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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
Business

P360 adds advanced Artificial Intelligence capabilities to its sales enablement platform BirdzAI

Life sciences commercial organizations can now forecast sales, predict churn, analyze brand propensity and launch new products with BirdzAI

PISCATAWAY TOWNSHIP, N.J.–(BUSINESS WIRE)–#AI—P360, a leading developer of technology for life sciences companies, today announced major updates to its sales enablement platform BirdzAI. The BirdzAI platform now includes advanced Artificial Intelligence (AI) capabilities that enable real-time decision-making for sales organizations by providing deep insights derived from a wide variety of proprietary and tertiary datasets. Key features include sales forecasting, churn prediction, brand propensity analysis, next best action insights and more.


“By adding advanced artificial intelligence capabilities to our BirdzAI platform, we are helping life sciences companies eliminate the guesswork often associated with sales operations,” stated P360 CEO and Founder Anupam Nandwana. “For example, BirdzAI’s churn forecasting capabilities puts predictive forecasting for physician prescriptions directly in the hands of company representatives. Sales teams are able to see in real-time which brands a specific physician is prescribing, and which ones they might be stepping away from.”

BirdzAI, which is backed by P360’s robust Data360 commercial data hub, enables life sciences companies to manage their business processes and data from a single platform, eliminating manual work and operational delays. With BirdzAI remote teams are also able to share data with the enterprise without delay, no matter where they might be.

The BirdzAI platform also offers unique functionality for companies launching new drugs into the marketplace. Key features and tested processes include customer alignment, customer master data management, territory planning and sizing, call planning, incentive compensation strategy and payout, roster management and field and management reporting.

“Our data is as expansive as it is valuable, so we are always looking for new ways to leverage it more efficiently and effectively, said Greg Daly, Senior Analyst, Sales Operations at Osmotica Pharmaceuticals. “Partnering with P360 has allowed us to do just that. Their Machine Learning Models put our data to work for us, allowing us to spend more time applying the insights that our data contains, and less time finding them.”

BirdzAI is built on Microsoft Azure and is compatible with existing commercial infrastructure and integrates seamlessly with leading CRM and ERP systems.

Delivering a 360 view through the pharma, physician and patient ecosystem, P360 designs and deploys capabilities that ensure the highest efficiencies and returns on sales operations, data management, clinical trials, patient centricity, and IoT innovation. With expertise in supporting commercial operations for companies of all sizes, P360 has built an industry-leading platform that gives customers ownership of their data and the ability to leverage artificial intelligence and machine learning capabilities.

Earlier this year, P360 launched their industry first IoT Product Swittons for physician remote engagement. In addition, P360 CEO Anupam Nandwana was recently named to the PharmaVoice 100, which recognize the most inspirational, motivational and transformational individuals throughout the life-sciences industry. To learn more about P360, visit P360.com.

About P360

Based in Piscataway Township, New Jersey, P360 is a leading developer of technology for the life sciences industry. Product offerings include BirdzAI, PatientJourney360, Data360, Trials360 and Swittons. To learn more about P360, visit P360.com.

Contacts

Brian Fitzgerald

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

Categories
Healthcare

Merck’s KEYTRUDA® (pembrolizumab) reduced the risk of distant metastasis or death by 40% versus placebo as adjuvant treatment in resected, high-risk stage III melanoma

Long-Term Findings From EORTC1325/KEYNOTE-054 Show Adjuvant KEYTRUDA Demonstrated a Sustained Recurrence-Free Survival Benefit Versus Placebo Across Stage IIIA (>1 mm Lymph Node Metastasis), IIIB and IIIC Melanoma

Merck Is Advancing a Broad Clinical Program Evaluating KEYTRUDA for the Early Treatment of Cancer

KENILWORTH, N.J., & BRUSSELS–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, and the European Organisation for Research and Treatment of Cancer (EORTC) today announced new and updated findings from the Phase 3 EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma. Late-breaking, first-time study results showed that with 3.5 years of follow-up, adjuvant KEYTRUDA met the key secondary endpoint of distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 40% versus placebo (HR=0.60 [95% CI, 0.49-0.73]; p<0.001), with 3.5-year DMFS rates of 65.3% and 49.4%, respectively. In addition, KEYTRUDA demonstrated a sustained recurrence-free survival (RFS) benefit versus placebo across stage IIIA (>1 mm lymph node metastasis), IIIB and IIIC melanoma, with 3.5-year RFS rates of 59.8% for KEYTRUDA versus 41.4% for placebo (HR = 0.59 [95% CI, 0.49-0.70]; p<0.001). The RFS and DMFS benefits were observed across key subgroups, including disease stages (both according to AJCC-7 and AJCC-8), BRAF mutation status and PD-L1 expression.

“Despite surgical intervention, patients diagnosed with high-risk stage III melanoma can experience disease recurrence, and for those with distant metastasis, they often face a significantly worse prognosis,” said Alexander Eggermont, study chair, Chief Scientific Officer Princess Máxima Center, Utrecht, Netherlands. “These new and updated data, including first-time results for distant metastasis-free survival are significant, showing that adjuvant KEYTRUDA not only delayed recurrence but also delayed distant metastasis, further reinforcing the benefits of KEYTRUDA for these patients with stage III melanoma.”

“In KEYNOTE-054, adjuvant treatment with KEYTRUDA also continued to demonstrate long-term improvements in the prevention of new disease compared to placebo, with nearly 60% of patients alive and recurrence-free after 3.5 years,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Taken together with the new distant metastasis-free survival results shown in this trial, these data point to the important role KEYTRUDA plays in melanoma in the adjuvant setting and are encouraging for the evaluation of KEYTRUDA in earlier disease states in other tumor types.”

These late-breaking data were presented as a proffered paper at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on Saturday, Sept. 19 (Abstract #LBA46). As announced, data spanning more than 15 types of cancer will be presented from Merck’s broad oncology portfolio and investigational pipeline at the congress. A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck and keep up to date with ESMO news and updates by using the hashtag #ESMO20.

KEYTRUDA is currently approved for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection in more than 70 countries based on the results from EORTC1325/KEYNOTE-054. Merck’s broad clinical development program in melanoma and skin cancers is addressing areas of unmet need by investigating KEYTRUDA in earlier stages of disease and in combination with other anti-cancer therapies across multiple potential registration-enabling studies, including KEYNOTE-716, LEAP-003 and LEAP-004.

EORTC1325/KEYNOTE-054 Trial Design and Additional Subgroup Data (Abstract #LBA8)

EORTC1325/KEYNOTE-054 (ClinicalTrials.gov, NCT02362594) is a Phase 3, randomized, double-blind study sponsored by Merck and conducted in collaboration with the EORTC designed to evaluate adjuvant therapy with KEYTRUDA versus placebo in patients with resected, high-risk melanoma (stage IIIA [>1 mm lymph node metastasis], IIIB and IIIC). The co-primary endpoints are RFS for all patients and RFS in patients whose tumors expressed PD-L1. Secondary endpoints include DMFS and overall survival (OS) in all patients and in patients whose tumors expressed PD-L1. Data from a three-year analysis of RFS were presented in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. In accordance with the trial protocol, the study is continuing in order to evaluate the secondary endpoint of OS; however, upon documented recurrence, patients were eligible for crossover/re-challenge with KEYTRUDA.

Key Subgroup Analysis Results From EORTC1325/KEYNOTE-054

3.5-Year DMFS Rate, %

DMFS, HR

P-Value (Log Rank)*

PD-L1 Positive (n=853)

KEYTRUDA

66.7%

0.61 (95% CI, 0.49-0.76)

<0.001

Placebo

51.6%

PD-L1 Negative (n=116)

KEYTRUDA

58.0%

0.49 (99% CI, 0.24-0.99)

0.008

Placebo

40.2%

With BRAF V600 E/K Mutation (n=440)

KEYTRUDA

63.7%

0.53 (99% CI, 0.36-0.77)

<0.001

Placebo

43.4%

Without BRAF Mutation (n=449)

KEYTRUDA

62.1%

0.73 (99% CI, 0.50-1.07)

0.035

Placebo

51.4%

*Stratified by stage given at randomization

In addition, the DMFS benefit demonstrated with KEYTRUDA was similar in patients with AJCC-7 stage IIIA (HR=0.64), IIIB (HR=0.58) and IIIC (HR=0.61) melanoma. Adjuvant KEYTRUDA decreased the incidence of distant metastasis as a first recurrence by 43% (at 3.5 years: 24.9% versus 39.5%, HR= 0.57 [95% CI, 0.46-0.72]; p<0.001).

No new safety data were identified as part of the 42-month analysis. The safety profile of KEYTRUDA was consistent with what has been seen in previously reported studies among patients with advanced melanoma. Grade 3-5 immune-related adverse events occurred in 7.7% of patients who received KEYTRUDA and 0.6% of patients who received placebo.

About EORTC

European Organisation for the Research and Treatment of Cancer (EORTC) is an academic clinical research organization, bringing together investigators from all disciplines, across all tumour types, to conduct research that improves quality of life and survival of cancer patients. It conducts research from translational to large, prospective, multi-centre, phase III clinical trials evaluating new therapies and treatment strategies as well as quality of life of patients. EORTC network comprises more than 5300 professionals in over 1000 hospitals and institutes in more than 30 countries, supported by Headquarters in Brussels, Belgium.

About Melanoma

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past few decades – approximately 287,000 new cases were diagnosed worldwide in 2018. In the U.S., melanoma is one of the most common types of cancer diagnosed and is responsible for the vast majority of skin cancer deaths. In 2020, more than 100,000 people are expected to be diagnosed, and nearly 7,000 people are expected to die of the disease in the U.S. alone.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

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

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

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

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

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

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

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

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

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

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

Gastric Cancer

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

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

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

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Tumor Mutational Burden-High

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

Cutaneous Squamous Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA® (pembrolizumab)

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

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

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment.

Contacts

Media Contacts:

Merck:

Pamela Eisele

(267) 305-3558

Ayn Wisler

(908) 740-5590

EORTC:

Davi Kaur

+32 (0)2 774 1513

Investor Contacts:

Merck:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

Read full story here

Categories
Healthcare

World-Champion Gymnast Aly Raisman partners with Sanvello to advance mental health solutions

Leading behavioral care provider also introduces nationwide availability of new mental health coaching services and expands therapy offering to 10 states

MINNETONKA, Minn.–(BUSINESS WIRE)–Sanvello Health, Inc., a leading digital mental health care provider and a UnitedHealth Group (NYSE: UNH) company, today announced a new partnership with gold medal gymnast and wellness advocate, Aly Raisman. The news strategic partnership also comes as Sanvello launches its new mental health coaching services and an expanded therapy offering, both available within the app.


An active user of Sanvello, Raisman will help reach millions of people worldwide who can benefit from taking action to improve their mental health. She’ll also work closely with the Sanvello team to build out new services and offerings for global app users, informed by her own personal experience.

“Working with a professional therapist and building in self-care practices to my everyday routine have really helped me through some very tough times,” says Raisman. “I want to help others create space to focus on their own mental health, and Sanvello is a great place to start. There’s no one-size-fits-all for mental health, but with so many types of support within Sanvello, you can choose the path that feels right to you. Together, we want to encourage help-seeking behavior and improve the mental health care experience so more people around the world can take small steps to feel better.”

The partnership, and launch of in-app coaching and therapy services comes at a critical time: The impact of the COVID-19 pandemic has more people than ever in need of quality mental health care. More than one-third of American adults are experiencing symptoms of an anxiety disorder, and one-quarter are experiencing symptoms of a depressive disorder, according to CDC survey data — up more than 250% from a year ago.

“We’re seeing thousands of people come to Sanvello every day seeking help for stress, anxiety and depression. People are overwhelmed, and they’re choosing Sanvello as their first stop to find better mental health,” says Brian Sauer, chief executive officer of Sanvello. “With a new academic year upon us adding new stressors, we’re expecting the need to only increase. Over three-quarters of our users with stress, anxiety and depression report feeling better within just 60 days. We are eager to partner with Aly to continue to bring the best digital mental health support we can to people around the world.”

The additional services rounds out the company’s care service offering, making Sanvello Health the nation’s first and only digital behavioral health care provider with a completely seamless and integrated patient experience, combining the power of content and care to serve a broad population across multiple diagnoses such as anxiety, depression and trauma-related conditions.

The full Sanvello patient experience now includes:

  • Therapy services available in 10 states: California, Colorado, Florida, Massachusetts, Minnesota, New Jersey, New York, Rhode Island, Texas, and Washington. More states will be added by year-end, with these services serving 80% of the U.S. population.
    • Three-quarters of Sanvello Therapy users saw 50% improvement — clinically significant improvement — within 60 days.
  • Highly trained coaches providing personalized support to help people identify their goals, break down barriers, apply cognitive behavioral therapy (CBT) concepts to everyday life, and remain engaged and motivated through their mental health journeys.
    • Sixty percent of Sanvello Coaching users report feeling better within 60 days and are twice as likely to have clinically significant improvement in their assessment scores — their increased engagement results in superior outcomes.
  • An ever-expanding library of self-care resources including meditation, coping tools and CBT-based Guided Journey experiences that help people stay engaged, build healthy habits and feel better through more frequent interactions.
    • Sixty percent of Sanvello Guided Journey users report feeling better within 60 days.

Used by over 3.5 million people worldwide, Sanvello holds the No. 1 search position for stress and anxiety in the app stores and has a consumer approval rating of 4.8/5 stars. Sanvello is also covered by the health plans of 37 million Americans through partnerships with major insurance payers.

Consumers interested in learning more can try a free 14-day trial of Sanvello Premium + Coaching by downloading Sanvello from their app store.

About Sanvello Health, Inc.

Sanvello Health, Inc. is a leading digital mental health care provider and the company’s digital platform holds the #1 search position for stress and anxiety in app stores. Through partnerships with major insurance payers, employers, and higher education institutions, Sanvello offers covered management and treatment of stress, anxiety, and depression for over 37 million people. By innovating the mental health care experience and bringing together patients, providers, and payers, the Sanvello platform helps millions of people around the world find relief when they need it and feel happier over time. Download Sanvello from the App Store or Google Play. For more information, visit sanvello.com or follow us on Facebook, Instagram, and Twitter.

About UnitedHealth Group

UnitedHealth Group (NYSE: UNH) is a diversified health care company dedicated to helping people live healthier lives and helping make the health system work better for everyone. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. For more information, visit UnitedHealth Group at www.unitedhealthgroup.com or follow @UnitedHealthGrp on Twitter.

Contacts

Caroline Landree

651-308-2481

caroline.landree@uhg.com

Categories
Local News

Dodge Momentum Index inches up in August

HAMILTON, N.J.–(BUSINESS WIRE)–The Dodge Momentum Index increased 1.8% in August to 126.5 (2000=1000) from the revised July reading of 124.2. The Momentum Index, issued by Dodge Data & Analytics, is a monthly measure of the first (or initial) report for nonresidential building projects in planning, which have been shown to lead construction spending for nonresidential buildings by a full year. In August, the commercial component rose 3.3%, while the institutional component moved 1.2% lower.


The August increase in the overall Momentum Index is the second consecutive rise and a further sign that the construction sector continues to post a modest recovery following the large declines in April and June. This recovery, though, is uneven. The commercial component has risen 9% from its June low and is just 13% below its 2018 peak fueled by increased planning activity for warehouse and office projects. The institutional component, however, has declined for five consecutive months and has yet to hit bottom. The institutional component is now 34% below its recent peak. The public side of the building market is suffering as state and local government revenues have declined, creating budget cuts across the country. This has led to a significant pullback in education projects entering planning, placing substantial downward pressure on the institutional component of the Momentum Index.

In August, 11 projects each with a value of $100 million or more entered planning. The leading commercial projects were a $262 million UPS distribution facility in Mebane NC and a $200 million Amazon distribution center (Project Star) in San Antonio TX. The leading institutional projects were the $150 million BayCare South Florida Baptist Hospital in Plant City FL and the $125 million second phase of the Veterans Memorial Arena in Binghamton NY.

About Dodge Data & Analytics: Dodge Data & Analytics is North America’s leading provider of commercial construction project data, market forecasting & analytics services and workflow integration solutions for the construction industry. Building product manufacturers, architects, engineers, contractors, and service providers leverage Dodge to identify and pursue unseen growth opportunities that help them grow their business. On a local, regional or national level, Dodge empowers its customers to better understand their markets, uncover key relationships, size growth opportunities, and pursue specific sales opportunities with success. The company’s construction project information is the most comprehensive and verified in the industry. Dodge is leveraging its more than 125-year-old legacy of continuous innovation to help the industry meet the building challenges of the future. Learn more at www.construction.com.

Contacts

Media Contact: Nicole Sullivan | AFFECT Public Relations & Social Media | +1-212-398-9680,

nsullivan@affectstrategies.com

Categories
Healthcare

Exelixis and Catalent enter into collaboration, license, and exclusive option agreement to develop antibody-drug conjugates leveraging SMARTag® bioconjugation technology

  • Companies will partner to develop novel antibody-drug conjugates using Catalent’s SMARTag bioconjugation platform and monoclonal antibodies from Exelixis’ growing preclinical pipeline
  • Agreement includes exclusive options on multiple targets over three-year term, with potential to extend time and scope of the collaboration
  • Deal is the fifth pipeline-enhancing agreement signed by Exelixis since 2018

ALAMEDA, Calif. & SOMERSET, N.J.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) and Catalent today announced a partnership under which Catalent’s Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag® site-specific bioconjugation technology.

Under the terms of the agreement, Catalent will use its SMARTag® bioconjugation platform to build ADCs using monoclonal antibodies (mAbs) from Exelixis’ growing preclinical pipeline. In exchange for an upfront payment to Catalent of $10 million, Exelixis received an exclusive option to nominate up to a fixed number of targets using the SMARTag® ADC platform over a three-year period. The companies plan to advance the ADCs into preclinical development, and, prior to filing an Investigational New Drug application, Exelixis may exercise its exclusive option to a worldwide license of the related ADC program and continue clinical development and commercialization. Exelixis will provide research & development funding, and Catalent will be eligible for development and commercial milestones and royalties on net sales of any product commercialized as part of the collaboration.

Developed by Catalent’s Redwood Bioscience subsidiary, the SMARTag® technology platform provides optimized site-specific protein-modification and linker technologies for ADCs and other bioconjugates. The SMARTag® platform overcomes the limitations associated with traditional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity, and stability and enables the development of ADCs with a wider therapeutic window and improved manufacturability.

“With our lead product CABOMETYX now a global oncology franchise, over the past several years Exelixis has moved beyond our small molecule medicinal chemistry roots to build out a pipeline that encompasses a variety of promising therapeutic modalities,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. “Our collaboration with Catalent – the fifth pipeline-enhancing agreement we’ve signed since 2018 – provides an attractive framework for identifying and advancing differentiated ADC product candidates with the potential to improve upon current ADC therapies. We are looking forward to working with Catalent as we rapidly advance our mission to help cancer patients recover stronger and live longer.”

“The SMARTag® platform has recently demonstrated promising results in the clinic, highlighting the potential to create ADCs with significantly expanded therapeutic indices,” commented Mike Riley, Region President, Catalent Biologics, North America. “We are excited to partner with Exelixis, a leading oncology biotechnology company, and leverage our experienced team, unique SMARTag® technology platform, and deep analytical expertise to develop ADCs targeting various oncology indications.”

About Catalent Biologics

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,900 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

About Exelixis

Founded in 1994, Exelixis, Inc. is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ immediate and potential future financial and other obligations under the collaboration, option and exclusive license agreement with Catalent; the potential for the collaboration with Catalent to result in the advancement of differentiated ADC product candidates with the potential to improve upon current ADC therapies and advance Exelixis’ mission to help cancer patients recover stronger and live longer; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationship with Catalent, including Catalent’s adherence to its obligations under the collaboration, option and exclusive license agreement and the level of Catalent’s assistance to Exelixis in completing clinical trials, pursuing regulatory approvals or successfully commercializing partnered compounds in the territories where they may be approved; the continuing COVID-19 pandemic and its impact on Exelixis’ research and development and commercial activities; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; Exelixis’ and Catalent’s ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2020, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.

MINNEBRO is a Japanese trademark.

Catalent and SMARTag are registered trademarks of Catalent Pharma Solutions, Inc. or its affiliates or subsidiaries in the United States and other countries.

Contacts

Exelixis
Investors Contact:
Susan Hubbard

Executive Vice President,

Public Affairs & Investor Relations

(650) 837-8194

shubbard@exelixis.com

Media Contact:
Hal Mackins

For Exelixis, Inc.

(415) 994-0040

hal@torchcommunications.com

Catalent

Media Contact:
Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency

Categories
Business

Russo’s introduces ‘Nonna’s Pizza’ a classic Italian favorite now available to order

Chef Anthony Russo introduces an Italian favorite to the menu.

Nonna’s Pizza is now available at participating locations. Free delivery included.

HOUSTON–(BUSINESS WIRE)–#ItalianKitchen–Nonna’s Pizza, also known as grandma’s pie, is a traditional Italian pizza that grandmother’s would make for the entire family. The signature dish is said to have originated on Long Island and now has spread to the greater New York area. Chef Anthony Russo is now introducing this legendary pizza to several of his locations in the Texas marketplace for the first time.

Nonna’s Pizza also known as Nonna’s Pie is a rectangular pizza that is cooked in an olive oil-coated pan. Traditionally, the pizza is covered in a thin layer of mozzarella cheese and then topped with fresh tomatoes. Oftentimes, the mozzarella is placed directly on the dough, and the sauce goes on top of that, but this is not always the case. What makes Nonna’s unique is the crust. The dough is quickly stretched on the pan, giving it little time to rise before baking in the oven. This gives the pizza its signature thinner, crisper crust. The crust is what separates Nonna’s Pizza from other similar thinner crust pizzas, like Sicilian Pizza.

Using high-quality ingredients is what makes Chef Anthony Russo’s Nonna’s Pie rise above competitors. Chef Russo always uses the best quality ingredients to ensure a delicious final product. Nonna’s Pie includes Sicilian extra virgin olive oil, Robusto pizza sauce, premium roma tomatoes, fresh-cut basil, and Wisconsin’s signature mozzarella cheese.

This pie is very nostalgic for Chef Anthony Russo. Russo reminisces on his childhood when Grandma would make it for him.

“This was our go-to pizza growing up,” Chef Anthony Russo states. “We used to have it for dinner every Sunday night at Grandma’s house. She used to use fresh homemade marinara sauce and fresh-made dough left over from the bread recipe. Grandma would place the dough square pan, then top it with marinara sauce, fresh basil and fresh mozzarella cheese. We are very excited to be one of the first pizzerias to bring Nonna’s Pizza to the Texas.”

Nonna’s Pie is now available for a limited time for pick-up or free delivery for just $16. Call or order online today. Nonna’s Pizza is only available at participating locations only. Please contact your local store for more details. To learn more about Russo’s safety measures, menu, lunch specials, delivery, takeout, catering, or to order online, please visit www.nypizzeria.com. See store for details.

Chef Anthony Russo’s Bio: The son of first-generation Italian immigrants, Anthony Russo, Russo’s New York Pizzeria Founder and CEO, grew up in a New Jersey home where the kitchen was the center of family life. He learned to cook from relatives visiting from Sicily and Naples, and worked at his family’s restaurant, Russo’s Italian, at the Jersey Shore each summer.

The family relocated to Galveston, Texas in 1978, yet remained steadfast in their commitment to serving fine Italian cuisine no matter where they called home. Anthony’s father opened Russo’s Italian Restaurant, which quickly became a favorite among locals, and reinforced Anthony’s passion for creating and serving homemade Italian fare.

In 1985, Anthony opened his first pizza restaurant, Russo’s Pizza, when he was just 18 years old. In 1992, just seven years later, Anthony introduced his first Russo’s New York Pizzeria in Houston, Texas, where using fresh, homemade ingredients and unique family recipes, became a model for success.

Fast forward to today and Russo’s Restaurants is now a national and international franchisor of the casual dining brand Russo’s New York Pizzeria. With its corporate office located in Houston, Texas – Russo’s Restaurants has surpassed 50 locations with over ten more planned in 2020. Composed of a mix of corporate and franchised locations in Texas, Oklahoma, and Florida, Russo’s has also entered international markets as well, with locations in Riyadh, Saudi Arabia, Dubai, Abu Dhabi, and Sharjah, in the United Arab Emirates.

Chef Anthony Russo created Russo’s Restaurants by applying his unique, family recipes featuring New York-style pizza, handcrafted pasta dishes, calzones, salads, sandwiches, soups and desserts. At its heart, Russo’s Restaurants reflects Chef Anthony’s commitment to his New York roots where food and family come first.

Russo’s corporate support team is strong and collaborative with a franchisee-friendly corporate culture and is ready for expansion. What separates Russo’s from the rest of the pizza industry is not only a great support team ready to tackle it all, but also the unique family recipes and fresh ingredients. With no additives or preservatives, Russo’s New York Pizzeria & Italian Kitchen creates dishes from ingredients that are safe and reliable from trusted brands. Chef Russo adds, “Our mission statement is: ‘If it isn’t fresh, don’t serve it.’ That is the Russo family promise.” The average store investment ranges from $350,000- $895,000. Qualified candidates must have at least $200,000 in liquid capital. To learn more about Russo’s Franchise Opportunities, our menu, lunch specials, delivery, takeout, catering, or to order online, please visit www.nypizzeria.com.

Contacts

Lynn Zeller-Aldana

Russo’s Restaurants

(346) 802-4700

Lynn@NYPizzeria.com