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Eagle Pharmaceuticals announces publication of preclinical study of Intranasal Dantrolene in Journal of Alzheimer’s Disease

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that preclinical research on dantrolene sodium was published today in the peer-reviewed Journal of Alzheimer’s Disease.1 The article reported results from an academic-based study that demonstrated dantrolene sodium administered intranasally improved both memory and cognition in a mouse model of Alzheimer’s disease. Eagle markets a formulation of dantrolene sodium but did not sponsor the study.

The study evaluated plasma and brain dantrolene concentrations, effectiveness, and safety when dantrolene sodium was given in doses of five milligrams per kilogram three times a week either intranasally or as a subcutaneous injection. The study also compared dosing when started early, before Alzheimer’s disease symptoms develop, versus later, after onset of Alzheimer’s disease symptoms. Intranasal and subcutaneous dantrolene sodium administration each significantly improved hippocampal-dependent and -independent memory in the early treatment group, but only intranasal dantrolene improved cognition in the late treatment group.

  1. Shi Y, Zhang L, Gao X, et al. Intranasal Dantrolene as a Disease-Modifying Drug in Alzheimer 5XFAD Mice [published online ahead of print, 2020 Jun 27]. J Alzheimers Dis. 2020;10.3233/JAD-200227. doi:10.3233/JAD-200227.

About Alzheimer’s disease

About 50 million people have dementia globally, of whom 60 to 70 percent have Alzheimer’s disease, according to the World Health Organization. In the US, 5.8 million people are living with Alzheimer’s, which has no cure and is the sixth leading cause of death.

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.

Forward-Looking Statements

This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including the potential of dantrolene sodium as a treatment for Alzheimer’s disease. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc.:

Lisa M. Wilson

In-Site Communications, Inc.

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

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Healthcare

Merck’s KEYTRUDA® (pembrolizumab) in combination with chemotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in locally advanced or first-line metastatic esophageal cancer

KEYTRUDA Is First Anti-PD-1 Therapy in Combination With Chemotherapy to Show Superior Survival Benefit as First-Line Treatment for Patients With Esophageal Cancer Regardless of Histology

Results of Phase 3 KEYNOTE-590 Trial to be Submitted to Global Regulatory Authorities

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (cisplatin plus 5-fluorouracil [5-FU]), met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with locally advanced or metastatic esophageal cancer. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared with chemotherapy (cisplatin plus 5-FU), the current standard of care, in the intention-to-treat (ITT) population. The study also met the key secondary endpoint of objective response rate (ORR), with significant improvements for KEYTRUDA in combination with chemotherapy compared with chemotherapy alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be shared with global regulatory authorities and have been submitted for presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

“Esophageal cancer is a devastating malignancy with a high mortality rate and few treatment options in the first-line setting beyond chemotherapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “In this pivotal study, KEYTRUDA plus chemotherapy resulted in superior overall survival compared with the current standard of care in the full study population and across all patient groups evaluated. These results build upon our research reinforcing the survival benefits of KEYTRUDA, and we look forward to engaging regulatory authorities as quickly as possible.”

KEYTRUDA is currently approved in the U.S. and China as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer – including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers – through its broad clinical program.

About KEYNOTE-590

KEYNOTE-590 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03189719) evaluating KEYTRUDA in combination with chemotherapy compared with placebo plus chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal carcinoma (adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type 1 adenocarcinoma of the esophagogastric junction). The primary endpoints are OS and PFS. The secondary endpoints include ORR, duration of response and safety. The study enrolled 749 patients who were randomized to receive:

  • KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 35 cycles); plus cisplatin (80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles); plus 5-FU (800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration, for up to 35 cycles); or
  • Placebo; plus cisplatin (80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles); plus 5-FU (800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration, for up to 35 cycles).

About Esophageal Cancer

Esophageal cancer, a type of cancer that is particularly difficult to treat, begins in the inner layer (mucosa) of the esophagus and grows outward. The two main types of esophageal cancer are squamous cell carcinoma and adenocarcinoma. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. Globally, it is estimated there were more than 572,000 new cases of esophageal cancer diagnosed and nearly 509,000 deaths resulting from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 18,500 new cases of esophageal cancer diagnosed and more than 16,000 deaths resulting from the disease in 2020.

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 1,200 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

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.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of 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 confirmatory trials.

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 head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of 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.

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. 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 confirmatory trials. 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 [combined positive score (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 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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

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).

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 (mut/Mb)] 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.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor–blocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Kristen Drake

(908) 334-4688

Investors:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

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Healthcare

Romance Awareness Month: Maria Sophocles, MD spotlights intimacy, sex & women’s health needs

PRINCETON, N.J.–(BUSINESS WIRE)–When considering the many aspects of a healthy relationship, the importance of intimacy and safe, enjoyable sex is at the top of the list no matter what age or stage of life a woman might be in. Maria Sophocles, MD, OB/GYN and Director of Women’s Healthcare of Princeton, NJ sees patients of all ages and stresses that a pleasurable, fulfilling sex life is possible at any point in a woman’s life as long as she prioritizes her wants, needs, and sexual health.

“As a practicing OB/GYN, my patients provide unique insights into what women endure during various life stages. The consensus – it is completely normal to feel and act differently about sex at age 35 than 65. As women age, our bodies change and so do our wants and needs,” says Sophocles. “While every woman’s journey is unique, it’s important to prioritize sexual health and wellness to maintain healthy relationships and ensuing sex lives.”

Dr. Sophocles provides the following tips for women at any stage:

  1. Early 20’s-late 20’s: Party on-but take note! As newfound independence is celebrated and new jobs, careers, and relationships form, so does the possibility of new sexual partners. Increased sexual activity can introduce higher levels of bacteria into the delicately balanced vaginal ecosystem and can throw off healthy levels of vaginal pH. So, do practice safe sex, urinate before and after sex, and take a daily vaginal probiotic like RepHresh Pro-B, which helps to balance out the good and bad bacteria in the vagina.
  2. 30’s: As many women focus on their future and building a family, one in eight couples struggle with infertility, so it’s important to stay on top of menstrual cycles and schedule regular OB/GYN appointments. When trying to conceive, make sure the lubricant you use is fertility-friendly, like Pre-Seed. Additionally, keep accurate pregnancy tests on hand that can provide an early result such as First Response.
  3. 40’s-50’s: Perimenopause and menopause mark these decades, signaling symptoms like hot flashes, weight gain, vaginal dryness, and changes in sex drive which can mean painful sex. A vaginal, estrogen-free moisturizer like Replens soothes dry vaginal cells and lasts for 3-days after insertion.
  4. 60’s and beyond: As many find themselves ‘empty nesters,’ it’s a great time to focus on each other and shake things up in the bedroom to keep long term relationships exciting. Consider keeping a long-lasting, silicone lube like Replens Silky Smooth next to the bed to maximize comfort and eliminate painful sex.

“Regardless of age, women should be having healthy, satisfying and intimate connections with their partners,” adds Sophocles. “Don’t hesitate to bring up issues with your partner and communicate your needs – this will go a long way in ensuring a successful and happy relationship no matter what stage you are in life.”

Contacts

Lauren Powers

Lauren.powers@gcomworks.com
646-964-4446

Categories
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

Categories
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

Categories
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

Categories
Healthcare

LabVantage COVID-19 LIMS solution implemented for onsite workplace health and safety

—Leading Consumer Goods Company Offers Employee Health Testing at In-House Test Centers—

SOMERSET, N.J.–(BUSINESS WIRE)–#COVID–LabVantage Solutions, Inc., the leading provider of laboratory informatics solutions and services including purpose-built LIMS solutions that allow labs to go live faster and at a lower total cost, today announced that a Fortune 100 global consumer packaged goods (CPG) company has deployed the LabVantage COVID-19 LIMS solution to ensure employee health and safety in the workplace.

The U.S.-based CPG company opened an in-house COVID-19 testing center where employees can quickly and safely be tested for the SARS-CoV-2 virus that causes COVID illnesses. In-house health and laboratory professionals, using LabVantage’s purpose-built COVID-19 laboratory information management system (LIMS), can quickly schedule, collect samples, test, track, and report results.

The CPG company already uses the LabVantage enterprise LIMS across areas of its organization. When LabVantage announced its new purpose-built solution specific to the COVID-19 pandemic, the company was able to implement it in under six weeks for onsite employee testing that supports a safer workplace.

“LabVantage COVID-19 LIMS is a full-featured, pre-configured solution for companies, colleges, and universities looking for a way to keep their employees and students safe in the workplace or on campus with the confidence that comes with accurate and comprehensive testing,” said LabVantage CEO, John Heiser. “It’s illustrative of our ability to transform scientific data into knowledge that drives better outcomes for our business partners.”

Having the testing process onsite saves time and gives the employees the convenience of not having to go to a hospital or doctor’s office for a test. Employees displaying symptoms, or those who request a test, can be scheduled quickly for an appointment. LabVantage COVID-19 LIMS prepares the sample request, labels sample specimens, tracks all patient and sample data following privacy and security protocols such as HIPAA and GDPR, and handles results and reporting in a single easy-to-use interface.

Dr. Heiser pointed out that the LabVantage COVID-19 LIMS solution is ideal for companies that are equipped to conduct all testing-related work in-house, as well as for organizations that do not have their own testing facilities who work with third-party laboratories. In addition, LabVantage’s ISO-27001 certification, existing validation practices, and Certificate of Release allows companies to focus their validation efforts on critical functions while still being able to confidently point to a reliable solution.

The COVID-specific LIMS solution incorporates LabVantage’s deep knowledge of laboratory workflows, along with numerous features designed to make it easy for laboratories to perform coronavirus testing using RT-PCR, isothermal nucleic acid amplification, and serology methods. LabVantage COVID-19 LIMS can be hosted on the cloud or offered as SaaS and is highly scalable, which are important attributes as testing volumes escalate.

The LabVantage COVID-19 LIMS is available immediately. For more information on LIMS for coronavirus testing, visit here.

About LabVantage Solutions

A recognized leader in enterprise laboratory software solutions, LabVantage Solutions dedicates itself to improving customer outcomes by transforming data into knowledge. The LabVantage informatics platform is highly configurable, integrated across a common architecture, and 100% browser-based to support hundreds of concurrent users. Deployed on-premise, via the cloud, or SaaS, it seamlessly interfaces with instruments and other enterprise systems – enabling true digital transformation. The platform consists of the most modern laboratory information management system (LIMS) available, integrated electronic laboratory notebook (ELN), laboratory execution system (LES), and scientific data management system (SDMS); and, for healthcare settings, a laboratory information system (LIS). We support more than 1500 global customer sites in the life sciences, pharmaceutical, medical device, biobank, food & beverage, consumer packaged goods, oil & gas, genetics/diagnostics, and healthcare industries. Headquartered in Somerset, NJ, with global offices, LabVantage has, for four decades, offered its comprehensive portfolio of products and services to enable customers to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate record-keeping, and comply with regulatory requirements. For more information, visit labvantage.com.

Contacts

Media Contact:
Brandwidth Solutions LLC

Debra Harrsch

Phone: 215-997-8575

Email: dharrsch@BWSmarketing.com

Categories
Business

Topcon acquires Henson perimeter business

Company Adds Leading Perimetry Screening Devices to Its Global Product Portfolio

NEWBURY, United Kingdom–(BUSINESS WIRE)–#SeeingEyeHealthDifferently–Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that it has acquired the Henson line of perimetry products, including the Henson 9000 and 7000, from Elektron Eye Technology (EET) of Cambridge, UK.


The acquisitions include the transfer of a number of EET staff to Topcon’s team. Manufacturing will continue in the UK as it has throughout the years past.

The Henson line of perimetry products are well regarded in the eye care industry for their accuracy, speed and ease of use. The Henson 9000 is the ideal perimeter for the early detection of glaucoma and the ongoing monitoring of established loss, while the Henson 7000 is an affordable, lightweight, mobile perimeter designed to perform suprathreshold glaucoma screening in the central field.

Mr. John Trefethen, Global VP of Marketing & Product Design for Topcon Healthcare commented, “The acquisition of the Henson range of products will provide us with the opportunity to strategically develop this area of the company’s product portfolio. With Topcon’s growing emphasis on screening and early disease detection, the Henson product range perfectly complements our global strategy. I welcome the EET team members to the Topcon Healthcare Family.”

Mr. Trefethen continued, “As the global rate of glaucoma continues to rise, Topcon is pleased to incorporate the award-winning Henson perimeters into our brand portfolio. We look forward to working with Professor Henson and the talented team from EET to further develop this innovative product line, bringing critical glaucoma screening, monitoring and early disease detection tools to the global eye care community. Topcon’s mission remains the same, to enable greater and greater access to healthcare providers in all faucets of disease detection and diagnosis. We remain fully committed to the continued development of medical devices and software platforms that allow today’s eye care providers to practice smarter, safer and more efficiently, including our screening, automated and remote diagnostics solutions.”

For more information on Topcon Healthcare, please visit www.topconhealth.com.

About Topcon Healthcare

Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever- changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management, safe distancing and ground-breaking remote diagnostic technology.

A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.

About Elektron Eye Technology (EET)

Elektron Eye Technology (Cambridge, UK) is a subsidiary of Elektron Technology and home to spectrum of world-class fast-moving engineered product (FMEP) brands, including the Henson Perimeters and the Macular Pigment Screener (MPS II). They are the ophthalmic instruments of choice for eye care professionals involved in the screening and monitoring of glaucoma and age-related macular degeneration (AMD). Designed in partnership with respected eye care professionals, their accuracy, efficiency and ease of use ensures that they meet the needs of optometrists and ophthalmologists, as well as the patients they work with every day.

Contacts

John Trefethen, MFA

Global Vice President, Marketing & Product Design Topcon Healthcare

E-mail: jtrefethen@topcon.com