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MJH Life Sciences™ continues moving all live events to virtual through first quarter of 2021

Industry giant will continue to leverage its proprietary online virtual platform and technology through at least March 2021

CRANBURY, N.J.–(BUSINESS WIRE)–#CME–MJH Life Sciences™ confirmed today that all conferences, satellite symposia, award programs and educational programming produced by the privately owned health care media company will take place in virtual format through March 2021.

From the start of the COVID-19 pandemic, MJH Life Sciences™ has adapted existing events and developed new programs to provide timely, critical health care information and education wherever clinicians are.

“Because of our state-of-the-art in-house studio and technology platforms, we were able to pivot successfully to virtual programming right from the start of the COVID-19 lockdown,” said Mike Hennessy Jr., president, and CEO of MJH Life Sciences™. “Events and education are key pillars of how we deliver on our mission to help health care professionals improve quality of life. So, we have taken great care to ensure we are delivering the greatest value, content, and accessibility, all while remaining comfortable and safe. The further upside of our decision is that even more people will be able to experience our events and continuing education without having to decide whether travel is safe enough for them – plus it will help us deliver value to and continue to build our growing global presence.”

Since March, MJH has hosted more than 600 virtual events in various formats, with a combined attendance of over 200,000 health care professionals. Most recently, MJH produced the widely attended and highly rated “COVID-19: A Race for a Vaccine” webinar to help provide clarity and insight about current clinical trials and to address questions regarding distribution of potential COVID-19 vaccines.

The experience gained and lessons learned from producing hundreds of virtual events over the past 4+ months have resulted in knowledge and understanding that will help MJH continue to optimize and perfects its future events. Upcoming large-scale virtual events include Fetch dvm360® Conference, Pharmacy Benefit Management Institute’s 26th Annual National Conference, Physicians’ Education Resource® (PER®), Chemotherapy Foundation Symposium (CFS®), Miami Breast Cancer Conference®, and PTCE’s legacy Directions in Oncology Pharmacy™ and Directions in Pharmacy® spring conference series.

About MJH Life Sciences™

MJH Life Sciences™ is the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels, providing health care professionals with the information and resources they need to optimize patient outcomes. MJH Life Sciences™ combines the reach and influence of its powerful portfolio of digital and print product lines, live events, educational programs and market research with the customization capabilities of a boutique firm. Clients include world-leading pharmaceutical, medical device, diagnostic and biotech companies. For more information, visit https://www.mjhlifesciences.com/.

Contacts

MJH Life Sciences™ Media Contact
Alexandra Ventura, 609-716-7777, ext. 121

aventura@mjhlifesciences.com

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Healthcare

Swittons introduces smart IoT devices for pharmaceutical lab digital transformation initiatives

PISCATAWAY TOWNSHIP, N.J.–(BUSINESS WIRE)–#IoT—Swittons, a P360 company, today announced a new line of Internet of Things (IoT) enabled smart devices built specifically for pharmaceutical labs. The fully customizable devices align with strategic Lab of the Future (LoTF) initiatives and help automate various laboratory workflows between people and existing digital lab equipment, systems and solutions. Built on an agile technology platform, Swittons devices are easy to deploy within pharmaceutical laboratories of all types.


“There are profound changes taking place in the area of life science research and development,” stated Swittons CEO and Founder Anupam Nandwana. “Driven by technological advances and the development of precision medicines, these modernization initiatives are designed to propel laboratory efficiencies into the future, allowing scientists to spend more time on science. This has changed the very concept of what the lab is, and Swittons is a key part of that evolution.”

The Swittons software platform is designed to provide life sciences companies with a modern, flexible user interface that not only integrates with other systems, but other IoT devices as well. This flexibility gives labs the power to create their own LoTF, configured in the way that works best for their specific use case. This means Swittons devices can be uniquely programmed, even within an individual laboratory, so end users aren’t forced into workflows that don’t fit their job function. In addition, the devices take up very little desk space, so they are conveniently available and work seamlessly within individual work styles.

Swittons devices are designed to be compatible with existing IT systems and integrate with lab support platforms and services such as LIMS, eDOC and ticketing systems. Swittons also features a powerful backend portal and reporting system, where administrators can view user CLICKS in one convenient location. The devices are even able to trigger phone and video calls via a built-in integration with Microsoft Teams.

Each Swittons device can be custom branded, and programmed for a wide range of laboratory scenarios. In pharmaceutical lab settings, Swittons fills the gap between the scientist and the lab by automating functions such as:

  • Trigger equipment maintenance
  • Open equipment service ticket
  • Indicate equipment availability
  • Trigger a video call
  • Notify of temperature control deviation
  • Notify of spill/cleaning needed
  • Equipment occupancy notification
  • Open Tickets in service software such as ServiceNow, Salesforce Service Cloud, Microsoft Dynamics
  • Reorder reagents
  • Re-stock disposable supplies
  • Report OOS or Aberrant result
  • Summon a lab runner
  • Open SOP software
  • Alert in an emergency

Swittons is built on Microsoft Azure, and each device comes out of the box ready and automatically connects through a Wi-Fi or GSM cellular connection. More information about Swittons for LoTF initiatives is available HERE.

Swittons is powered by the technology and expertise developed by P360. Delivering a 360-view through the pharma physician, laboratory and patient ecosystem, P360 designs and deploys capabilities that ensure the highest efficiencies and returns on sales operations, data management, clinical trials, patient centricity and IoT innovation. To learn more about P360, visit P360.com.

About Swittons

Based in Piscataway Township, New Jersey, and powered by P360, Swittons is an end-to-end enterprise IoT solution for commercial acceleration. From dashboard to device to data, Swittons powers seamless engagement. Swittons for physicians and pharma is changing everything about how businesses communicate. To learn more, visit Swittons.com.

Contacts

Brian Fitzgerald

Brian.Fitzgerald@P360.com
808-754-0437

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Healthcare

Bristol Myers Squibb and the Bristol Myers Squibb Foundation commit $300 million to accelerate and expand health equity and diversity and inclusion efforts

Five–year commitment builds on long-standing investment in health equity

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) and the Bristol Myers Squibb Foundation announced today a combined investment of $300 million as part of a series of commitments. For Bristol Myers Squibb and the Bristol Myers Squibb Foundation, the commitments are designed to address health disparities, increase clinical trial diversity and for Bristol Myers Squibb, to increase the company’s spend with diverse suppliers and continue to increase Black/African American and Hispanic/Latino representation at all levels of the company. These commitments build on each entity’s experience addressing health disparities and, for Bristol Myers Squibb, its investments in increasing the diversity of its workforce.

The combined $300 million investment to health equity focuses on raising disease awareness and education, increasing health care access, and improving health outcomes for medically underserved populations. The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. and increasing the diversity of investigators through a fellowship program over five years.

“Our company has a long history of addressing health disparities as part of our overall mission to serve patients with serious disease,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. “Now more than ever, we recognize the urgent need to do more to address serious gaps in care among the underserved in communities around the world. This commitment reflects our belief that investments toward achieving health equity, and increasing diversity and inclusion are opportunities to advance our vision of transforming patients’ lives through science.”

This investment follows Bristol Myers Squibb’s previous announcement to expand its existing patient support program to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. In recent months, though, COVID-19 has exposed the severity of social and health disparities in the U.S. that increase the risk for infection and poorer health outcomes for Black/African American and Hispanic/Latino communities.

Bristol Myers Squibb and the Bristol Myers Squibb Foundation recognize the need to take concrete steps to better serve and collaborate with an increasingly diverse U.S. population and underserved communities around the world.

The commitments include:

  • Increasing clinical trial diversity: Bristol Myers Squibb will extend the reach of clinical trials into underserved patient communities in urban and rural U.S. geographies. The Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities, and ultimately to enroll underserved patients into clinical trials.

“Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Over the next five years, we will extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry.”

  • Strengthening health equity work across the business: Bristol Myers Squibb will accelerate its efforts to reach at-risk patients with disease awareness and education programs and information about its patient support programs, including programs for people who cannot afford their medicines. Bristol Myers Squibb will also continue to advocate for policies that promote health equity.
  • Increasing the company’s spend with diverse suppliers: Bristol Myers Squibb will spend $1 billion globally by 2025 with Black/African American and other diverse-owned businesses to help create jobs and generate positive economic impact in diverse communities.
  • Increasing the diversity of the company’s workforce: Bristol Myers Squibb will expand the diversity of its workforce and leadership to ensure it reflects the evolving demographics of the patients the company serves. The company achieved gender parity across its workforce in 2015. By 2022, Bristol Myers Squibb aims to achieve gender parity at the executive level globally; double executive representation of Black/African American employees in the U.S.; and double executive representation of Hispanic/Latino employees in the U.S.

“As a patient focused company, it is vital that our workforce reflect the people, cultures and communities we serve,” added Ann Powell, chief human resources officer, Bristol Myers Squibb. “We recognize that meeting the needs of patients means we must continue to grow a powerfully diverse, and broadly inclusive, workforce.”

  • Expanding our employee giving program: Bristol Myers Squibb Foundation will provide a 2-to-1 match for U.S. employee donations to organizations that fight health disparities and discrimination.

The commitments by the Bristol Myers Squibb Foundation build on the more than 100 active grantee projects funded by the Foundation globally to improve access to care and support, and health outcomes that have reached nearly 1.5 million people worldwide. For more information on these commitments and the work Bristol Myers Squibb is doing to transform patients’ lives through science, visit BMS.com.

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 us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

About the Bristol Myers Squibb Foundation

The Bristol Myers Squibb Foundation promotes health equity and seeks to improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease. The Foundation engages partners to develop, test, sustain and spread innovative clinic-community partnerships to help patients access care and support for cancer in the U.S., China, Africa, and Brazil and for cardiovascular diseases, multiple sclerosis, and rheumatoid arthritis in the United States. For more information about the Bristol Myers Squibb Foundation, visit us at BMS.com/Foundation.

Contacts

BRISTOL MYERS SQUIBB
Media:
609-252-3345

MEDIA@BMS.COM

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Healthcare

TYME announces outcome of interim futility review for HopES Sarcoma Phase II study

  • Principal Investigator of the HopES Sarcoma Study Recommended Continuation of the Trial

BEDMINSTER, N.J.–(BUSINESS WIRE)–$TYME—Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced today a positive outcome of an interim futility review for the HopES Sarcoma Phase II clinical trial that is evaluating TYME’s lead cancer metabolism-based candidate, SM-88, as a potential oral treatment for patients with Ewing’s Sarcoma and other high-risk sarcomas.

“It is evident that the salvage cohort will pass the futility test and meet the criteria for expansion,” said Sant Chawla, M.D., founder of the Sarcoma Oncology Center, Santa Monica, CA and principal investigator for the HopES Sarcoma trial.

The interim futility review was completed in late July and, based on the analysis of the data and recommendations of Dr. Sant Chawla, the study will proceed with the current trial design as planned. The next major milestone in the HopES Sarcoma trial is expected in calendar year 2021. Sarcomas represents a great unmet medical need and significant opportunity for all stakeholders. There are more than 12,000 patients diagnosed each year without meaningful treatment options.

“We are pleased to have reached this important point in the HopES Sarcoma trial and now await the final results of the trial to determine the potential of oral SM-88 in high-risk sarcomas in an effort to improve the lives of these patients with, what we believe could be, a better safer approach,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “To date, SM-88 has demonstrated encouraging tumor responses in 15 different cancers across four separate studies with minimal serious grade 3 or higher adverse events.”

The HopES Sarcoma trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88, with the conditioning agents methoxsalen, phenytoin and sirolimus, in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing’s sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. Patient dosing began in January 2020. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously treated metastatic sarcoma, sponsored by the Sarcoma Oncology Research Center. The primary objectives are to measure efficacy events, including overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST 1.1), and incidence of treatment-emergent adverse events. Learn more at TYMETRIALS.com.

About Sarcomas and Ewing’s Sarcoma

Sarcomas are rare cancers in adults but are more common in children. There are approximately 12,0001 new sarcoma cases annually in the U.S. alone. There are many “subtypes” of sarcoma, as it can arise in many tissue structures throughout the body (nerves, muscles, joints, bone, fat, blood vessels – collectively referred to as the body’s “connective tissues”). Sarcomas are most frequently found in the limbs, as this is where the majority of the body’s connective tissues are found but can also present within the sites of more “common” cancers (e.g., breast sarcoma, stomach sarcoma, lung sarcoma, ovarian sarcoma, etc.). Sarcoma cancers often grow hidden deep in the body and are often diagnosed when the tumor size limits effective treatment options.

Ewing’s sarcoma is a primary bone cancer within a group of cancers known collectively as the Ewing’s sarcoma family of tumors. Ewing’s sarcoma is a type of tumor that forms in the bone or soft tissue. It is a rare type of cancer that is often overlooked and receives minimal recognition and research funding. Although Ewing’s sarcoma is typically a pediatric cancer, (it accounts for 30% of bone cancers in children), it can also be found in adults. The most commonly affected areas include the pelvis, thigh, lower leg, upper arm, and chest wall.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

About the Joseph Ahmed Foundation

The Joseph Ahmed Foundation (JAF) is a 501(c)(3) non-profit organization that was founded in 2016 by the family of Joseph Ahmed, who lost his courageous battle with Ewing’s Sarcoma eight months after his diagnosis on September 1, 2014, at the age of 16. Through their tragic loss and grief, Joseph’s loved ones established the Joseph Ahmed Foundation which is dedicated to raising public awareness for the importance of early detection of the disease, and the urgent need of funding for research and development of innovative treatment and therapies to treat Ewing’s Sarcoma and other forms of pediatric cancer. JAF’s mission is to provide resources for research programs and support services through fundraising, philanthropic donations, corporate sponsorship and grants. JAF is comprised of passionate board members and volunteers who all share the same vision, finding a cure. The foundation can be reached at 212-867-8667. The global website is www.thejosephahmedfoundation.org

About Tyme Technologies

Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

Forward-Looking Statements/Disclosure Notice

In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates, including SM-88, and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical and clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words including their use in the negative or by discussions of future matters such as effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company’s ongoing preclinical and clinical trials and ability to analyze data from those trials, the cost of development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the severity, duration, and economic impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final data from any clinical trial may differ from prior or preliminary study data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on May 22, 2020, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission available at www.sec.gov.

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

1 https://www.cancer.org/cancer/soft-tissue-sarcoma/about/key-statistics.html

Contacts

For Investor Relations & Media Inquiries:

Investor Relations

1-212- 461-2315

investorrelations@tymeinc.com
media@tymeinc.com

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Healthcare

Bayer names Lori Moore as vice president, head of U.S. Pharmaceutical Communications

WHIPPANY, N.J.–(BUSINESS WIRE)–Lori Moore, former Managing Director at Deloitte, will be joining Bayer as Vice President, Head of Pharmaceutical Communications in the United States, the company announced today.


Moore spent the last six years in senior communications roles at Deloitte, most recently as the Managing Director leading efforts to transform internal communications. Prior to joining Deloitte, Moore served in communications leadership positions at Novo Nordisk and Sanofi. In her new role at Bayer, Moore will be responsible for developing and executing external and internal communication strategies for the company’s pharmaceutical portfolio in the United States, with a specific emphasis on cardiology, oncology, women’s health, hematology and radiology.

Moore officially starts today and will be based in Whippany, N.J. She will report directly to Raymond F. Kerins, Jr., Senior Vice President of Corporate Affairs, and serve on the U.S. Corporate Affairs and Pharmaceutical Leadership Teams.

“I’m delighted to have Lori join the Bayer team as she brings more than 20 years of experience in the pharmaceutical industry,” Kerins said. “Her impressive knowledge and expertise will help us advance our communications about the company’s pharmaceutical business here in this country.”

Throughout her career, Moore has served in various positions leading marketing communications, corporate branding, internal communications and public relations. In her most recent role, she was responsible for transforming and implementing a new internal communications strategy to support the business needs at Deloitte. Earlier, she served as the head of communications for Deloitte’s audit and risk advisory business.

Prior to her time at Deloitte, Moore spent nine years at Novo Nordisk as the Executive Director for Communications and Public Affairs, where she oversaw all strategic communications, including brand and reputation management, crisis management and employee engagement in the United States. Earlier in her career, Moore managed the Global Product communications for Sanofi where she was responsible for the communications around product launches, programs and issues management.

“I’m honored to join the Bayer team at such a critical time of growth for the division,” Moore said. “Bringing innovative medicines to market is at the heart of what we do, and I look forward to communicating this important story with patients, physicians and providers throughout the United States.”

Moore holds a Master of Science degree in Communications from Northwestern University and a Bachelor of Arts in Journalism from Northern Illinois University.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

Social Media Channels

– Facebook: BayerUnitedStates
– Twitter: BayerUS
– Instagram: BayerUS
– YouTube: BayerUS

Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Carolyn Nagle

Bayer U.S.

Email: carolyn.nagle@bayer.com
Mobile: 201-419-0337

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Healthcare

Opdivo® (nivolumab) plus Yervoy® (ipilimumab) demonstrates durable survival benefit vs. chemotherapy in patients with previously untreated malignant pleural mesothelioma

CheckMate -743 is the first and only Phase 3 trial in which first-line immunotherapy treatment improved survival in patients with malignant pleural mesothelioma

With these positive results, Opdivo plus Yervoy has now shown clinical benefit in six different tumor types, including durable, superior overall survival vs. chemotherapy in two thoracic cancers

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) plus Yervoy® (ipilimumab) demonstrated a significant improvement in overall survival (OS) in patients with previously untreated, unresectable malignant pleural mesothelioma (MPM) in the Phase 3 CheckMate -743 clinical trial. With a minimum follow-up of 22 months, treatment with Opdivo plus Yervoy reduced the risk of death by 26%, demonstrating a median OS of 18.1 months vs. 14.1 months for platinum-based standard of care chemotherapy (Hazard Ratio [HR]: 0.74 [96.6% Confidence Interval [CI]: 0.60, 0.91]; p=0.002). At two years, 41% of patients treated with the Opdivo plus Yervoy combination were alive, compared to 27% of patients treated with chemotherapy.

The safety profile of Opdivo plus Yervoy was consistent with previously reported studies, and no new safety signals were observed.

These data will be presented at the 2020 World Conference on Lung Cancer Virtual Presidential Symposium hosted by the International Association for the Study of Lung Cancer on August 8, 2020, 7:00 a.m. EDT (Abstract #3).

“An aggressive cancer with a five-year survival rate of less than 10 percent, malignant pleural mesothelioma has shown resistance to many clinical treatments,” said Paul Baas, M.D., Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute and the University of Leiden. “Now, for the first time, we have evidence that a dual immunotherapy combination showed a superior, sustained overall survival benefit compared to chemotherapy in the first-line treatment of all types of malignant pleural mesothelioma. The CheckMate -743 data support the potential for nivolumab plus ipilimumab to become a new standard of care.”

Histology is a well-established prognostic factor in mesothelioma, with non-epithelioid patients generally experiencing poorer outcomes. In CheckMate -743, Opdivo plus Yervoy showed improvements in survival across both non-epithelioid and epithelioid MPM, with a larger magnitude of benefit observed in the non-epithelioid subgroup. With the dual immunotherapy combination, median OS was 18.7 months for epithelioid patients and 18.1 months for non-epithelioid patients, compared to 16.5 months and 8.8 months, respectively, with chemotherapy (epithelioid subgroup HR: 0.86 [95% CI: 0.69, 1.08]; and non-epithelioid subgroup HR: 0.46 [95% CI: 0.31, 0.68]).

“These data in malignant pleural mesothelioma follow on the established long-term efficacy of Opdivo plus Yervoy in patients with non-small cell lung cancer and further demonstrate the combination’s potential to change survival expectations in thoracic cancers,” said Sabine Maier, Vice President, Oncology Clinical Development, Bristol Myers Squibb. “For more than 15 years, no new systemic treatment options that can extend survival have been approved for patients with malignant pleural mesothelioma. We look forward to discussions with global health authorities over the coming months about the positive results from CheckMate -743.”

Opdivo plus Yervoy is a unique combination of two immune checkpoint inhibitors that features a potentially synergistic mechanism of action, targeting two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor. Some of the T cells stimulated by Yervoy can become memory T cells, which may allow for a long-term immune response.

About CheckMate -743

CheckMate -743 is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo plus Yervoy compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma (n=605). In the trial, 303 patients received Opdivo at 3 mg/kg every two weeks and Yervoy at 1 mg/kg every six weeks for up to 24 months or until disease progression or unacceptable toxicity; 302 patients received cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 21 day cycles for six cycles or until disease progression or unacceptable toxicity. The primary endpoint of the trial was OS in all randomized patients. Key secondary endpoints included objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS). Exploratory endpoints included safety, pharmacokinetics, immunogenicity and patient reported outcomes.

About Malignant Pleural Mesothelioma

Malignant pleural mesothelioma is a rare but aggressive form of cancer that forms in the lining of the lungs. It is most frequently caused by exposure to asbestos. Diagnosis is often delayed, with the majority of patients presenting with advanced or metastatic disease. Prognosis is generally poor: in previously untreated patients with advanced or metastatic malignant pleural mesothelioma, median survival is less than one year and the five-year survival rate is approximately 10%.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

Indications

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Important Safety Information

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only.

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (11/49) of patients. Hyperthyroidism occurred in 10% (5/49) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, severe to life-threatening endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin and Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue.

Contacts

Bristol Myers Squibb

Media Inquiries:
Media@BMS.com
609-252-3345

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

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Healthcare

Zelis announces 30-Year Healthcare Technology Veteran, R. Andrew Eckert, as new chief executive officer

BEDMINSTER, N.J.–(BUSINESS WIRE)–#GPTWcertified–Zelis, the industry’s leading claims cost and payments optimization platform with proprietary technology and solutions to price, pay and explain healthcare claims, announced that R. Andrew Eckert has joined the company as its new Chief Executive Officer. A 30-year veteran of the healthcare technology industry, Eckert has had a lifelong focus on enabling healthcare innovation and leading strong teams to their full potential.


During his career, Eckert has served as CEO of some of the healthcare industry’s most notable and impactful healthcare technology companies, including TriZetto Corporation, Eclipsys Corporation, and Valence Health. In each case, Eckert helped deliver client success, product and technology innovation and strong growth. Immediately prior to joining Zelis, Eckert was the CEO of Acelity, a global advanced wound care company which was sold to 3M in October 2019. Earlier in his career, Eckert served as CEO of CRC Health Group, a leading behavioral health provider owned by Bain Capital, and SumTotal Systems, a leading education technology software company.

Eckert serves on the Board of Directors of Becton Dickinson, a medical technology company, and as Chair of the Board of Directors of Varian Medical Systems, a radiation oncology treatments and software company.

“Zelis’ mission is to optimize the healthcare payments cycle – which we define as pricing, paying and explaining the claim – on behalf of payors, providers and consumers. Andy’s deep experience leading multiple companies that serve Zelis’ core constituencies, combined with his track record of driving outstanding client success, makes him a terrific choice to lead Zelis going forward,” said Dave Ament, Managing Partner of Parthenon Capital.

“I am delighted that Andy is joining Zelis,” said Devin O’Reilly, Managing Director, Bain Capital. “Andy is a highly seasoned CEO and he will help position the company to grow, innovate, and transform our industry.”

“I’m thrilled to be joining Zelis. We are a heavyweight in healthcare technology and are at the epicenter of solving some of the industry’s most intractable challenges. I believe our company will continue to make a huge impact in making the U.S. healthcare system more understandable and affordable,” said Eckert. “I look forward to further building and strengthening the company’s momentum in serving our clients with innovative solutions.”

About Zelis

Zelis is the healthcare industry’s leading claims cost and payments optimization platform with superior technology and solutions to price claims, pay claims and explain claims, all at enterprise scale on a claim-by-claim basis. Zelis leverages proprietary technology, robust analytics, extensive payment and provider networks, and innovative claim savings channels to deliver to the industry superior administrative and medical cost savings. Zelis was founded on a belief that there is a “better way” to determine the cost of a healthcare claim, manage payment related data, and make the claim payment. Zelis provides the industry’s only comprehensive, integrated platform to take a claim through the entire pre-payment to payments lifecycle. Zelis’ ~1000 associates serve more than 700 payor clients, including the top-5 national health plans, Blues plans, regional health plans, TPAs and self-insured employers, and more than 1.5 million providers. Zelis delivers more than $5B of claims savings, $50B of provider payments and 500 million payment data communications annually, and enjoys a highly recurring revenue model and a strong margin profile.

Contacts

Thuy-An Wilkins

Zelis

908.389.8756

Thuy-An.Wilkins@zelis.com

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Healthcare

Merck and Hanmi Pharmaceutical enter into licensing agreement to develop Efinopegdutide, an investigational once-weekly therapy for nonalcoholic steatohepatitis (NASH)

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Hanmi Pharmaceutical today announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis (NASH).

“Data from phase 2 studies has provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH,” said Dr. Sam Engel, associate vice president, Merck clinical research, diabetes and endocrinology, Merck Research Laboratories. “We continue to build on our proud legacy of developing meaningful medicines for the treatment of metabolic diseases and look forward to advancing this candidate.”

Under the agreement, Merck will be granted an exclusive license to develop, manufacture and commercialize efinopegdutide in the United States and globally. Hanmi will receive an upfront payment of $10 million and is eligible to receive milestone payments up to $860 million associated with the development, regulatory approval and commercialization of efinopegdutide, as well as double-digit royalties on sales of approved product. Hanmi retains an option to commercialize efinopegdutide in Korea.

“This licensing agreement supports Hanmi’s goals of developing and providing innovative therapies to the patients who need them,” said Dr. Se Chang Kwon, CEO and president, Hanmi Pharmaceutical. “We believe that Merck’s strong scientific expertise in metabolic diseases makes it well positioned to advance this candidate forward and maximize its potential for patients around the world.”

About efinopegdutide

Efinopegdutide is a GLP-1/glucagon receptor dual agonist, which activates both the GLP-1 and glucagon receptors. The safety and efficacy of efinopegdutide has previously been evaluated in multiple Phase 1 and Phase 2 clinical trials, including for the treatment of severely obese individuals with and without type 2 diabetes mellitus.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Hanmi Pharmaceutical

Hanmi Pharmaceutical is a Korea-based pharmaceutical company, fully integrated with strong focus in R&D which is strategically designed in 3 major fields: 1) Biologics: LAPSCOVERY platform applied long-acting pipelines. Key targeting areas are diabetes and obesity; 2) NCE: Mainly oncology targeted pipelines; and 3) Fixed-dose combination programs. The company has worked closely with global partners on various co-developments and collaborations. Hanmi continues to further expand through “Open Innovation Strategy” by finding potential partners for innovative solutions.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Merck Media:

Pam Eisele

(267) 305-3558

Sienna Choi

(908) 740-1256

Merck Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

Categories
Healthcare

Eagle Pharmaceuticals to discuss second quarter 2020 financial results on August 10, 2020

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq: EGRX) today announced that the Company will release its 2020 second quarter financial results on Monday, August 10, 2020, before the market opens.

Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, August 10, 2020

Time

8:30 a.m. ET

Toll free (U.S.)

877-876-9173

International

785-424-1667

Webcast (live and replay)

www.eagleus.com, under the “Investor Relations” section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc:
Lisa M. Wilson

T: 212-452-2793

E: lwilson@insitecony.com

Public Relations for Eagle Pharmaceuticals, Inc.:
Faith Pomeroy-Ward

T: 817-807-8044

E: faith@fpwservices.com

Categories
Healthcare

Teva announces new strategic focus in the Japanese market

  • Japan Business Venture shifts focus to specialty assets and a portfolio of select generics that meet patients’ medical needs
  • Remains positioned to address unmet patient needs in core therapeutic areas
  • Will divest majority of current non-differentiated generics portfolio, as well as local manufacturing
  • Business venture remains committed to serving its Japanese patients and healthcare professionals

TEL AVIV, Israel–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), who holds (through its Japanese affiliates) with Takeda a joint business venture (the “BV”) in the Japanese market, announced today a new strategy for its local commercial operations. Nearly five years since its inception, and following an in-depth review of market opportunities, the BV’s new strategy will focus on commercializing a selection of complex generics, specialty assets and other pipeline opportunities.

This shift will include a divestment of the majority of the BV’s generic and operational assets to Nichi-Iko Pharmaceutical Co., Ltd. This transaction is expected to close by early 2021.

The BV will retain approximately 20 generic molecules and several pipeline assets, as well as its robust portfolio of authorized generics, LLPs and specialty assets. The BV will seek to address unmet patient needs with products from its portfolio and pipeline and will continue to combine Teva’s deep marketing expertise, commercial and medical excellence, coupled with financial rigor, with Takeda’s leading brand reputation and strong distribution presence in Japan.

Gianfranco Nazzi, Executive Vice President, International Markets Commercial, said: “The Teva and Takeda business venture has always aimed to address the wide-ranging needs of patients and healthcare professionals in Japan. Our new strategy will allow each of the parties to leverage its core strengths, and ultimately better serve the Japanese patients. For Teva, and in line with the company’s strategic objectives, the new model presents a chance to drive better performance by focusing our Japan business on a portfolio of select generics and pipeline of specialty assets, while continuing to put patients and healthcare professionals at the center of our strategy.”

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 specialty 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 specialty and biopharmaceutical products. Learn more at 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 re: our new strategic focus in the Japanese market, 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:

  • the potential that the expected benefits and opportunities related to our new strategic focus may not be realized or may take longer to realize than expected;
  • risks related to the satisfaction of the conditions to closing the disposition of certain of our joint venture’s generic and operational assets (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the disposition does not close, and the companies’ ability to consummate the disposition on the terms agreed by the parties;
  • our ability to successfully compete in the marketplace, including: competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • 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: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
  • compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” 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

United States

Kevin C. Mannix (215) 591-8912

Israel
Ran Meir 972 (3) 926-7516

PR Contacts

United States
Doris Li (973) 265-3752

Israel

Yonatan Beker

972 (54) 888 5898