Life Science News

-- First Treatment in 30 Years to Improve Upon Standard of Care (SOC) for Second-Line Treatment of DLBCL –

- - Based on Landmark ZUMA-7 Study, Patients with DLBCL Treated Second-Line with Yescarta Had Event-Free Survival of 8.3 Months versus Two Months for SOC [4-fold greater improvement] --

-- In ZUMA-7, Yescarta Patients with DLBCL were 2.5 Times More Likely than SOC to be Alive at Two Years Without Cancer Progression or Need for Additional Treatments --

Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Commission (EC) has granted approval for the use of Yescarta ® (axicabtagene ciloleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. The approval is based on results from the pivotal Phase 3 ZUMA-7 study, the largest and longest trial of a CAR T-cell therapy versus SOC in this patient population. Yescarta is now the first Chimeric Antigen Receptor (CAR) T-cell therapy approved for patients in Europe who do not respond to first-line treatment. This provides an important additional treatment option for the most common form of non-Hodgkin lymphoma. Although 60% of newly diagnosed LBCL patients, including those with DLBCL, will respond to their initial treatment, 40% will relapse or will not respond and need second-line treatment.

"We are very proud to announce Kite's fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world," said Christi Shaw, CEO, Kite. "Today's approval marks an important step by providing patients in Europe this option of CAR T-cell therapy earlier in their treatment journey."

SOC therapy for this patient population has historically been a multi-step process expected to end with a stem cell transplant. The process starts with chemoimmunotherapy, and if a patient responds to and can tolerate further treatment, they move on to high-dose chemotherapy (HDT) followed by a stem cell transplant (ASCT).

"This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with axicabtagene ciloleucel resulted in an overall better outcome for patients than standard of care, especially in terms of event-free survival, marking a new era for treatment earlier in the disease pathway for more patients," said Professor John Gribben, Professor of Medical Oncology at the Cancer Research UK Barts Centre, London. "The ZUMA-7 data has also broadened our understanding of this CAR T-cell therapy, allowing us to better manage or prevent side-effects, which is important as it moves earlier in the treatment pathway and for older patients and those with medical conditions for whom the standard of care might have been difficult."

The ZUMA-7 study demonstrated that at a median follow-up of two years, Yescarta-treated patients had a four-fold greater improvement in the primary endpoint of event-free survival (EFS; hazard ratio 0.40; 95% CI: 0.31-0.51, P

In the ZUMA-7 trial, Yescarta had a safety profile that was consistent with previous studies. Among the 170 Yescarta-treated patients evaluable for safety, Grade ≥3 cytokine release syndrome (CRS) and neurologic events were observed in 6% and 21% of patients, respectively. No Grade 5 CRS or neurologic events occurred. In the SOC arm, 83% of patients had Grade ≥3 events, mostly cytopenias (low blood counts).

About ZUMA-7

ZUMA-7 is an ongoing, randomized, open-label, global, multicenter (US, Australia, Canada, Europe, Israel) Phase 3 study of 359 patients at 77 centers, evaluating the safety and efficacy of a single-infusion of Yescarta versus current SOC for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose chemotherapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. The primary endpoint is event free survival (EFS). Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes and safety.

In the analysis of patient reported outcomes (PROs), patients receiving Yescarta and eligible for the PROs portion of the study (n=165), showed statistically significant improvements in Quality of Life (QoL) at Day 100 compared with those who received SOC (n=131), using a pre-specified analysis for three PRO-domains (EORTC QLQ-C30 Physical Functioning, EORTC QLQ-C30 Global Health Status/QOL, and EQ-5D-5L visual analog scale [VAS]). There was also a trend toward faster recovery to baseline QoL in the Yescarta arm versus SOC.

About Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is the most common sub-type of non-Hodgkin lymphoma (NHL), representing around 30% of cases. High-grade B-cell lymphoma (HGBL) is a recently introduced, rare subset of LBCL marked by aggressive B-cell lymphomas including tumors with Burkitt-like or blastoid tumors without double-hit characteristics. In Europe it is estimated that up to 38,000 new cases of LBCL were diagnosed in 2020. Although first-line treatment can be effective in around 60% of cases, 40% will relapse or not respond and need second-line treatment. For people who relapse, or who do not respond to first-line treatment, outcomes are often poor. Most patients with refractory (no response) LBCL have no curative treatment options.

About Yescarta

Yescarta was first approved in Europe in 2018 and is currently indicated for five types of blood cancer: Diffuse Large B-Cell Lymphoma (DLBCL); Large B-Cell Lymphoma (LBCL); High-Grade B-Cell Lymphoma (HGBL); Primary Mediastinal Large B-Cell Lymphoma (PMBCL); and Follicular Lymphoma (FL). For the full European Prescribing Information, please visit: https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta . Please see full US Prescribing Information , including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
  • Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
  • Limitations of Use : YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.

CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and the median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; ≥ Grade 3 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com . Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

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.

Forward-Looking Statements

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 the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yescarta; uncertainties relating to regulatory applications and related filing and approval timelines, the risk that physicians may not see the benefits of prescribing Yescarta for the treatment of LBCL; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other 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 Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING , is available at www.kitepharma.com and www.gilead.com .

Kite, the Kite logo, Yescarta and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company's website at www.kitepharma.com . Follow Kite on social media on Twitter ( @KitePharma ) and LinkedIn .

Jacquie Ross, Investors
investor_relations@gilead.com

Anna Padula, Media
apadula@kitepharma.com

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CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

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.

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Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

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

  • Covid-19 has proven to be the "great revealer" of disparities in healthcare

  • Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020
  • Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational
  • Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

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.

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HOOKIPA Advances HIV and HBV Vaccine Research with Gilead

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:

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Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors

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:

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Gilead Sciences Announces Promotion in Oncology Division

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.

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The Impact of Inaction - New Publication Reveals Not All of Canada is on Track to Meet Global Hepatitis C Elimination Goal

  • 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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AMGEN ANNOUNCES WEBCAST OF 2022 EVERCORE ISI HEALTHCARE CONFERENCE

Amgen (NASDAQ:AMGN) will present at the Evercore ISI HealthCONx Conference at 11:20 a.m. ET on Tuesday, November 29, 2022 . David M. Reese M.D., executive vice president of Research and Development at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

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Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") announces that, subsequent to the LOI Sirona and Wanbang Biopharmaceuticals (" Wanbang ") have signed an expanded, international partnership agreement to collaborate on licencing Sirona's SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence.

Wanbang (a wholly owned subsidiary of Shanghai Fosun Pharmaceutical) and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes.

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AbbVie to Present at the Evercore ISI HealthCONx Conference

ABBVie (NYSE: ABBV) will participate in the 5 th Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, November 29, 2022 . Rob Michael vice chairman and president, Jeffrey R. Stewart executive vice president, commercial operations, Scott Reents senior vice president and chief financial officer, and Tom Hudson senior vice president, R&D and chief scientific officer, will present at 9:55 a.m. Central time .

A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the session will be available later that day.

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AbbVie Announces European Commission Approval of SKYRIZI® for the Treatment of Moderate to Severe Active Crohn's Disease

A significantly higher proportion of patients on SKYRIZI achieved clinical remission, endoscopic response, mucosal healing and endoscopic remission at week 12 in induction studies compared to placebo 1 2 3 - A significantly higher proportion of patients achieved clinical remission and endoscopic response at week 52 with SKYRIZI maintenance 1, 2, 3 - Crohn's disease is a chronic, systemic inflammatory disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain and can require urgent medical care 4, 5 ,6

NORTH CHICAGO, Ill. , Nov. 23, 2022 /PRNewswire/ -- ABBVie (NYSE: ABBV) announced the European Commission (EC) approved SKYRIZI ® (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. 1,2,3

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AbbVie Highlights Blood Cancer Data From Its Growing Oncology Pipeline at the 64th ASH Annual Meeting

- Nearly 65 abstracts, including 15 oral presentations on 7 investigational and approved medicines across 8 cancer types, to be presented at the American Society of Hemaotology (ASH) annual congress

ABBVie (NYSE: ABBV) will present results from nearly 65 company and partner abstracts across 8 types of cancer during the upcoming American Society of Hematology (ASH) annual meeting ( December 10-13 ) in New Orleans, Louisiana .

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