contakt@mzgroup.us www.mzgroup.us
Certain information set forth in this press release contains statements that reflect "forward-looking information", as such term is defined under Canadian securities laws ("forward-looking statements"). These forward-looking statements are often identified by words such as "intends", "anticipates", "expects", "believes", "plans", "likely" or similar words. Specifically, this news release includes forward-looking statements regarding: the Company's partnership with SHLI; the HET program's intention and implementation; the planned integration of Smart Health RM and Engagency into the HET program; Contakt's intention to launch vaccine hesitancy ads for SHLI; the Company's long-term view and future business plans. The forward-looking statements reflect the Contakt World's management's expectations, estimates, or projections concerning future results or events, based on the opinions, assumptions and estimates considered reasonable by management at the date the statements are made. Although Contakt World believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements involve risks and uncertainties and undue reliance should not be placed on forward-looking statements, as unknown or unpredictable factors could cause actual results to be materially different from those reflected in the forward-looking statements. The forward-looking statements may also be affected by risks and uncertainties in the business of Contakt World, including those described in the Company's public filings available on www.SEDAR.com. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change, except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
The Canadian Securities Exchange (CSE) has not reviewed, approved or disapproved the content of this news release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92368
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HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.
As quoted in the press release:
HOOKIPA and Gilead Sciences designed and tested multiple arenaviral vectors expressing HIV and HBV immunogens, optimizing each for potential preclinical immunogenicity, safety and manufacturability. In 2019, HOOKIPA earned multiple Gilead milestone payments for the delivery of research vectors and advancing the programs closer to clinical studies. On the basis of promising preclinical data, Gilead has committed to preparations to advance the HBV and HIV vectors toward development, with the HBV development decision triggering an additional milestone payment to HOOKIPA. To enable the development activities and expanded research programs, Gilead has agreed to reserve manufacturing capacity and expanded the HOOKIPA resources allocated to the Gilead collaboration.
Click here to read the full press release.
Kite, a Gilead Company (Nasdaq: GILD), today announced results from an ongoing Phase 1 study conducted by the National Cancer Institute (NCI) showing that clinical responses were observed with investigational T cell receptor (TCR) cell therapy targeting human papillomavirus type 16 (HPV-16) E7 in solid tumor cancers caused by HPV. These findings were presented today in a poster session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #3043).
As quoted in the press release:
Partial responses (Response Evaluation Criteria in Solid Tumors (RECIST); RECIST 1.1) were observed in three out of the seven evaluable patients and another two patients had stable disease. To date, the responses have lasted as long as nine months and have occurred in patients with vulvar, oropharyngeal and anal cancer. Two of these patients had been previously treated with anti-PD1 checkpoint blockade.
“Metastatic HPV-cancers are incurable and poorly addressed by standard therapies,” said Christian S. Hinrichs, MD, Lasker Clinical Research Scholar at the Center for Cancer Research’s Experimental Transplantation and Immunology Branch (ETIB) at the NCI and lead study investigator. “The early results from this Phase 1 trial support the continued evaluation of TCR therapy in HPV-associated cancers.”
Click here to read the full press release.
Gilead Sciences (NASDAQ:GILD) shared the promotion of Dr. Alessandro Riva to executive vice president of Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs. As quoted in the press release:
Dr. Riva will become a member of Gilead’s senior leadership team. Dr. Riva joined Gilead in January 2017 as Senior Vice President, Hematology and Oncology Therapeutic Area Head. He has been instrumental in expanding Gilead’s oncology program with the recent acquisition of Kite Pharma, establishing the company as a leader in the field of cellular therapy. He has also guided the strategy and development of Gilead’s broader oncology pipeline during his tenure.
Click here to read the full press release.
The Gummy Project (CSE: GUMY) (FSE: 0OS0) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the Virgin Hotels Chicago to become a supplier of gummies for each of the hotel's 250 guest room mini-bars.
"We continue to meticulously execute our strategic expansion in the US and are super excited to add the Virgin Hotels Chicago to the list of hotels that will have our gummies for sale in each of the guest rooms," said Charlie Lamb, President & CEO of GUMY. "We plan to add additional hotels in both the US and Canada in the very near future and very much look forward to capitalizing on this momentum that we have created since launching only a few short months ago."
The purchase order was received from the Virgin Hotels Chicago on September 28, 2022. This captivating Chicago hotel is located in the heart of the Loop in downtown Chicago steps from The Magnificent Mile and Millennium Park. This first class, stylish hotel is the first of its kind with incredible food options and work and play at your fingertips.
Virgin Hotel's sustainability platform aims to meet the needs of today without compromising tomorrow and this reflected in its truly green recycling, efficiency, energy and air quality standards which help create a new standard and better environment for all.
"Virgin Hotels Chicago is dedicated to operating in a sustainable fashion while providing each of its guests with only the most enjoyable and personalized stay experiences and we are thrilled that our Peachy Bees and Watermelon Sharks will now play a role in achieving these goals," said Anthony Gindin, Chief Marketing Officer at GUMY.
The Company also to announces that it has issued a total of 1,700,000 options pursuant to its incentive stock option plan ("Plan") to directors, employees, and consultants. Each option entitles the holder to subscribe for one common share of the Company for $0.05 for a period of 5 years, subject to the terms of the Plan.
We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.
Charlie Lamb, President & CEO, Director Telephone: 1(236) 317-2812 - Toll free 1(888) 556-9656 E-mail: investors@shopgummies.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138791
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ABBVie (NYSE: ABBV) today revealed the spectrum of new data from studies of risankizumab (SKYRIZI ® ) in Crohn's disease and upadacitinib (RINVOQ ® ) in ulcerative colitis and Crohn's disease that will be presented as live presentations and e-Posters at the United European Gastroenterology (UEG) Week 2022, October 8-11 in Vienna and online. In total, ABBVie is presenting 17 abstracts across a broad range of studies in inflammatory bowel disease (IBD).
"With two decades of world-class science and an unwavering commitment to patients, we continue to advance research within our robust gastro portfolio with the goal of positively impacting the lives of people living with inflammatory bowel disease," said Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical Affairs, Immunology, AbbVie. "Our data at UEG Week 2022 reinforce our dedication to innovation and partnership with the gastroenterology community to help address a wide range of patient needs and investigate diverse solutions to help advance standards of care for IBD patients."
Key data to be presented include:
* The use of upadacitinib and risankizumab are investigational in Crohn's disease in the European Union.
AbbVie abstracts in the UEG Week 2022 program include:
Session Details (All Times CEST)
Induction and Maintenance Treatment with Risankizumab Leads to Symptomatic Relief in Patients with Moderate to Severe Crohn's Disease
Fatigue Improvement Correlates with Reductions in Work Productivity Impairment and Related Indirect Cost in Patients with Crohn's disease: Post Hoc Analysis of Two Phase 3 Risankizumab Induction Trials
Baseline and Early Predictors of Response to Risankizumab Induction and Maintenance Treatment in Patients with Moderate to Severe Crohn's Disease
52-Weeks Risankizumab Subcutaneous Maintenance Dosing is Efficacious and Well Tolerated in Patients with Moderate to Severe Crohn's Disease Who Had Delayed Response to 12-Weeks IV Risankizumab Induction
Clinical and Endoscopic Improvements with Risankizumab Induction and Maintenance Dosing Versus Placebo are Observed Irrespective of Number of Prior Failed Biologics
Efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis receiving 16 weeks' extended induction treatment followed by 52 weeks' maintenance treatment in the U-ACHIEVE/U-ACCOMPLISH trials
Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active ulcerative colitis: Final results from the Phase 3 U-ACHIEVE Maintenance study
Benefit-risk assessment of upadacitinib treatment in patients with moderately to severely active ulcerative colitis
Matching-Adjusted Indirect Comparison of Upadacitinib Versus Vedolizumab as Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
Benefits of high versus low dose upadacitinib as maintenance treatment in ulcerative colitis patients who were responders to 8-week induction with upadacitinib: Results from the U-ACHIEVE phase 3 maintenance trial
Symptoms and Laboratory Values as Proxies for Endoscopic and Histologic Clinical Endpoints in Ulcerative Colitis: A Mediation Analysis Based on Upadacitinib Phase 3 Induction Trials
Efficacy of Upadacitinib Dose Escalation in Phase 3 Long-term Extension Ulcerative Colitis Study
Impact of Inflammatory Burden on Efficacy of Upadacitinib Maintenance Therapy in Ulcerative Colitis: Results from the Phase 3 U-ACHIEVE Study
Efficacy and Safety of Upadacitinib Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease: Results from a Randomized Phase 3 U-EXCEL Study
Disease State Abstracts / Inflammatory Bowel Disease
Steroid use in a high proportion of IBD patients – first results from the German cohort of the IBD-DICE study
Patient-reported burden of corticosteroid use in inflammatory bowel disease in the UK: results from the Determinants, Incidence and Consequences of Corticosteroid Excess (DICE) impact questionnaire
Patterns of corticosteroid exposure and excess in inflammatory bowel disease: Results from the Determinants, Incidence and Consequences of Corticosteroid Excess (DICE) online monitoring tool
The full scientific program for the UEG Week 2022 is available here .
Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon. 1,2 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence. 1,3 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death. 2,4 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease. 5
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain and rectal bleeding. 2,6,7 It is a progressive disease, meaning it gets worse over time. 2,7 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically. 5
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 8-15 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. 8
In the EU, RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 8 The use of upadacitinib in Crohn's disease is not approved and its safety and efficacy have not been established by global regulatory authorities. Phase 3 trials of RINVOQ in atopic dermatitis, axial spondylarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, Takayasu arteritis and ulcerative colitis are ongoing. 9-15
US Indications and Important Safety Information about RINVOQ ® (upadacitinib) 8
U.S. USES RINVOQ is a prescription medicine used to treat:
It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, or ankylosing spondylitis.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
U.S. IMPORTANT SAFETY INFORMATION
What is the most important information I should know about RINVOQ?
RINVOQ may cause serious side effects, including:
Do not take RINVOQ if:
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
̶ Warm, red, or painful skin or sores on your body
̶ Burning when urinating or urinating more often than normal
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should I do or tell my HCP AFTER starting RINVOQ?
̶ Pain or tenderness in one or both legs
̶ Sudden unexplained chest or upper back pain
̶ Shortness of breath or difficulty breathing
What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.
A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for Full Prescribing Information and Medication Guide for RINVOQ.
Globally, prescribing information varies; refer to the individual country product label for complete information.
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. 16,17 The use of risankizumab in Crohn's disease is not approved in the EU and its safety and efficacy have not been established by regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. 9,18,19
US Indications and Important Safety Information about SKYRIZI ® (risankizumab) 17
What is the most important information I should know about SKYRIZI ® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious side effects, including:
Serious Allergic Reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.
Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"
Liver problems in people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your doctor right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach(abdominal) pain, tiredness(fatigue), loss of appetite, yellowing of the skin and eyes (jaundice) and dark urine.
The most common side effects of SKYRIZI in people treated for Crohn's Disease include upper respiratory infections, injection site reactions, fever, headache, stomach(abdominal) pain, back pain, joint pain, and low red blood cells (anemia).
The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.
These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use it.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600mg/10mL intravenous infusion, and a 360mg/2.4mL single-dose prefilled cartridge with on-body injector.
This is the most important information to know about SKYRIZI. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.
Globally, prescribing information varies; refer to the individual country product label for complete information.
With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .
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.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .
Some statements in this news release are, or may be considered, 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, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.
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Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) (" Sirona ") announces the release of a corporate update which highlights the company's recent team meeting in France, the current pipeline, and the latest deal structure.
With the success of the licensing deal with AbbVie, the company needs to prepare for its next phase of growth.
Dr. Wolfgang Bieber reports "In my professional opinion, as a chemist of over three decades, I've never seen anything like Sirona's technology platform, which is undoubtedly revolutionary in terms of its potential to provide endless solutions to current and future pharmaceutical obstacles."
The full corporate update can be viewed at the following link: https://www.sironabiochem.com/wp-content/uploads/2022/09/Sirona-Corporate-Update-September-2022.pdf
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's laboratory, TFChem, is in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
For more information regarding this press release, please contact:
Investor Enquiries: Jonathan Williams Managing Director Momentum PR Phone: 1.450.332.6939 Email: jwilliams@momentumpr.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
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Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular diseases ("CVD"), announced today that an abstract submitted by its international research collaborators from Houston Methodist DeBakey Heart & Vascular Center was accepted for poster presentation at The Annual Scientific Meeting of the Heart Failure Society of America ("HFSA2022") to be held in person September 30th to October 3rd, 2022 in Washington, DC.
The poster will be presented for general viewing within the "Basic and Translational Science" category of the HFSA2022 Scientific Programme on September 30, 2022, from 6:15 – 6:30 PM EDT.
The Heart Failure Society of America is a multidisciplinary organization working to improve and expand heart failure care through collaboration, education, research, innovation, and advocacy. Members include physicians, scientists, nurses, nurse practitioners, pharmacists, and patients.
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular diseases ("CVD"). The Company's lead product candidate, CardiolRx™, is an oral pharmaceutical that is being clinically developed for use in CVD.
Cardiol has received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two orphan drug indications: (i) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the "ARCHER" trial) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and the leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multi-center open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations.
In addition, CardiolRx is being evaluated in a Phase II/III multi-national, randomized, double-blind, placebo-controlled study (the "LANCER" trial). LANCER is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD, and to investigate the influence CardiolRx has on key biomarkers associated with heart disease.
Cardiol is also developing a subcutaneous formulation of cannabidiol targeting the inflammation and fibrosis associated with the development and progression of heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the U.S. exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to, statements relating to the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular disease. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form dated March 23, 2022, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855 trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138661
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The Gummy Project (CSE: GUMY) (FSE: 0OS0) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce it has received a purchase order from The Canada Life Centre, home of the National Hockey League's Winnipeg Jets and American Hockey League's Manitoba Moose.
"We are absolutely thrilled that our Peachy Bees and Watermelon Sharks will be available for fans to enjoy at Jets and Moose games," said Charlie Lamb, President & CEO of GUMY. "Our multi-channel sales strategy now includes high traffic sports and entertainment venues, with Canada Life Centre marking our entrance into this sector and a key milestone for the Company. In a very short time period, we have been able to form partnerships with and have our gummies for sale in major grocery chains, a national airline, hotels (both in the US and Canada), one of the largest passenger ferry systems in the world and now a professional sports stadium and we very much look forward to continuing to execute our strategic expansion both in Canada and the US."
Canada Life Centre (formerly MTS Centre and Bell MTS Place) is an indoor arena in downtown Winnipeg, Manitoba. The arena is the home to the National Hockey League's Winnipeg Jets and their American Hockey League affiliate, the Manitoba Moose. The arena stands on the former Eaton's site and is owned and operated by True North Sports & Entertainment. The 440,000 square building was constructed opened on November 16, 2004, replacing the since-demolished Winnipeg Arena. It has a capacity of 15,321 for hockey and 16,345 for concerts.
"Being born in Winnipeg myself, it's a dream come true to know that our gummies will be sold at Winnipeg Jets games," said Anthony Gindin, CMO of GUMY. "This also marks our expansion into the exciting new sales vertical of sports and entertainment venues."
We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.
Charlie Lamb, President & CEO, Director Telephone: 1(236) 317-2812 - Toll free 1(888) 556-9656 E-mail: investors@shopgummies.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138511
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ABBVie (NYSE: ABBV) announced today the availability of the XEN ® 63 Gel Implant, a surgical implant designed to lower high eye pressure in open angle glaucoma sufferers, where previous medical treatment options have failed. 1 The XEN 63 Gel Implant is an additional option for surgeons, clinically proven to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma. 3
"I see the impact of glaucoma on patients' quality of life every day in my practice. Glaucoma typically damages the peripheral vision first, so it often goes unnoticed by patients as the disease worsens. That's why glaucoma is known as the silent thief of sight," said Dr. David Yan , Ophthalmologist-in-Chief, Mount Sinai Hospital, University of Toronto and Glaucoma Service Director, Kensington Eye Institute. "XEN 63 Gel Implant offers patients a new surgical option to reduce intraocular pressure when medical therapy cannot adequately control the disease and renewed hope to prevent optic nerve damage."
XEN 63 is a gel implant consisting of a small 6mm long tube, delivered via a micro-incisional glaucoma surgery. 1 , 2 It creates a new fluid outflow channel using a similar principle to conventional trabeculectomy, but allows fluid to bypass the impaired trabecular meshwork, the drainage system that becomes impaired in glaucoma. 2 ,4
"Glaucoma affects more than 728,000 Canadians. It is one of the leading causes of preventable blindness. Anyone can develop glaucoma but there are several different factors that can increase your risk of developing the disease," said Doug Earle , President and CEO of Fighting Blindness Canada. "It's both exciting and important to see new, innovative treatment options being approved that could have a positive impact on Canadians living with primary open angle glaucoma."
"As a leader in Eye Care in Canada , we are committed to help preserve and protect people's vision through innovating and addressing the greatest unmet needs in glaucoma," says Tracey Ramsay , Vice President and General Manager, AbbVie Canada. "Today, we're pleased to launch the XEN 63 Gel Implant and offer a minimally invasive solution for uncontrolled primary open angle glaucoma."
The glaucoma treatment spectrum extends from pharmacotherapy involving topical medications (eye drops) as the first-line therapy to traditional, invasive filtration surgeries, such as trabeculectomy and aqueous shunt implantation. 5,6,7 Common challenges associated with pharmacotherapy include ineffective use (e.g., incorrect dose timing or administration), 8 ,9 local or systemic side effects (e.g., irritation) or toxicity, 10,11 and considerable lifetime costs. 12 Filtration surgical options are typically used in advanced glaucoma cases or when targeting a very low intraocular pressure as a treatment outcome. 13 These invasive surgeries may be considered for medically refractory cases, or when there are such issues as intolerable side effects or from ineffective use of medications. 14
Glaucoma affects more than 728,000 Canadians and takes the form of several related disease types, the most common being open angle glaucoma. 15 Glaucoma is characterized by a build-up of aqueous humour fluid and increased intraocular pressure (IOP) that damages the optic nerve. 15 There is no cure for glaucoma, but early detection and treatment can help prevent damage to the optic nerve, and as a result, save vision. 15
XEN is a gel implant consisting of a small 6mm long tube, delivered via a micro-incisional glaucoma surgery, which is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. 1 The XEN filtration procedure creates a new fluid outflow channel using a similar principle to trabeculectomy, but allows fluid to bypass the impaired trabecular meshwork. 2,3 XEN is inserted via an ab-interno approach 1 (from within the anterior chamber) and allows aqueous humor to flow out from the anterior chamber into the subconjunctival space, minimizing tissue disruption seen with trabeculectomy or traditional glaucoma drainage implants. 1,3, 16 XEN 63 consists of a small tube that is 6mm long. 1 The inner diameter of XEN63 is 63µm and the external diameter is 170µm. 1 XEN63 has an outflow resistance of 2-3mmHg. 6 XEN63 was developed to increase the aqueous humor flow rate with the intention of potentially providing lower IOPs.
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 @abbviecanada on Twitter and Instagram , or find us on LinkedIn.
AbbVie Canada. Add XEN 63 Gel Implant Health Canada directions for use.
European Glaucoma Society Terminology and Guidelines for Glaucoma, 5th Edition. (2021). British Journal of Ophthalmology , 105(Suppl 1), pp.1–169. doi:10.1136/bjophthalmol-2021-egsguidelines
Lavin-Dapena C, Cordero-Ros R, D'Anna O, Mogollón I. XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study. Eur J Ophthalmol. 2021 Jul;31(4):1829-1835. doi: 10.1177/1120672120952033. Epub 2020 Aug 18. PMID: 32811168. https://pubmed.ncbi.nlm.nih.gov/32811168/
De Gregorio A, et al. Clin Ophthalmol. 2018;12:773-782. doi:10.2147/OPTH.S146919.
Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE, US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67.
Malvankar-Mehta MS, Iordanous Y, Chen YN, Wang WW, Patel SS, Costella J, et al. iStent with phacoemulsification versus phacoemulsification alone for patients with glaucoma and cataract: A meta-analysis. PLoS One [Internet]. 2015 [cited 2018 Jan 2];10(7):e0131770. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4492499/
Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104.
Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, et al. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9.
Terminology and guidelines for glaucoma [Internet]. 4th ed. Savona (ITA): European Glaucoma Society; 2014 Jun. [cited 2017 Aug 8]. Available: http://www.icoph.org/dynamic/attachments/resources/egs_guidelines_4_english.pdf
Everitt DE, Avorn J. Systemic effects of medications used to treat glaucoma. Ann Intern Med. 1990 Jan 15;112(2):120-5.
Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Ther Adv Chronic Dis [Internet]. 2014 Jan [cited 2017 Dec 22];5(1):30-43. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871276
Iordanous Y, Kent JS, Hutnik CM, Malvankar-Mehta MS. Projected cost comparison of Trabectome, iStent, and endoscopic cyclophotocoagulation versus glaucoma medication in the Ontario Health Insurance Plan. J Glaucoma. 2014 Feb;23(2):e112-e118.
Perez-Torregrosa VT, Olate-Perez A, Cerda-Ibanez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A, et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol. 2016 Sep;91(9):415-21.
Michael Raj, Charlotte Wells, Caitlyn Ford. Minimally Invasive Glaucoma Surgery: Implementation Considerations. Ottawa: CADTH; 2018. (Environmental scan; no. 76). https://www.cadth.ca/minimally-invasive-glaucoma-surgery-implementation-considerations-0
Fighting Blindness. Glaucoma. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/
Lewis RA. J Cataract Refract Surg. 2014;40(8):1301–6. doi: 10.1016/j.jcrs.2014.01.032.
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