Category: Local News

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Business Local News

Dr. Reddy’s Laboratories enters into definitive agreement with Citius Pharmaceuticals, Inc. to sell its rights to anti-cancer agent E7777 (denileukin diftitox)

HYDERABAD, India & PRINCETON, N.J. — (BUSINESS WIRE) — Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), announced that it has entered into a definitive agreement with Citius Pharmaceuticals, Inc. (“Citius”) pursuant to which it sold all of its rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets.

Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

In March 2016, Dr. Reddy’s had acquired the exclusive global rights (excluding Japan and Asia) to the investigational anti-cancer agent E7777 from Eisai Co. Ltd.

Erez Israeli, Chief Executive Officer, Dr. Reddy’s, said: “Addressing unmet patient needs in oncology remains a prime focus area for us. E7777 has significant potential as an important component of systemic therapy for CTCL and other cancers. Post acquiring from Eisai, significant progress was made on the CTCL development front. We are confident of Citius’ ability to realize the full potential of E7777 in the treatment of CTCL as well as in their ability to develop this promising drug for additional oncology and immuno-oncology indications.”

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2021. The company assumes no obligation to update any information contained herein.

Contacts

INVESTOR RELATIONS

AMIT AGARWAL
AMITA@DRREDDYS.COM

MEDIA RELATIONS
USHA IYER

USHAIYER@DRREDDYS.COM

Categories
Local News Politics

Mercer County Exec. Hughes makes statement on storm recovery

 

TRENTON – In the aftermath of Hurricane Ida, Mercer County Executive Brian Hughes responded with a statement Thursday, thanking the public officials and all others who helped to save lives.

 

“As Mercer County begins to fully grasp and assess the destruction caused by the remnants of Hurricane Ida, I wish to thank the heroic first responders, the police, firefighters, EMTs, emergency workers and public works professionals, who worked throughout the day and night to save lives,” said Hughes.

 

“The courage and commitment our first responders have displayed throughout this crisis is awe-inspiring and appreciated,” he said.

 

However, he acknowledged that a few lives and have been lost. Hughes notes that it is with great sadness that he must report that despite the countless rescues that took place overnight, they are aware that at least two Mercer County souls have been lost.

 

He encouraged residents who have been displaced from their homes or who have lost property, that Mercer County is here to assist them.

 

“For those who made it through the storm without harm, I encourage you to check on the well-being of your friends and neighbors and to offer comfort in any way you can,” he said.

 

Finally, Hughes thanked “Gov. Phil Murphy for his quick action in declaring a State of Emergency in New Jersey, which will allow Mercer County to seek federal reimbursement for its disaster response and help us begin to pick up the pieces and recover.”

 

Categories
Environment Local News

St. Michaels Farm welcomes cows with climate project at D&R Greenway

PRINCETON, N.J. — Earlier this month, D&R Greenway and Soil Carbon Partners [SCP] announced the arrival of 15 cows to St. Michaels Farm Preserve in Hopewell.

St. Michaels Farm Preserve cows near Red Barn at St. Michaels Farm Preserve
— Photo by Brad Fay

 

They are already grazing on a diverse mix of forage grasses and legumes planted by SCP. Beginning in early spring 2021, Soil Carbon Partners, led by managing member Ed Huling, applied a special mix of organic materials to 50 acres of farm fields on the land trust’s St. Michaels Farm. Based on 20 years of SCP’s research and refinement, this soil mix contains abundant minerals, organic matter and beneficial soil organisms. The newly enriched soil is the heart of the matter in this ground-breaking Climate Project.

 

In the first two months following the application of soil enrichment materials, the dry weight of newly planted forage grasses is already 300% greater compared to control plots. Growing more food on less land is essential for combatting climate change, because if food production per acre could be significantly increased, we would no longer need to cut down forests to feed a growing population. Recent Princeton research proves that forests powerfully cool the planet. The authors, Sara Cerasoli and Amilcare Porporato, recently published their breakthrough research on the cooling effect of forests in the Proceedings of the National Academy of Sciences.

 

The third milestone in SCP’s three-part climate mitigation program, along with soil restoration and higher forage crop productivity, was bringing fifteen Hereford and Devon cattle to graze on the fields. Over the course of history, cows, buffalo, elk, and other grazing animals eating grass on pastures sequestered hundreds of billions of tons of atmospheric carbon in soil around the world. By doing so, these grazing animals have been key players in keeping the earth cool for tens of thousands of years. They are just as important now to keeping the grass trimmed, and actively drawing down CO2 from the atmosphere and sequestering it in soil.

St Michaels Farm Preserve, Ed Huling, in field with Soil Carbon Partners forage in Soil Carbon Partners amended soil
— Courtesy photo

 

Knee-deep in nutrient-rich grasses, the herd already surpasses the well known description of contented cows. In addition, a unique feature of their fenced pasture is a movable “cow umbrella” which shades the cattle from hot summer sun. Above their heads, white-breasted tree swallows and ruddy-breasted barn swallows waltz and even sing in welcome. A mockingbird flashes by in unaccustomed silence. As always, at St. Michaels Farm Preserve, calm is the norm. It is increased by the response of the Herefords and Devons to their abundant array of grasses. Gazing across the farm, visitors who walk the trails will notice differing heights of plants that indicate varying fertility formulations and application rates.

 

Ed Huling of SCP is thankful to D&R Greenway and the community, “We are very grateful for D&R Greenway Land Trust’s ongoing and active support of this Climate Project through use of their fields and managing their land to accommodate our farming activities. We also appreciate the warm welcome, curiosity and understanding shown to us by community members.” Through local connections, these first cows to arrive to the preserve came from Charlie and Lucia Huebner’s nearby Beechtree farm in Hopewell, provided for this key phase of research.

 

D&R Greenway, a nonprofit organization that counts on donations from individuals to care for this land, permanently preserved the 415 acre farm in 2010, saving it from development into 1,050 houses and a shopping center. The land trust maintains bird boxes and habitat on the farm, and ensures the continuation of agriculture. Six miles of trails through woods and along farm roads are provided to the public on this popular preserve. St. Michaels Farm Preserve visitors and hikers are urged to stay upon designated trails, and keep away from the animals for your safety and their continued tranquility.  Fences are electric, and people should maintain 10 feet distance and keep children from approaching them. Dogs should be kept on a leash, as is the preserve’s rule, to keep them from approaching and barking at the farm animals and fellow walkers.

St. Michaels Farm Preserve new portable cow shade
— Courtesy photo

 

D&R Greenway CEO & President, Linda Mead, remembers “Eleven years ago, when D&R Greenway opened the St. Michaels Farm Preserve, the cattle of Jon and Robin McConaughy’s Double Brook Farm were pastured upon these same fields where the new Herefords and Devons graze today. We have missed seeing cows on the fields since they were moved away these past 5 years. You could say we’ve been waiting ‘til the cows come home.”

 

Three independent advisors from leading universities are measuring results of this scientific project. In weeks to come, they will monitor the cattle’s individual weight gain, expected to surpass that of cows grazing upon conventional grasses today. Throughout the Climate Project, SCP will continue to manage grazing patterns at St. Michaels Farm, to optimize grasses’ ongoing sequestration of carbon. The ability to sequester carbon in farm and forest soils is increasingly recognized as a key strategy for helping slow climate change. Extreme weather events this summer occurring all over the world have been attributed to climate change. D&R Greenway and Soil Carbon Partners believe that techniques like this could be a part of the solution.

 

Read more on our website! https://drgreenway.org/

 

BACKGROUND

 

The mission of Soil Carbon Partners is to produce nutrient-dense organic food and help mitigate climate change.

 

D&R Greenway Land Trust, an accredited nonprofit, has saved over 21,000 acres of New Jersey land since its 1989 founding. D&R Greenway’s mission is connecting land with people from all walks of life. Preserving land for life and creating public trails grants everyone the opportunity to enjoy the great outdoors.

 

The land trust’s preserved farms and community gardens provide local organic food for neighbors—including those in need. D&R Greenway’s strategic land conservation and stewardship combat climate change, protect wildlife, and ensure clean drinking water for future generations. D&R Greenway’s Johnson Education Center, home to its art galleries in Princeton, is closed to the public, to ensure health and safety, during the COVID emergency.

 

Our outdoor trails and labyrinth are open. Visit our Facebook and Instagram pages and www.drgreenway.org to learn about the organization’s latest news and virtual programs. D&R Greenway Land Trust, One Preservation Place, Princeton NJ, 08540. The best way to reach D&R Greenway Staff during the COVID pandemic is by e-mail, or by calling D&R Greenway at 609-578-7470.

Categories
Local News Science

Bristol Myers Squibb receives European Commission approval for Abecma (Idecabtagene Vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma

Abecma represents the only cell therapy approved for multiple myeloma

Approval of Abecma is based on the pivotal KarMMa trial of patients worldwide, including five European countries, which demonstrated rapid, deep and durable responses with a well-understood and predictable safety profile

Abecma expands upon Bristol Myers Squibb’s leadership in cell therapy research and multiple myeloma, offering an innovative option to patients in need

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ABECMA—Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Abecma is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.1 Abecma is delivered via a single infusion with a target dose of 420 x 106 CAR-positive viable T cells within a range of 260 to 500 x 106 CAR-positive viable T cells. Abecma is approved for use in all European Union (EU) member states.*

“The EC approval of Abecma is an important milestone for the treatment of multiple myeloma, and moves us closer to offering a first-in-class, personalized therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “With this third regulatory approval for Abecma worldwide, we are proud to be advancing the science of cell therapy and continuing to bring this first anti-BCMA CAR T cell therapy to patients in need.”

In Europe, nearly 50,000 people are diagnosed with multiple myeloma each year.2 Despite advances in treatment, multiple myeloma remains an incurable disease, and many patients suffer through periods of remission and relapse. Patients with relapsed and refractory multiple myeloma who have been exposed to all three major drug classes often have poor clinical outcomes and few remaining treatment options.3,4,5,6

“In multiple myeloma, when a patient’s cancer is no longer responding to their current treatment regimen or the patient relapses, the disease becomes increasingly difficult to treat,” said Jesus San Miguel, M.D., Ph.D., Medical Director of the Clinica Universidad de Navarra, Navarra, Spain and KarMMa clinical trial investigator. “In the KarMMa trial, treatment with ide-cel proved to elicit deep and durable responses in a significant proportion of patients with triple-class exposed multiple myeloma, including many who were heavily pretreated and had high-risk disease. The approval is important for patients in Europe, as it represents another potential therapeutic option for clinically meaningful outcomes and long-term disease control.”

Bristol Myers Squibb is committed to making Abecma commercially available to patients in the EU. The company is currently focused on several required factors, including treatment center qualification and onboarding, completion of reimbursement procedures and scaling up its manufacturing capacity to meet increasing global demand. The company is also actively pursuing options to expand its manufacturing global supply network to make Abecma available to more patients around the world, including the addition of a European-based manufacturing facility in Leiden, Netherlands. Meanwhile, Bristol Myers Squibb will continue to manufacture Abecma for EU and U.S. patients at the company’s state-of-the-art cellular immunotherapy manufacturing facility in Summit, New Jersey.

“Multiple myeloma patients who have tried and exhausted multiple rounds of treatment options have been hoping for new and transformative options,” said Brian G.M. Durie, Chairman, International Myeloma Foundation. “The approval of Abecma, an innovative anti-BCMA CAR T cell therapy, is an exciting milestone for patients in the European Union.”

Abecma was granted Conditional Marketing Authorization under the European Medicines Agency PRIME (Priority Medicines) scheme. Conditional Marketing Authorization is granted in the interest of public health where the benefit of immediate availability fulfills a critical unmet need. Conditional Marketing Authorization in the EU is initially valid for one year but can be extended or converted into a full Marketing Authorization after the submission and assessment of additional confirmatory data. For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers and help support access to therapies, including Abecma.

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

Abecma Clinical Trial Results

The efficacy of Abecma is based on results from the pivotal KarMMa study in which 128 patients with relapsed and refractory multiple myeloma who had received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and were refractory to the last treatment regimen were treated with Abecma.7

In the study, the overall response rate (ORR) was 73% (95% CI: 66-81), and 33% of patients achieved a complete response (CR; 95% CI: 25-41). Onset of response was rapid with a median time to response of one month. In addition, responses were durable, with a median duration of response of 10.6 months (95% CI: 8.0 – 11.4), and 23 months (95% CI: 11.4 – 23.3) for those who achieved a CR.7

In a pooled safety analysis of 184 patients treated with Abecma in the KarMMa and CRB-401 studies, cytokine release syndrome (CRS) occurred in 81% of patients, with Grade >3 CRS, using the Lee grading system, occurring in 5.4% of patients. There was one case of fatal (Grade 5) CRS reported. The median time to onset of CRS was one day (range: 1-17 days) and the median duration of CRS was five days (range: 1-63 days). Any grade neurotoxicity (NT) of the 128 patients receiving Abecma in the KarMMa study occurred in 18% of patients, including Grade 3 events in 3.1% of patients, with no Grade 4 or 5 events occurring. The median time to onset of NT was two days (range: 1-10 days) and the median duration was three days (range: 1-26 days).7

The most common (>20%) adverse reactions in the pooled safety analysis included neutropenia, CRS, anaemia, thrombocytopenia, infections – pathogen unspecified, leucopenia, fatigue, diarrhoea, hypokalaemia, hypophosphataemia, nausea, lymphopenia, pyrexia, cough, hypocalcaemia, infections – viral, headache, hypomagnesaemia, upper respiratory tract infection, arthralgia, and oedema peripheral. The most common Grade 3 or 4 adverse reactions were neutropenia (88.6%), anaemia (58.2%), thrombocytopenia (53.5%), leucopenia (45.1%), lymphopenia (30.4%), infections – pathogen unspecified (17.9%), hypophosphataemia (17.4%), febrile neutropenia (14.7%), hypocalcaemia (7.1%), infections – viral (7.1%), pneumonia (6.0%), CRS (5.4%), hypertension (5.4%) and hyponatraemia (5.4%).7

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
  • Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
  • Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
  • ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. CRS occurred in 85% (108/127) of patients receiving ABECMA. Grade 3 or higher CRS (Lee grading system) occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 – 23 days) and the median duration of CRS was 7 days (range: 1 – 63 days) in all patients including the patient who died. The most common manifestations of CRS included pyrexia (98%), hypotension (41%), tachycardia (35%), chills (31%), hypoxia (20%), fatigue (12%), and headache (10%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Fifty four percent (68/127) of patients received tocilizumab; 35% (45/127) received a single dose while 18% (23/127) received more than 1 dose of tocilizumab. Overall, across the dose levels, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab.

Overall rate of CRS was 79% and rate of Grade 2 CRS was 23% in patients treated in the 300 x 106 CAR+ T cell dose cohort. For patients treated in the 450 x 106 CAR+ T cell dose cohort, the overall rate of CRS was 96% and rate of Grade 2 CRS was 40%. Rate of Grade 3 or higher CRS was similar across the dose range. The median duration of CRS for the 450 x 106 CAR+ T cell dose cohort was 7 days (range: 1-63 days) and for the 300 x 106 CAR+ T cell dose cohort was 6 days (range: 2-28 days). In the 450 x 106 CAR+ T cell dose cohort, 68% (36/53) of patients received tocilizumab and 23% (12/53) received at least 1 dose of corticosteroids for treatment of CRS. In the 300 x 106 CAR+ T cell dose cohort, 44% (31/70) of patients received tocilizumab and 10% (7/70) received corticosteroids. All patients that received corticosteroids for CRS also received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. CAR T cell-associated neurotoxicity occurred in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 – 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median duration of neurotoxicity was 5 days (range: 1 – 61 days). The median duration of neurotoxicity was 6 days (range: 1 – 578) in all patients including those with ongoing neurotoxicity at the time of death or data cut off. Thirty-four patients with neurotoxicity had CRS. Neurotoxicity had onset in 3 patients before, 29 patients during, and 2 patients after CRS. The rate of Grade 3 neurotoxicity was 8% in the 450 x 106 CAR+ T cell dose cohort and 1.4% in the 300 x 106 CAR+ T cell dose cohort. The most frequently reported (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (20%), tremor (9%), aphasia (7%), and delirium (6%). Grade 4 neurotoxicity and cerebral edema in 1 patient has been reported with ABECMA in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have been reported after treatment with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs and symptoms of neurologic toxicities. Rule out other causes of neurologic symptoms. Monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of patients receiving ABECMA. One patient treated in the 300 x 106 CAR+ T cell dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved. The rate of HLH/MAS was 8% in the 450 x 106 CAR+ T cell dose cohort and 1% in the 300 x 106 CAR+ T cell dose cohort. All events of HLH/MAS had onset within 10 days of receiving ABECMA with a median onset of 7 days (range: 4-9 days) and occurred in the setting of ongoing or worsening CRS. Two patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional standards.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. Infections (all grades) occurred in 70% of patients. Grade 3 or 4 infections occurred in 23% of patients. Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%) had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 patient (0.8%) had cytomegalovirus (CMV) pneumonia associated with Pneumocystis jirovecii. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, preemptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 16% (20/127) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit prolonged cytopenias following lymphodepleting chemotherapy and ABECMA infusion. In the KarMMa study, 41% of patients (52/127) experienced prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. Rate of prolonged neutropenia was 49% in the 450 x 106 CAR+ T cell dose cohort and 34% in the 300 x 106 CAR+ T cell dose cohort. In 83% (43/52) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 65% (40/62) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 2.1 months. Median time to cytopenia recovery was similar across the 300 and 450 x 106 dose cohort.

Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to institutional guidelines.

Hypogammaglobulinemia: Plasma cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with ABECMA. Hypogammaglobulinemia was reported as an adverse event in 21% (27/127) of patients; laboratory IgG levels fell below 500 mg/dl after infusion in 25% (32/127) of patients treated with ABECMA.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

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

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include CRS, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, and Summary of Product Characteristics for ABECMA.

About Abecma

Abecma is the first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, first approved in the U.S. in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is also approved in Canada for relapsed and refractory multiple myeloma. Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement with Bristol Myers Squibb and bluebird bio. Bristol Myers Squibb will assume sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S.

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

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

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

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Kimberly Whitefield

Kimberly.Whitefield@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Read full story here

Categories
Local News

N.J. implements self-certification tool for eviction prevention

As summer starts to wind down, many New Jersey residents are concerned about homelessness in the winter months ahead, and how  the COVID-19 eviction moratorium will protect them.

 

Thus, the State has introduced critical protections to renter households who experienced economic hardships during the pandemic by introducing an income self-certification tool on their website.

 

According to the State’s website, “All renter households with incomes below 120% of the area median income are protected from eviction or removal at any time for nonpayment of rent, habitual late payment of rent, or failure to accept a rent increase that accrued from March 1, 2020, to Aug. 31, 2021.”

 

Some renters may even be protected from eviction or removal through Dec. 31, 2021, and depending on their household’s income level and specific circumstances, they could receive other assistance and services.

 

To take advantage of the income self-certification tool and to complete the required form online, households should:

 

The self-certification tool will help renters understand which protections they are eligible for, and allow them to submit a self-certification of  income to the courts, and send a copy of that form to their landlords, or keep it for their records.

 

How to use this online income self-certification form

 

  1.  Answer the questions in the online form.

 

2 .After answering all the questions, review the form on the screen and, if correct, type your name to officially certify that the contents are true. You are certifying that your answers are true under penalty of perjury.

 

3.  After typing your name, click “Complete.”

 

4.  A copy of the form for your records will be sent to your email address you provided in the form. It is very important that you retain your copy of the form. In addition to what you will receive by email, the online tool will allow you to download and print your form.

 

5. Send (by email, hard copy, or U.S. mail) a copy of your form to your landlord. It is very important that your landlord has been    notified of your self-certification and possible protection under the new law.

 

6.   The online tool also allows you to send the form directly to the court if you have a docket number for an eviction case for non-payment of rent (or failure to pay rent increase or for habitual late payment) that has been filed against you. If there is a pending eviction action against you for unpaid rent from March 1, 2020, to December 31, 2021, include the docket number on your form so that the form is also sent to the courts after you complete it. The court will notify you separately when your form is processed by them, and your pending eviction case dismissed.

 

7.  If there is not a pending eviction action against you for non-payment of rent and you are otherwise eligible for protection, your form will be retained in a database linked to the courts. Should an eviction action be filed against you for rent accrued between March 1, 2020, and December 31, 2021, after your form has been completed, it will be sent to the court for you at that time. However, you should bring a copy of your form with you at any legal proceedings you are summoned to attend.

Categories
Local News Science

Rocket Pharmaceuticals announces FDA lifts clinical hold on Danon Disease trial of RP-A501

— Initiation of Pediatric Patient Dosing of RP-A501 Expected in Q3 —

— Comprehensive Clinical Update from Phase 1 Clinical Trial Planned for Q4 —

 

CRANBURY, N.J. — (BUSINESS WIRE) — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today announces that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s Phase 1 clinical trial of RP-A501 for the treatment of Danon Disease, allowing patient enrollment to resume. The hold was removed after the Company addressed the FDA’s requests to modify the trial protocol and other supporting documents with revised guidelines for patient selection and management. The Company has initiated steps to resume the program as soon as possible and expects to commence dosing in the low-dose (6.7e13 vg/kg) pediatric patient cohort in the third quarter.

“We are grateful for the collaboration between the FDA and our team in reaching agreement on protocol updates allowing us to resume patient enrollment in our Danon Disease trial. We look forward to progressing this critical work on behalf of all Danon patients,” said Gaurav Shah, M.D., Chief Executive Officer of Rocket Pharma. “We are moving as quickly as possible to resume dosing and commence treatment this quarter. Additionally, given the activity observed among young adults in our low-dose cohort, in agreement with the FDA, we are now proceeding with the pediatric cohort. This is another important step forward as we believe the pediatric Danon population has the potential to realize the maximum benefit from our Danon Disease gene therapy program. We continue to anticipate reporting updated longer-term data from the low-dose (6.7e13 vg/kg) and higher-dose (1.1e14 vg/kg) young adult cohorts in the fourth quarter.”

Rocket’s Danon Disease program was placed on clinical hold by the FDA in May of 2021 to modify the study protocol and other supporting documents with revised guidelines for patient selection and safety management. No new drug-related safety events were observed in the low-dose or higher-dose young adult cohorts as part of the clinical hold or during the hold.

The non-randomized, open-label Phase 1 trial is designed to enroll both pediatric and young adult male patients to assess the safety and tolerability of a single intravenous (IV) infusion of RP-A501. Additional outcome measures include cardiomyocyte and skeletal muscle transduction by gene expression, histologic correction via endomyocardial biopsy and clinical stabilization via cardiac imaging and functional cardiopulmonary testing.

About RP-A501

RP-A501 is an investigational gene therapy product being developed for Danon Disease and the first potential gene therapy for monogenic heart failure. It consists of a recombinant adeno-associated serotype 9 (AAV9) capsid containing a functional version of the human LAMP2B transgene (AAV9.LAMP2B). RP-A501 is currently being evaluated in an ongoing Phase 1 clinical trial, in which the Company observed preliminary activity data of RP-A501 as well as a favorable tolerability profile.

About Danon Disease

Danon Disease is a rare X-linked inherited disorder caused by mutations in the gene encoding lysosome-associated membrane protein 2 (LAMP-2), an important mediator of autophagy. This results in accumulation of autophagosomes and glycogen, particularly in cardiac muscle and other tissues, which ultimately leads to heart failure, and for many male patients, death during adolescence or early adulthood. It is estimated to have a prevalence of 15,000 to 30,000 patients in the U.S. and the Europe. The only available treatment option for Danon Disease is cardiac transplantation, which is associated with substantial complications and is not considered curative. There are no specific therapies available for the treatment of Danon Disease.

About Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”) is advancing an integrated and sustainable pipeline of genetic therapies that aim to correct the root cause of complex and rare childhood disorders. The company’s platform-agnostic approach enables it to design the best potential therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket’s clinical programs using lentiviral vector (LVV)-based gene therapy are for the potential treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia and Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. Rocket’s first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. For more information about Rocket, please visit www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking Statements

Various statements in this release concerning Rocket’s future expectations, plans and prospects, including without limitation, Rocket’s expectations regarding its guidance for 2021 in light of COVID-19, the safety and effectiveness of product candidates that Rocket is developing to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Infantile Malignant Osteopetrosis (IMO) and Danon Disease, the expected timing and data readouts of Rocket’s ongoing and planned clinical trials, Rocket’s plans for the advancement of its Danon Disease program following the lifting of the FDA’s clinical hold and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “will give,” “estimate,” “seek,” “will,” “may,” “suggest” or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket’s ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rocket’s ongoing trials, our expectations regarding the delays and impact of COVID-19 on clinical sites, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket’s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Rocket’s Annual Report on Form 10-K for the year ended December 31, 2020, filed March 1, 2021 with the SEC. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Media
Kevin Giordano

Director, Corporate Communications

kgiordano@rocketpharma.com

Investors
Mayur Kasetty, M.D.

Director, Business Development & Operations

investors@rocketpharma.com

Categories
Environment Local News

D&R Greenway Land Trust in conjunction with Garden State Watercolor Society’s 51st Annual Art Exhibit announces, ‘Recovery’ — first exhibit opening since COVID at its Johnson Education Center Gallery

D&R Greenway Land Trust, in partnership with the Garden State Watercolor Society, announces the reopening of its Marie L. Matthews Art Gallery with the aptly named exhibit “Recovery,” at their Johnson Education Center in Princeton.

Cottage on Lewis Island — Photo by Carol Sanzalone

 

This river-focused 51st Annual Juried Exhibition will be available for reserved timed viewings from Aug.11 through Oct. 17, 2021.

 

Along with the juried exhibit, in the lobby of the Johnson Education Center, they will greet visitors with the Garden State Watercolor Society’s 3rd Annual Art Installation of over 100 mini-paintings illustrating aspects of the Delaware River, displayed among river stones.

 

Interested persons can learn more by attending a Virtual Art Opening Cocktail Hour on Tues., Aug. 17, 2021, 5:30 – 6:30 p.m.  Please RSVP to rsvp@drgreenway.org, by noon on August 17 to receive the zoom link to the virtual Happy Hour.  An in-person Reception and Awards Ceremony will take place on Friday, September 10 at the Johnson Education Center, outdoors. For more information and to reserve a space, visit www.gswcs.org.

I’mmm back!
— Photo by Jill Crouch

 

Opportunities to experience the exhibit include in person viewings by appointment only, made by calling 609 558-0207.  Reserved timed entries will be available three days a week through the run of the show, with monthly Saturday hours.  Visitors will be invited to follow CDC guidelines when they enter the Johnson Education Center to view the exhibit, with masks and social distancing. Entries will be timed so that each visitor and their guests remain separated from others viewing the exhibit. Events had been on hold for over a year and this will be the first returning indoor gallery exhibit.

 

Garden State Watercolor Society’s “Recovery” portrays the wild landscape, recreation, birds, fish, flora and fauna of the Delaware River with creative imagination. Artists illustrate the natural beauty we all love. The art works showcase what “Recovery” signifies to each of us, in representational or abstract ways.

 

“This exhibit celebrates what we at D&R Greenway have learned over the past year and a half, that nature heals and helps us recover from isolation and trauma,” shares Linda Mead, D&R Greenway’s CEO and President. “Our founding mission to preserve water quality by saving land along our region’s waterways is reflected in the focus on the Delaware River.” The river is a comeback success story, with progress made in cleaning up the river celebrated in 2020 when American Rivers named the Delaware the “American River of the Year”.  The river landscape has long been a place of reflection and beauty for area residents and artists.

Portrait of an Eastern Box Turtle
— Photo by James Fiorentino

 

Tess Fields, GSWS President declares, “I was delighted when the D&R Greenway Land Trust challenged us with the theme of the Delaware River and its recovery. I grew up on the Delaware and have a great respect and fondness for it. Each season on the river holds its own particular beauty. It can be calm and serene, or, after a storm, it can be dangerous and threatening. GSWS Artists embraced the theme and created a wide variety of wonderful art. I hope that people will come to view the exhibit at D&R Greenway’s Johnson Education Center. GSWS is thrilled to be hanging its first exhibit in two years!”

 

This special 2021 “Recovery” exhibit by the Garden State Watercolor Society, hosted by D&R Greenway, recognizes the importance of the preservation of water that supplies 15 million people.  Wildlife and vegetation benefit from stewardship of the Delaware River and its adjacent land and natural resources in local communities like Lambertville and Bordentown, and in cities that include Trenton, Camden and Philadelphia, PA and Wilmington, DE. The Delaware River’s waters have become a critical resource and connection for people, providing inspiration, safe passage and restorative recreation and meditation. The Delaware remains the longest free-flowing river in the eastern U.S., with the most extensive National Wild and Scenic River protection of any watershed in the country.

https://www.americanrivers.org/2020/04/river-of-the-year-for-2020-the-delaware-river/

 

Featured as the gateway to the exhibit is the Garden State Watercolor Society’s 3rd Annual Art Installation, a distinctive mini-art representation of aspects of the Delaware River with over a hundred 5”x7” paintings created by GSWS artists. Challenged to paint using only cool colors of blue, green and purple, the collaborative exhibit shows the imaginative creativity of the artists. The installation art celebrates the Delaware River: clean water, return of wildlife and source of scenic landscapes and interaction of nature and people. This installation exhibit follows the previous challenges of “Head and Shoulders” art installation in 2019–in which portraits were done in primary colors of red, yellow and blue only, and “Beautiful Creatures” in 2020–using secondary colors: orange, green and purple, and showing: animals, birds and insects. Both were well-received; this installation is expected to draw much interest as well.

 

The community is invited to call 609-558-0207 to make a reservation to visit the free installation and exhibit, in person. Artist entry and prizes were juried by Tim Saternow, a Signature Member of the American Watercolor Society whose watercolor paintings explore the lost and forgotten areas on the edges of the urban scene. Art is available for sale. A percentage of each purchase will support D&R Greenway’s mission of preserving and caring for land and inspiring a conservation ethic, now and forever.

 

BACKGROUND:

 

The Garden State Watercolor Society was founded in 1969 by Dagmar Tribble, a noted watercolorist. Over its existence, GSWS has been a beacon whose award-winning artists have inspired generations. The nonprofit organization’s goal is to encourage painting in water media and provide educational and exhibition opportunities for artists and residents of NJ, PA, NY or DE. Please visit www.gswcs.com for updates.

 

D&R Greenway Land Trust, an accredited nonprofit, has reached a milestone of over 21,000 acres of land preserved since 1989. By preserving land for life and creating public trails, it gives everyone the opportunity to enjoy the great outdoors. The land trust’s preserved farms and community gardens provide local organic food for our neighbors—including those most in need. Through strategic land conservation and stewardship, D&R Greenway combats climate change, protects birds and wildlife, and ensures clean drinking water for future generations. D&R Greenway’s mission is centered in connecting land with people from all walks of life.

 

D&R Greenway’s Johnson Education Center, home to its art galleries in Princeton, is the location for this exhibit.  Visit www.drgreenway.org to learn about the organization’s latest news and virtual programs.  D&R Greenway Land Trust, One Preservation Place, Princeton NJ 08540.

Categories
Business Local News

NRG Energy, Inc. announces proposed offering of Sustainability-Linked Senior Notes

PRINCETON, N.J. — (BUSINESS WIRE) — NRG Energy, Inc. (NYSE:NRG) intends to commence an offering of $1.1 billion in aggregate principal amount of senior notes due 2032 (the “New Notes”). The New Notes will be senior unsecured obligations of NRG and will be guaranteed by each of NRG’s current and future subsidiaries that guarantee indebtedness under NRG’s credit agreement. The New Notes are being issued under NRG’s Sustainability-Linked Bond Framework, which sets out certain sustainability targets, including reducing greenhouse gas emissions.

 

NRG intends to use the net proceeds from the offering, together with cash on hand and borrowings under one or more of its liquidity facilities, to repurchase, pursuant to NRG’s concurrent exercise of its optional redemption rights, (i) all of the $1.0 billion outstanding aggregate principal amount of its 7.25% senior notes due 2026 (the “2026 Notes”) and (ii) $355 million of the $1.23 billion outstanding aggregate principal amount of its 6.625% senior notes due 2027 (the “2027 Notes”), and to pay fees and expenses incurred in connection with the repurchase of the 2026 Notes and 2027 Notes.

 

The New Notes and related guarantees are being offered only to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), or, outside the United States, to persons other than “U.S. persons” in compliance with Regulation S under the Securities Act. The New Notes and related guarantees have not been registered under the Securities Act 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 the registration requirements. This press release does not constitute an offer to sell any security, including the New Notes, nor a solicitation for an offer to purchase any security, including the New Notes, the 2026 Notes or the 2027 Notes.

 

About NRG

At NRG, we’re bringing the power of energy to people and organizations by putting customers at the center of everything we do. We generate electricity and provide energy solutions and natural gas to millions of customers through our diverse portfolio of retail brands. A Fortune 500 company, operating in the United States and Canada, NRG delivers innovative solutions while advocating for competitive energy markets and customer choice, working towards a sustainable energy future.

 

Forward-Looking Statements

This communication contains forward-looking statements that may state NRG’s or its management’s intentions, beliefs, expectations or predictions for the future. Such forward-looking statements are subject to certain risks, uncertainties and assumptions, and typically can be identified by the use of words such as “will,” “expect,” “estimate,” “anticipate,” “forecast,” “plan,” “believe” and similar terms. Although NRG believes that its expectations are reasonable, it can give no assurance that these expectations will prove to have been correct, and actual results may vary materially. Factors that could cause actual results to differ materially from those contemplated above include, among others, risks and uncertainties related to the capital markets generally and whether NRG will offer the New Notes or consummate the offering, the anticipated terms of the New Notes and the anticipated use of proceeds.

 

The foregoing review of factors that could cause NRG’s actual results to differ materially from those contemplated in the forward-looking statements included herein should be considered in connection with information regarding risks and uncertainties that may affect NRG’s future results included in NRG’s filings with the SEC at www.sec.gov.

Contacts

Investors:
Kevin L. Cole, CFA

609.524.4526

investor.relations@nrg.com

Media:
Candice Adams

609.524.5428

candice.adams@nrg.com

Categories
Education Healthcare Local News

N.J. students to return to the classroom with new covid masks restrictions

All students will be back for full-time, in-person instruction for the 2021-2022 school year, but all students, educators, staff, and visitors will be required to wear face masks inside school buildings, regardless of vaccination status, for the start of this academic year.

 

And, parents or guardians will not be able to opt children out of in-person instruction as was previously allowed for the 2020-2021 school year.

 

With students, educators, staff, and visitors being required to wear face masks indoors for the start of the 2021-2022 school year, effective Monday, August 9, 2021, masks are required in the indoor premises of all public, private, and parochial preschool, elementary, and secondary school buildings, with limited exceptions as outlined below.

 

Exceptions to the mask requirement that remain unchanged from the 2020-2021 school year, include:

 

  • When doing so would inhibit the individual’s health, such as when the individual is exposed to extreme heat indoors;
  • When the individual has trouble breathing, is unconscious, incapacitated, or otherwise unable to remove a face covering without assistance;
  • When a student’s documented medical condition or disability, as reflected in an Individualized Education Program (IEP) or Educational Plan pursuant to Section 504 of the Rehabilitation Act of 1973, precludes use of a face covering;
  • When the individual is under two (2) years of age;
  • When an individual is engaged in an activity that cannot be performed while wearing a mask, such as eating and drinking or playing an instrument that would be obstructed by the face covering;
  • When the individual is engaged in high-intensity aerobic or anerobic activity;
  • When a student is participating in high-intensity physical activities during a physical education class in a well-ventilated location and able to maintain a physical distance of six feet from all other individuals; or
  • When wearing a face covering creates an unsafe condition in which to operate equipment or execute a task.

 

Other public health guidance for the masks mandate for in-person learning

 

The Department of Education, in partnership with the Department of Health, has produced a health and safety guidance document detailing recommendations designed to provide a healthy and safe environment for students and staff during the 2021-2022 school year.

These strategies are recommendations, not mandatory standards. The absence of one or more of these strategies should not prevent school facilities from opening for full-day, in-person operation.

Where possible, the Department’s recommendations should be used to develop a layered approach to help prevent the spread of COVID-19, and schools should implement as many layers as feasible.

For full details on these recommendations, refer to the NJ’s Department of Education and the Department of Health’s health and safety guidance for the 2021-2022 school year

 

The strategies and procedures include:

 

Vaccination

Most K-12 schools will have a mixed population of fully vaccinated, partially vaccinated, and unvaccinated individuals at any given time, thereby requiring the layering of preventive measures to protect individuals who are not fully vaccinated. Local Education Agencies (LEAs) are encouraged to have a system in place to determine the vaccination status of students and staff, however, if an LEA is unable to determine the vaccination status of individual students or staff, those individuals should be considered not fully vaccinated.

 

Social Distancing and Cohorting

 

Though physical distancing recommendations must not prevent a school from offering full-day, full-time, in person learning to all students for the 2021-2022 school year, LEAs should consider implementing physical distancing measures as an effective COVID-19 prevention strategy to the extent they are equipped to do so while still providing regular school operations to all students and staff in-person.

 

During periods of high community transmission or if vaccine coverage is low, if the maximal social distancing recommendations below cannot be maintained, LEAs should, where possible, prioritize other prevention measures including masking, screening testing, and cohorting.

 

LEAs should actively promote vaccination for all eligible students and staff. As vaccine eligibility expands, LEAs should consider school-wide vaccine coverage among students and staff as an additional metric to inform the need for preventive measures such as physical distancing and masking

 

Parental Screening

Parents/caregivers should be strongly encouraged to monitor their children for signs of illness every day as they are the front line for assessing illness in their children. Students who are sick should not attend school. Schools should strictly enforce exclusion criteria for both students and staff.

 

Schools should provide clear and accessible directions to parents/caregivers and students for reporting symptoms and reasons for absences.

 

Testing

At all levels of community transmission, NJ Department of Health recommends schools work with their local health departments to identify rapid viral testing options in their community for the testing of symptomatic individuals and asymptomatic individuals who were exposed to someone with COVID-19.

 

Response to Symptomatic Students and Staff

Schools should ensure that procedures are in place to identify and respond to a student or staff member who becomes ill with COVID-19 symptoms.

 

— Sources: NJ Department of Education: The Road Forward; Executive Order 251

Categories
Business Local News

Universal Display Corporation announces second quarter 2021 financial results

EWING, N.J. —  (BUSINESS WIRE) — $OLED #OLED—Universal Display Corporation (Nasdaq: OLED), enabling energy-efficient displays and lighting with its UniversalPHOLED® technology and materials, today reported financial results for the second quarter ended June 30, 2021.

“Looking to the year, we are on track to achieve approximately 30% year-over-year sales growth, translating into a new record high for annual revenue for the Company,” said Sidney D. Rosenblatt, Executive Vice President and Chief Financial Officer of Universal Display. “As we anticipate ongoing momentum in the OLED industry to increase in 2021 and beyond, we are excited about the long and vast runway of forecasted growth for the market. Given this expected growth, we are continuing to fuel and fortify our innovation engine, expand our global infrastructure, and invest in our people to advance our leadership position and further enable our customers and the OLED ecosystem.”

 

Rosenblatt continued, “Energy-efficiency and sustainability are key cornerstones of our UniversalPHOLED technology and materials. The discovery of our proprietary phosphorescent technology was an enabling breakthrough in the OLED industry. With efficiencies that are up to four times higher than conventional OLED materials, UDC’s patented and award-winning phosphorescent OLED technology and UniversalPHOLED materials are proven to be integral in enabling high-performance, low-power consumption and energy-efficiency in OLED displays and lighting. Our energy-efficiency initiatives are expanding as we continue to invent and develop new OLED materials and technologies, including progress toward delivery of an all-phosphorescent red, green and blue emissive system, that can enable a sustainable and low-carbon future.”

 

Financial Highlights for the Second Quarter of 2021

  • Total revenue in the second quarter of 2021 was $129.7 million as compared to $58.0 million in the second quarter of 2020. The increase in revenue was due to strengthened demand for OLED products utilizing our emitter material, as well as the recovery in sales that were adversely affected by the impact of the COVID-19 pandemic during the three months ended June 30, 2020. Even though we believe we have experienced the worst effects of the COVID-19 pandemic, we remain uncertain as to the possibility of its re-emergence and any corresponding negative impact on OLED market demand.
  • Revenue from material sales was $77.4 million in the second quarter of 2021 as compared to $31.9 million in the second quarter of 2020.
  • Revenue from royalty and license fees was $48.2 million in the second quarter of 2021 as compared to $22.4 million in the second quarter of 2020.
  • Cost of material sales was $25.3 million in the second quarter of 2021 as compared to $10.3 million in the second quarter of 2020.
  • Operating income was $49.9 million in the second quarter of 2021 as compared to operating loss of $1.2 million in the second quarter of 2020.
  • Net income was $40.5 million or $0.85 per diluted share in the second quarter of 2021 as compared to $815,000 million or $0.02 per diluted share in the second quarter of 2020.

 

Revenue Comparison

($ in thousands)

Three Months Ended June 30,

2021

2020

Material sales

$

77,438

$

31,927

Royalty and license fees

48,212

22,380

Contract research services

4,010

3,661

Total revenue

$

129,660

$

57,968

Cost of Materials Comparison

($ in thousands)

Three Months Ended June 30,

2021

2020

Material sales

$

77,438

$

31,927

Cost of material sales

25,316

10,277

Gross margin on material sales

52,122

21,650

Gross margin as a % of material sales

67

%

68

%

Financial Highlights for the First Half of 2021

  • Total revenue in the first half of 2021 was $263.7 million as compared to $170.2 million in the first half of 2020. The increase in revenue was due to strengthened demand for OLED products utilizing our emitter material, as well as the recovery in sales that were adversely affected by the impact of the COVID-19 pandemic during the three months ended June 30, 2020. Even though we believe we have experienced the worst effects of the COVID-19 pandemic, we remain uncertain as to the possibility of its re-emergence and any corresponding negative impact on OLED market demand.
  • Revenue from material sales was $157.2 million in the first half of 2021 as compared to $98.5 million in the first half of 2020.
  • Revenue from royalty and license fees was $99.1 million in the first half of 2021 as compared to $65.5 million in the first half of 2020.
  • Cost of material sales was $46.3 million in the first half of 2021 as compared to $30.5 million in the first half of 2020.
  • Operating income was $113.5 million in the first half of 2021 as compared to $43.3 million in the first half of 2020.
  • Net income was $92.2 million or $1.94 per diluted share in the first half of 2021 as compared to $39.0 million or $0.82 per diluted share in the first half of 2020.

Revenue Comparison

($ in thousands)

Six Months Ended June 30,

2021

2020

Material sales

$

157,246

$

98,502

Royalty and license fees

99,098

65,458

Contract research services

7,316

6,285

Total revenue

$

263,660

$

170,245

Cost of Materials Comparison

($ in thousands)

Six Months Ended June 30,

2021

2020

Material sales

$

157,246

$

98,502

Cost of material sales

46,315

30,488

Gross margin on material sales

110,931

68,014

Gross margin as a % of material sales

71

%

69

%

2021 Guidance

The Company continues to believe that its 2021 revenue will be approximately in the range of $530 million to $560 million. The OLED industry remains at a stage where many variables can have a material impact on its growth, and the Company thus caveats its financial guidance accordingly.

Dividend

The Company also announced a third quarter cash dividend of $0.20 per share on the Company’s common stock. The dividend is payable on September 30, 2021 to all shareholders of record on September 16, 2021.

Conference Call Information

In conjunction with this release, Universal Display will host a conference call on Thursday, August 5, 2021 at 5:00 p.m. Eastern Time. The live webcast of the conference call can be accessed under the events page of the Company’s Investor Relations website at ir.oled.com. Those wishing to participate in the live call should dial 1-877-524-8416 (toll-free) or 1-412-902-1028. Please dial in 5-10 minutes prior to the scheduled conference call time. An online archive of the webcast will be available within two hours of the conclusion of the call.

About Universal Display Corporation

Universal Display Corporation (Nasdaq: OLED) is a leader in the research, development and commercialization of organic light emitting diode (OLED) technologies and materials for use in display and solid-state lighting applications. Founded in 1994 and with subsidiaries and offices around the world, the Company currently owns, exclusively licenses or has the sole right to sublicense more than 5,000 patents issued and pending worldwide. Universal Display licenses its proprietary technologies, including its breakthrough high-efficiency UniversalPHOLED® phosphorescent OLED technology that can enable the development of energy-efficient and eco-friendly displays and solid-state lighting. The Company also develops and offers high-quality, state-of-the-art UniversalPHOLED materials that are recognized as key ingredients in the fabrication of OLEDs with peak performance. In addition, Universal Display delivers innovative and customized solutions to its clients and partners through technology transfer, collaborative technology development and on-site training. To learn more about Universal Display Corporation, please visit https://oled.com/.

Universal Display Corporation and the Universal Display Corporation logo are trademarks or registered trademarks of Universal Display Corporation. All other company, brand or product names may be trademarks or registered trademarks.

All statements in this document that are not historical, such as those relating to the Company’s technologies and potential applications of those technologies, the Company’s expected results and future declaration of dividends, as well as the growth of the OLED market and the Company’s opportunities in that market, are forward-looking financial statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are cautioned not to place undue reliance on any forward-looking statements in this document, as they reflect Universal Display Corporation’s current views with respect to future events and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated. These risks and uncertainties are discussed in greater detail in Universal Display Corporation’s periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission, including, in particular, the section entitled “Risk Factors” in Universal Display Corporation’s Annual Report on Form 10-K for the year ended December 31, 2020. Universal Display Corporation disclaims any obligation to update any forward-looking statement contained in this document.

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UNIVERSAL DISPLAY CORPORATION AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(in thousands, except share and per share data)

June 30, 2021

December 31, 2020

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$

542,914

$

630,012

Short-term investments

190,540

99,996

Accounts receivable

99,629

82,261

Inventory

104,653

91,591

Other current assets

55,156

20,746

Total current assets

992,892

924,606

PROPERTY AND EQUIPMENT, net of accumulated depreciation of $81,721 and $72,493

113,187

102,113

ACQUIRED TECHNOLOGY, net of accumulated amortization of $163,343 and $153,050

59,960

70,253

OTHER INTANGIBLE ASSETS, net of accumulated amortization of $6,848 and $6,155

10,386

10,685

GOODWILL

15,535

15,535

INVESTMENTS

8,500

5,000

DEFERRED INCOME TAXES

35,579

37,695

OTHER ASSETS

114,676

103,341

TOTAL ASSETS

$

1,350,715

$

1,269,228

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Accounts payable

$

10,334

$

13,801

Accrued expenses

27,247

41,404

Deferred revenue

122,978

105,215

Other current liabilities

2,004

4,540

Total current liabilities

162,563

164,960

DEFERRED REVENUE

46,174

57,086

RETIREMENT PLAN BENEFIT LIABILITY

79,966

78,527

OTHER LIABILITIES

70,396

55,941

Total liabilities

359,099

356,514

SHAREHOLDERS’ EQUITY:

Preferred Stock, par value $0.01 per share, 5,000,000 shares authorized, 200,000 shares of Series A Nonconvertible Preferred Stock issued and outstanding (liquidation value of $7.50 per share or $1,500)

2

2

Common Stock, par value $0.01 per share, 200,000,000 shares authorized, 49,054,059 and 49,013,476 shares issued, and 47,688,411 and 47,647,828 shares outstanding, at June 30, 2021 and December 31, 2020, respectively

491

490

Additional paid-in capital

638,991

635,595

Retained earnings

427,188

353,930

Accumulated other comprehensive loss

(33,772

)

(36,019

)

Treasury stock, at cost (1,365,648 shares at June 30, 2021 and December 31, 2020)

(41,284

)

(41,284

)

Total shareholders’ equity

991,616

912,714

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$

1,350,715

$

1,269,228

UNIVERSAL DISPLAY CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF INCOME

(UNAUDITED)

(in thousands, except share and per share data)

Three Months Ended June 30,

Six Months Ended June 30,

2021

2020

2021

2020

REVENUE:

Material sales

$

77,438

$

31,927

$

157,246

$

98,502

Royalty and license fees

48,212

22,380

99,098

65,458

Contract research services

4,010

3,661

7,316

6,285

Total revenue

129,660

57,968

263,660

170,245

COST OF SALES

27,969

12,643

51,267

35,102

Gross margin

101,691

45,325

212,393

135,143

OPERATING EXPENSES:

Research and development

24,101

21,397

47,406

40,894

Selling, general and administrative

20,239

16,147

36,643

31,550

Amortization of acquired technology and other intangible assets

5,497

5,490

10,985

10,980

Patent costs

1,809

1,858

3,644

3,496

Royalty and license expense

149

1,618

261

4,902

Total operating expenses

51,795

46,510

98,939

91,822

OPERATING INCOME (LOSS)

49,896

(1,185

)

113,454

43,321

Interest income, net

75

1,268

208

3,415

Other income, net

221

170

280

372

Interest and other income, net

296

1,438

488

3,787

INCOME BEFORE INCOME TAXES

50,192

253

113,942

47,108

INCOME TAX (EXPENSE) BENEFIT

(9,651

)

562

(21,714

)

(8,138

)

NET INCOME

$

40,541

$

815

$

92,228

$

38,970

NET INCOME PER COMMON SHARE:

BASIC

$

0.85

$

0.02

$

1.94

$

0.82

DILUTED

$

0.85

$

0.02

$

1.94

$

0.82

WEIGHTED AVERAGE SHARES USED IN COMPUTING NET INCOME PER COMMON SHARE:

BASIC

47,299,627

47,227,294

47,284,773

47,160,163

DILUTED

47,356,864

47,243,991

47,347,596

47,190,505

CASH DIVIDENDS DECLARED PER COMMON SHARE

$

0.20

$

0.15

$

0.40

$

0.30

UNIVERSAL DISPLAY CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(in thousands)

Six Months Ended June 30,

2021

2020

CASH FLOWS FROM OPERATING ACTIVITIES:

Net income

$

92,228

$

38,970

Adjustments to reconcile net income to net cash provided by operating activities:

Amortization of deferred revenue and recognition of unbilled receivables

(110,993

)

(58,644

)

Depreciation

9,229

7,283

Amortization of intangibles

10,985

10,980

Change in excess inventory reserve

1,117

611

Amortization of premium and discount on investments, net

(128

)

(3,280

)

Stock-based compensation to employees

14,624

12,918

Stock-based compensation to Board of Directors and Scientific Advisory Board

704

708

Deferred income tax expense (benefit)

1,458

(336

)

Retirement plan expense

4,457

2,828

Decrease (increase) in assets:

Accounts receivable

(17,368

)

(8,046

)

Inventory

(14,179

)

(21,181

)

Other current assets

(5,712

)

(5,967

)

Other assets

(15,005

)

(5,942

)

Increase (decrease) in liabilities:

Accounts payable and accrued expenses

(17,036

)

(20,332

)

Other current liabilities

(2,536

)

(639

)

Deferred revenue

92,816

75,683

Other liabilities

14,455

6,416

Net cash provided by operating activities

59,116

32,030

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchases of property and equipment

(20,668

)

(11,804

)

Purchases of intangibles

(394

)

(25

)

Purchases of investments

(193,951

)

(404,232

)

Proceeds from sale and maturity of investments

100,000

412,760

Net cash used in investing activities

(115,013

)

(3,301

)

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of common stock

787

590

Payment of withholding taxes related to stock-based compensation to employees

(13,018

)

(13,165

)

Cash dividends paid

(18,970

)

(14,215

)

Net cash used in financing activities

(31,201

)

(26,790

)

(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

(87,098

)

1,939

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

630,012

131,627

CASH AND CASH EQUIVALENTS, END OF PERIOD

$

542,914

$

133,566

The following non-cash activities occurred:

Unrealized (loss) gain on available-for-sale securities

$

(35

)

$

1,242

Common stock issued to Board of Directors and Scientific Advisory Board that was earned and accrued for in a previous period

300

300

Net change in accounts payable and accrued expenses related to purchases of property and equipment

366

390

Contacts

Universal Display Contact:
Darice Liu

investor@oled.com
media@oled.com
+1 609-964-5123