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Amerigroup’s New Jersey Health Plan to be renamed Wellpoint in January 2024

  • No impact or changes to members’ health plan benefits, services, and care provider network as a result of the new name
  • New name reflects the company’s continued evolution to deliver whole health
  • Wellpoint is focused on improving the health of individuals and communities at all points of life

 

 

ISELIN, N.J. — (BUSINESS WIRE) — Amerigroup New Jersey, Inc., a subsidiary of Elevance Health serving NJ FamilyCare/ Medicaid and Medicare enrollees, will begin rebranding as Wellpoint in January 2024 to reflect the company’s evolution to support whole health.

 

There will be no impact or changes to Wellpoint members’ healthcare benefits or coverage. Members will continue to have access to their established primary care providers, specialists, hospitals, and other healthcare facilities. Also, healthcare providers who serve Wellpoint members will have continued access to tools and resources to help streamline day-to-day administrative tasks.

 

“This rebranding is a continuation of our bold and ambitious purpose to improve the health of humanity by serving people across their entire health journey; connecting them to care, support and resources; and simplifying healthcare to make health more equitable and accessible,” said Patrick Fox, MD, president of Amerigroup New Jersey. “Our local presence enables us to design our benefits and programs to fit the unique needs of New Jersey communities. Wellpoint is a name that illustrates our dedication to being a lifetime, trusted health partner with a mission to help people live well across all life points.”

 

Wellpoint’s suite of health benefits is designed for consumers at any stage of life offering access to simple, supportive health solutions to help foster whole health. In addition, Wellpoint plans are committed to helping individuals improve their health through Healthy Reward incentives for wellness visits and added benefits such as gift cards for completing health screenings, newborn supplies for new mothers, and resources to support emotional well-being.

 

Subject to state regulator approval, new ID cards with the Wellpoint brand will be mailed in early 2024. Members can continue using their current card to access all existing services until they receive their new card. New Jersey members who have questions can contact Member Services via the phone number on the back of their ID card.

 

For member and provider information and updates, please visit www.wellpoint.com.

 

About Wellpoint

Wellpoint, part of the Elevance Health family of brands, focuses on improving physical health as well as the behavioral and social drivers that impact it through a comprehensive suite of Medicare, Medicaid, and Commercial products. The Wellpoint companies offer healthcare services for consumers at any stage of life seeking to make the right care decisions and helps individuals and communities make real, positive progress with health plans that foster independence, confidence, and whole-person health. For more information, please visit www.wellpoint.com.

Contacts

Stephanie DuBois

(603) 722-3087

stephanie.dubois@anthem.com

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Expert advises creators and business founders on ‘Founder’s Exit Paradox’

The departure of founders from their business creations, termed the “Founder’s Exit Paradox,” is a complex phenomenon characterized by emotional involvement and detachment.

 

Despite existing research, a comprehensive understanding and guidance that encompass emotional, relational and existential dimensions are lacking.  As founders face the intricate interplay between emotional attachment and separation, they encounter challenges in employing effective coping strategies.

 

Furthermore, departing from not only their ventures, but also the people who contributed to their success, partnerships and collaborators, adds another layer of emotional complexity. Additionally, the transition brings forth questions about finding meaning and purpose in post-exit life

Business Exit Authority Jerome Myers, PE, MBA, PMP explores a holistic framework that addresses the emotional, psychological and practical aspects of the Founder’s Exit Paradox (self-image, relationships, work, health, prosperity and significance) in a way that empowers them to navigate the departure journey with resilience, transform personally and leave a lasting legacy.

To address the emotional complexities of departing from one’s creation, founders must first grasp the nuanced dynamics of the Founder’s Exit Paradox.

 

This understanding involves recognizing the interplay between emotional involvement and detachment, along with the amalgamation of behavioral, affective and cognitive processes. Jerome can extrapolate: 

  • Leveraging Coping Orientations
  • Integration of Positive Psychology Principles
  • Adoption of the Red Pill Model
  • Barrier Recognition and Dismantling
  • Promoting Awareness, Destigmatization, and Community Building
  • Fostering Personal Transformation and Legacy
  • Ongoing Self-Reflection and Adaptation

 

About the Expert

An award-winning engineer turned business strategist, Jerome uses his rich experience and innate understanding of human emotions to ensure that your journey from the corporate world to entrepreneurship is a fulfilling one.  At the helm of a division of a multibillion-dollar Fortune 550 company, Jerome created a thriving $20M operation with 175 dedicated team members. Now, he employs that expertise to advise leaders across diverse industries, from real estate to healthcare, guiding them to double their revenue, harmony in their work-life integration, and ramp up their charitable contributions.

His multifaceted experience also extends to the realm of real estate and academia. Jerome wears the hat of a general partner in a multifamily real estate portfolio and lends his strategic acumen to the North Carolina Agricultural and Technical State University Entrepreneurship Advisory Board, driving entrepreneurial progress.  But, Jerome’s efforts to guide newly-exited operators (NEOs) doesn’t stop there. As the host of the DreamCatchers podcast, he assists founders in addressing the six centers of doubt they will face following a significant life transition. Self-image, relationship, work, health, prosperity, and significance; none of these challenges are insurmountable when navigated with the right guidance and perspective.

Jerome’s transformative program, the NEO Navigator, maps out the eight key exits a founder might encounter, from leaving a corporate role and becoming a ‘Chief Everything Officer’ to finally transitioning into roles of thought leadership and board chairmanship. He provides strategic guidance for each stage, culminating in successful business exits and the creation of a diverse post-exit investment portfolio. The ultimate goal? To help founders contribute to the causes they hold dear and leave a lasting legacy.  Whether grappling with the early stages of leaving corporate America or strategizing post-exit portfolio building, Jerome’s insightful advice and empathic approach helps founders navigate each transition with grace and confidence.

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Sotyktu (deucravacitinib) long-term data demonstrate durable efficacy and consistent safety for up to three years in moderate-to-severe plaque psoriasis

Clinical response was maintained at 73.2% for Psoriasis Area and Severity Index (PASI) 75 with three years of continuous Sotyktu treatment in the POETYK PSO long-term extension trial

 

Sotyktu demonstrated a consistent safety profile with no increases in adverse events or serious adverse events and no emergence of any new safety signals

 

New data to be presented at the 2023 European Academy of Dermatology and Venereology Congress as part of 50 company-sponsored scientific presentations, demonstrating robust and growing body of dermatology research

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #Dermatology—Bristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. At Week 148, clinical response rates were maintained with continuous treatment with modified nonresponder imputation (mNRI) responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75, 48.1% for PASI 90 and 54.1% for static Physician’s Global Assessment (sPGA) 0/1. Sotyktu demonstrated a consistent safety profile with no increases in the rates of adverse events (AEs) or serious AEs over time, and no emergence of any new safety signals.

 

These data (oral presentation #FC02.7) and 49 additional abstracts demonstrating Bristol Myers Squibb’s ongoing commitment to dermatology research are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany taking place October 11-14, 2023.

 

“These new, positive, three-year results reinforce the long-term efficacy and well-established safety profile of once-daily Sotyktu, the first and only TYK2 inhibitor available, and add to our confidence in its role as an oral treatment of choice for adults with moderate-to-severe plaque psoriasis,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO clinical trial program and professor and chief of dermatology at the University of California, Los Angeles. “For my patients, more days of relief from this chronic disease mean that they can focus on other aspects of their lives, and these POETYK PSO long-term data add to the evidence that we have the ability to offer a new standard of care to patients seeking an oral treatment option.”

 

The safety analysis assessed 1,519 patients who received at least one dose of Sotyktu across POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE. The efficacy analysis assessed 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the LTE trial. Cumulative exposure from parent trial randomization was 3,294 patient-years (PYs) for the safety analyses.

 

Clinical efficacy outcomes were maintained in patients who were continuously treated with Sotyktu from baseline through Week 148, with sustained response rates for PASI 75 (Week 16, 61.1%; Week 52, 72.6%; Week 148, 73.2%), PASI 90 (Week 16, 35.2%; Week 52, 45.6%; Week 148, 48.1%) and sPGA 0/1 (Week 16, 57.5%; Week 52, 58.1%; Week 148, 54.1%).

 

At three years, cumulative exposure-adjusted incidence rates (EAIRs)/100 PYs were similar or decreased compared with rates observed at two years, respectively, for AEs (144.8, 154.4), serious AEs (5.5, 6.1), discontinuation due to AEs (2.4, 2.8), herpes zoster (0.6, 0.7), malignancies (0.9, 0.9), major adverse cardiovascular events (0.3, 0.4), venous thromboembolism (0.1, 0.1) and deaths (0.3, 0.4). EAIRs/100 PYs were calculated as the number of patients with an AE over the total exposure time for all patients at risk (time to an initial AE occurrence for patients with AE and time of total exposure for patients without an AE).

 

“As the leader in TYK2 innovation, Bristol Myers Squibb continues to advance our long-term understanding of our first-in-class, oral Sotyktu treatment for plaque psoriasis and explore its full potential across serious immune-mediated diseases,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience Development, Bristol Myers Squibb. “These new data validate the potential of Sotyktu to provide long-term, clinically relevant improvement for individuals living with moderate-to-severe plaque psoriasis.”

 

Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.

 

About the POETYK PSO Clinical Trial Program

PrOgram to Evaluate the efficacy and safety of Sotyktu (deucravacitinib), a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were global Phase 3 studies designed to evaluate the safety and efficacy of Sotyktu compared to placebo and Otezla® (apremilast) in patients with moderate-to-severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multicenter, randomized, double-blind trials that evaluated Sotyktu (6 mg once daily) compared to placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

 

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician’s Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating Sotyktu versus placebo and Otezla.

 

Across both clinical trials and timepoints, significantly more Sotyktu-treated patients achieved a sPGA score of 0/1, PASI 75 response and PASI 90 response. Responses persisted through Week 52, as 81% (187/230) of patients who achieved PASI 75 with Sotyktu at Week 24 maintained their response at Week 52 in POETYK PSO-1. In POETYK PSO-2, 80% (119/148) of patients who continued Sotyktu maintained PASI 75 response compared to 31% (47/150) of patients who were withdrawn from Sotyktu.

 

Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials, patients could enroll in the ongoing POETYK PSO long-term extension (LTE) trial (NCT04036435) and receive open-label Sotyktu 6 mg once-daily. In the LTE trial, 1,221 patients were enrolled and received at least one dose of Sotyktu. Efficacy was analyzed utilizing treatment failure rules method of imputation, along with sensitivity analyses using modified non-responder imputation and as-observed analysis, which have been used in similar analyses with other agents.

 

In addition to POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE, Bristol Myers Squibb has evaluated Sotyktu in two other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427).

 

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate-to-severe plaque psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.

 

About Sotyktu (deucravacitinib)

Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.

 

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.

 

SOTYKTU U.S. INDICATION

SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Limitations of Use:

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.

 

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:

  • with chronic or recurrent infection
  • who have been exposed to tuberculosis
  • with a history of a serious or an opportunistic infection
  • with underlying conditions that may predispose them to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.

 

Viral Reactivation

Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.

 

Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.

 

Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.

 

Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.

 

Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

 

Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.

 

Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.

 

Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.

 

ADVERSE REACTIONS

Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.

 

SPECIFIC POPULATIONS

Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

 

Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.

 

Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.

SOTYKTU is available in 6 mg tablets.

Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.

 

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Otezla® (apremilast) is a registered trademark of Amgen Inc.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies may not be consistent with the results of this study, that Sotyktu, for the indication described in this release, may not be commercially successful, that any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such product candidate for such indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

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Curio Digital Therapeutics: Pivotal trial for postpartum depression Digital Therapeutic meets efficacy endpoints

Patients treated with MamaLift Plus demonstrated clinically meaningful, statistically significant improvements in depressive symptoms, as measured by the Edinburgh Postnatal Depression Scale

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — Curio Digital Therapeutics, Inc. “(Curio),” today announced positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial. SuMMER (NCT05958095), a study executed by HITLAB, a renowned healthcare innovation and research organization, is a randomized clinical trial of MamaLift Plus, a digital therapeutic for women experiencing perinatal mood disturbances.

 

SuMMER is a national, randomized, placebo (sham)-controlled pivotal trial evaluating MamaLift Plus for eight weeks in 141 patients (ITT population) randomized in a 2:1 ratio to the MamaLift Plus arm (N = 95) and control (sham digital) arm (N = 46). Patients had baseline EPDS scores ≥ 13 but not exceeding 19, and a confirmed diagnosis of postpartum depression prior to enrollment.

 

The SuMMER trial met its primary endpoint, a ≥4-point improvement in Edinburgh Postnatal Depression Scale (EPDS) score. The EPDS is the most commonly used depression screening tool for the perinatal population, and an improvement of four or more points is clinically meaningful. Preliminary results indicate that approximately 83% of participants in the intervention arm achieved a ≥ 4-point improvement in EPDS score, compared to only 22% in the control arm (p-value < 0.001). Approximately 82% of patients in the intervention arm achieved an EPDS reduction to <13, compared to only 30% in the control arm (p-value < 0.001). Patients with EPDS scores ≥ 13 are candidates for interventional therapy.

 

“We are excited to see the data on this critical research endeavor. The positive results from the SuMMER trial underscore the efficacy of MamaLift Plus to address postpartum depression and improve the lives of women experiencing perinatal mood disturbances,” said Professor Stan Kachnowski, PhD, Principal Investigator and HITLAB Chair. “Our collaboration exemplifies HITLAB’s commitment to advancing women’s healthcare innovations, and we look forward to continuing to drive positive change in the field of digital therapeutics and mental health through rapid evidence generation.”

 

“We are delighted and encouraged by the strong findings from the SuMMER study,” said Shailja Dixit, Chief Executive Officer of Curio. “Digital therapeutics continue to be an important option for women suffering from depressive symptoms. We are profoundly grateful to the study participants and the research team for their contributions to this research. We look forward to continued guidance from the FDA to bring this important intervention to market.”

 

Acknowledgments

Curio extends its appreciation to the SuMMER investigators and their research teams for their collaboration in conducting a successful trial. Curio would like to thank its clinical staff, including medical monitors and licensed mental health providers, for their commitment to patient safety. Curio would also like to thank the SuMMER study participants, without whom this important research would not have been possible. Thank you to the participants for sharing your experiences with us and, in so doing, contributing to a vision where all women have access to evidence-based behavioral health care.

 

About Curio Digital Therapeutics, Inc.

Curio Digital Therapeutics, Inc. is a pioneer in developing digital therapeutics solutions and novel neurobehavioral interventions across the lifecycle for women. Curio aims to create a world where every woman can access a behavioral health solution at her fingertips. The Curio Platform is reshaping maternal mental health care by leveraging proprietary algorithms, clinically validated screening tools, and personalized digital, neurobehavioral interventions to facilitate timely identification and care. For more information, visit Curio at https://www.curiodigitaltx.com/.

 

ABOUT HITLAB

Established in 1998, HITLAB is a leading evidence-based, healthcare innovation lab specializing in the delivery of world-class digital health research and education. We help leading organizations ideate, create, and evaluate technology-based solutions to pressing healthcare challenges across the globe. HITLAB works with a wide variety of stakeholders in both the public and private sectors to design and disseminate studies, programs, and products that improve healthcare access and delivery. www.hitlab.org

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include, but are not limited to, statements regarding MamaLift and MamaLift Plus.

 

These forward-looking statements are based upon projections, estimates, and assumptions that are considered reasonable by Curio and its management. However, they are inherently subject to risks and uncertainties. Factors that may cause actual results to differ materially from those expressed or implied by any forward-looking statements contained in this press release include, but are not limited to, (i) Protracted or delayed adoption of Curio products by providers, (ii) Reluctance on the part of patients to use Curio products, (iii) The possibility that Curio may be adversely affected by economic, business, regulatory, and/or competitive factors, (iv) Evolution or policy changes in the markets in which Curio operates, (v) and the impact of COVID-19, including new public health lockdown measures or the emergence of new strains of the virus, on Curio’s business.

 

Curio cautions readers not to put undue reliance on forward-looking statements, which are current only as of the date they were made. Curio assumes no obligation to update, restate, or revise any such forward-looking statements in light of new expectations or events, future or otherwise.

Contacts

Robert Keough

Senior Designer & Marketing Lead

RobertK@curiodigitaltx.com

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IEEE EMBS welcomes Professor He (Helen) Huang as Editor-in-Chief of TNSRE Journal

PISCATAWAY, N.J. — (BUSINESS WIRE) — IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Engineering in Medicine and Biology Society (EMBS), on Friday announced the incoming appointment of Professor He (Helen) Huang as editor-in-chief of IEEE Transactions on Neural Systems and Rehabilitation Engineering (TNSRE). Her duties will commence on Jan. 1, 2024.

Dr. Huang’s research focuses on neural-machine interfaces, prosthetic and exoskeleton control, human-robot interaction, and human movement control. She has more than 15 years of experience as a professor, and currently teaches at the University of North Carolina Chapel Hill and North Carolina State University. She is the Jackson Family Distinguished Professor within the Joint Department of Biomedical Engineering (BME) of both universities, and is the director of the Closed-Loop Engineering for Advanced Rehabilitation core. Dr. Huang also co-founded AVEX Motion, in 2022, a spin-off of her research lab work in wearable robotics and rehabilitation at the Joint Department of BME.

 

“As we look ahead to Dr. Huang’s stewardship of IEEE TNSRE, we anticipate an exciting chapter of growth, innovation, and impactful research,” said Paul Sajda, Ph.D., president of the IEEE EMBS. “Her remarkable achievements throughout the course of her career as a researcher, author, and associate editor give us confidence in her tenure at the journal.”

 

Dr. Huang earned her M.S. and Ph.D. in biomedical engineering from Arizona State University. She has earned numerous accolades, including the Delsys Prize for Innovation in Electromyography, the Mary E. Switzer Fellowship with NIDRR (now NIDILRR), the NSF CAREER Award, the ASA SPES Award, and the ALCOA Foundation Distinguished Engineering Research Award. She is a distinguished fellow of AIMBE, IEEE and a member of many other esteemed organizations.

 

“I aspire to improve the lives of people with disabilities by creating the symbiotic relationship between people with limb loss and robotic prostheses in my own research,” said Dr. Huang. “As editor-in-chief of TNSRE, I want to amplify the voices of my colleagues in the neural systems and rehabilitation engineering fields, and illuminate the importance of this work. I look forward to working with the editors and the team at IEEE TNSRE in accomplishing the missions of the journal and the society, and providing quality, field-leading research to our peers.”

 

About the IEEE Engineering in Medicine and Biology Society

The IEEE Engineering in Medicine and Biology Society (EMBS) is the world’s largest international society of Biomedical Engineers. With more than 9,500 members residing in some 97 countries around the world, it’s a true global connection, providing access to the most fascinating people, practices, information, ideas, opinion and fellowship from one of science’s fastest growing fields: biomedical engineering. From formalized mathematical theory through experimental science, from technological development to practical clinical applications, IEEE EMBS members support scientific, technological, and educational activities as they apply to the concepts and methods of the physical and engineering sciences in biology and medicine. By working together, we can transform and revolutionize the future of medicine and healthcare. For more information about the IEEE EMBS, please visit www.embs.org.

Contacts

Azeem Zeekrya

HDMZ

azeem.zeekrya@hdmz.com
(312) 506-5244

Categories
Business Healthcare International & World Lifestyle Science Technology

Teva to host conference call to discuss third quarter 2023 financial results at 8 a.m. ET on Nov. 8, 2023

TEL AVIV, Israel — (BUSINESS WIRE) — Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its third quarter 2023 financial results on Wednesday, Nov. 8, 2023, at 7 a.m. ET. Following the release, Teva will conduct a conference call and live webcast, at 8 a.m. ET.

 

In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin.

 

A live webcast of the call will be available on Teva’s website at: https://ir.tevapharm.com/Events-and-Presentations

 

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com.

 

Cautionary Note Regarding Forward-Looking Statements

This document and the conference call, may contain 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. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace; our substantial indebtedness; our business and operations in general including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the sections 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.

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

Categories
Business Economics Healthcare Lifestyle Programs & Events Technology

Digital Health Solution, Dentistry.One, bridges the gap between dental and medical care for improved health and lower costs – Visit us at HLTH 2023

Booth #2450-22 (DiMe Virtual First Care Pavilion) and Booth #4950-5 (CareQuest Systemic Health Pavilion)

 

METUCHEN, N.J. — (BUSINESS WIRE) — Dentistry.One, a virtual-first dental care solution introduced by MouthWatch, LLC, will showcase at Booth #2450-22 (DiMe Virtual First Care Pavilion) and Booth #4950-5 (CareQuest Systemic Health Pavilion) during the upcoming HLTH 2023 conference in Las Vegas.

 

“It is an honor to be at HLTH 2023 alongside thousands of individuals and organizations dedicated to enhancing patient health through technology and innovation,” said Brant Herman, Founder and CEO, MouthWatch, LLC and Dentistry One LLC.

 

“We are excited to demonstrate how Dentistry.One is digitally bridging the gap that has existed for far too long between dental and medical care,” continued Herman. “We’re leveraging teledentistry technology and oral health expertise to tangibly remove barriers to improved health and lower costs, especially for patients with oral-systemic conditions.”

 

Studies have shown that with proper oral health care, patients with oral-systemic conditions, such as heart disease, diabetes, and pregnancy, experience better health outcomes and a lower cost of care. According to a study published in Science Direct, cost of care for diabetes is reduced annually by $2,840.00 per patient; heart disease, $1,090.00 per patient, and pregnancy, $2,433 per patient.

 

“With the proven oral-systemic connection and compelling data underscoring the positive impact of preventive oral healthcare, it could not be a better time to participate in HLTH 2023,” said Dr. Carolyn Brown, Chief Dental Officer at Dentistry One. “We look forward to strategizing with other innovative companies at HLTH and investors in health technology, with the goal of rapidly accelerating medical-dental integration with best-in-class virtual care and a tech stack built for tomorrow.”

 

Dentistry.One provides 24/7 access to a nationwide network of on-demand dentists and a team of Care Advisors, experts in dental hygiene. Individuals can more easily prioritize their oral health and organizations focused on patient health, such as health plans, employers, benefits brokers, and dental service organizations, can differentiate their portfolio of benefits, improve the member, patient, or employee experience, and achieve their business goals.

 

Dentistry.One virtual-first care services range from emergency care, live and asynchronous consultations for oral-systemic related conditions, pre-and-post op support, ortho consultations, surgical clearance, e-prescriptions (non-narcotic), and second opinions, to timely answers to general dental concerns that help prevent development of more serious and costly health issues.

 

Care Advisors make the patient journey seamless with personalized care coordination to in-office appointments, assistance with benefits navigation, and oral health coaching. In addition, Dentistry.One increases patient engagement in oral health through data-driven educational campaigns tailored to address specific health topics aligned with individual needs.

 

To schedule time to speak with us about Dentistry.One during HLTH 2023, please click here.

 

About MouthWatch, LLC

MouthWatch, LLC, is a leader in developing digital technology solutions that drive success for dental professionals, improve oral health care, and enhance the overall patient experience.

 

Headquartered in Metuchen, New Jersey, MouthWatch is widely known for its intraoral cameras that help engage patients in treatment planning through high quality, affordable imaging technology, and its TeleDent software that provides practices and organizations with a teledentistry option to engage patients with providers remotely.

 

MouthWatch launched Dentistry.One, a virtual-first care network that addresses the expectations of today’s modern healthcare consumers, the need for greater efficiency in healthcare, and the proven connection between good oral health and total health. Dentistry.One features on-demand dental consultations, personalized care coordination, and oral health coaching for prioritizing oral health.

 

MouthWatch hardware and software are in use at over 40,000 practices, over 30 leading Dental Service Organizations (DSOs), and over 100 dental schools. The company has been recognized three times in the Inc. 5000.

 

For more information, visit mouthwatch.com or dentistry.one.

Contacts

Media Contact:
Shifra Pfister

Marketing Operations Manager

MouthWatch, LLC & Dentistry One LLC

shifra@mouthwatch.com
609.721.3187

Categories
Business Healthcare Lifestyle Science

Sanofi and Teva announce exclusive collaboration to deliver inflammatory bowel disease treatment

  • TEV ‘574, a novel anti-TL1A therapy, is being developed to treat ulcerative colitis and Crohn’s disease
  • Collaboration supports Sanofi’s immunology strategy of exploring novel mechanisms of action for chronic inflammatory diseases
  • Collaboration leverages the innovative R&D and commercial expertise of both companies

 

PARIS & PARSIPPANY, N.J. — (BUSINESS WIRE) — Sanofi (EURONEXT: SAN and NASDAQ: SNY) and Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announce today a collaboration to co-develop and co-commercialize asset TEV ‘574, currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn’s Disease, two types of inflammatory bowel disease.

 

Paul Hudson

Chief Executive Officer, Sanofi

“Anti-TL1As are a promising class of therapies, and we believe that TEV ‘574 could emerge as a best-in-class option for people living with serious gastrointestinal diseases. This collaboration strengthens our commitment to advancing innovative treatment options for inflammatory conditions with a high unmet need and bolsters our goal to be an industry leader in immunology.”

 

Richard Francis

President and Chief Executive Officer, Teva

“This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy. This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A. We are honored to partner with Sanofi to bring their proven capabilities, leadership, and success in the immunology and gastroenterology space together with our capabilities to optimize development and global launches.”

 

Under the terms of the new collaboration agreement, Teva will receive an upfront payment of €469 million ($500 million) and up to €940 million ($1 billion) in development and launch milestones. Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement and Sanofi will lead the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. The transaction will become effective after customary closing conditions are met. Initial program results are expected to be available in 2024.

 

Inflammatory bowel disease (IBD) is the term for two conditions — Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. The common symptoms for both conditions are persistent diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. An estimated ~10 million people worldwide live with IBD.

 

Teva Investor Call

Teva will hold an investor call and live webcast today (Wednesday, October 4, 2023) at 8:00 a.m. ET to discuss this collaboration. To participate, please register in advance here to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will be available on Teva’s website at: https://ir.tevapharm.com/Events-and-Presentations.

 

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com.

 

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

Teva 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 our exclusive collaboration with Sanofi, including uncertainties around the effective date of the collaboration and our ability to satisfy the closing conditions related thereto; risks related to the timing of and our ability to achieve expected results for TEV-48574 (anti-TL1A), including our ability to commercialize TEV-48574 (anti-TL1A); the extent to which we will realize the anticipated financial and other benefits of the Sanofi collaboration; our ability to satisfy the conditions to receiving milestone cash payments under the Sanofi collaboration agreement; the risk that we will incur significant costs in connection with the development of TEV-48574 (anti-TL1A), which may exceed any revenue generated by TEV-48574 (anti-TL1A); risks that regulatory approvals and other requirements may delay the development and commercialization of TEV-48574 (anti-TL1A); our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; our substantial indebtedness which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, 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.

 

Contacts

Sanofi Media Relations
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com

Sanofi Investor Relations
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Teva Investor Relations
Ran Meir | (267) 468-4475

Yael Ashman | +972 (3) 914 8262

Sanjeev Sharma | (973) 524-1908

Teva Corporate Affairs
Kelley Dougherty | (973) 658-0237

Eden Klein | +972 (3) 906 2645

Categories
Business Healthcare Lifestyle Science

Additional results of POSLUMA® (Flotufolastat F 18) performance in newly diagnosed, high-risk prostate cancer patients presented at ASTRO

− Sub-group analysis from Blue Earth Diagnostics’ Phase 3 LIGHTHOUSE trial highlights POSLUMA utility to guide treatment selection and potentially avoid futile surgery –

 

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, on Wednesday announced results from a sub-group analysis from the Phase 3 LIGHTHOUSE trial (NC04186819) which evaluated the safety and diagnostic performance of POSLUMA® (flotufolastat F 18) PET in men with newly diagnosed prostate cancer. Specifically, this sub-group examined the performance of flotufolastat F 18 PET in newly diagnosed, high-risk prostate cancer patients who had negative results with conventional imaging. Recently approved by the U.S. FDA, POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

 

Results highlights:

  • The sensitivity and specificity of flotufolastat F 18 for the detection of pelvic lymph nodes in 174 patients who underwent surgery ranged from 24-33% and 92-96%, respectively, across 3 blinded, independent readers.
  • The detection rate for M1 lesions (lesions that have spread beyond the pelvic area) for flotufolastat F 18 in 197 patients was 14% – 25% across the 3 readers.
  • Of identified lesions, 16-25 were successfully verified as True Positive, providing a M1 Verified Detection Rate (VDR) of 8.1 – 13%, across the 3 readers.

 

“Effective initial staging of prostate cancer, particularly with regards to the detection of metastatic disease, is critical to optimal clinical management of patients,” said Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering. “The demonstrated performance of PSMA-PET imaging fits an important unmet need, given that conventional imaging techniques are limited in the information they provide. This analysis from the LIGHTHOUSE study showed that flotufolastat F 18 provides clinically useful information about the presence of both metastatic pelvic lymph nodes and M1 disease prior to surgery in patients with high-risk prostate cancer who had negative results on conventional imaging. Such information can help guide treatment selection and potentially avoid futile surgery for patients with high-risk disease.”

 

“We are pleased to present these results from the LIGHTHOUSE study to the radiation oncology community at ASTRO,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA provides physicians with high-quality diagnostic information based on its diagnostic performance even at low PSA levels, high-affinity PSMA binding and low urinary bladder activity. In a post-hoc Phase 3 analysis, as well as in preclinical and Phase 1 studies, POSLUMA demonstrated low urinary bladder activity, providing for enhanced image evaluation in the prostate and regions near the ureters for patients with prostate cancer. The product is labeled with the radioisotope fluorine-18 (18F) to leverage the high image quality of 18F-labeled PSMA PET imaging, to facilitate effective detection of disease and enable broad, readily available geographic access for patients through the manufacturing and distribution network of our commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company. Nationally recognized clinical oncology guidelines for prostate cancer now include POSLUMA, alongside and for all the same categories as the other currently FDA-approved PSMA PET radiopharmaceuticals.”

 

The findings were discussed in a poster Q&A session at the 2023 ASTRO Annual Meeting on October 3, 2023,“Diagnostic Performance of 18F-rhPSMA-7.3 PET in Men with Newly Diagnosed High-risk Prostate Cancer and Negative Conventional Imaging,” by Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. on behalf of Gary A. Ulaner, MD, Ph.D., Hoag Family Cancer Institute, Irvine, Calif. and University of Southern California, Los Angeles, Calif., for the LIGHTHOUSE Study Group. Full session details and the abstract are available in the ASTRO online program here.

 

About the study

The sub-group analysis of LIGHTHOUSE data evaluated a subgroup of patients with high/very high-risk prostate cancer who had no evidence of nodal or metastatic disease on conventional imaging. Treatment-naïve patients scheduled for radical prostatectomy (RP) plus pelvic lymph node (PLN) dissection underwent flotufolastat F 18 PET. Local readers interpreted the scans prior to RP and ahead of a blinded read by 3 central readers. If the local read indicated M1 disease, verification (biopsy, surgery, or confirmatory follow-up imaging) of PET-positive M1 lesions was attempted before treatment. The analysis evaluated flotufolastat F 18 sensitivity and specificity for detection of PLN metastases in all high/very high-risk patients with negative conventional imaging at baseline who underwent flotufolastat F 18 PET and subsequent surgery. Histopathology was used as the standard of truth (SoT). Additionally, the M1 verified detection rate (VDR; % of patients with true positive (TP) M1 lesions using histopathology or follow-up imaging as SoT out of all patients scanned) was assessed in an extended population of all patients who had flotufolastat F 18 PET, regardless of surgery.

 

The sensitivity and specificity for PLN detection among 174 men with very/high-risk PCa and negative conventional imaging ranged from 24-33% and 92-96%, respectively, across the 3 readers. M1 lesions were identified in 28-51 of the 197 patients in the extended population, giving an overall M1 detection rate of 14-26%, across the 3 readers. Of the identified lesions, 16-25 were successfully verified (predominantly using follow-up imaging as SoT) as TP, providing a M1 VDR of 8.1-13%, across the 3 readers.

 

No serious adverse events were observed in the LIGHTHOUSE study. Overall, 28 of the 356 (7.9%) patients who received flotufolastat F 18 had at least one treatment-emergent adverse event that was considered possibly related to flotufolastat F 18. The most frequently reported adverse event for patients in the LIGHTHOUSE study was injection site pain among 0.8% (3/356) of patients.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

 

Indication and Important Safety Information About POSLUMA

 

INDICATION

POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
  • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
  • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
  • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

 

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

 

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0) 7917 536939

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Culture Healthcare Lifestyle

Inspira Health unveils Inspira Medical Center Mannington

The integration of Salem Medical Center, an affiliate of Inspira Health is now complete, marking the health system’s expansion with a fourth hospital in South Jersey by rebranding as IMC Mannington

 

SALEM, N.J. — (BUSINESS WIRE) — Inspira Health announced that the integration Salem Medical Center, an affiliate of Inspira Health, into the health system is complete, as of Oct. 1.

 

The hospital has been rebranded as Inspira Medical Center (IMC) Mannington, effective immediately. Services at IMC Mannington include Bariatric; Behavioral and Mental Health; Cardiology; Emergency; Gastroenterology; Orthopedics; Surgical Services; Urology; and Wound Care.

 

“The finalization of this integration marks a significant milestone for our entire health system and community as Inspira Medical Center Mannington officially becomes part of the Inspira Health family,” said Amy Mansue, President and Chief Executive Officer at Inspira Health.

 

“Our combined expertise and dedication will enable us to deliver high-quality patient care and empower healthier communities as one collective team.”

 

For more than 70 years, Inspira has been steadfast in its commitment to providing safe, high-quality care to the residents of Salem County. IMC Mannington represents a seamless extension of this legacy, dedicated to offering the latest medical innovation and evidence-based care that helps each patient achieve the best possible health outcome.

 

“This integration stands firmly on the pillars of our shared mission, vision and values,” said Lydia Stockman, RN, MHA, FACHE, Senior Vice President and Chief Administrative Officer, Inspira Medical Centers. “Last December, we began the integration of Salem into our health system and over that time, we’ve gained a better understanding of the needs of the staff at Salem and the community in which they serve. With this transition, our medical staff and health care practitioners are equipped to enhance the quality, safety and patient experience to all those we serve.”

 

“With Inspira Medical Center Mannington, we stand on the threshold of an exciting new era of health care in the region,” said Warren E. Moore, FACHE, Executive Vice President, Chief Operating Officer at Inspira Health. “Together, we will redefine the standard of excellence in health care delivery for our neighbors today and for generations to come.”

 

For more information about Inspira Medical Center Mannington, please visit https://www.inspirahealthnetwork.org/.

 

About Inspira Health

Inspira Health is a charitable nonprofit health care organization and a regional leader in physician training, with approximately 277 medical residents and fellows in 15 nationally accredited programs at its hospitals in Elmer, Mullica Hill and Vineland.

 

The system traces its roots to 1899 and comprises four medical centers, two comprehensive cancer centers, eight multi-specialty health centers, and locations throughout South Jersey. These include urgent care; outpatient imaging and rehabilitation; sleep medicine labs; cardiac testing facilities; behavioral health, digestive health and wound care centers; home care and hospice; and more than 35 primary and specialty physician practices in Gloucester, Cumberland, Salem, Camden and Atlantic counties. Additionally, Inspira EMS services six South Jersey counties.

 

Inspira’s 1,200-member medical staff and more than 7,000 employees provide an unwavering commitment to delivering a superior patient experience at every point of the journey. Technology and innovation investments provide a robust provider directory and a range of services, including online scheduling and virtual visits for both primary and specialty care providers. With a commitment to multi-channel digital access, Inspira is able to meet consumer demand for self-service and personalized care options.

 

Accredited by DNV Healthcare and committed to the principles of high reliability, Inspira Health is focused on clinical excellence and patient safety. For more information about Inspira Health, visit http://www.InspiraHealthNetwork.org or call 1-800-INSPIRA.

 

Contacts

Red Thread PR on behalf of Inspira Health

inspirapr@redthreadpr.com