Tag: New Jersey

Categories
Science Technology

Investigational combination of Aliqopa® (copanlisib) and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin’s Lymphoma

  • In the Phase III trial CHRONOS-3 of 458 patients with indolent non-Hodgkin’s Lymphoma (iNHL), the investigational combination of Aliqopa and rituximab was statistically significant in delaying disease progression or death (HR=0.52, 95% CI 0.39, 0.69) compared to rituximab and placebo, with a median progression-free survival (PFS) of 21.5 months (95% CI 17.8, 33.0) versus 13.8 months (95% CI 10.2, 17.5)1
  • The CHRONOS-3 trial included several prespecified iNHL subgroups including follicular lymphoma (FL; n=275), marginal zone lymphoma (MZL; n=95), small lymphocytic lymphoma (SLL; n=50), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM; n=38)1
  • Bayer is discussing the data from CHRONOS-3 with health authorities worldwide

Abstract: CT001

WHIPPANY, N.J. — (BUSINESS WIRE) — Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival (PFS) with the investigational combination of Aliqopa® (copanlisib) and rituximab given intravenously in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to the combination of rituximab and placebo. After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002). No new safety signals were identified for Aliqopa in the combination arm of the study.1 The data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology.

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending PFS in patients with relapsed iNHL following at least one prior rituximab-containing therapy. Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included.2

In 2017, Aliqopa was approved for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies based on the results of a single-arm, multicenter, Phase II clinical trial (CHRONOS-1).3 Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

“In clinical practice, we have seen an overall improvement in the prognosis of iNHL patients, yet relapsed disease is still a prominent treatment challenge,” said Matthew J. Matasar, M.D., Medical Oncologist, Regional Care Network Medical Site Director, Memorial Sloan Kettering Cancer Center (MSK) Bergen. “The results reported with the combination of copanlisib and rituximab suggest a potential advancement for patients with these diverse types of cancers.”

“Bayer is committed to putting patients’ needs first and delivering innovative treatment options that address areas of high unmet need, and clinical research is the first step in that process,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer. “These data highlight the potential of Aliqopa and rituximab as a new strategy for treating these patients and we look forward to advancing regulatory discussions.”

Bayer is in discussions with health authorities worldwide regarding the data from CHRONOS-3.

Additional CHRONOS-3 Data Being Presented at AACR

In addition to the primary endpoint of PFS, data on the secondary endpoints of ORR and complete response rate (CRR) will also be presented. Best ORR for the combination of Aliqopa and rituximab was 80.8% (95% CI 76, 85) versus 47.7% (95% CI 40, 56) for rituximab and placebo (p<0.0001), with 33.9% and 14.6% of patients achieving CR, respectively. Of the relapsed iNHL patients included in the trial, 60% had FL, 20.7% marginal zone lymphoma (MZL), 10.9% small lymphocytic lymphoma (SLL) and 8.3% lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). Analysis of the subtypes will be presented at AACR and published in The Lancet Oncology.1

All-grade treatment-emergent adverse events (TEAEs) observed with the Aliqopa and rituximab combination that occurred in more than 20% of the patients included hyperglycemia (69.4%), hypertension (49.2%), diarrhea (33.6%), neutropenia (20.8%), nausea (22.5%) and pyrexia (20.5%). Discontinuation due to all-grade TEAEs in CHRONOS-3 for Aliqopa and rituximab was 32% versus 8% for rituximab and placebo.1

Aliqopa is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant activity against alpha and delta isoforms the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.4 Aliqopa is approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Accelerated approval was granted for this indication based on an ORR of 59% (n=61/104; 95% CI 49, 68), including 14% (15/104) of CRs from the open-label, single-arm multicenter, Phase II clinical trial (CHRONOS-1), in a total of 142 subjects, which included 104 subjects with follicular B-cell non-Hodgkin’s Lymphoma who had relapsed disease following at least two prior treatments. In the updated two-year follow-up analysis conducted on data until 16 weeks after the last patients eligible for full analysis started treatment, Aliqopa ORR was 59% (n=61; 95% CI 49, 68), including 20% CR (n=21).5 Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. Efficacy based on ORR was assessed by an Independent Review Committee.

Disclosure: This study was sponsored by Bayer AG. Dr. Matasar has received honoraria from Bayer AG and subsidiaries of Bayer AG for advising and related activities. Bayer AG also provides research funding for Dr. Matasar through Memorial Sloan Kettering Cancer Center (MSK). In addition, Dr. Matasar has received honoraria from Roche/Genentech for advising and related activities, and the company also provides research funding for him through MSK.

About Aliqopa® (copanlisib) Injection3

Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Aliqopa is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.

IMPORTANT SAFETY INFORMATION FOR ALIQOPA® (copanlisib)

Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection.

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk. Withhold ALIQOPA in patients with suspected PJP infection of any grade. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis.

Hyperglycemia: Grade 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with ALIQOPA monotherapy. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with ALIQOPA may result in infusion-related hyperglycemia. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

Of the twenty patients with diabetes mellitus treated in CHRONOS-1, seven developed Grade 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should only be treated with ALIQOPA following adequate glucose control and should be monitored closely.

Achieve optimal blood glucose control before starting each ALIQOPA infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia.

Hypertension: Grade 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients treated with ALIQOPA monotherapy. Serious hypertensive events occurred in 0.9% of 317 patients. Treatment with ALIQOPA may result in infusion-related hypertension. The mean change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion; BP remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hypertension.

Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients treated with ALIQOPA monotherapy. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of non-infectious pneumonitis.

Neutropenia: Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of neutropenia.

Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with ALIQOPA monotherapy respectively. Serious cutaneous reaction events were reported in 0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of severe cutaneous reactions.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ALIQOPA can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.

Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).

Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the ALIQOPA dose to 45 mg when concomitantly administered with strong CYP3A inhibitors.

Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose.

For important risk and use information about Aliqopa, please see the full Prescribing Information.

About CHRONOS-3

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Aliqopa in combination with rituximab versus placebo in combination with rituximab in patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing therapy. Histological subtypes included in the trial were follicular lymphoma (FL), small lymphocytic lymphoma (SLL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), and marginal zone lymphoma (MZL). Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included (NCT02367040). The study enrolled 458 participants.2

About non-Hodgkin’s Lymphoma

Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018.6,7

Indolent NHL consists of multiple subtypes, including follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). While the disease is typically slowly growing, it can become more aggressive over time. Despite treatment advances, there remains a need for improved treatment options for the relapsed or refractory stage of the disease. After response to initial therapy, response rates and duration of response decline with subsequent lines of therapy, underscoring the need for patients whose disease has already progressed.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

© 2021 Bayer

BAYER, the Bayer Cross and Aliqopa are registered trademarks of Bayer.

Forward-Looking Statements

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

______________________________________________________________________________

References

  1. Matasar, M., Capra, M., Özcan, M., et.al. CHRONOS-3: randomized Phase III study of copanlisib plus rituximab vs rituximab/placebo in relapsed indolent non-Hodgkin lymphoma (iNHL) CT001. In: Proceedings of the 112th Annual Meeting of the American Association for Cancer Research; 2021 April 10-15. Philadelphia (PA): AACR; 2021. Abstract CT001
  2. ClinicalTrials.gov. Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin’s Lymphoma (iNHL) (CHRONOS-3). Available online: https://clinicaltrials.gov/ct2/show/NCT02367040. Last Accessed: March 2021.
  3. Aliqopa (copanlisib) for injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; November 2020.
  4. Scott, W.J., Hentemann, M.F., Rowley, R.B., et al. ChemMedChem 2016, 11, 1517-1530. Discovery and SAR of novel 2,3-dihydroimidazo[1,2-c]quinazoline PI3K inhibitors: Identification of copanlisib (BAY 806946).
  5. Dreyling, M., Santoro, A., Mollica, L., et al. J. Hematol. 2020, 95, 362-371. Long-term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2-year follow-up of the CHRONOS-1 study.
  6. World Cancer Research Fund. Worldwide cancer data: Global cancer statistics for the most common cancers. Available online: https://www.wcrf.org/dietandcancer/cancer-trends/worldwide-cancer-data. Last Accessed: March 2021
  7. Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R.L., Torre, L.A. and Jemal, A. (2018), Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68: 394-424. https://doi.org/10.3322/caac.21492

PP-ALI-US-0689-1 04/21

Contacts

Media Contact:
Rose Talarico, Tel. +1 862.404.5302

E-Mail: rose.talarico@bayer.com

Categories
Business Technology

Vision Solar, a cutting edge renewables company projected to exceed $150M for 2021, hires seasoned CIO, Greg Young, to drive its innovation and digital transformation

BLACKWOOD, N.J. — (BUSINESS WIRE) —#renewables — On March 17th, Vision Solar, which is one of the leaders in Residential Solar Panel Installations, found their “purple unicorn,” and announced Greg Young as their new Chief Information Officer.

Young is a candidate with a profile that possesses the skills and experiences that are rare. Vision Solar with its forward-thinking digital transformation and innovative trajectory, is happy to have Young join their diverse leadership team.

Greg Young has over 20 years of professional experience within the Information Technology Industry. Prior to joining Vision Solar, Greg Young served as Chief Information Officer and Global Vice President for Hardinge Inc. It was here that Young created a proven successful record in integrating scalable technology solutions. His experiences have given him the ability to continuously deliver value by driving organizations to break through operational and performance success.

 

“I’m very excited to join Vision Solar during this time of exponential growth. I look forward to helping the company grow through innovation,” Young stated.

Young’s goal in his new position is to lead Vision Solar’s digital transformation journey by delivering cutting-edge and scalable solutions that drive business results, and provide a competitive edge that differentiates us within Renewables space, in all of our current and future locations, nationwide.


About Vision Solar

Vision Solar is one of the fastest growing solar energy companies in the United States. Their full-service renewable energy company installs solar services for residential homes in Pennsylvania, Arizona, New Jersey, Massachusetts and Florida. Over the past three years, Vision Solar has grossed over $100 million in revenue, with significant increase in projected growth to produce 1000+ high-quality Green Jobs by 2022. To learn more, visit: https://visionsolar.llc

Contacts

John Czelusniak,

jczelusniak@visionsolar.llc

Categories
Business

Organon announces pricing of senior notes offering

KENILWORTH, N.J. — (BUSINESS WIRE) — Organon Finance 1 LLC, a subsidiary of Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC has priced its previously announced offering of €1,250,000,000 aggregate principal amount of 2.875% senior secured notes due 2028 (the “euro secured notes”), $2,100,000,000 aggregate principal amount of 4.125% senior secured notes due 2028 (the “U.S. dollar secured notes”) and $2,000,000,000 aggregate principal amount of 5.125% senior unsecured notes due 2031 (the “unsecured notes” and together with the euro secured notes and U.S. dollar secured notes, the “notes”), in connection with the previously announced spinoff of Organon & Co. (“Organon”) from Merck. As part of the spinoff, the notes will be assumed by Organon, and a Dutch private limited company and wholly owned subsidiary of Organon which will act as co-issuer of the notes.

Organon intends to use the net proceeds from the notes offering, together with available cash on its balance sheet and borrowings under senior secured credit facilities which Organon anticipates entering into, to repay one or more intercompany loans or notes owed by Organon to a Merck affiliate and to pay fees and expenses related to the spinoff. The proceeds of the notes offering will be held in escrow until satisfaction of the conditions precedent to the spinoff and certain other escrow release conditions (the “Effective Date”).

Each series of notes will be issued at an issue price of 100%. From and after the Effective Date, the euro secured notes and the U.S. dollar secured notes will be guaranteed on a senior secured basis, and the unsecured notes will be guaranteed on a senior unsecured basis, jointly and severally, by all of Organon’s existing or future subsidiaries that guarantee its proposed senior secured credit facilities. Prior to the Effective Date, each series of notes will be senior secured obligations solely of the Organon Finance 1 LLC, and will not be guaranteed by Organon or any of its subsidiaries.

The notes offering is expected to close on April 22, 2021, subject to customary closing conditions.

The notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the “Prospectus Regulation”) or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”).

In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation. In the United Kingdom, this announcement is directed only at persons who are “qualified investors” within the meaning of the UK Prospectus Regulation.

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK.

In the United Kingdom, this announcement is directed only at persons (i) that have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”); (ii) falling within Article 49(2)(a) to (d) (“high net worth companies, unincorporated associations etc.”) of the Order; or (iii) at whom this announcement may otherwise be directed without contravention of Section 21 of the Financial Services and Markets Act 2000, as amended (all such persons together being referred to as “relevant persons”). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Organon

Organon will be a global healthcare company formed through a spinoff from Merck to focus on improving the health of women throughout their lives. It will have a portfolio of more than 60 trusted medicines that address an entire spectrum of conditions women face. Led by the growing reproductive health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in future growth opportunities in women’s health. In addition, Organon will pursue opportunities to partner with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast-growing international markets.

Organon is expected to have a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, N.J.

About Merck

For 130 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.

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. Examples of forward-looking statements include statements with respect to the company’s plans to spinoff certain of its businesses into an independent company, the timing and structure of such spinoff, the characteristics of the business to be separated, the expected benefits of the spinoff to the company and the expected effect on the company’s dividends. 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 whether the proposed spinoff will be completed on the proposed timetable or at all. 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, uncertainties as to the timing of the proposed spinoff; uncertainties as to the status of any required regulatory approvals; the possibility that various conditions to the consummation of the spinoff may not be satisfied; the effects of disruption from the transactions contemplated in connection with the spinoff; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; the impact of the global outbreak of novel coronavirus disease (COVID-19); 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 2020 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

Media Contacts:

Patrick Ryan

(973) 275-7075

Jessica Fine

(908) 608-4859

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107

Categories
Business

American Water publishes first annual Inclusion & Diversity Report

CAMDEN, N.J.–(BUSINESS WIRE)–American Water (NYSE: AWK), the largest publicly traded U.S. water and wastewater utility company, announced today that it has released its first annual Inclusion & Diversity Report.

“At American Water, we regularly reflect on our values and our culture. This report highlights the efforts we have undertaken and the strides we have made advancing the company’s commitment to inclusion and diversity,” said Walter Lynch, President and CEO, American Water. “We are committed to building a diverse and inclusive culture that reflects the communities we serve.”

The report shares through a transparent lens the inclusion and diversity strategies, practices, policies, and programs from across the business. It includes more than 100 data points related to American Water’s culture of inclusion and caring. The report also exemplifies how the company is constantly striving, thanks to the contributions of every employee, to build an inclusive and mutually respectful workplace.

“We’re stronger because we have different ideas, viewpoints, experiences and backgrounds,” said Valoria Armstrong, Chief Inclusion Officer and Vice President of External Affairs, American Water. “Most importantly, we embrace and encourage one another to respect and value those differences. At American Water, we believe that inclusion and diversity are vital elements to our success.”

American Water has received various awards and recognitions demonstrating our commitment to inclusion & diversity, examples include:

  • Awarded 2020 National Corporation of the Year by Eastern Minority Supplier Development Council
  • Top scoring (100%) company on the Disability Equality Index
  • Top 100 Best for Vets Employers by Military Times
  • Inclusion in the 2021 Bloomberg Gender-Equality Index
  • Named a 2020 DiversityInc Noteworthy Company

The full report can be found in the Inclusion & Diversity section of the company’s website.

About American Water

With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly traded water and wastewater utility company. The company employs more than 7,000 dedicated professionals who provide regulated and market-based drinking water, wastewater and other related services to 15 million people in 46 states. American Water provides safe, clean, affordable and reliable water services to our customers to help make sure we keep their lives flowing. For more information, visit amwater.com and follow American Water on Twitter, Facebook and LinkedIn.

Contacts

Media Contact:
Joseph Szafran

External Affairs Manager

856-955-4304

joseph.szafran@amwater.com

Categories
Sports & Gaming

Allied Esports tournament marks first esports betting opportunity in New Jersey

Two-Week VIE.gg CS:GO Legend Series Competition Now Offered to Sports Bettors and Esports Enthusiasts Daily Through September 13

IRVINE, Calif.–(BUSINESS WIRE)–Allied Esports, a global esports entertainment company and a subsidiary of Allied Esports Entertainment, Inc. (NASDAQ: AESE), has created the first opportunity for legal esports betting in New Jersey through its VIE.gg CS:GO (Counter-Strike: Global Offensive) Legend Series tournament, which runs through September 13. The announcement allowing legal esports betting in the state was made by the New Jersey Economic Development Authority (NJEDA) and the New Jersey Division of Gaming Enforcement (DGE), and was facilitated by New Jersey-based gaming and esports agency Gaud-Hammer Gaming Group.


Allied Esports’ previously announced data and video rights licensing agreement with GRID Esports, a leading esports data provider, paved the way for the tournament’s live-server data to be distributed to participating sportsbooks and other online vendors in the Garden State, allowing bettors to engage with the event in real time.

“We are extremely proud that bettors in New Jersey will place their first legal esports wagers on the VIE.gg CS:GO Legend Series,” said Fran Ng, CEO of Allied Esports Entertainment. “Between our recent data and video rights agreements and focus on competitive integrity, we have raised the value of one of our key tournament brands and provided our partners with an innovative business solution. We are excited to play a new role in the rapidly growing esports betting market and believe we have taken the necessary steps to capture future opportunities in the U.S. and around the world with our unique offerings.”

“This is a momentous decision for esports betting in the U.S., and Allied Esports’ commitment to increased fan engagement and integrity allows for states and operators to function securely in their approach,” said Moritz Mauer, CEO of GRID Esports. “Each day, esports wagering gets closer to legitimacy across all 50 states and our ongoing effort in evangelizing esports data for betting and media is made possible by partners like Allied Esports. We are honored to join them in a part of history that starts this week in New Jersey.”

According to figures released by the NJDGE, New Jersey’s sportsbooks took $315.1 million in bets in July 2020, up 91% over June’s total and up 25.4% from the same month of 2019. Sports betting revenue was $29.6 million, up 65.2% over last July. For 2019, the first full calendar year of legal sports betting in New Jersey, a total of $4.55 billion was wagered at New Jersey sportsbooks, with $3.8 billion of that total online. Those wagers resulted in $299 million in gross revenue and $36.7 million in tax revenue for the state.

Through Allied Esports’ agreements with GRID Esports and naming rights partner Esports Entertainment Group, Inc. (NASDAQ: GMBL, GMBLW), a licensed online gambling company with a focus on esports wagering and 18+ gaming, the VIE.gg CS:GO Legend Series represents the first time Allied Esports has offered the use of its tournament data and video rights for the enhancement of regulated consumer betting. Allied Esports also recently announced its membership in the Esports Integrity Commission (ESIC) to maintain and enforce the competitive gaming regulations and conduct in its tournaments, effective immediately.

Each broadcast during the VIE.gg CS:GO Legend Series tournament prominently features a wagering component, including dynamic live odds that are on display for the entirety of each match. The online event is produced by Allied Esports from its HyperX Esports Studio in Hamburg, Germany and streamed live on Twitch.tv/AlliedEsports from 6 a.m. to 1 p.m. PDT (9 a.m. – 4 p.m. EDT) each day. For the tournament bracket and schedule of matchups, visit AlliedEsports.gg/LegendSeries.

The VIE.gg CS:GO Legend Series is a showcase of 16 teams from multiple European countries, the Commonwealth of Independent States (CIS) region and South America competing online for €50,000 ($59,000) in total prize money. The lineup includes the top-ranked CS:GO teams from five countries – Belarus, Bulgaria, Norway, Romania and Ukraine – and seven teams ranked in the top 50 globally.

Created in 2017, Allied Esports’ original Legend Series tournament brand was designed to expand the competitive ecosystem and total prize pool for teams ranked outside of the first tier. The VIE.gg CS:GO Legend Series is Allied Esports’ sixth edition of the CS:GO Legend Series and the first to feature a licensing partner and title sponsor. Additional versions of the series have previously included Overwatch, League of Legends, FIFA, COD Blackout and VALORANT.

About Allied Esports

Named one of the World’s Most Innovative Companies by Fast Company, Allied Esports International, Inc. is at the forefront of esports entertainment with a global network of properties designed to serve as competition battlegrounds, community experience hubs and content production centers.

Through direct operation or membership in the Allied Esports Property Network, the world’s first esports affiliate program, Allied Esports’ facilities span North America, Europe, China and Australia, and include the world-renowned HyperX Esports Arena Las Vegas, a fleet of mobile arenas, the HyperX Esports Trucks, and the HyperX Esports Studio in Hamburg, Germany.

Allied Esports’ properties serve as the home to a number of online and offline proprietary productions and events, including Friday Frags and Saturday Night Speedway, as well as original partner programs like the Simon Cup and VALORANT Ignition Series: Allied Esports Odyssey.

For more information about Allied Esports, visit AlliedEsports.gg and follow @AlliedEsports. Allied Esports International, Inc. is a subsidiary of Allied Esports Entertainment, Inc.

About Allied Esports Entertainment

Allied Esports Entertainment, Inc. (NASDAQ: AESE) is a global leader in esports entertainment, providing innovative infrastructure, transformative live experiences, multiplatform content and interactive services to audiences worldwide through its strategic fusion of two powerful brands: Allied Esports and the World Poker Tour (WPT). For more information, visit AlliedEsportsEnt.com.

Forward Looking Statements

This press release includes “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of us, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include: our ability to execute on our business plan; our ability to retain key personnel; general economic and market conditions impacting demand for our products and services; adequacy of our funds for future operations; our future expenses, revenue and profitability; our ability to develop new products; our dependence on key suppliers, manufacturers and strategic partners; and industry trends and the competitive environment in which we operate. These and other risk factors are discussed in our reports filed with the Securities and Exchange Commission. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Media Contacts:
Brian Fisher

Allied Esports

brian@alliedesports.com

Investor Contact:
Lasse Glassen

Addo Investor Relations

lglassen@addoir.com
424-238-6249

Categories
Business

Columbia Care raises approximately $14 million of non-dilutive capital through second sale leaseback

The Transaction Includes the Company’s New Jersey Cultivation and Manufacturing Facility and Dispensary; Additional Sale Leaseback Financings Expected in 2H 2020

NEW YORK–(BUSINESS WIRE)–Columbia Care Inc. (NEO: CCHW) (CSE: CCHW) (OTCQX: CCHWF) (FSE: 3LP) (“Columbia Care” or the “Company”) announced the close of its sale leaseback transaction with Innovative Industrial Properties (NYSE:IIPR) (“IIP”) valued at approximately $14 million. The transaction includes the Company’s dispensary, cultivation and manufacturing facilities in Vineland, New Jersey, totaling approximately 54,000 square feet.

Upon closing, Columbia Care entered into a long-term, triple-net lease agreement with IIP and will continue to develop, operate, and manage the properties. The Company’s New Jersey dispensary commenced sales operations in June, while its cultivation facility recently completed its first harvest and is expected to sell finished, packaged products into both the wholesale and retail markets. Columbia Care expects to continue expanding its cultivation, manufacturing and packaging capabilities over the next 12 months, in addition to adding two more dispensaries and introducing home delivery throughout the state. New Jersey is a rapidly growing market that is expected to transition from medical-only to adult use in 1Q 2021. There are currently 78,000 registered patients and only 11 operating dispensaries in the state.

“Coupled with our other recent financing announcements, this incremental non-dilutive capital will bolster our already strong balance sheet and enable us to continue to execute against our growth and profitability initiatives across the United States,” said Nicholas Vita, CEO of Columbia Care. “With the adult use cannabis measure likely to be passed by New Jersey voters in November, we remain well-positioned to be one of the market leaders in the Garden State. Columbia Care is thrilled to partner with IIP as we capitalize on the positive tailwinds across our various markets and achieve adjusted EBITDA profitability later this year.”

IIP President and CEO Paul Smithers commented: “We are excited to partner with the team at Columbia Care as we believe the cannabis market in New Jersey is poised for strong growth in the coming years. We look forward to enabling Columbia Care to further its position as a leading operator in the state.”

About Columbia Care Inc.

Columbia Care is one of the largest and most experienced cultivators, manufacturers and providers of medical and adult use cannabis products and related services with licenses in 18 US jurisdictions1 and the EU. Columbia Care has completed more than 1.8 million sales transactions since inception and working in collaboration with renowned and innovative teaching hospitals and medical centers globally, continues to be a patient-centered health and wellness company setting the standard for compassion, professionalism, quality, care and innovation in the rapidly expanding cannabis industry. For more information on Columbia Care, please visit www.col-care.com.

Caution Concerning Forward-Looking Statements

This press release contains certain statements that constitute forward-looking information within the meaning of applicable securities laws and reflect the Company’s current expectations regarding future events. The Company has made assumptions with respect to its New Jersey operations including adult use legalization passage, home delivery, its ability to find suitable additional dispensary locations as well as its ability to negotiate additional lease arrangements satisfactory to the Company; complete all planned construction in a timely manner and attract qualified staff. Columbia Care has also made certain general industry assumptions in the preparation of such forward-looking statements including projections that may be impacted by macroeconomic factors and other factors not controllable by the Company. While Management believes its assumptions and forward-looking statements to be reasonable at the time of preparation, there can be no assurance that actual results will be consistent with such forward-looking statements. Investors are also advised to review other risk factors discussed under “Risk Factors” in Columbia Care’s Annual Information Form dated March 31, 2020, filed with the applicable Canadian securities regulatory authorities on SEDAR at www.sedar.com and described from time to time in documents filed by the Company with Canadian securities regulatory authorities.

1 Includes Colorado, subject to successful completion of the acquisition of The Green Solution and W. Virginia industrial hemp cultivation license.

Contacts

Investor Contact:
Gary F. Santo, Jr.

Investor Relations

+1.212.271.0915

ir@col-care.com

Media Contact:
Gabriella Velez

5WPR

columbiacare@5wpr.com

Categories
Business

Eldorado Resorts secures approval from New Jersey Casino Control Commission in connection with its pending acquisition of Caesars Entertainment

RENO, Nev.–(BUSINESS WIRE)–Eldorado Resorts, Inc. (NASDAQ: ERI) (“Eldorado” or the “Company”) announced that at a meeting today, the Company received approval from the New Jersey Casino Control Commission in connection with its pending acquisition of Caesars Entertainment Corporation (NASDAQ: CZR) (“Caesars”), subject to applicable conditions. Eldorado and Caesars have received all required regulatory approvals necessary to close the merger.

About Eldorado Resorts, Inc.

Eldorado is a leading casino entertainment company that owns and operates twenty-one properties in eleven states, including Colorado, Florida, Illinois, Indiana, Iowa, Louisiana, Mississippi, Missouri, Nevada, New Jersey, and Ohio. In aggregate, Eldorado’s properties feature approximately 22,400 slot machines, VLTs and e-tables and approximately 640 table games, and over 11,200 hotel rooms. For more information, please visit www.eldoradoresorts.com.

About Caesars Entertainment

Caesars Entertainment is one of the world’s most diversified casino-entertainment providers and the most geographically diverse U.S. casino-entertainment company. Since its beginning in Reno, Nevada, in 1937, Caesars Entertainment has grown through development of new resorts, expansions and acquisitions. Caesars Entertainment’s resorts operate primarily under the Caesars®, Harrah’s® and Horseshoe® brand names. Caesars Entertainment’s portfolio also includes the Caesars Entertainment UK family of casinos. Caesars Entertainment is focused on building loyalty and value with its guests through a unique combination of great service, excellent products, unsurpassed distribution, operational excellence and technology leadership. Caesars Entertainment is committed to its employees, suppliers, communities and the environment through its PEOPLE PLANET PLAY framework. For more information, please visit www.caesars.com/corporate.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current expectations of Eldorado and are subject to uncertainty and changes in circumstances. These forward-looking statements include, among others, statements regarding the timing and completion of the merger with Caesars Entertainment Corporation. These forward-looking statements may be identified by the use of words such as “expect,” “anticipate,” “believe,” “estimate,” “potential,” “should,” “will” or similar words intended to identify information that is not historical in nature. The inclusion of such statements should not be regarded as a representation that the forward-looking events discussed in this document will occur or be achieved. There is no assurance that the merger with Caesars Entertainment Corporation will be consummated, and there are a number of risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein. Information on risks and uncertainties is available in Eldorado’s recent filings with the SEC, including its reports on Form 10-K, Form 10-Q and Form 8-K. Other unknown or unpredictable factors may also cause actual results to differ materially from those projected by the forward-looking statements.

The forward-looking statements in this document speak only as of date of this document. These factors are difficult to anticipate and are generally beyond the control of Eldorado. Eldorado undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events unless required to do so by law.

Contacts

Brian Agnew

Eldorado Resorts Inc.

775/328-0112

investorrelations@eldoradoresorts.com

Joseph N. Jaffoni, Richard Land, James Leahy

JCIR

212-835-8500

eri@jcir.com

Categories
Politics

Democrats brace for nomination in NJ primaries

Hillary Clinton - Tribute

New Jersey’s presidential primaries have been taking place today, but it still remains to be seen if results of the primaries will have a bearing on the presidential race.

Polls opened at 6:00 A.M. and voters have 14 hours to cast votes for their preferred candidates for the November election.

According to a count conducted by the Associated Press, Democrat, Hillary Clinton has already drawn sufficient support from number of delegates to secure her party’s nomination. However, despite Clinton’s ascendancy becoming more and more obvious with each passing day, Vermont Senator, Bernie Sanders has pressed on and has kept urging voters to show their support for his rhetoric.

Front-running Republican presidential nominee Donald Trump on the other hand, has already received the required number of delegate backing that is required to clinch nomination.

Voters in New Jersey have choices for US House, county and local races.

According to Douglas Perry of The Oregon Live, the race will be a tight contest in California but expects New Jersey to go for Clinton.

Sanders is already lagging behind Clinton in the delegate hunt by a great amount and with little or no time left on the clock. It is clear that the former Secretary of State will get the nomination her camp has been so confident about in recent weeks. With a sizeable pledged-delegate lead and potential unpledged superdelegates on her side, one has to wonder how Sanders is going to cut down such a huge advantage his adversary is enjoying right now.

However, in theory, all is not lost for the Sanders camp. If the Vermont senator is able to secure wins in California, Montano and North Dakota, he will enjoy a considerable momentum and will also put pressure on Clinton.

As it looks now, Hillary Clinton has 1,812 pledged delegates while Sanders has 1,525 which means that Clinton heads into today’s polls boasting a huge lead in pledged delegates. With the way things have panned out in the last few hours, it will be hard for Sanders to overcome Clinton’s existing pledged delegates unless he goes on to secure what now appears to be unlikely landslide victories tonight.

Categories
Local News

Vacant NJN building stirs concerns

Nearly two years after Gov. Christie closed New Jersey Network (NJN), there are concerns about the vacant building just sitting there at a corner in Trenton.

The former NJN is located at 25 Stockton St., and Ernie Kovacs Place. It was once a lighted area, with many colorful studio lights showing through the big glass windows all over the building.

“It is a beautiful building and when it is lit up with all the neon signs in the windows; it kind of brings life back to that corner across from City Hall, and it complements the City,” said Councilwoman, Marge Caldwell-Wilson.

Gregory Tift, a New Jersey State employee and a Communications Workers of America Local 1039 leader, also thinks that the governor needs to address concerns about the vacant NJN building.

Tift talks about the special election that the governor is planning to hold this fall to fill the seat of the recently deceased, New Jersey Sen. Frank Lautenberg. He believes the governor priorities are a bit “misplaced,” because this unnecessary election will cost millions of dollars at a time when he closed NJN to save the state money.

Categories
Local News

Social media talk about U.S. public TV