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Six Flags Great Adventure announces opening of triple world record-shattering ‘Jersey Devil Coaster’

World’s Tallest, Fastest, and Longest Single-Rail Coaster to Debut June 13

Exciting Ride Video & Photos: https://6fla.gs/4u

 

JACKSON, N.J. — (BUSINESS WIRE) — #jerseydevil—Six Flags Great Adventure, the World’s Ultimate Thrill Park, today announced that its highly-anticipated Jersey Devil Coaster will preview to press June 10 and debut to the public June 13. Jersey Devil Coaster will rank as the world’s tallest, fastest and longest single rail coaster—towering 13 stories, flying at speeds up to 58 miles-per-hour, and propelling riders single file through the dark and foreboding woods over 3,000 feet of track. Inspired by infamous New Jersey mythology, the cutting-edge coaster will feature five intense elements, including three dramatic inversions.


Legend says the Jersey Devil has haunted the Pine Barrens for centuries, soaring stealthily through the woods in the dark of night before attacking its prey. Modern-day folklore places this beast near the theme park’s Great Lake, with its menacing, curled horns manifesting under a full moon.

“Jersey Devil folklore has been a source of fear and intrigue here in the Pine Barrens for more than 200 years. We’ll immerse riders in this iconic piece of New Jersey history on our monstrous, new scream machine,” said Park President John Winkler. “Jersey Devil Coaster is the perfect addition to our unrivaled collection of award-winning, innovative, and thrilling roller coasters.”

The Jersey Devil Coaster includes the following key features:

  • Elaborately-themed entrance portal, and a queue design that features informative storyboards on the Jersey Devil’s origin;
  • Four sleek trains of 12 passengers each, sitting low and inline style (one rider per row) with their legs straddling either side of the monorail track;
  • Three thousand feet of soaring, single-rail, I-beam track;
  • Tension-building ascent up a towering, 130-foot lift hill;
  • Speeds up to 58 mph;
  • Intense elements including a steep, 87-degree first drop and an overbanked cutback; and
  • Three dramatic inversions, including a 180-degree stall, raven dive, and zero-gravity roll.

With dark, New Jersey folklore at the heart of this new ride, some are questioning whether the ride’s statistics were planned, mere coincidence, or rooted in something more sinister.

  • The Jersey Devil was the cursed 13th child of Mother Leeds
    • The coaster is 13 stories tall;
    • Jersey Devil is the park’s 13th roller coaster;
    • Each train carries 12 human passengers, with the Jersey Devil himself as the lead car…a total of 13 riders; and
    • Jersey Devil will open to the public June 13.

Folklore buffs will enjoy finding the historical “Easter eggs” that Six Flags designers incorporated into the Jersey Devil’s entrance and queue design.

Riders must meet the 48-inch height requirement. Jersey Devil Coaster is located along the lakefront near Safari Kids and Congo Rapids. A new Jersey Devil BBQ restaurant is located across from the ride’s entrance.

Six Flags Members and Season Pass holders will enjoy an exclusive preview of Jersey Devil Coaster June 11 and 12 prior to the grand opening to the public June 13. For more information about Jersey Devil Coaster, and this season at Six Flags Great Adventure, visit www.sixflags.com/greatadventure

About Six Flags Entertainment Corporation

Six Flags Entertainment Corporation is the world’s largest regional theme park company and the largest operator of waterparks in North America, with 27 parks across the United States, Mexico, and Canada. For nearly 60 years, Six Flags has entertained millions of families with world-class coasters, themed rides, thrilling waterparks and unique attractions. Six Flags is committed to creating an inclusive environment that fully embraces the diversity of our team members and guests. For more information, visit www.sixflags.com.

About Six Flags Great Adventure, Wild Safari and Hurricane Harbor

Six Flags Great Adventure is the World’s Largest Thrill Park with world-class, award-winning rides like Kingda Ka, El Toro, Nitro, and Zumanjaro: Drop of Doom. The park offers two areas just for the littlest guests and great family rides for the whole family, plus entertainment, shopping, and a wide variety of dining options. Its Wild Safari Drive-Thru Adventure is one of the largest self-guided drive-through safari outside of Africa and gets guests up-close to more than 1,200 animals from around the globe in the privacy of their own vehicles. Six Flags Hurricane Harbor is one of the Northeast’s largest waterparks with more than 25 refreshing attractions for the whole family. www.sixflags.com/greatadventure

Contacts

Kristin Fitzgerald, kfitzgerald@sftp.com
732/928-2000 x2832

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Business Local News

Bristol Myers Squibb announces positive topline results from Phase 3 TRANSFORM trial evaluating Breyanzi (lisocabtagene maraleucel) versus chemotherapy followed by stem cell transplant in second-line relapsed or refractory large B-cell lymphoma

Study met primary and key secondary endpoints, demonstrating a highly statistically significant improvement in event-free survival, complete response rate and progression-free survival compared to standard of care

Breyanzi safety results consistent with data from pivotal TRANSCEND NHL 001 trial

Results represent the first time a therapy has demonstrated benefit compared to high-dose chemotherapy and stem cell transplant in relapsed or refractory large B-cell lymphoma, and support the potential of Breyanzi in earlier lines of therapy in this patient population

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #BCell—Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from TRANSFORM, a global, randomized, multicenter Phase 3 study evaluating Breyanzi (lisocabtagene maraleucel) as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) compared to salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant, which is currently considered a gold standard treatment for these patients. Results of a pre-specified interim analysis conducted by an independent review committee showed the study met its primary endpoint of demonstrating a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care. Overall survival data were immature at the time of this interim analysis. Safety results were consistent with the known safety profile of Breyanzi for the treatment of LBCL in the third-line setting, and no new safety concerns were identified in this second-line setting.

“We ambitiously designed the TRANSFORM trial to evaluate Breyanzi’s potential in the second-line setting for patients with relapsed or refractory large B-cell lymphoma against the standard of care regimen of high-dose chemotherapy and autologous stem cell transplant,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology and Cell Therapy Development, Bristol Myers Squibb. “These positive interim results build on our commitment to bring CAR T cell therapies into earlier lines and highlight the potential of Breyanzi to transform the treatment paradigm for this difficult-to-treat disease, possibly supplanting the need for patients to undergo current aggressive treatment regimens.”

The results represent the first time a therapy has shown a benefit over standard of care high-dose chemotherapy and stem cell transplant in relapsed or refractory LBCL, and the first time a CD19-directed CAR T cell therapy has demonstrated potential as a second-line therapy in this patient population. The company will complete an evaluation of the TRANSFORM data and looks forward to sharing the results at an upcoming medical conference, as well as with health authorities. Bristol Myers Squibb thanks the patients and investigators who are participating in the TRANSFORM clinical trial.

Breyanzi, a CD19-directed CAR T cell therapy, was approved by the U.S. Food and Drug Administration (FDA) in February 2021 for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding cytokine release syndrome and neurotoxicity.

About TRANSFORM

TRANSFORM (NCT03575351) is a pivotal, global, randomized, multicenter Phase 3 trial evaluating Breyanzi compared to current standard of care regimens, including high-dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT), in adults with large B-cell lymphoma that is primary refractory or relapsed within 12 months of initial therapy and who are eligible for stem cell transplant. Patients were randomized to receive Breyanzi or standard of care salvage therapy, including rituximab plus dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP), rituximab plus ifosfamide, carboplatin and etoposide (R-ICE), or rituximab plus gemcitabine, dexamethasone and cisplatin (R-GDP) per the investigators’ choice before proceeding to HDCT and HSCT. The primary endpoint of the study is event-free survival, defined as time from randomization to death from any cause, progressive disease, failure to achieve complete response or partial response by nine weeks post-randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first. Complete response rate is a key secondary endpoint. Other efficacy endpoints include progression-free survival, overall survival, overall response rate and duration of response. All enrolled patients have large B-cell lymphoma and were relapsed or refractory within 12 months from CD20 antibody and anthracycline containing first-line therapy.

About Breyanzi

Breyanzi is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4-1BB signaling domain enhances the expansion and persistence of the CAR T cells. Breyanzi is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Breyanzi is also approved in Japan for relapsed and refractory LBCL, and Marketing Authorization Applications for Breyanzi are currently under review in the European Union, Switzerland and Canada. Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in earlier lines of treatment for patients with relapsed or refractory LBCL and other types of lymphoma. For more information, visit clinicaltrials.gov.

U.S. FDA-Approved Indication for Breyanzi

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
  • BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.

Cytokine Release Syndrome (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with BREYANZI. CRS occurred in 46% (122/268) of patients receiving BREYANZI, including ≥ Grade 3 (Lee grading system) CRS in 4% (11/268) of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 119 of 122 patients (98%) with a median duration of 5 days (range: 1 to 17 days). Median duration of CRS was 5 days (range 1 to 30 days) in all patients, including those who died or had CRS ongoing at time of death.

Among patients with CRS, the most common manifestations of CRS include fever (93%), hypotension (49%), tachycardia (39%), chills (28%), and hypoxia (21%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Sixty-one of 268 (23%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of BREYANZI. Twenty-seven (10%) patients received tocilizumab only, 25 (9%) received tocilizumab and a corticosteroid, and 9 (3%) received corticosteroids only.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, occurred following treatment with BREYANZI. CAR T cell-associated neurologic toxicities occurred in 35% (95/268) of patients receiving BREYANZI, including ≥ Grade 3 in 12% (31/268) of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of the first event was 8 days (range: 1 to 46 days). The onset of all neurologic events occurred within the first 8 weeks following BREYANZI infusion. Neurologic toxicities resolved in 81 of 95 patients (85%) with a median duration of 12 days (range: 1 to 87 days). Three of four patients with ongoing neurologic toxicity at data cutoff had tremor and one subject had encephalopathy. Median duration of neurologic toxicity was 15 days (range: 1 to 785 days) in all patients, including those with ongoing neurologic events at the time of death or at data cutoff.

Seventy-eight (78) of 95 (82%) patients with neurologic toxicity experienced CRS. Neurologic toxicity overlapped with CRS in 57 patients. The onset of neurologic toxicity was after onset of CRS in 30 patients, before CRS onset in 13 patients, same day as CRS onset in 7 patients, and same day as CRS resolution in 7 patients.

Neurologic toxicity resolved in three patients before the onset of CRS. Eighteen patients experienced neurologic toxicity after resolution of CRS.

The most common neurologic toxicities included encephalopathy (24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%), dizziness (6%), and ataxia (6%). Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, have occurred in patients treated with BREYANZI.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily at a certified healthcare facility during the first week following infusion, for signs and symptoms of CRS and neurologic toxicities. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion; evaluate and treat promptly. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

BREYANZI REMS

Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:

  • Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab.
  • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.

Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-888-423-5436.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. Infections (all grades) occurred in 45% (121/268) of patients. Grade 3 or higher infections occurred in 19% of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections occurred in 5%, and viral and fungal infections occurred in 1.5% and 0.4% of patients, respectively. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines.

Febrile neutropenia has been observed in 9% (24/268) of patients after BREYANZI infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Avoid administration of BREYANZI in patients with clinically significant active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Ten of the 11 patients in the TRANSCEND study with a prior history of HBV were treated with concurrent antiviral suppressive therapy to prevent HBV reactivation during and after treatment with BREYANZI. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 31% (84/268) of patients, and included thrombocytopenia (26%), neutropenia (14%), and anemia (3%). Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI. The adverse event of hypogammaglobulinemia was reported as an adverse reaction in 14% (37/268) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 21% (56/268) of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 32% (85/268) of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Effects on Ability to Drive and Use Machines

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

Adverse Reactions

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (> 2%) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.

The most common nonlaboratory adverse reactions of any grade (≥ 20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision—transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.

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.

Juno Therapeutics, Inc. is a wholly owned subsidiary of Bristol-Myers Squibb Company. The approval of Breyanzi is based on a Biologics License Application that was submitted by Juno Therapeutics. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Bristol Myers Squibb 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 future study results will be consistent with the results to date, that Breyanzi may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, and, if approved, whether such product candidate for such indication described in this release will be commercially successful. 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, 2020, 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 Company

Media Inquiries:

media@bms.com

Kimberly Whitefield

kimberly.whitefield@bms.com

Investors:

Tim Power

609-252-7509

timothy.power@bms.com

Categories
Business

Ruby Has fulfillment launches industry-first DTC Consortium and think tank

Over 100 companies including DTC brands, major marketplaces, technology, and finance firms have joined as founding members

 

BAY SHORE, N.Y. — (BUSINESS WIRE) — Ruby Has, the leading international hyper-growth e-commerce fulfillment company, announced today it launched the DTC Consortium (https://www.dtcconsortium.co), an industry alliance and think tank dedicated to the Direct-to-Consumer (DTC) space. Over 100 companies from every corner of the industry have joined pre-launch as founding members.


The DTC Consortium brings together companies within this space to share expertise, resources and solutions. It helps organizations to comprehensively navigate their go-to-market strategies including funding, technology, fulfillment, reverse logistics, international, marketing, vertical-specific considerations and more. Because many DTC brands have an Omni-channel strategy, the consortium also covers Marketplaces, B2B, Drop-ship/EDI, FBA, FBM, and SFP (Seller Fulfilled Prime).

 

Benefits of joining include: events and conferences, invitations to publish content, speaking opportunities, subject-specific roundtables, community, thought leadership, education and opportunities to lead by joining topic and vertical-specific councils.

 

“There are e-commerce organizations that often focus on resellers, while others cover important yet niche areas of focus, and trade shows lack year-round relevance,” said Esther Kestenbaum Prozan, president and chief operating officer, Ruby Has Fulfillment and chair of the DTC Consortium Executive Council. “The time is now for an alliance like this to work on solving challenges facing the industry. Thought leadership has always been at the forefront for Ruby Has and we’re thrilled to take this to another level with an organized community to further the interests of all DTC organizations.”

 

Paul Austin-Menear, vice president of e-commerce operations at DTC brand Nanoleaf and founding member added, “Nanoleaf is thrilled to be a founding member of the DTC Consortium. Direct-to-consumer e-commerce continues to grow rapidly and is a strategic advantage for consumer-facing brands. The work of the group will advance our shared interests and be a strong voice in encouraging technological and process innovations across the entire spectrum of supply chain providers.”

 

Evan Wright, director of growth, cross border at DTC e-commerce enablement company Avalara noted, “Our company is focused on solutions that help e-commerce brands thrive in the global compliance landscape. We look forward to sharing industry insights and ideas with other industry partners.”

 

“I’m delighted to be a founding member of the DTC Consortium,” said Curtis Mo, partner at Silicon Valley-based global law firm DLA Piper who has worked extensively with VC and PE backed DTC companies from formation and funding through their growth trajectories and exits. “DLA Piper has a long history of supporting some of the world’s best DTC and e-commerce brands and I look forward to helping to develop this industry through thought leadership.”

 

DTC brands and DTC e-commerce enablement companies can apply to join as founding members at: https://www.dtcconsortium.co.

 

About Ruby Has Fulfillment:

Ruby Has is one of the fastest growing e-commerce fulfillment providers (ranked by Crain’s Fast 50 since 2018 and Inc. 5000 for five consecutive years) for direct-to-consumer brands and retailers. Ruby Has Fulfillment leads the 3PL industry with cutting-edge technology, seamless integration, and an uncompromising commitment to quality. With distribution center locations in New York, New Jersey, California, Nevada, Kentucky and Ontario, Canada, Ruby Has provides a strategically located international footprint of fulfillment solutions, with faster shipments and reduced costs. For more information, visit rubyhas.com.

Contacts

Ali Finer

Ruby Has

ali@rubyhas.com
612-209-4575

Categories
Business Technology

QPharma launches Neolytica, an AI focused healthcare analytics firm

MORRISTOWN, N.J. — (BUSINESS WIRE) — QPharma, a leader in Medical, Commercial and Compliance Services for the life sciences industry is proud to announce the launch of Neolytica, a subsidiary, that will take healthcare analytics to an entirely new level.

QPharma has been a pioneer in the compliance space for 25 years and has achieved tremendous success and traction in recent times in healthcare analytics – specifically with Ti Expert™, the KOL mapping and HCP targeting solution, and NotifyMe™ the KOL/HCP activity alert solution. This is one of the key drivers behind launching Neolytica, which focuses on platforms and solutions using next generation technologies like NLP, AI, face recognition, and chat bots to amplify the much-required technological advancements in analysis for the healthcare community. This amplification is primarily focused on Medical Affairs/MSL, Market Access, Commercial Marketing and Sales teams’ analytics and insights.

 

A significant part of QPharma’s growth is the result of its ability to identify gaps in the industry and to solve those gaps with innovative solutions. QPharma’s decision to focus on and invest in data analytics and AI, synergizes well with its expertise in the pharmaceutical industry. The outcome: Neolytica, a healthcare analytics subsidiary with a portfolio of innovative products and solutions. Neolytica will afford our clients the advantage of improved analytics and relevant insights using next-generation technologies delivered through its state-of-the-art solutions.

 

“QPharma’s recent successes have been driven by innovations like Sample Direct-to-Patient, Sentiment Analysis and NotifyMe, which addressed specific gaps during the Covid-19 crisis. By addressing these gaps through innovation, it impressed upon us the impact QPharma could have in the industry, if it focused and invested more on analytics,” said QPharma President and CEO, Patrick Den Boer. “QPharma’s health analytics solution has grown at an average of 205% over the past two years. We are creating end-to-end KOL mapping and HCP targeting strategies for 15 out of the top 20 pharmaceutical companies and have played a pivotal role in the successful launch of 25 drugs, including a recent Covid-19 antibody treatment,” said Badal Shah, Managing Director, KOL and Targeting Solutions at QPharma. Den Boer further added, “Based on the recent success of our health analytics solution, we are confident Neolytica will act as a catalyst in the industry to address the need for innovative and insightful analytical solutions.”

 

Backed by award-winning leadership and ably supported by a global team of industry experts, Neolytica’s solutions and portfolio of products will deliver significant value to the strategic and operational aspects of Medical Affairs, Market Access, Commercial Marketing and Commercial Sales.

Read more about Neolytica at www.neolytica.ai.

 

About QPharma, Inc.

Founded in 1994, QPharma is the industry leader in cloud-based software and services for life sciences. The Commercial Services division provides solutions that include sample management and distribution, product launch management, online training, and HCP/KOL targeting and engagement. Services offered by the company’s Professional Services division include validation services, project management, auditing, and training. QPharma is a National Association of Boards of Pharmacy Verified Accredited Wholesale Distributor, and an approved American Medical Association Database Licensee.

Contacts

Media Contact
Patrick O’Hara | Patrick.OHara@qpharmacorp.com | +1 973.656.0011

Categories
Business

AM Best to sponsor and exhibit at Bermuda Captive Conference

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best will sponsor and exhibit at the annual Bermuda Captive Conference, to be held June 14-15, 2021.

AM Best is a longtime sponsor of the Bermuda Captive Conference and in 2021 is a bronze-level sponsor of the online event. The conference will cover a host of issues paramount for captive insurers and their owners, including the COVID-19 pandemic, emerging technologies and innovation, environmental, social and governance principles and domicile and regulatory developments. Conference attendees can access AM Best’s online booth to learn about the rating agency, its role in the insurance industry and the resources it offers to insurance professionals, including Best’s Credit Ratings, insurance data and analytic resources and financial data products.

For more information about the Bermuda Captive Conference’s virtual event, please visit the conference overview and agenda.

AM Best remains the leading rating agency of alternative risk transfer entities, with more than 200 such vehicles rated throughout the world. For current Best’s Credit Ratings and independent data on the captive and alternative risk transfer insurance market, please visit www.ambest.com/captive.

AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2021 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Categories
Business Technology

Aetrex makes advanced 3D foot scanning technology affordable for all retailers with launch of Albert 3DFit

Provides state-of-the-art 3D scanning and accurate footwear recommendations at less than half the price of scanners currently on the market

TEANECK, N.J. — (BUSINESS WIRE) — Aetrex Worldwide, Inc. (“Aetrex”), a global market leader in foot scanning technology, orthotics and comfort and wellness footwear, today announced Albert 3DFit, a sleek and modern 3D foot scanner created to revolutionize the retail industry by making 3D fit technology available to stores of all sizes. Offering the most innovative technologies at a fraction of the cost of competitors, this scanner can calculate customers’ 3D foot measurements in less than 10 seconds with accuracy up to 1 millimeter. It features Aetrex’s FitGenius™ AI platform, which matches customers’ unique foot profiles with their ideal footwear styles and sizes to provide personalized footwear recommendations that can be accessed across a retailer’s digital shopping platforms after leaving the store.


“Recent studies have shown that 25% of consumers would like to experience a fit technology when shopping for footwear. Albert 3DFit helps retailers of all sizes address this need,” said Kumar Rajan, Vice President of Technology at Aetrex. “Having the industry’s largest technology development team, we were able to use our vast experiences, coupled with our ability to engineer our own hardware and software, to develop an innovative 3DFit experience that’s affordable for all interested retailers.”

Albert 3DFit can guide customers through the scanning process manually by using a tablet, or touch-free with voice activation technology. The software uses artificial intelligence to match footwear data by brand and style to each unique foot’s profile providing sizing recommendations in seconds, resulting in personalized shoe recommendations to help customers make informed buying decisions. After leaving the store, users can leverage the software’s FitGenius feature to view and shop footwear styles that work best for their unique feet, whether shopping on a personal computer or phone, making online shopping a seamless experience.

“The FitGenuis technology plug-in allows retailers to easily integrate the shoe recommendation software into their website or across their email blasts and social media. Each shoe is assigned a FitGenius score so customers can ensure the right fit on the first try when buying online, reducing their returns,” said Larry Schwartz, CEO at Aetrex.

The Albert 3DFit scanner also provides retailers with important data that they can use to optimize key areas of their business, such as marketing, store performance, and product planning and development. Retailers can then use the collected data to develop targeted digital marketing messages to customers based on their unique foot profiles to create an uptick in engagement and conversation rates. With units launching in stores this Fall, the Albert 3DFit scanner is available now for retailers to purchase at $1,995 or $55.42/month.

Since the inception of Aetrex’s foot scanning technology in 2002, the company has placed over 10,000 scanners globally, averaging a total of 2.5 million scans per year and 40 million scans total. To build on this momentum, Aetrex will also be launching their new mobile app for at-home foot sizing and footwear recommendations later this year. To learn more about the Albert 3DFit scanner, visit aetrex.com.

About Aetrex

Aetrex Worldwide, Inc. is widely recognized as the global leader in foot scanning technology, orthotics, and comfort and wellness footwear. Aetrex has developed state-of-the-art foot scanning devices, including Albert, Albert 2 and iStep, designed to accurately measure feet and determine foot type and pressure points. Since 2002, Aetrex has placed over 10,000 scanners worldwide that have performed more than 40 million unique customer foot scans, currently averaging more than 2.5 million scans a year.

The company is renowned for its over-the-counter orthotics – the worlds #1 foot orthotic. With fashion, function and quality at the forefront, Aetrex also designs and manufactures stylish, performance footwear. Based in New Jersey, Aetrex is consistently named one of New Jersey’s Top 100 Privately Held Companies and was also included in NJBIZ’s Top 30 Manufacturing Companies. It has remained privately owned by the Schwartz family for three generations. For additional information, visit www.aetrex.com.

Contacts

Media
Rajira Hernandez

Matter Communications

978-225-8082

aetrex@matternow.com

Categories
Business Technology

HealthSTAR Communications announces exciting new leadership position for the HealthSTAR Network

MAHWAH, N.J. — (BUSINESS WIRE) — #HealthSTARtswithUS–HealthSTAR Communications, a leading independent healthcare communications network, announces Mark Fleischer has accepted the role as Executive Vice President.

“I am pleased to announce Mark Fleisher has joined the HealthSTAR Network as Executive Vice President,” stated Chris Sweeney, Chairman and Chief Executive Officer of HealthSTAR Communications. “Mark will participate on the HealthSTAR Operating Committee and play a vital role in overseeing all phases of the HealthSTAR Network. Mark has vast leadership experience and passion for cutting-edge technology and data, service delivery and innovative solutions. His addition only strengthens our ambitious mission to change the way marketing services are executed in the life sciences industry.” In his new role, Mr. Fleischer will have overall responsibility for the HealthSTAR Network business, with an initial focus on strategy for growth, technology, and deepening customer relationships.

Mr. Fleischer has over 20 years of experience in the healthcare industry having held senior leadership roles in multiple organizations. Mr. Fleischer spent 12 years at Dendrite International in a variety of leadership roles. In 2007 Mr. Fleischer was part of the team that merged Dendrite with Cegedim to create a $1B global technology, information, and service provider to the life sciences industry. His last role with Cegedim Dendrite was as Senior Vice President and General Manager of North America. He also spent two years as Vice President and General Manager of Marketing Services for Cardinal Health. In 2015, Mr. Fleischer successfully raised capital and completed a management buyout of Physicians World from UDG Healthcare. He quickly tripled the size of Physicians World and positioned it as a recognized leader in executing peer-to-peer education in the pharmaceutical industry. In 2019 Physicians World was acquired by Veeva Systems where Mr. Fleischer joined the leadership team and spent a year leading the business and overseeing the integration.

“I’m excited to be joining HealthSTAR. The HealthSTAR Operating Committee has done an outstanding job building a full-service medical communications network to support their customers and the healthcare industry during a very complex time and are positioned for continued success well into the future. We believe HealthSTAR is poised to continue to deliver innovative communications capabilities and expand our service offering to continue the growth we’ve experienced in recent years,” said Mr. Fleischer.

The HealthSTAR Network continues to innovate through cutting-edge clinical story-telling expertise, proprietary engagement formats, customized creative branding all supported through HealthSTARs robust compliance-focused technology platform; offering clients full-service medical communications across a products life-cycle. HealthSTAR is a market transforming company that is built on a 23-year legacy of service, with a focus on continued innovation and growth.

About HealthSTAR Communications

HealthSTAR Communications is a full-service medical communications network of companies that has been transforming the life sciences industry for over two decades, generating over 2.5 billion dollars of revenue. The HealthSTAR Communications Network is made up of four distinct divisions—HealthSTAR Strategic Engagements, HealthSTAR Fusion Group, Centron, and HealthSTAR Patient Engagements – spanning disciplines but always working seamlessly with its clients across to offer holistic, full-lifecycle, best-in-market solutions.

HealthSTAR Strategic Engagements (HSE) is a strategic and tactical promotional events business that is quickly approaching its two-millionth live promotional speaker event since its inception in 1998. Combined with unparalleled service, our industry leading enterprise events technology platform, MER360®, built to manage every aspect of compliant events, enforce business rules, and capture all transactional data important to our clients. HealthSTARse.com

HealthSTAR Fusion Group (HFG) is a medical education agency that provides scientific strategy, impactful clinical content, and medical education expertise. At its core, HealthSTAR Fusion Group offers clients experience, expertise, and proven results that deliver the right message to the right target audience. HealthSTARfg.com

Centron is an award-winning healthcare communications agency with a focus on specialty brands, especially oncology and rare diseases. Centron excels in analyzing and optimizing their services in creative branding, campaign ideation, integrated strategic services, and promotional communications for each client’s unique needs. Centronnyc.com

HealthSTAR Patient Engagements (HPE) is a full-service patient engagement agency offering brands the ability to create meaningful impacts and messages that resonate with patients/caregivers through compliant programs, specialized patient-focused content, and years of experience meeting the unique and specific challenges that patient education brings. HPE leverages the HealthSTAR Networks proven models of success, proprietary technology, and content expertise, and strives to make the complex simple for both brands, patients, caregivers, and the entire patient ecosystem.

Contacts

Thomas Sweeney

Chief of Staff

HealthSTAR Strategic Engagements

201-560-5539

tcsweeney@healthstarcom.com

Categories
Business Technology

Majesco announces cloud-native core containerization support for P&C Core Suite and L&A and Group Core Suite

Provides insurance industry stakeholders portability, agility, speed-to-market, and ease of environment management in a highly scalable and secure fashion to accelerate their path to the future of insurance

 

MORRISTOWN, N.J. — (BUSINESS WIRE) — Majesco, a global leader of cloud insurance software solutions for insurance business transformation, today announced cloud-native core containerization for Majesco P&C Core Suite and Majesco L&A and Group Core Suite to provide portability, agility, speed-to-market, and ease of environment consistency management for companies accelerating their business transformation on the cloud.

Majesco P&C Core Suite and Majesco L&A and Group Core Suite are built as Docker images, orchestrated using Kubernetes and deployed as Helm charts enabling customers to run on any Cloud infrastructure. With the first decomposition completed, Majesco will continue to assess the right balance of further decomposition into granular microservices based on customer and market driven demands. With parallel run validations, this transition is seamless – with no business interruptions – and requires no additional testing or change efforts for carriers.

“As an early proponent and provider of cloud, Majesco is dedicated to delivering cloud-native technologies to the insurance industry. Containerization of our core suite solutions is a testament to our commitment to deliver choice, flexibility, and relentless innovation to the insurance industry that meet the dynamically changing business and IT demands of today and tomorrow,” said Manish Shah, Chief Product Officer at Majesco. “As the industry accelerates their effort to modernize, optimize, and innovate their business, Majesco is leading the way by simplifying the challenges faced by companies by breaking down silos and empowering the industry to pursue a cloud-native agenda in our highly scalable and secure applications.”

With cloud-native core Containerization support, Majesco’s cloud operations will be more reliable, responsive, and secure. Additional benefits include:

  • Consistency–-Enable consistency of deployments across all environments through same app deployment structure and infrastructure configurations.
  • Dynamic Scalability – Dynamic adjustments to computing resources by automatically scaling to new nodes based on load for better ROI and operational readiness.
  • Superior Availability – Separation of functionality across containers and monitor for problem detection and self-healing to deliver higher availability.
  • Enhanced Security – Applications isolation from host and each other, Kubernetes secrets for provisioning passwords/keys and automatic app management and deployment provides enhanced security.
  • Faster Deployment – Standardized docker images enable faster deployment of Majesco Apps as well as faster patching for host OS.
  • Cloud Platform Agnostic – Abstraction from host OS, inherent feature of containerization makes app run on any cloud platform.
  • Cost Effectiveness – Scaling of lightweight containers, auto-scaling and high degree of automation significantly reduce operating costs with horizontal scaling.

“The insurance industry has embraced the cloud for their core systems, but there is still a wide gap between a lift-and-shift approach and true cloud native infrastructure,” said Jeff Goldberg, EVP of Research and Consulting at Novarica. “To realize the full value of cloud adoption, insurers need systems that are made for scalable, rapid deployment, supported by ongoing updates, and that tie into a broader network of data providers and emerging solutions. The future of core systems looks less like insurers licensing a technology and more like them placing their insurance products into an ecosystem that allows them to focus on their differentiated business.”

Majesco was named a Leader in the October 2020 Magic Quadrant for P&C Core Insurance Platforms, North America and a Visionary in the August 2020 Magic Quadrant for Life Insurance Policy Administration Systems, North America. The company also received an XCelent award for Depth of Service in Celent’s Policy Administration Systems: North America Property Casualty Report, and named the Top “Best-in-Class” Vendor in the P&C Policy Administration Aite Matrix Report.

About Majesco

Majesco is the leading software partner to both the P&C and L&A insurance markets to modernize, optimize and innovate their businesses at speed and scale. Over 330 insurers, from greenfields, start-ups and MGAs to the largest insurers, reinsurers and brokers use Majesco’s next generation SaaS platform solutions of core, data and analytics, digital, distribution, absence management and a rich ecosystem marketplace of established and InsurTech partners to build the future of insurance.

Our technology, expertise and leadership help insurers innovate and connect to build the future of their business. With over 825 successful implementations and over 65% of our customers on Cloud with Majesco platform solutions, together we have an amazing track record of innovation and real-world results. For more details on Majesco, please visit www.majesco.com.

Gartner Disclaimer

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

Contacts

Laura Tillotson

Director, Marketing Communications and Creative Services

+ 201 230 0752

laura.tillotson@majesco.com

Categories
Healthcare Science

New data on KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) versus sunitinib in first-line treatment for patients with advanced renal cell carcinoma from pivotal phase 3 CLEAR/KEYNOTE-581 trial presented at 2021 ASCO Annual Meeting

Results From New Analysis Evaluating Health-Related Quality of Life (HRQoL) Based on Patient-Reported Outcomes Using Three HRQoL Scales

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J. — (BUSINESS WIRE) —$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced new investigational data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated the combinations of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Results from a new analysis evaluating health-related quality of life (HRQoL) based on patient-reported outcomes are being presented during an oral abstract session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502). Data from CLEAR/KEYTNOTE-581 were originally presented at the 2021 Genitourinary Cancers Symposium (ASCO GU) and published in the New England Journal of Medicine, and data from this trial are currently under review with the U.S. Food and Drug Administration (FDA).

“This new analysis expands our understanding of the results we’ve seen from the CLEAR/KEYNOTE-581 trial in the treatment of patients with advanced renal cell carcinoma,” said Dr. Robert Motzer, Medical Oncologist, Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center. “The additional data showed an improvement of specific health-related quality of life measures for patients who received KEYTRUDA plus LENVIMA compared with sunitinib, supporting the importance of this combination as a potential new first-line treatment option for patients.”

“We continue to see an increasing number of patients diagnosed with advanced renal cell carcinoma and remain committed to improving outcomes for those facing this difficult-to-treat disease,” said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. “This new analysis builds on earlier findings from the CLEAR/KEYNOTE-581 trial and further supports the potential use of KEYTRUDA plus LENVIMA for the treatment of patients in the first-line setting.”

“This analysis addresses questions of interest to healthcare professionals who treat patients with advanced renal cell carcinoma and reinforces the KEYTRUDA plus LENVIMA combination as a possible new treatment option for patients with this disease,” said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. “These results reflect Eisai and Merck’s shared commitment to relentlessly pursue thorough scientific investigations with the goal of improving cancer care.”

Data From Health‐Related Quality of Life (HRQoL) Analysis From CLEAR/KEYNOTE-581

In an analysis of a secondary endpoint of HRQoL scores in the CLEAR/KEYNOTE-581 trial, KEYTRUDA plus LENVIMA and LENVIMA plus everolimus were evaluated to determine the impact on HRQoL compared to sunitinib in patients with advanced RCC. This was assessed based on patient-reported outcomes using three HRQoL and symptom measures: Functional Assessment of Cancer Therapy Kidney Symptom Index – Disease-Related Symptoms (FKSI-DRS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer – Core 30 (EORTC QLQ-C30) and European Quality of Life Five-Dimensions – 3-Level System (EuroQoL EQ-5D-3L). Unless otherwise noted, HRQoL analyses were based on data from randomized patients who received at least one dose of study treatment. No adjustments for multiple testing or estimation were used; p-values (two-sided) and confidence intervals (CI) are nominal and descriptive. Longitudinal change from baseline was assessed by mixed model analysis. Least squares mean differences (LSMD) and 95% CI were calculated from baseline. Time to deterioration (based on changes in HRQoL and disease-related symptom scores ≥ meaningful thresholds) was assessed using time to first deterioration (TTD), which is the number of weeks between randomization and the first deterioration event, and time until definitive deterioration (TUDD), which is the number of weeks between randomization and the earliest deterioration event with no subsequent recovery above the deterioration threshold or no subsequent HRQoL assessment data. All times to deterioration were calculated and compared using the Kaplan-Meier method, stratified log-rank tests and Cox models.

KEYTRUDA plus LENVIMA demonstrated similar changes from baseline at mean follow-up (Week 46) on 14 out of 18 HRQoL and disease-related symptom scores and better HRQoL and disease-related symptom scores for the following measures (LSMD [95% CI]): physical functioning (3.01 [0.48, 5.54]), fatigue (-2.80 [-5.52, -0.08]), dyspnea (-2.79 [-5.33, -0.25]) and constipation (-2.19 [-4.19, -0.18]), as measured by the QLQ-C30, versus sunitinib. LENVIMA plus everolimus demonstrated similar changes from baseline at mean follow-up (Week 46) on 14 out of 18 HRQoL and disease-related symptom scores and worse HRQoL and disease-related symptom scores in the following measures (LSMD [95% CI]): Global Health Score/QoL (-2.81 [-5.08, -0.54]), pain (2.80 [0.11, 5.49]), appetite loss (4.23 [1.34, 7.13]) and diarrhea (5.26 [2.61, 7.91]) compared to sunitinib.

KEYTRUDA plus LENVIMA demonstrated a similar TTD in 14 out of 18 HRQoL and disease-related symptom scores, and a delay in TTD for physical functioning, dyspnea, appetite loss, and EQ-5D visual analog scale compared to sunitinib. KEYTRUDA plus LENVIMA demonstrated a delay in TUDD in 16 out of 18 HRQoL and disease-related symptom scores and a similar TUDD for cognitive functioning and financial difficulties compared to sunitinib.

Dr. Motzer has provided consulting and advisory services for Merck and Eisai.

About CLEAR (Study 307)/KEYNOTE-581

The CLEAR/KEYNOTE-581 trial is a multicenter, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The primary endpoint is progression-free survival, as assessed by independent review per RECIST v1.1. Secondary endpoints include overall survival, objective response rate, HRQoL and safety. A total of 1,069 patients were randomized (1:1:1) to receive:

  • LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (200 mg intravenously [IV] every three weeks for up to 24 months); or
  • LENVIMA (18 mg orally once daily) in combination with everolimus (5 mg orally once daily); or
  • Sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment).

Treatment continued until unacceptable toxicity or disease progression as determined by the investigator and confirmed by independent radiologic review committee using RECIST v1.1. Administration of KEYTRUDA plus LENVIMA was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. KEYTRUDA was continued for a maximum of 24 months; however, treatment with LENVIMA could be continued beyond 24 months. Assessment of tumor status was performed at baseline and then every eight weeks.

About Renal Cell Carcinoma (RCC)

Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In the U.S., it is estimated there will be nearly 76,000 new cases of kidney cancer diagnosed and almost 14,000 deaths from the disease in 2021. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 13% for patients with metastatic disease.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

  • solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, and fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

  • in combination with platinum- and fluoropyrimidine-based chemotherapy, or
  • as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA 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 tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus 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. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.

Contacts

Merck Media Relations
Melissa Moody: (215) 407-3536

Justine Moore: (347) 281-3754

Merck Investor Relations
Peter Dannenbaum: (908) 740-1037

Courtney Ronaldo: (908) 740-6132

Eisai Inc. Media Relations
Michele Randazzo: (551) 579-4465

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Business International & World

Hayward Holdings updates on fire at facility in Yuncos, Spain

BERKELEY HEIGHTS, N.J. — (BUSINESS WIRE) — Hayward Holdings, Inc. (NYSE: HAYW) a global designer, manufacturer and marketer of a broad portfolio of pool equipment and associated automation systems, announced today that one of the buildings at its production campus in Yuncos, Spain was affected by a fire. All employees were safely evacuated with no major injuries.

The impacted building manufactures fiberglass laminated filters. No other manufacturing lines on the Yuncos campus (pumps, ladders, lighting, injected filters) were impacted. Production and service of these product ranges started again this morning from Yuncos without interruption.

“We appreciate the quick assistance of the fire department. Employees followed our well-established protocols, I am pleased to say all employees are safe and the impact to our business is not material,” said Kevin Holleran, CEO of Hayward Holdings. “While we investigate the cause of the fire and rebuild to our exacting standards, customers can be assured that we have a full-range of alternative filtration technologies to offer.”

About Hayward Holdings, Inc.

Hayward Holdings, Inc. (NYSE: HAYW) is a global designer, manufacturer and marketer of a broad portfolio of pool equipment and associated automation systems. Hayward designs, manufactures and markets a full line of innovative, energy-efficient pool and spa equipment, with brands including AquaVac®, AquaRite®, ColorLogic®, Navigator®, OmniLogic®, OmniHub™, TriStar®, Super Pump®, TurboCell®, pHin™, CAT Controllers®, HCP Pumps and Saline C® Series.

Contacts

Investor Relations:

Hayward Investor Relations

908-288-9706

investor.relations@hayward.com

Media Relations:

Lisa Wolford

917-846-0881

lwolford@soleburytrout.com