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Merck to present new data from its extensive infectious diseases and vaccines pipeline and portfolio during IDWeek 2020

Data from More Than 50 Clinical and Epidemiological Abstracts Across Vaccines, HIV, Antibiotics and Antimicrobials Show the Breadth of the Company’s Commitment to Addressing the Threat of Infectious Diseases

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that new clinical and epidemiological data from its broad infectious diseases and vaccines program will be presented at IDWeek 2020 from Oct. 21 – 25, 2020. Clinical data to be presented include new subgroup analyses from the Phase 3 RESTORE-IMI 2 trial evaluating the safety and efficacy of RECARBRIO™ (imipenem, cilastatin, and relebactam) in adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), and a new pooled analysis of the safety and efficacy of PIFELTRO™ (doravirine) or DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) in adults 50 years of age and older living with HIV-1 who are treatment-naïve. As part of Merck’s commitment to greater understanding of infectious diseases, Merck researchers will present epidemiological data including two multicenter evaluations of bacterial infections and antimicrobial use among COVID-19 tested patients, and 12 studies evaluating disease burden and vaccination strategies. Merck will also be sharing updates from SMART (Study for Monitoring Antimicrobial Resistance Trends) surveillance program-related abstracts accepted by the congress.

“This year, we’ve all witnessed the devastating impact infectious diseases can have on patients and society. The pandemic reinforces the compelling need for Merck to continue our unwavering, decades-long commitment to addressing the threat of infectious diseases through research,” said Dr. Nicholas Kartsonis, senior vice president, infectious diseases and vaccines, Merck Research Laboratories. “The breadth of our portfolio in infectious diseases will be on display at IDWeek as we share new research in vaccines, HIV and antibacterials.”

Select abstracts in the IDWeek program include:

Pediatric Infectious Diseases

  • Evaluation of the Impact of a Single-dose Hepatitis A Vaccination in Brazil: a time-series analysis. Poster: 1392. Bierrenbach AL, et al.
  • Current practices in the diagnosis and treatment of varicella infections in the United States. Poster: 1387. Fergie J, et al.
  • Effectiveness of M-M-R® II in outbreaks – a systematic literature review of real-world observational studies. Poster: 1390. Li S, et al.
  • Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States (US). Poster: 1393. Petigara T, et al.
  • Caregiver Burden related to Rotavirus Gastroenteritis: a systematic literature review. Poster: 1379. Carias C, et al.
  • Current status of the legal landscape regarding Rotavirus Vaccination in the United States. Poster: 1380. Bhatti A, et al.
  • Rotavirus Gastroenteritis among older adults: discussion based on a systematic literature review. Poster: 1381. Carias C, et al.

Pneumococcal Disease

  • Incidence of Acute Otitis Media in Children in the United States before and after the introduction of Pneumococcal Conjugate Vaccines (PCV7 and PCV13) during 1998-2018. Poster: 1479. Hu T, et al.
  • Incidence of Non-Invasive Pneumococcal Pneumonia in Children in the United States before and after Introduction Pneumococcal Conjugate Vaccines (PCV7 and PCV13) during 1998-2018. Poster: 1480. Hu T, et al.

Certain HPV-Related Cancers and Disease

  • Observational Study of Routine Use of 9-Valent Human Papillomavirus Vaccine: Safe in More Than 140,000 Individuals. Poster: 5. Hansen J, et al.

HABP/VABP & Antibiotics

  • Imipenem/Cilastatin (IMI)/Relebactam (REL) in Hospital Acquired/Ventilator-Associated Bacterial Pneumonia (HABP/VABP): Subgroup Analyses of Critically Ill Patients in the RESTORE-IMI 2 Trial. Poster: 1460. Chen L, et al.
  • Clinical and Microbiologic Outcomes by Causative Pathogen in Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Treated with Imipenem/Cilastatin (IMI)/Relebactam (REL) Versus Piperacillin/Tazobactam (PIP/TAZ). Poster: 1230. Losada M, et al.
  • Multivariate Regression Analysis to Determine Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Trial. Poster: 1574. Tipping R, et al.

Antimicrobial Epidemiology/Surveillance

  • Comparison of the Epidemiology and Pathogens Cultured from Patients Hospitalized with SARS-CoV-2 Positive versus SARS-CoV-2 Negative in the US: A Multicenter Evaluation. Poster: 373. Puzniak L, et al.
  • Epidemiology of Antimicrobial Use Among SARS-CoV-2 Positive and Negative Admissions in the US: A Multicenter Evaluation. Poster: 379. Puzniak L, et al.
  • Comparison of Ceftolozane/Tazobactam, Ceftazidime/Avibactam, and Meropenem/Vaborbactam Activity Against P. aeruginosa: A Multicenter Evaluation. Poster: 1603. Moise P, et al.
  • Frequency of Carbapenem-resistant Pseudomonas aeruginosa Among Respiratory Pathogens Impacts First-Line Beta-Lactam Susceptibility: Potential Role for Ceftolozane/Tazobactam (C/T) and/or Imipenem/Relebactam (I/R). Poster: 1450. Klinker K, et al.
  • Activity of Ceftolozane/Tazobactam Against Gram-Negative Isolates From Lower Respiratory Tract Infections – SMART United States 2018. Poster: 1587. Lob S, et al.
  • Epidemiology and Susceptibility to Imipenem/Relebactam of Gram-Negative Pathogens From Patients With Lower Respiratory Tract Infections – SMART United States 2017-2018. Poster: 1609. Lob S, et al.

HIV

  • Efficacy and Safety of Doravirine in Treatment-Naïve Adults ≥50 Years Old With HIV-1. Poster: 1011. Mills A, et al.

For more information and access to IDWeek’s virtual program, please visit the IDWeek 2020 website.

About RECARBRIOTM (imipenem, cilastatin, and relebactam) for injection 1.25 g

RECARBRIO is indicated for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.

RECARBRIO is also indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae and Pseudomonas aeruginosa.

RECARBRIO is also indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa.

Approval of the cUTI and cIAI indications is based on limited clinical safety and efficacy data for RECARBRIO.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Safety Information for RECARBRIO

Hypersensitivity Reactions: RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with RECARBRIO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams, and other allergens. If a hypersensitivity reaction to RECARBRIO occurs, discontinue the therapy immediately.

Seizures and Other Central Nervous System (CNS) Adverse Reactions: CNS adverse reactions, such as seizures, confusional states, and myoclonic activity, have been reported during treatment with imipenem/cilastatin, a component of RECARBRIO, especially when recommended dosages of imipenem were exceeded. These have been reported most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) and/or compromised renal function. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether RECARBRIO should be discontinued.

Increased Seizure Potential Due to Interaction with Valproic Acid: Concomitant use of RECARBRIO, with valproic acid or divalproex sodium may increase the risk of breakthrough seizures. Avoid concomitant use of RECARBRIO with valproic acid or divalproex sodium or consider alternative antibacterial drugs other than carbapenems.

Clostridioides difficile-Associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including RECARBRIO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C difficile may need to be discontinued.

Development of Drug-Resistant Bacteria: Prescribing RECARBRIO in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions: The most frequently reported adverse reactions occurring in ≥2% of cUTI and cIAI patients treated with RECARBRIO were diarrhea (6%), nausea (6%), headache (4%), vomiting (3%), alanine aminotransferase increased (3%), aspartate aminotransferase increased (3%), phlebitis/infusion site reactions (2%), pyrexia (2%), and hypertension (2%). The most frequently reported adverse reactions occurring in ≥5% of HABP/VABP patients treated with RECARBRIO were aspartate aminotransferase increased (11.7%), anemia (10.5%), alanine aminotransferase increased (9.8%), diarrhea (7.9%), hypokalemia (7.9%), and hyponatremia (6.4%).

About ZERBAXA® (ceftolozane and tazobactam) for injection (1.5g)

ZERBAXA is indicated for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.

ZERBAXA is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.

ZERBAXA used in combination with metronidazole is indicated for the treatment of patients 18 years and older with complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Safety Information for ZERBAXA

Patients with renal impairment: Decreased efficacy of ZERBAXA has been observed in patients with baseline CrCl of 30 to <50 mL/min. In a clinical trial, patients with cIAIs with CrCl >50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the same trial, patients with CrCl 30 to <50 mL/min had a clinical cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when treated with meropenem. A similar trend was also seen in the cUTI trial. Dose adjustment is required for patients with CrCl 50 mL/min or less. All doses of ZERBAXA are administered over 1 hour. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.

Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane/tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.

Clostridioides difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.

Development of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.

Adverse reactions: The most common adverse reactions occurring in ≥5% of patients in the HABP/VABP trial were hepatic transaminase increased (11.9%), renal impairment/renal failure (8.9%), and diarrhea (6.4%). The most common adverse reactions occurring in ≥5% of patients in the cUTI and cIAI trials were headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%), and pyrexia (5.6%) in the cIAI trial.

About PIFELTROTM (doravirine, 100 mg) and DELSTRIGOTM (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg)

PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. DELSTRIGO contains a boxed warning regarding posttreatment acute exacerbations of hepatitis B (HBV) infection. See Selected Safety Information below.

Selected Safety Information for PIFELTRO and DELSTRIGO

Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV)

All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted.

PIFELTRO and DELSTRIGO are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO.

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min.

In clinical trials in HIV-1 infected adults, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

Co-administration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.

If DELSTRIGO is co-administered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.

If PIFELTRO is co-administered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).

Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min.

The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).

By Week 96 in DRIVE-FORWARD, 2% of adult subjects in the PIFELTRO group and 3% in the DRV+r group had adverse events leading to discontinuation of study medication.

By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO (doravirine/3TC/TDF) group and 7% in the EFV/FTC/TDF group had adverse events leading to discontinuation of study medication.

In DRIVE-FORWARD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, mean changes from baseline at Week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-SHIFT, mean changes from baseline at Week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium.

The safety of DELSTRIGO in virologically-suppressed adults was based on Week 48 data from subjects in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult subjects was similar to that in subjects with no ARV treatment history.

Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of subjects in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of subjects had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of subjects in the delayed switch group experienced ALT and AST elevations of greater than 1.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Sarra S. Herzog

(201) 669-6570

Investors:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107

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Merck to present new data from the company’s diverse HIV portfolio and pipeline at HIV Glasgow 2020

Researchers Will Present Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination with Doravirine, and Phase 1/1b Data for MK-8507, an Investigational NNRTI for the Treatment of HIV-1 Infection

Company Plans to Advance MK-8507 into Phase 2 Evaluating its Efficacy and Safety in Combination with Islatravir as a Once-Weekly Oral Regimen

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that nine abstracts from the company’s diverse HIV portfolio and pipeline will be presented at the 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020, October 5-8, 2020). During the congress, researchers will present new data from Merck’s HIV development program, including 96-week results from efficacy and safety analyses from the Phase 2b study of islatravir (Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI)) in combination with doravirine (PIFELTRO™) in adults with HIV-1 infection who had not previously received antiretroviral treatment. Additionally, Merck will share results from Phase 1/1b studies of MK-8507, an investigational oral non-nucleoside reverse transcriptase inhibitor (NNRTI) under development for once-weekly oral administration in combination with islatravir. These and other data, including 144-week results from the Phase 3 DRIVE-SHIFT study evaluating the effect of switching from a stable antiretroviral therapy (ART) regimen to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate), will be shared via oral and poster presentations during the virtual congress.

“Merck remains at the forefront of research to develop new medicines for people living with HIV. The new data we will present at HIV Glasgow 2020 from our HIV research programs – for doravirine, islatravir, and now MK-8507 – demonstrate our sustained innovation and unwavering commitment to help address the global burden of HIV,” said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. “Our plans to evaluate MK-8507 as a potential partner with islatravir, as well as the ongoing clinical trials of islatravir and doravirine, illustrate the diversity of candidates in our HIV pipeline and our quest to transform the way HIV is treated.”

Select abstracts in the HIV Glasgow 2020 program include:

  • Islatravir in combination with doravirine maintains HIV-1 viral suppression through 96 weeks. Oral Presentation O415. Abstract 4913173. J.M. Molina et al.
  • Renal safety through 96 weeks from a phase 2 trial (P011) of islatravir and doravirine in treatment-naïve adults with HIV-1. Poster Presentation P048. Abstract 4919993. F. Post et al.
  • Analysis of protocol defined virologic failure through 96 weeks from a phase 2 trial (P011) of islatravir and doravirine in treatment-naïve adults with HIV-1. Poster Presentation P047. Abstract 4913025. C. Orkin et al.
  • Long-term treatment safety and efficacy following switch to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF): Week 144 results of the DRIVE-SHIFT trial. Poster Presentation P037. Abstract 4922614. P. Kumar et al.
  • Single doses of MK-8507, a novel HIV-1 NNRTI, reduced HIV viral load for at least a week. Oral Presentation O416. W. Ankrom et al.
  • Safety, tolerability and pharmacokinetics following single- and multiple-dose administration of the novel NNRTI MK-8507 with a midazolam interaction arm. Poster Presentation P099. Abstract 4913210. W. Ankrom et al.
  • Islatravir Selects for HIV-1 Variants in MT4-GFP cells that Profoundly Reduce Replicative Capacity in PBMCs and Reduce Susceptibility to Islatravir but not NRTIs. Poster Presentation P120. Abstract 4920686. T. Diamond et al.

For more information, including details around the virtual programming, please visit the HIV Glasgow 2020 website.

Indications and Usage for PIFELTRO and DELSTRIGO

PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.

Selected Safety Information about PIFELTRO and DELSTRIGO

Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV)

All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted.

PIFELTRO and DELSTRIGO are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO.

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min.

In clinical trials in HIV-1 infected adults, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

Co-administration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.

If DELSTRIGO is co-administered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.

If PIFELTRO is co-administered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).

Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min.

The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).

By Week 96 in DRIVE-FORWARD, 2% of adult subjects in the PIFELTRO group and 3% in the DRV+r group had adverse events leading to discontinuation of study medication.

By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO group and 7% in the EFV/FTC/TDF group had adverse events leading to discontinuation of study medication.

In DRIVE-FORWARD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-SHIFT, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium.

The safety of DELSTRIGO in virologically-suppressed adults was based on Week 48 data from subjects in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult subjects was similar to that in subjects with no ARV treatment history.

Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of subjects in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of subjects had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of subjects in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen.

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Mothers infected with HIV-1 should be instructed not to breastfeed if they are receiving PIFELTRO or DELSTRIGO due to the potential for HIV-1 transmission.

About Islatravir (MK-8591)

Islatravir (formerly MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, as well as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single investigational agent, across a variety of formulations.

Our Commitment to HIV

For more than 30 years, Merck has been committed to scientific research and discovery in HIV, and we continue to be driven by the conviction that more medical advances are still to come. Our focus is on pursuing research that addresses unmet medical needs and helps people living with HIV and their communities. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that hinder continued progress.

Our Commitment to Infectious Diseases

For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.

About Merck

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

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

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

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

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

Please see Prescribing Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf; and Patient Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf

Please see Prescribing Information for DELSTRIGO (doravirine/3TC/TDF) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf and Patient Information for DELSTRIGO (doravirine/3TC/TDF) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf

Contacts

Media:

Pamela Eisele

(267) 305-3558

Sarra S. Herzog

(201) 669-657

Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

October 1, 2020

Categories
Business

Merck Animal Health completes acquisition of worldwide rights to VECOXAN® brand of parasiticides for ruminant portfolio

Broadens Merck Animal Health’s Position with Enhanced Parasite Protection in Calves and Lambs

MADISON, N.J.–(BUSINESS WIRE)–$MRK #AnimalHealth–Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE:MRK), today announced the completion of its previously announced acquisition of the worldwide rights to VECOXAN® (diclazuril), an oral suspension for the prevention of coccidiosis in calves and lambs, from Elanco Animal Health.

VECOXAN is efficacious, in lambs, against the prevention of coccidiosis caused by Eimeria crandallis and Eimeria ovinoidalis, and in calves, against coccidiosis caused by Eimeria bovis and Eimeria zuernii. VECOXAN is available in Europe, South Africa, South Korea and Japan.

Parasite control and protection is an essential and significant part of ruminant overall health management and outcomes. “With advanced digital and diagnostic solutions to manage the welfare of animals as critical components of our technology, we are dedicated to advancing the health and well-being of animals and the people who take care of them,” said Rick DeLuca, president, Merck Animal Health. “This complementary product for youngstock will add to our existing portfolio of veterinary medicines, including parasiticides, vaccines and services, which provides a full range of complementary solutions for our customers, and underscores our commitment to The Science of Healthier Animals®.”

Coccidiosis, a common cause of scours (diarrhea) in lambs and calves that is highly prevalent on cattle and sheep farms, is caused by protozoan parasites called Eimeria that multiply in the intestinal wall, transmitted from animal to animal by the fecal-oral route. Clinical signs include painful scours with or without blood, and decreased appetite and depression, which may progress to dehydration and weight loss. Coccidiosis primarily affects young animals; calves and lambs as young as three to four weeks of age may be affected.

Coccidiosis causes significant economic loss to farmers and producers due to reduced feed conversion, reduced growth rates, reduced performance or death, and by increased susceptibility to other infections, such as intestinal disease or Bovine Respiratory Disease.

About VECOXAN

VECOXAN is an anticoccidial of the benzeneacetonitrile group without antimicrobial activity and has anticoccidial activity against Eimeria species. The product can be used in calves and lambs, beef and dairy, of any weight, in any management system, without environmental restrictions. It has a zero-day meat withdrawal period.

About Merck Animal Health

For more than a century, Merck, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, is the global animal health business unit of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com or connect with us on LinkedIn, Facebook, and Twitter at @MerckAH.

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

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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

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

Contacts

Merck

Media:

Hester de Voogd

+1 (201) 463-0407

Hester.de.voogd@merck.com

Pam Eisele

+1 (267) 305-3558

Pamela.Eisele@merck.com

Merck

Investors:

Michael DeCarbo

+ 1 (908) 740-1807

Michael.DeCarbo@merck.com

Categories
Healthcare

Teva announces new strategic focus in the Japanese market

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

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

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

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

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

About Teva

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 re: our new strategic focus in the Japanese market, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

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

and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Contacts

IR Contacts

United States

Kevin C. Mannix (215) 591-8912

Israel
Ran Meir 972 (3) 926-7516

PR Contacts

United States
Doris Li (973) 265-3752

Israel

Yonatan Beker

972 (54) 888 5898

Categories
Business

AM Best affirms credit ratings of Union Medical Benefits Society Limited

SINGAPORE–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Rating of “a” of Union Medical Benefits Society Limited (UniMed) (New Zealand). The outlook of these Credit Ratings (ratings) is stable.

The ratings reflect UniMed’s balance sheet strength, which AM Best categorises as very strong, as well as its strong operating performance, limited business profile and appropriate enterprise risk management.

UniMed’s balance sheet strength assessment is supported by its risk-adjusted capitalisation, which AM Best categorised as strongest in fiscal-year 2019, and is expected to remain at this level over the medium term, as measured by Best’s Capital Adequacy Ratio (BCAR). This reflects the company’s low underwriting leverage and prudent investment approach. In addition, AM Best views the company as having a favourable liquidity position. As a not-for-profit insurer, UniMed has no dividend commitments, but AM Best considers its financial flexibility as limited. Notwithstanding this, the company’s sizeable capital buffer provides protection against potential adverse developments in future earnings or balance sheet items.

AM Best views UniMed’s operating performance to be strong, with a five-year average return-on-equity ratio of 9.9% and five-year average operating ratio of 87.9% (fiscal-years 2015-2019), albeit with a moderate level of volatility over this period. The company’s overall earnings have been driven by sound underwriting performance and stable investment returns. UniMed benefits from an efficient cost structure that allows it to offer competitive health coverage and premiums to its members. The company’s loss ratio also has reduced over the past several years, driven in part by improvements in its surgical claims approval process and diligent control over timely and appropriate rates adjustments. While the public health care system in New Zealand is responsible for the pandemic response to COVID-19, AM Best does expect a level of volatility in UniMed’s prospective loss experience. For fiscal-year 2020, claims volumes are expected to fall from the deferral of elective surgeries during the country’s lockdown period, followed by a subsequent catch up in claims activity over the coming fiscal periods.

AM Best assesses UniMed’s business profile as limited. The company is a small-sized, not-for-profit insurer with a market share of 4% in New Zealand’s health insurance industry, based on 2019 gross written premiums. UniMed’s underwriting portfolio continues to have limited product line and geographical diversification. In addition, the company has a concentration toward a few large group medical accounts, which increases the susceptibility of overall earnings to changes in the performance of these key accounts. Despite ongoing challenging market conditions, UniMed’s membership has increased in fiscal-year 2019 due to a portfolio transfer from The Education Benevolent Society Incorporated and its newly launched retail offering. Prospectively, UniMed’s top line may be affected adversely due to cancellations and weaker sales as a result of economic downturn related to COVID-19.

Ratings are communicated to rated entities prior to publication. Unless stated otherwise, the ratings were not amended subsequent to that communication.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

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 New York, London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2020 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Sin Yee Chuah

Financial Analyst
+65 6303 5022
sinyee.chuah@ambest.com

Doniella Pliss
Director, Analytics
+65 6303 5024
doniella.pliss@ambest.com

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

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

Categories
Local News

NRG Energy Inc. to hold investor call to discuss acquisition of Direct Energy

PRINCETON, N.J.–(BUSINESS WIRE)–On Friday, July 24, 2020 at 9:00 a.m. Eastern Time, NRG Energy Inc. (NYSE: NRG) will hold an investor call to discuss its acquisition of Direct Energy, as announced today by Centrica PLC, as well as a preview of the Company’s second quarter 2020 financial results.

A live webcast of the conference call, including presentation materials, can be accessed through NRG’s website at http://www.nrg.com and clicking on “Presentations & Webcasts” in the “Investors” section found at the top of the home page. The webcast will be archived on the site for those unable to listen in real time.

About NRG Energy

At NRG, we’re bringing the power of energy to people and organizations by putting customers at the center of everything we do. We generate electricity and provide energy solutions and natural gas to more than 3.7 million residential, small business, and commercial and industrial customers through our diverse portfolio of retail brands. A Fortune 500 company, operating in the United States and Canada, NRG delivers innovative solutions while advocating for competitive energy markets and customer choice, and by working towards a sustainable energy future. More information is available at www.nrg.com. Connect with NRG on Facebook, LinkedIn and follow us on Twitter @nrgenergy, @nrginsight.

Contacts

Investors:
Kevin L. Cole, CFA

609.524.4526

investor.relations@nrg.com

Media:
Candice Adams

609.455.3777

candice.adams@nrg.com

Categories
Business

City of Atlanta selects Prudential Retirement to oversee more than $330M in assets

NEWARK, N.J.–(BUSINESS WIRE)–$PRU–The city of Atlanta, the ninth-largest metropolitan area in the nation, chose Prudential Retirement as record keeper for its defined contribution retirement plans. Prudential Retirement is a business unit of Prudential Financial, Inc. (NYSE: PRU).


Prudential will oversee $337 million in retirement assets, which will cover 8,600 government employees as of June 1, 2020. The partnership adds to Prudential’s public sector portfolio, which oversees $49.3 billion across 225 plans for 827,259 participants.

According to John Gaffney, deputy chief finance officer for the city of Atlanta, Prudential was selected for its efficient model, investment flexibility and cost savings. “The city of Atlanta wants to deliver retirement plans that help our dedicated workers build and secure their financial stability,” said Gaffney. “Prudential is the right partner to ensure our plans are optimized for long-term success.”

As the retirement industry continues to navigate uncertainty in response to COVID-19, Prudential’s strength – which has weathered crises including two world wars, the 1918 Spanish influenza, the Great Depression, 9/11 and the global financial crisis of 2008 – coupled with its long-term strategic view provides much needed support and reassurance for plan sponsors.

“Prudential is committed to innovative plan designs that meet the needs of plan sponsors and participants, particularly during these unprecedented times,” says Michael Domingos, senior vice president and head of sales and strategic relationships at Prudential Retirement. “We are thrilled to share this expertise with the city of Atlanta and help its employees maintain financial wellness.”

For more information, visit www.prudential.com/employers/retirement.

About Prudential Retirement

Prudential Retirement delivers retirement plan solutions for public, private, and nonprofit organizations. Services include defined contribution, defined benefit and nonqualified deferred compensation recordkeeping, administrative services, investment management, comprehensive employee education and communications, and trustee services, as well as a variety of products and strategies, including institutional investment and income products, pension risk transfer solutions and structured settlement services. With more than 85 years of retirement experience, Prudential Retirement helps meet the needs of 4.6 million participants and annuitants. Prudential Retirement has $466 billion in retirement account values as of March 31, 2020. Retirement products and services are provided by The Prudential Insurance Company of America (PICA), Newark, N.J., or its affiliates.

About Prudential Financial, Inc.

Prudential Financial, Inc. (NYSE: PRU), a financial services leader with more than $1 trillion of assets under management as of March 31, 2020, has operations in the United States, Asia, Europe, and Latin America. Prudential’s diverse and talented employees are committed to helping individual and institutional customers grow and protect their wealth through a variety of products and services, including life insurance, annuities, retirement-related services, mutual funds and investment management. In the U.S., Prudential’s iconic Rock symbol has stood for strength, stability, expertise and innovation for more than a century. For more information, please visit news.prudential.com.

1038140-00001-00

Contacts

MEDIA:

Anjelica Sena. 973-802-6930

anjelica.sena@prudential.com