BostonGene and Saga University Announce Collaboration to Uncover Biomarkers for Improved Immunotherapy Response in Lung Cancer Patients




BostonGene and Saga University Announce Collaboration to Uncover Biomarkers for Improved Immunotherapy Response in Lung Cancer Patients

Study designed to explore novel markers for identifying responders with immune checkpoint inhibitors in patients resistant to targeted therapies

WALTHAM, Mass.–(BUSINESS WIRE)–BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, and Saga University located in Saga, Japan and known for its commitment to educating and training researchers and professionals in the medical and healthcare fields, announced today the launch of a collaboration aimed at discovering biomarkers for immunotherapy (IO) treatment response and treatment-related toxicity in advanced non-small cell lung cancer (NSCLC) patients.

EGFR-TKI treatment effectively targets EGFR mutation-positive NSCLC. Still, acquired resistance often leads to recurrence within 1 to 2 years, presenting a challenge for post-treatment optimization. Immune checkpoint inhibitors (ICIs) are standard therapy for NSCLC, but the efficacy in EGFR mutation-positive cases is limited. However, combination therapy with ICIs and anti-angiogenic agents has shown promise in EGFR-positive lung cancer.

This study will evaluate the tumor microenvironment (TME) utilizing the BostonGene Tumor Portrait^™ test in tissue samples collected before EGFR-TKI treatment and before ICI administration in patients with EGFR-positive lung adenocarcinoma. The study aims to examine the relationship between TME characteristics and the effectiveness of ICIs in these patients and investigate TME changes resulting from EGFR-TKI therapy. Furthermore, researchers will review cases where small-cell transformation occurred as a mechanism of EGFR-TKI resistance, aiming to elucidate the molecular mechanisms underlying this transformation within the TME context. By addressing these objectives, we enhance our understanding of TME dynamics and its implications for treatment response, ultimately informing improved therapeutic strategies for EGFR-positive lung adenocarcinoma.

“We are dedicated to advancing medical research directly impacting patient care. By partnering with BostonGene, we aim to uncover novel biomarkers to revolutionize how we approach immunotherapy treatment in EGFR-positive lung cancer, ultimately improving patient outcomes,” said Dr. Naoko Aragane, Professor of Saga University.

“Our collaboration with Saga University underscores our dedication to advancing the standard of care in Japan by bringing novel technologies to the region. The study marks an opportunity to delve deep into the complexities of the tumor microenvironment in EGFR-positive lung cancer patients, equipping oncologists with more targeted and effective immunotherapy strategies for their patients,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

BostonGene, NEC Corporation and Japan Industrial Partners established BostonGene Japan Inc., a joint venture leveraging BostonGene’s advanced molecular technology and NEC’s biocomputational algorithms in 2023. The company aims to deliver its industry-leading personalized tests to cancer patients in Japan and collaborate with academic and industry partners to accelerate the development of targeted therapies.

About BostonGene Corporation 

BostonGene has a mission to provide transformative, AI-integrated molecular analytics and biomarker discovery for precision matching of therapies to improve the lives of patients living with cancer and other immune-related diseases. BostonGene’s concierge-service model provides customized client solutions using a multi-omic approach prioritized for real-world impact to optimize standard-of-care therapies, accelerate research and provide cost-effective, measurable data-driven results. BostonGene’s tests reveal key drivers of each patient’s unique disease profile, including an in-depth profile of the immune microenvironment, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene’s tests generate a personalized roadmap for therapeutic decision-making for each patient. For more information, visit BostonGene at http://www.BostonGene.com.

Contacts

Media:
BostonGene

Erin O’Reilly

+1-617-283-2285

Erin.Oreilly@BostonGene.com

Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine




Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine

• Novel 505(b)(2) presentation of a key injectable for treating non-squamous non-small cell lung cancer and malignant pleural mesothelioma, does not require reconstitution, dilution, or refrigeration
• Amneal plans to launch two to three branded oncology 505(b)(2) products per year going forward – this is the first of 2024

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU^®, the first and only ready-to-use presentation of pemetrexed for injection. This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.

“The launch of PEMRYDI RTU highlights Amneal’s deep commitment to oncology as we invest to develop injectable products that are important to healthcare providers and patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “In this first ready-to-use version, we offer hospitals and oncology clinics a new, value-added presentation that should improve pharmacy efficiency by eliminating preparation steps and freeing up refrigerator space with shelf stability for up to 24 months. We expect to launch two to three 505(b)(2) injectables per year going forward.”

PEMRYDI RTU^® has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J9324: Injection, pemetrexed (pemrydi rtu). PEMRYDI RTU^® injectable is available in two vial sizes: 100mg/10mL and 500 mg/50mL.

PEMRYDI RTU^® is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Adverse effects include myelosuppression, renal failure, skin toxicity, interstitial pneumonitis and radiation recall. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for pemetrexed for the 12 months ended February 2024 were $287 million.

About Amneal 

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Cautionary Statement on Forward-Looking Statements 

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Contacts

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Teva’s New Real-World Evidence Presented at the 2024 AAN Annual Meeting Confirms Effectiveness and Patient Satisfaction for HD Chorea with the 4-week Titration Kit for AUSTEDO® (deutetrabenazine) Tablets




Teva’s New Real-World Evidence Presented at the 2024 AAN Annual Meeting Confirms Effectiveness and Patient Satisfaction for HD Chorea with the 4-week Titration Kit for AUSTEDO® (deutetrabenazine) Tablets

• Almost 80% of patients with Huntington’s disease (HD) chorea were able to achieve optimal dosing within four weeks with the 4-week Titration Kit in final START study results
• START study results further support real-world effectiveness, safety, adherence and patient satisfaction with the 4-week Titration Kit for AUSTEDO
• AUSTEDO remains the only vesicular monoamine transporter 2 (VMAT2) inhibitor available with 3-year data for this progressive condition^1,2

TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO. As a fatal, neurodegenerative disease, HD can cause cognitive deterioration, behavioral and/or psychological problems and uncontrollable body movements known as chorea – a symptom that can have a significant impact on daily activities like eating or talking.^3-5 These data are being presented at the 2024 American Academy of Neurology (AAN) Annual Meeting.

“90% of HD patients experience chorea,^3,4 so it’s important for patients to have a treatment option that not only helps address symptoms, but helps provide a positive patient experience,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “We remain committed to exploring ways to evolve the AUSTEDO treatment experience to meet the needs of the HD community, and these latest real-world data reinforce the role of the 4-week Titration Kit for AUSTEDO in empowering patients with HD chorea to find their optimal dose, adhere consistently to their treatment plan, and achieve effective outcomes.”

The START study was a Phase 4 study investigating real-world treatment outcomes for patients starting AUSTEDO with the 4-week Titration Kit. Final results from the HD cohort of the START study show that by week 24:

• 76% (13/17) of patients successfully completed the titration kit, with more than 90% adherence and a 33% mean reduction in total maximal chorea (TMC) score from baseline
• 53% (9/17) of patients achieved treatment success using the Clinical Global Impression of Change (CGIC) and 71% (12/17) using the Patient Global Impression of Change (PGIC)
• 100% (12/12) of patients who completed the satisfaction survey found the kit easy to use and 100% (7/7) of providers who completed the satisfaction survey found the kit helpful in ensuring patient adherence to the titration schedule

The safety profile of AUSTEDO in this study was consistent with the pivotal studies.

“These data demonstrate that we can have confidence in this treatment approach that allows patients to adjust their medication based on their individual HD chorea symptoms,” said Karen Anderson, MD, Professor, Psychiatry and Neurology at Georgetown University School of Medicine and Director, Huntington’s Disease Care, Education and Research Center. “I’m glad to see this outcome as it gives clinicians more confidence and patients more control.”

About Chorea Associated with Huntington’s Disease (HD)

Huntington’s Disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems.³ Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in approximately 90% of patients.^3,4 Chorea can have a significant impact on daily activities and progressively limit peoples’ lives.³

About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets

AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.

INDICATIONS AND USAGE

AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia. Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets.

Please see accompanying full Prescribing Information, including Boxed Warning.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: the development and commercial success of AUSTEDO and AUSTEDO XR; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products, competition for our innovative medicines, our ability to achieve expected results from investments in our product pipeline, our ability to successfully execute our Pivot to Growth strategy; the effectiveness of our patents and other measures to protect our intellectual property rights; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

______________________

1. Hauser, R. A., Barkay, H., Fernandez, H. H. et al. Long-Term Deutetrabenazine Treatment for Tardive Dyskinesia is Associated with Sustained Benefits and Safety: A 3-Year, Open-Label Extension Study. Frontiers in Neurology (2022). https://doi.org/10.3389/fneur.2022.773999.
2. Frank, S., Testa, C., Edmondson, M.C. et al. The Safety of Deutetrabenazine for Chorea in Huntington Disease: An Open-Label Extension Study. CNS Drugs (2022). https://doi.org/10.1007/s40263-022-00956-8.
3. Huntington’s Disease. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/health-information/disorders/huntingtons-disease#toc-what-is-huntington-s-disease-. Accessed April 16, 2024.
4. Thorley, E. M., Iyer, R. G., Wicks, P., Curran, C., Gandhi, S. K., Abler, V., Anderson, K. E., & Carlozzi, N. E. (2018). Understanding How Chorea Affects Health-Related Quality of Life in Huntington Disease: An Online Survey of Patients and Caregivers in the United States. The patient, 11(5), 547–559. https://doi.org/10.1007/s40271-018-0312-x
5. Claassen DO, DeCourcy J, Mellor J, Johnston C, Iyer RG. Impact of chorea on self-care activity, employment, and health-care resource use in patients with Huntington’s disease. JHEOR. 2021;8(1):99-105. doi:10.36469/jheor.2021.24620

Contacts

IR Contacts

Ran Meir +1 (267) 468-4475

Yael Ashman +972 (3) 914 8262

Sanjeev Sharma +1 (973) 658 2700

PR Contacts
Kelley Dougherty +1 (973) 832-2810

Eden Klein +972 (3) 906 2645

Charles River Laboratories Launches Alternative Methods Advancement Project to Reduce Reliance on Animal Testing




Charles River Laboratories Launches Alternative Methods Advancement Project to Reduce Reliance on Animal Testing

Initiative focuses on innovation, partnerships, and advocacy as part of $500 million investment in driving change

WILMINGTON, Mass.–(BUSINESS WIRE)–$CRL #LIFEatCRL–Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it is launching its Alternative Methods Advancement Project (AMAP), an initiative dedicated to developing alternatives to reduce animal testing. The initiative aims to drive the new standard for drug discovery and development and encapsulates the Company’s initial $200 million investment over the past four years and its five-year goal of investing an additional $300 million. This investment spans a portfolio of technology innovations, partnerships, and advocacy efforts to reduce the use of animal testing.

Strategy to Drive Transformation

Understanding that stakeholders across drug development must collaborate to pursue these advances, AMAP is comprised of Charles River experts in animal welfare, science, technology, operations, and advocacy. Currently an internal initiative, AMAP plans to include partner organizations and funding to encourage collective efforts to innovate and bring best-in-class solutions to the forefront, industry-wide.

Building on the imperative to deliver on the 3Rs (Replacement, Reduction, and Refinement), Charles River has spearheaded the addition of the fourth R of Responsibility to capture its role in driving progress. AMAP delivers on this commitment to the 4Rs with a dedicated pursuit of scientific and technological innovation and by aligning the Company’s strategic efforts with the focus needed to advance animal alternatives. Grounded in the need to prove the scientific rigor, AMAP initiatives include research projects confirming the safety and efficacy of alternatives – ensuring patient safety remains the utmost priority.

AMAP focus is on three key pillars:

• Products & Services: Charles River is committed to innovating and expanding its portfolio to include more animal alternatives. By following the science and introducing new alternative modalities only when they are proven, Charles River intends to set the standard for ensuring patients receive needed treatments safely, swiftly, and successfully. The recent launch of Endosafe® Trillium™, the Company’s first rapid animal-free bacterial endotoxin test, delivers on this imperative by meeting the highest scientific standards and offering a path to reducing reliance on horseshoe crab blood.
• Strategic Investments & Partnerships: Understanding that advancement requires collaboration, AMAP involves the continuation of Charles River’s strategy to partner with companies to co-develop solutions and continuing to identify externally-developed technologies to enhance client offerings.
  • Previous collaborative efforts include the launch of Logica® – the AI-solution for candidate nomination – with Valo, study validation of next-generation sequencing in viral safety assays with PathoQuest, and ongoing advancements in digital pathology with Deciphex. Additional efforts to expand AI adoption, validate substitutes for animal testing in support of clinical studies, and develop virtual training tools are underway.
• Advocacy: True transformation requires regulatory bodies and government agencies to compel industry-wide change. By pursuing partnerships and relationships with thought leaders, policy makers, and important non-governmental organizations (NGOs), Charles River plans to work with these public entities to build the infrastructure needed to support the pursuit of alternatives and inspire confidence in their acceptance as a new standard.

Through the adoption of digital technologies and AI, following advancements in science, and establishing relationships with industry changemakers, Charles River is dedicated to introducing innovative methodologies that reduce reliance on animal testing while bringing new therapies to patients faster without compromising safety.

Approved Quotes

• “Advances in science and technology have brought our industry to an inflection point. Alternatives are the path to the next frontier of drug development, allowing us to responsibly drive progress for the patients and animals that depend on our work. With our long history in embracing innovation in biopharmaceutical research, Charles River is well-positioned in setting this new standard for drug development.” – James C. Foster, Chairman, President and Chief Executive Officer of Charles River
• “The adoption of alternatives is a strategic imperative for the industry that requires scientific rigor to prove its possibility and expansive collaboration to drive change. AMAP is Charles River’s rallying cry that we must unite in the effort to not only build these innovations but also inspire confidence and transform the systems to ensure they can be effectively implemented.” – Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

Contacts

Investor Contact:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Media Contact:
Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Green Circle Life Expands Availability of Healthy Weight for Life Program for the SmartFHR™ Platform




Green Circle Life Expands Availability of Healthy Weight for Life Program for the SmartFHR™ Platform

PENSACOLA, Fla.–(BUSINESS WIRE)–#HealthCoaching—Green Circle Life (GCL), provider of the innovative communication and engagement platform SmartFHR™, complete with integrated health and wellbeing services, proudly announces that its highly successful Healthy Weight for Life program (HWFL) is now available to all users and corporate clients.

HWFL is an employer-offered weight management program designed to work with individuals to set realistic goals, attain and maintain their desired weight through lifestyle changes. The program, which provides private, personalized coaching, encourages users to engage in physical activities, nutritional adjustments and monitor weight outcomes. If needed, they can combine the use of prescription medications, such as Wegovy™ and Saxenda® by Novo Nordisk or Zepbound™ by Eli Lilly, with their personalized behavioral therapy to assist in managing chronic weight issues.

Dinesh Sheth, founder and CEO of Green Circle Life, emphasized, “Health and wellness are at the forefront of HR challenges, and obesity is a national epidemic. While newer medications are effective, cost is a barrier for both employers and employees. Our HWFL program addresses the need for sustained lifestyle changes, with an added layer of accountability, and demonstrates improved outcomes and tremendous ROI for employers. This well-designed program integrates pharmacy benefits, rewards management, and individualized coaching, making our platform unique in the marketplace.”

Following the measurable success of the program at AutoZone, the leading retailer and distributor of automotive replacement parts in the Americas, Green Circle Life is now offering the HWFL program to all clients. Matt Harmon, Vice President, Benefits, Compensation, HR Systems, AutoZone, said, “Healthy Weight for Life has made a remarkable impact on the lives of our AutoZoners’ and their families. Healthy weight is not a ‘one and done’ ‘one size fits all’ proposition but rather a constantly evolving journey. This program has served as the framework to help guide and navigate people through this often-complex journey. Beyond the tremendous impact to health and quality of life, we have seen better clinical outcomes with lower medical and prescription costs. We owe our success to our longstanding partnership with Green Circle Life with whom we have evolved our thinking together and are confident this program leads to real outcomes for AutoZoners and their families.”

According to the Center for Disease Control, 42% of the adult population is affected by obesity, contributing to elevated annual medical costs. HWFL emerges as a pivotal component of employer benefits aimed at enhancing outcomes and curbing health care expenditures. It is implemented in collaboration with employers, pharmacy benefit providers and medical service providers, forming a crucial part of employer benefits to improve outcomes and lower healthcare costs. The program works closely with pharmacy benefit managers to lower costs when compliant with the program and learn healthy habits to ensure users experience results, even after they no longer require medications. Incentives are integrated within the SmartFHR App to ensure employees compliant with the program protocol are able to fill their prescriptions with a lower copay.

Sal Morana RPh, PhD, who serves as EVP Pharmacy Benefits Lead at Alliant Employee Benefits, said, “From a clinical and financial perspective, the HWFL program offers employers an opportunity to maximize the return on investment from GLP-1 therapy for weight loss. After a careful review of the clinical data, it was clear that drug therapy alone is not enough to combat obesity and type 2 diabetes. It takes a combination of diet, behavioral change, and exercise along with drug therapy when appropriate to make a meaningful and enduring difference. The HWFL program accomplishes this goal by coupling drug therapy to behavior change in a meaningful and efficient way”

Employer Benefits:

• Comprehensive program catering to the entire workforce, irrespective of insurance participation.
• Effective management of wellness rewards to incentivize achievement of healthy weight management goals.
• Integration of pharmacy benefits to control costs through adherence and discounts.
• Support medication use through personalized sustainable lifestyle changes.

Employee Benefits:

• Personalized coaching and guidance from health coaches to ensure success.
• Integration of activity trackers, weight scales, and other personal health devices and apps.
• Convenient tracking of medication doses, weight, and other health metrics.
• Monitoring of daily meals and snacks to facilitate better nutritional choices.
• Regular reminders for medication, appointments, coaching and more.

The HWFL program is available to any employer seeking to instill accountability, offer personalized resources and deliver exceptional user experience in their pursuit of lifelong weight management goals. It can function as a standalone program or be integrated with existing third-party solutions. Regardless of health insurance, pharmacy benefits manager, and third-party point solution providers, the SmartFHR™ platform is designed to integrate third-party benefits providers for better user experience, fostering greater accountability and achieving superior outcomes with cost savings.

Green Circle Life’s health and wellness services are certified in Health Appraisal, Health Coaching and Self-Management Tools from the National Committee for Quality Assurance (NCQA), ensuring evidence-based programs that positively impact the health and wellbeing of employees and their families.

For more information, click here.

About Green Circle Life

Green Circle Life offers the patented SmartFHR™ platform for employers to empower employees and their families to live happier, healthier, and more productive lives. This helps employers attract and retain talent by providing employees access to all of their benefits and services, chronic condition management programs, wellness programs and one-one-one health and wellness coaching. SmartFHR delivers a greater return on investment with an engaged workforce, better healthcare outcomes, lower healthcare costs, reduced absenteeism and presenteeism, and improved profitability. The platform is SOC2 and HIPAA certified, client-branded and fully integrated with internal and external systems. For more information, visit www.greencirclelife.com and follow them on Twitter and LinkedIn.

Contacts

Laura Lenz

Laura@williammills.com
678-781-7226