Earlier Treatment With Repatha Resulted in a Lower Incidence of Major CV Events, Including CV Death
80% of Patients Achieved Guideline Directed LDL-C Levels of
Data Presented at ESC 2022 and Simultaneously Published in Circulation
Amgen (NASDAQ:AMGN) today presented new compelling data from the Phase 3 FOURIER open label extension (OLE) studies of Repatha ® (evolocumab) in adults with atherosclerotic cardiovascular disease (ASCVD) during the Aug. 29 late-breaking Hot Line Session of the European Society of Cardiology (ESC) Annual Meeting being held in Barcelona, Spain and online. These data were simultaneously published in Circulation . Repatha is the first and only proprotein convertase subtilisinkexin type 9 inhibitor (PCSK9i) to date to show long-term clinical outcomes in patients with ASCVD for up to 8.4 years. 1
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The FOURIER-OLE studies evaluated 6,635 patients from the FOURIER parent study (3,355 initially randomized to Repatha and 3,280 to placebo) from the U.S. and Europe . 1 The studies were designed to assess the long-term safety and tolerability of Repatha in adults with clinically evident ASCVD for a median follow up of up to five years and a maximum exposure to Repatha of more than eight years when parent and extension studies were combined. No new long-term safety findings were observed. 1
The OLE studies showed Repatha delivered medically significant and sustained reduction in low-density lipoprotein cholesterol (LDL-C) levels, with 80% of patients achieving a low-density lipoprotein cholesterol (LDL-C) level of 1 Additionally, the LDL-C reduction of 58% from baseline was consistent over long-term follow up (week 260) on Repatha. An additional prespecified exploratory analysis in the OLE studies showed a lower rate of major adverse cardiovascular events, including cardiovascular death, in patients originally randomized to Repatha (20% relative risk reduction [RRR] for major cardiovascular events and 23% RRR for cardiovascular death) versus those originally randomized to placebo in the parent FOURIER study. 1
"The new findings from the FOURIER-OLE studies confirm that earlier initiation of Repatha, combined with longer duration of treatment, has the potential to deliver a greater reduction in cardiovascular risk, including death," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "These data add to the robust body of evidence for Repatha, demonstrating that long-term treatment with Repatha is well tolerated in patients with stable ASCVD."
"These findings fill a significant gap in the body of research on the long-term safety and efficacy of PCSK9 inhibitors," said Michelle L. O'Donoghue M.D., MPH, senior investigator, TIMI Study Group at Brigham and Women's Hospital and Lead FOURIER-OLE Trial Investigator. "Importantly, earlier initiation of LDL-C lowering with evolocumab combined with consistent long-term use, further reduced the risk of major cardiovascular events and cardiovascular mortality in this study."
Cardiovascular disease (CVD) remains the leading cause of global mortality and a major contributor to disability and rising healthcare costs. 2,3 In the U.S., someone suffers a heart attack every 40 seconds. 4 Given systemic barriers in the U.S. healthcare system, only 3.2% of an estimated 18.7 million U.S. adults with ASCVD were actually taking an add-on lipid-lowering therapy, despite treatment being recommended to 61.4%. 5 Further, patients with ASCVD whose prescription for a PCSK9i was rejected had an 11% higher risk of having a cardiovascular event such as a heart attack or stroke within a year. 6
"LDL-C is a key modifiable risk factor for the development of cardiovascular disease, yet nearly half of post-MI patients fail to achieve guideline recommended LDL-C goals of Katherine Wilemon , founder and chief executive officer, Family Heart Foundation. "Nearly 1 in 5 patients who have had a heart attack will have another cardiovascular event within 1 year, so it's important that patients get their LDL-C to guideline recommended levels. With this new data, it's clear that Repatha can help patients achieve lower levels of LDL-C."
Detailed study results will be shared with regulatory authorities. Prolonged LDL-C reduction with Repatha is also being studied in patients without a prior heart attack or stroke in the ongoing VESALIUS-CV (NCT03872401) outcomes trial.
FOURIER (20110118) was a randomized placebo-controlled study of evolocumab, in patients with clinically evident ASCVD on stable effective statin therapy. FOURIER-OLE were multicenter, open-label extension studies designed to assess the extended long-term safety of evolocumab in subjects who completed the FOURIER study (20110118). The FOURIER-OLE is composed of studies 20130295 and 20160250, which enrolled 5,035 and 1,600 subjects who completed the FOURIER study (20110118) to receive open-label evolocumab and were followed up for a median of 5 and 4.6 years, respectively. All patients in the extension program were treated with open label evolocumab resulting in no concurrent placebo arm during this period. Although not all patients participated in FOURIER-OLE, baseline characteristics were broadly comparable between the originally randomized treatment arms, thereby allowing for reasonably unconfounded exploratory comparisons between groups.
FOURIER, a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint is the time to cardiovascular death, myocardial infarction or stroke.
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident ASCVD at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus effective statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.
FOURIER is part of Amgen's PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different populations) program of clinical studies investigating the impact of Repatha ® on LDL-C and CVD across multiple populations at high CV risk, including those managed by statins, statin-intolerant patients, those with genetic disorders and patients with atherosclerosis. To date, the PROFICIO program consists of 36 trials including more than 38,000 patients worldwide.
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Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels. The clinical benefits and safety of Repatha have been studied for 12 years in 50 clinical trials with over 47,000 patients. This vast body of evidence demonstrates that Repatha works rapidly.
Repatha is approved in more than 75 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.
In Europe, Repatha is approved for use in:
Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non–familial) or mixed dyslipidaemia, as an adjunct to diet:
Homozygous familial hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
Established atherosclerotic cardiovascular disease Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Primary hypercholesterolaemia and mixed dyslipidaemia in adults The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up–titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Established atherosclerotic cardiovascular disease in adults The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Important Safety Information This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special Warnings and Precautions: Renal impairment: There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR 2 ). Repatha should be used with caution in patients with severe renal impairment. Hepatic impairment: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL-C reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Repatha should be used with caution in patients with severe hepatic impairment. Dry natural rubber: The needle cover of the glass pre-filled syringe and of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions. Sodium content: Repatha contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially 'sodium-free'.
Interactions: No formal drug-drug interaction studies have been conducted for Repatha. No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid-lowering drugs other than statins and ezetimibe have been conducted.
Fertility, Pregnancy and Lactation: There are no or limited amount of data from the use of Repatha in pregnant women. Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. No data on the effect of evolocumab on human fertility are available.
Undesirable Effects: The following common ( > 1/100 to
Pharmaceutical Precautions: Store in a refrigerator (2 degrees C – 8 degrees C). Do not freeze. Keep the pre-filled syringe or the pre-filled pen in the original carton in order to protect from light. If removed from the refrigerator, Repatha may be stored at room temperature (up to 25 degrees C) in the original carton and must be used within 1 month.
Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor antibody indicated:
The safety and effectiveness of Repatha have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia or HeFH.
Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse Reactions in Adults with Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha and more frequently than placebo) were: diabetes mellitus (8.8% Repatha, 8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha, 4.8% placebo).
Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis.
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha compared with 7.7% in patients that received placebo.
Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.
Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.
Immunogenicity: Repatha is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436) or 844-REPATHA (844-737-2842) regarding Repatha® availability or find more information, including full Prescribing Information , at www.amgen.com and www.Repatha.com .
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CONTACT: Amgen, Thousand Oaks Michael Strapazon , 805-313-5553 (media) Jessica Akopyan , 805-440-5721 (media) Arvind Sood , 805-573-4142 (investors)
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BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer and other cancers, is pleased to welcome the appointment of Jane Gross, Ph.D. to its Board of Directors.
Dr. Jane Gross is a highly experienced biotech executive with over 30 years in leading research and development teams from discovery through preclinical evaluation and clinical development of therapeutics for the treatment of cancer and autoimmune and inflammatory diseases. Dr. Gross currently serves as an Independent Director for aTyr Pharmaceuticals (Nasdaq: LIFE), a biotechnology company developing novel therapeutics for respiratory diseases and multiple cancer indications.
"I am pleased to welcome Jane to our Board and look forward to leveraging her decades of industry, scientific, and corporate partnership expertise to advance BriaCell's rich pipeline of novel immunotherapies for cancer," stated Jamieson Bondarenko, BriaCell's Chairman of the Board.
Dr. Gross's experience includes roles as Chief Scientific Officer and SVP, Research and Non-Clinical Development at Aptevo Therapeutics (Nasdaq: APVO), during which she led the discovery of novel antibody-based, bispecific protein therapeutics as immunotherapies to treat diseases like cancer. Previously, Dr. Gross served as VP, Applied Research and Non-Clinical Development at Emergent BioSolutions (NYSE: EBS), during which she successfully introduced a drug to patients from design stage into clinic. This drug was partnered with Morphosys in a co-development transaction for treatment of metastatic castration resistant prostate cancer. Formerly, as VP, Immunology Research at ZymoGenetics, Dr. Gross discovered and developed 30+ new product candidates, completed partnerships and out-licensing of assets, and helped position ZymoGenetics for a successful acquisition by Bristol Myers Squibb (NYSE: BMY) in 2010.
"I am thrilled to join BriaCell's Board and work with the highly experienced directors and management team to help BriaCell develop its clinical pipeline and achieve its partnership strategy objectives," said Dr. Jane Gross. "I am particularly impressed with the Company's novel, off-the-shelf personalized immunotherapy approach and its potential to destroy cancer cells in a safe and effective manner."
Dr. Gross earned her Ph.D. in Immunology from the University of California, Berkeley under James P. Allison, Ph.D., who gained fame as the co-recipient of the 2018 Nobel Prize in Physiology or Medicine for being a pioneer in cancer immunotherapy, and her Post-Doctoral Fellowship from the University of Washington in Immunology under Dr. Roger M. Perlmutter, M.D., Ph.D., formerly of Merck Research Laboratories and Amgen (Nasdaq: AMGN).
BriaCell also announces that its Board of Directors has approved a grant of 10,000 options to purchase common shares in the capital of BriaCell to Dr. Gross in her role as a director of BriaCell, pursuant to the Company's stock option plan. The options have an exercise price of C$9.92 per share and a term of five years and vest immediately.
Additionally, each member of the Scientific Advisory Board has been awarded 2,600 options pursuant to the Company's stock option plan. The options have an exercise price of C$9.92 per share and a term of five years and vest in accordance with the terms of each option agreement. The grant of the options is subject to the approval of the TSX Venture Exchange.
Separately, BriaCell has also entered into a 6-month marketing and investor engagement contract with Toronto-based marketing firm North Equities Corp. (the "Contract"). North Equities Corp. specializes in various social media platforms and will be able to facilitate greater awareness and widespread dissemination of the Company's news. In connection with the Contract, the Company will pay North Equities CAD$105,000. North Equities Corp. does not have an equity stake in the Company currently.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://BriaCell.com/ .
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BriaCell's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under our profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Company Contact: William V. Williams, MD President & CEO 1-888-485-6340 info@BriaCell.com
Media Relations: Jules Abraham Director of Public Relations CORE IR 917-885-7378 julesa@coreir.com
Investor Relations Contact: CORE IR investors@briacell.com
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Esperion Therapeutics (NASDAQ:ESPR) shares increased by more than 10% after investors learned that the FDA will not require a long-term outcomes study prior to its potential approval of the company’s cholesterol-lowering drug. According to Fierce Biotech:
Investors and analysts have been fretting over exactly what the FDA will do with ETC-1002, an LDL-lowering pill that is angling for a share of a blockbuster market many believe lies in wait for a new class of PCSK9 drugs. While the oral ETC-1002 may not be as effective as the PCSK9 drugs, including the newly-approved Praluent from Regeneron ($REGN) and Sanofi ($SNY) as well as a rival Amgen ($AMGN) drug, it also has a shot at grabbing a significant share of the market with a less expensive and more easily managed drug that could do everything many patients in this huge market require. Overhanging all of these drugs has been a persistent fear that regulators would require a long-running cardiovascular outcomes trial to prove the therapy works as expected in improving patients’ health. But according to Esperion, the agency says it’s ready to give it a green light for a relatively narrow market–which still amounts to a patient pool of 9 million people–and then hold back on a broader approval until after the CVOT data comes in later.
Click here to read the entire article on Fierce Biotech.
- Public-Private Effort to Shift Traditional Model of Hepatitis Management to Primary Care and Help to Expand Care to More People in Need -
Gilead Sciences, Inc. today announced a new public-private initiative with the Partnership for Health Advancement in Vietnam (HAIVN), a collaboration between Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year initiative will have a phased approach to help address barriers that limit viral hepatitis diagnosis and care at primary healthcare facilities in Vietnam and the Philippines, two countries with high burdens of hepatitis B and C.
Gilead and HAIVN will work together with a multi-stakeholder coalition, involving national ministries of health, academic stakeholders including the University of Philippines-Manila (UP Manila), provincial hospitals and primary healthcare centers to support this pilot program. The focus of the program will be on person-centered approaches in training non-specialist community-based healthcare providers in prevention and management of viral hepatitis, incorporating education, screening, diagnosis and linkage to care for hepatitis B and C into routine patient visits for at-risk populations. Gilead and HAIVN will also aim to strengthen primary healthcare systems including the referrals and counter-referral systems to enhance coordination between specialist and primary care. The two organizations will make the outcomes and learnings from the initiative public to contribute towards better understanding of adequate public health approaches to improve person-centered, community-based management of viral hepatitis.
"This collaboration will provide evidence to support a shift from the current dependence on scarce and overstretched specialists to a broader group of primary care clinicians while simultaneously strengthening primary health care systems and expanding countries' capacity to diagnose, manage and treat viral hepatitis," said David Duong, MD, MPH, Director of the Harvard Medical School Program in Global Primary Care and Social Change and an internal medicine physician at Brigham and Women's Hospital. "Through this innovative initiative with Gilead, we will apply new patient-centered, community-based models to hepatitis care and treatment, building on the foundation that HAIVN has built."
The initiative will support national priorities for Vietnam and the Philippines: both governments are committed to strengthening primary healthcare and controlling hepatitis. The World Health Organization has set a global target to eliminate viral hepatitis as a public health problem by 2030, calling for 90% of people with hepatitis B and C to be diagnosed, 80% of those eligible for treatment to be treated and a 65% reduction in mortality, in addition to developing preventative actions. 1 However, despite the important gains in biomedical technology and management of viral hepatitis, implementation of best practices and access to diagnostics and treatment in both countries are still significantly limited and inconsistent. At the current pace, Vietnam and the Philippines are not expected to reach WHO targets before 2050.
"This approach has significant potential for application in many other disease areas and low- and middle-income countries where specialist providers are scarce," said Dr. Harald Nusser, Vice President, Head of Global Patient Solutions, Gilead Sciences. "More than proof of concept for eliminating viral hepatitis and strengthening healthcare systems, this initiative demonstrates the potential for the meaningful impact that public, private and academic collaborations can make on improving global health equity and achieving Sustainable Development Goal 3 regarding good health and well-being."
Hepatitis B and C lead to chronic disease in hundreds of millions of people globally and together are the most common cause of liver cirrhosis, liver cancer and viral hepatitis-related deaths. An estimated 354 million people worldwide live with hepatitis B or C, and for most, testing and treatment remain beyond reach. 2 In Vietnam, out of a population of 97 million, nearly 7.8 million people have hepatitis B and over 900,000 have hepatitis C. Based on 2020 estimates from the CDA Foundation's Polaris database, only 30% of Vietnamese people with hepatitis B have been diagnosed and only 3% treated. For hepatitis C, only 14% of cases have been diagnosed and 7% have been treated. 3 In the Philippines, over 10 million people are infected with hepatitis B and nearly 450,000 with hepatitis C, with the care cascade standing at 5% diagnosed and less than 1% treated for hepatitis B and 23% diagnosed and 1% treated for hepatitis C. 3
The 17 Sustainable Development Goals (SDG) were adopted by the United Nations (UN) Member States in 2015, as part of the 2030 Agenda for Sustainable Development. They are call to actions by all countries to unite in a global partnership to ensure peace and prosperity for people and planet. SDG 3 Good Health and Wellbeing is one of the SDGs that Gilead supports to improve global health and sustainable development. SDG 3 consists of several targets, including fighting communicable diseases, achieving universal health coverage, increasing health financing and support for health workforce in developing countries. For more information on the SDGs that Gilead support, please visit www.gilead.com .
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.
Gilead and the Gilead logo are 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.
1 WHO Global Health Sector Strategy on Viral Hepatitis 2016-201: Towards Ending Viral Hepatitis https://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf
2 https://www.who.int/health-topics/hepatitis#tab=tab_1
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--Initiative Creates Groundbreaking New, Royalty Free Inclusive Image Gallery In Strategic Partnership with Shutterstock Studios--
Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), and skinbetter science ® announce a new report from their DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative ® along with a long-term partnership with Shutterstock Studios. The report, titled Forces of Beauty ® provides a new understanding of what inclusive and representative beauty looks like today by shedding light on how narrowly defined Eurocentric ideals continue to impact women of color. By surveying over 4,000 women aged 21-65, from multiple geographic locations and backgrounds, the report explores what defines beauty, how beauty impacts women's lives, and the interplay between beauty and race. Some key insights include:
The full report and findings are available for download at DreamforEquity.com
"We are in a position, as industry leaders, to drive the necessary change within the aesthetics industry. We need to create a candid dialogue about racial representation and perceptions within our aesthetics community. We hope that the Forces of Beauty ® Report will contribute to moving us all in the right direction," said Jonah Shacknai , Executive Chairman of skinbetter science ® .
Forces of Beauty ® is the third deliverable from The DREAM Initiative ® , following the successful launches of both the Curriculum for Advancing Racial Equity (CARE) produced by Solomé Rose Consulting, LLC - the American Academy of Dermatology and other leading dermatology societies are supporting the curriculum's inaugural implementation in five highly regarded dermatology residency programs- and the Full Spectrum of Dermatology: A Diverse and Inclusive Atlas , developed by co-editors Misty Eleryan , MD, MS, and Adam Friedman , MD FAAD.
Forces of Beauty ® continues the exploration of the unique relationship between racial/ethnic diversity and beauty for women. The companies are raising awareness about the need for inclusive and representative beauty, providing education, and driving action among medical and consumer audiences.
"Historically, the industry hasn't included all women in its definition of beauty," said Carrie Strom , Senior Vice President at AbbVie and President of Global Allergan Aesthetics. "As industry leaders, our goal is to create a more equitable beauty and aesthetics industry that focuses on diversity, representation, and inclusion. That is what Forces of Beauty ® is about, impacting change and creating a space where the origins of beauty are honored, the definition of beauty is vastly expanded upon, and where uniqueness is the standard."
As part of its multi-media launch, Forces of Beauty ® will be brought to life through an engaging and emotional video series, produced by Shutterstock Studios, Shutterstock's end-to-end custom creative shop. The series, directed by Tiffany Frances , will feature four women as they share their stories and experiences linking directly to dedicated chapters within the report: defining beauty, empowering uniqueness, the history of beauty standards, and appropriation. Each chapter will support the report's overall findings which include: that women of all races strongly believe that "one of us cannot represent all of us"; that the standard of beauty should not be defined by only one group; and, that the origins of beauty and cultural practices be celebrated without being exploited.
Coinciding with the launch of Forces of Beauty ® , the DREAM Initiative ® will also unveil a first-of-its-kind partnership in the aesthetics category with Shutterstock Studios and introduce a royalty free, gallery of diverse images available to the public. The thousands of images will showcase beauty across race, culture, gender, age, ability level, and body type and will bring to life a key takeaway from the Forces of Beauty ® report that "one of us is not the face of all of us." A driving force behind the gallery is the goal to encourage industry peers to leverage these assets within their own efforts, creating a first step towards collective change to a more equitable industry. All inclusive marketing materials will be easily accessible on https://www.shutterstock.com/explore/dream .
"The DREAM Initiative ® brought us this incredible idea to create a more diverse royalty-free image set. And through our partnership on the Forces of Beauty ® report it helped us all recognized an important gap in the market. Most of the visuals used in advertising and branding do not reflect the diversity we see around us every day, and an online search of imagery reveals just how underrepresented many groups are in this space," said Aiden Darné, VP and Global Head of Shutterstock Studios. "Shutterstock interviewed over 2,700 marketers around the world last year and found that 74% of them wished they had access to more diverse content. This realization was the catalyst for a unified pledge to close that gap, and we are excited to partner with the DREAM initiative ® on this journey to put authentic representation at the center of all creative content."
To learn more visit DreamForEquity.com or follow us @AllerganAesthetics and @skinbetter
About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com or follow us on Instagram and LinkedIn .
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.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
About skinbetter science ® The skinbetter science ® team of aesthetic experts has a profound understanding of skin aging and what it takes to help defy the effects of time. Tapping into a rich dermatological heritage, the team at skinbetter science ® set out to create a new paradigm in clinical skincare. Cutting-edge, data-driven science is the principal driving force behind all our unique formulations. skinbetter science award-winning products are available exclusively through the leading dermatology, plastic surgery and medical aesthetics practices nationwide. For more information, visit us at Skinbetter.com or follow us on Facebook, Instagram and LinkedIn.
About Shutterstock Studios For 20 years, Shutterstock has contributed to films, documentaries, and storytelling of all types with its vast stock library. Now through its Studios arm, Shutterstock is putting forward stories of its own, leveraging the unique expertise of its production and creative professionals, and archive of over 60 million assets across photo and video, covering royals, film, music, sports, wars, politics and celebrities. Shutterstock Studios specializes in producing branded and commercial content plus documentary and nonfiction films. Studios has rapidly emerged as a best-in-class creative partner for brands globally using physical and virtual production to create evocative content. With the acquisition of TurboSquid, the world's largest 3D marketplace, Shutterstock Studios now offers Web3 services, and 2D and 3D animation.
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The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order from the 5-star luxury Four Seasons Hotel San Francisco to become a supplier of gummies for each of the hotel's 277 guest room mini-bars.
"We are thrilled to continue our strategic expansion in the US and honoured to have been selected by the luxury 5-star Four Seasons Hotel San Francisco to be a supplier of Peachy Bees and Watermelon sharks for hotel guest rooms," said Charlie Lamb, President & CEO of GUMY. "We very much look forward to developing a long-term relationship with The Four Seasons Hotel San Francisco, who not only are a world class hotel but who also share our commitment to a more sustainable future for everyone."
The purchase order was received from the Four Seasons Hotel San Francisco on September 12, 2022. The hotel has maintained Five Stars with the world-renowned authority in genuine Five Star service, Forbes Travel Guide. A staple in Bay Area luxury, Four Seasons Hotel San Francisco has been awarded the coveted Forbes Travel Guide Five Stars for the past 19 consecutive years.
"As we've previously mentioned, part of GUMY's multi-channel sales strategy includes targeting hotels and their guest rooms as distribution points for our gummies," said Mr Lamb. "With travel and hotel occupancy now soaring post-COVID, we feel that this will be a very lucrative component of our business model moving forward."
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/138005
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Komo Plant Based Foods Inc. (CSE:YUM) (OTCQB:KOMOF) (FRA:9HB) ("Komo") is pleased to announce Quality Foods will be carrying Komo's 2 serving Lasagna, Shepherd's Pie and Mac & Greens as well as both Meal Helpers (Bolognese and Taco Filling) at all Quality Foods locations
Quality Foods is a British Columbia owned, award-winning leader in the Canadian grocery industry with brick and mortar stores in 13 locations in B.C. including Qualicum Foods in Qualicam Beach, Quality Foods in Parksville, Nanoose Bay, Nanaimo (Harewood), Nanaimo (Northridge Village), Port Alberni, Comox, Courtenay, Campbell River, Powell River, Victoria (Langford) and Victoria (View Royal).
"Quality Foods, the Island original, is thrilled to add this new favourite local brand, Komo Comfort Foods, to their 'Good For You' program. Their ready to bake meals aren't only an easy dinner night, they are also hearty and made with only real ingredients. Perfect to add to your veggie night or simply enjoy a meat free option! Best of all, apart from being healthy - Komo tastes delicious," says Quality Food's Reena Kaback
Quality Foods is BC owned and operated since 1982. The Vancouver Island chain is an award-winning leader in the Canadian grocery industry, employing over 1,000 employees primarily on Vancouver Island (and Powell River). Since opening their original store in 1982 as Qualicum Foods in Qualicum Beach on Vancouver Island, they are proudly "an Island Original". Now they are Quality Foods, a BC owned and operated, award-winning leader in the Canadian grocery industry, employing over 1,000 people in thirteen full service grocery stores. The company was acquired by the Jim Pattison Group in 2017.
Komo Plant Based Foods Inc. is a premium plant-based food company that develops, manufactures and sells a variety of plant-based frozen meals that are always hearty, satisfying, and made with wholesome ingredients. At Komo, our mission is to help make plant-based meals a staple on every dinner table by sharing our love for feel-good food that connects the people to the planet. We believe plant-based eating is the future and - Change can start with a single biteTM. Our experienced plant-based innovation and development team recreates vegan versions of traditionally cheesy and meaty classics, with 100% plants. Komo's products are sold direct-to-consumer through our eCommerce website and a distribution network of online and brick and mortar grocery, convenience and natural retailer channels. Our operating subsidiary Komo Comfort Foods launched in 2021 with our flagship products: plant-based Lasagna, Shepherd's Pie and Chickenless Pot Pie and Komo Plant-Based Meal HelpersTM - versatile meal starters to allow the creation of many dishes at home. Komo's newest product is Mac & Greens. All of our products are 100% plant-based, made with wholesome ingredients, free from preservatives and frozen for freshness. Freezing products is a natural and effective way of keeping food products for longer without having to use any preservatives. Komo's meals have a frozen shelf life of 18 months.
Learn more at: www.komocomfortfoods.com and follow on Instagram: @komocomfortfoods
For further information, please contact: William White, President & CEO, Komo Plant Based Foods Inc. will@komoeats.com +1(236) 8000-YUM / (236) 800-0986
The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or Komo's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Komo's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, Komo's product development plans, its ability to launch its products on food delivery apps, its ability to retain key personnel, its revenues, and its expectation as to the acceptance of its products by retailer stores and consumers constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. Komo disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: KOMO Plant Based Foods Inc.
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, for approximately $405 million in cash. The acquisition provides Gilead with MiroBio's proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio's lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed in early August 2022. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.
"Inflammation is a key area of focus for Gilead, and MiroBio's novel discovery platform technology and pipeline provides the opportunity to develop potentially best-in-class large molecule therapeutics to help patients with currently unmet medical needs," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "This novel approach to inflammatory diseases has the potential to be an important part of providing durable remission for patients living with complex and chronic immune-mediated conditions."
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, inflammation 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 difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the transaction on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this transaction; the ability of Gilead to advance MiroBio's product pipeline and successfully commercialize MiroBio's products; the ability of the parties to initiate and complete clinical trials involving such products in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such products; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such products in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use; any assumptions underlying any of the foregoing; and other risks and uncertainties detailed from time to time in Gilead's periodic reports filed with the U.S. Securities and Exchange Commission (the "SEC"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. 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. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are 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.
Gilead and the Gilead logo are 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 (@GileadSciences) 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/20220919005772/en/
Jacquie Ross, Investors Investor_relations@gilead.com
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Five abstracts underscore the long-term safety and efficacy of voclosporin, including in Latino patients and patients with Class V lupus nephritis
Data presentation on pre-clinical asset AUR200 reinforces Aurinia's commitment to autoimmune disease
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, today announced that data from multiple studies of LUPKYNIS® (voclosporin), used to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), will be presented at American College of Rheumatology (ACR) Convergence 2022. ACR Convergence 2022 will take place November 10-14 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.
The abstracts for ACR Convergence 2022 are listed below and available online at: https://acrabstracts.org/meetings/acr-convergence-2022/ .
ACR Convergence 2022 Oral and Poster Presentations:
Title: Long-term Use of Voclosporin in Patients with Class V Lupus Nephritis: Results from the AURORA 2 Continuation Study Presenting author: Amit Saxena, M.D., Assistant Professor, Department of Medicine NYU Grossman School of Medicine Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0355
Title: Early Reductions in Proteinuria with Voclosporin Treatment Across Lupus Nephritis Biopsy Classes: Pooled Data from the AURA-LV and AURORA 1 Trials Presenting author: Anca Askanase, M.D., M.P.H., Professor of Medicine, Columbia University Irving Medical Center, Department of Rheumatology Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0356
Title: Voclosporin Is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations Presenting author: Hans-Joachim Anders, M.D., Professor of Nephrology and Head of Renal Division, University of Munich (LMU) Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0357
Title: Long-term Safety and Efficacy of Voclosporin in Hispanic and Latino Patients with Lupus Nephritis Presenting author: Ellen M. Ginzler, M.D., M.P.H., Vice Chair for Research, Department of Medicine Chief, Rheumatology Division, SUNY Downstate Health Science University Date: Saturday, November 12, 2022 Time: 1:00 p.m - 3:00 p.m ET Session: SLE-Treatment Poster I, Abstract 0358
Title: AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases Presenting author: Shawn Morales, Ph.D., Aurinia Pharmaceuticals Date: Monday, November 14, 2022 Time: 9:00 a.m - 10:00 a.m ET Session: Abstracts: B Cell Biology and Targets in Autoimmune and Inflammatory Disease , Abstract 1629
Title: Voclosporin for Lupus Nephritis: Assessment of Long-Term Safety and Efficacy Including Renal Outcome over Three Years of Treatment in the Phase 3 AURORA 1 and AURORA 2 Studies Presenting author: Cristina Arriens, M.D., Clinical Assistant Member, Oklahoma Medical Research Foundation Date: Monday, November 14, 2022 Time: 9:00 a.m - 10:30 a.m ET Session: Abstracts: SLE-Treatment, Abstract 1653
About Lupus Nephritis LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.
About LUPKYNIS LUPKYNIS® is the first U.S. FDA- and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.
About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Company's head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.
LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.
Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.
The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information , including Boxed Warning, and Medication Guide for LUPKYNIS.
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Investors DeDe Sheel dsheel@auriniapharma.com
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