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90% of companies unprepared for CCPA compliance, 95% unprepared for GDPR, says new research by CYTRIO

CYTRIO’s data privacy research shows CCPA non-compliance from Q4 2021 continues into Q1 2022 despite impending enforcements

 

BOSTON — (BUSINESS WIRE) — #AI—CYTRIO, a next-generation data privacy rights management company, released findings from additional independent research it conducted during Q1 2022 on the state of companies’ readiness to comply with the California Consumer Privacy Act (CCPA), California Privacy Rights Act (CPRA), and the European Union’s General Data Protection Regulation (GDPR). As of March 31, 2022, the findings uncovered that 90% of companies are not fully compliant with CCPA and CPRA Data Subject Access Request (DSAR) requirements. Further, 95% of companies are using error prone and time consuming manual processes for GDPR DSAR requirements.


“Our continuous research confirms that first generation privacy rights management solutions have not gained wide adoption due to cost and deployment complexity, resulting in a high percentage of CCPA non-compliance,” said Vijay Basani, founder and CEO of CYTRIO. “This problem will become more pronounced as CPRA enforcement takes effect in 2023 with the stringent 12-month lookback. Awareness of their data privacy rights by consumers coupled with the rise of data aggregators is driving an increased number of data requests. As the California Privacy Protection Agency (CPPA) begins active enforcement of CCPA and CPRA, non-compliance to DSAR requests will become cost prohibitive for both medium and large sized companies.”

 

CYTRIO released its inaugural State of CCPA Compliance research results in January, the largest of its kind, studying 5,175 U.S. companies with revenues ranging from $25 million to more than $5 billion. The findings showed that only 11% of companies were fully meeting CCPA requirements, while 89% of companies were either non-compliant or somewhat compliant. From January to March, CYTRIO researched an additional 1,570 companies for CCPA and GDPR DSAR compliance, bringing the total to 6,745 companies to date.

 

This most recent research shows only 10% of companies have deployed an automated CCPA DSAR management solution. Additionally, B2B and B2C companies of all sizes are equally and poorly unprepared for CCPA compliance, and B2B and B2C companies are also woefully unprepared for GDPR compliance, despite the regulation going into effect in May 2018 with $1.8 billion fines levied as of March 2022.

 

From Q4 2021 to Q1 2022, the top three most compliant verticals remained the same with Business Services, Retail, and Finance making up 54% of the companies researched. While the top three most compliant states (California, New York, and Texas) remained the same, the total number of companies from those states as a percentage of total companies decreased from 31% to 25%, indicating other states seem to be catching up.

 

Last month, Utah passed the Utah Consumer Privacy Act, moving closer to becoming the fourth state to enact privacy legislation in the U.S., behind California, Colorado, and Virginia. Currently, 22 states, including Alaska, Hawaii, Massachusetts, New York, Pennsylvania, Washington, Wisconsin, and New Jersey, have multiple consumer privacy legislation pending.

 

A key observation in this research was that DSARs coming from data aggregators are increasing in frequency and volume with the majority of requests being Right to Delete (Erasure). To be in compliance, companies must respond to these requests in a timely manner.

 

To access the full findings of CYTRIO’s most recent data privacy research, go to:

https://cytrio.com/ccpa-research-report-q1-2022/

 

About CYTRIO

CYTRIO’s software-as-a-service (SaaS) data privacy rights management platform helps organizations comply with data privacy regulations such as CCPA, CPRA, VCDPA, CPA, and others. The company offers an all-in-one solution built on automation, AI-led data discovery, and automated response workflows. CYTRIO’s solutions are simple to deploy, deliver value on day one, and do not require dedicated privacy teams to manage. Learn more at www.cytrio.com, and follow on LinkedIn and Twitter.

All trademarks recognized.

Contacts

Tracy Wemett

BroadPR

+1-617-868-5031

tracy@broadpr.com

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Business News Now!

1st Colonial Bancorp, Inc. reports first quarter 2022 net income

  • Net income was $1.7 million, or $0.34 per diluted share, for the three months ended March 31, 2022 compared to net income of $1.7 million, or $0.33 per diluted share, for the three months ended March 31, 2021. Net income was $1.7 million, or $0.35 per diluted share, for the fourth quarter of 2021.
  • Net interest income increased $1.0 million, or 21%, from the same period in 2021.
  • Net interest margin for the quarter ended March 31, 2022 was 3.46%, an 11% increase over the same period in 2021.
  • Non-interest expense declined $228 thousand, or 4.7%, from the same period in 2021.
  • Efficiency ratio improved to 63% for the first quarter of 2022, down from 65% for the first quarter of 2021.
  • Total assets grew $15.0 million, or 2%, during the first quarter of 2022 from $682.8 million as of December 31, 2021.
  • Total loans grew $33.3 million, or 7%, during the first quarter of 2022 from $501.9 million as of December 31, 2021.
  • Total deposits grew $15.5 million, or 3%, during the first quarter of 2022 from $610.5 million as of December 31, 2021.
  • The Company repurchased 18,563 shares of its common stock at an average price of $9.94 per share during the quarter ended March 31, 2022.

 

CHERRY HILL, N.J. — (BUSINESS WIRE) — 1st Colonial Bancorp, Inc. (FCOB), holding company of 1st Colonial Community Bank, recently reported net income of 1.7 million, or $0.34 per diluted share, for the three months ended March 31, 2022 compared to net income of $1.7 million, or $0.33 per diluted share, for the three months ended March 31, 2021.

 

 

Robert White, President and Chief Executive Officer, commented, “Our results for the first quarter show our continued financial strength and momentum, led by a significant increase in net interest income due to solid loan growth. We have been focused on replacing the non-recurring PPP revenue and the elevated mortgage revenue from the historically high volume of mortgage refinancing activity.”

 

“Loan demand remains strong in both commercial and consumer lending, with consumer being driven by purchase activity. Housing sales remain robust in our markets with inventory still low and demand remaining high. We continue to monitor new loan application volumes to measure further impact associated with the Federal Reserve’s decision to increase short-term rates in an attempt to reduce or control current inflation. We are also closely monitoring and managing our operating costs to limit the impact of high inflation on our bottom line.”

 

“Our team is committed to delivering exceptional products and services through multiple distribution channels to support the needs of our customers.”

 

Operating Results

Net Interest Income

Net interest income for the three months ended March 31, 2022 and 2021 was $5.8 million and $4.8 million, respectively. The increase in net interest income was primarily attributable to a $1.0 million increase in interest income on average loans outstanding. For the first quarter of 2022, average loan balances increased $78.5 million to $513.8 million from $435.3 million for the first quarter of 2021. When compared to the fourth quarter of 2021, net interest income declined $296 thousand from $6.1 million, which was directly related to a $435 thousand decline in net loan origination income on the SBA’s Paycheck Protection Program (“PPP”) loans. Average PPP loans outstanding declined from $23.9 million for the quarter ended December 31, 2021 to $8.7 million for the first quarter of 2022.

 

The net interest margin was 3.46% for the first quarter of 2022 compared to 3.12% for the first quarter of 2021. The improvement in net interest margin was mostly related to an increase in the yield on interest-earning assets coupled with a reduction in the average rate paid on interest-bearing liabilities. The average yield on interest-earning assets grew 22 basis points from 3.63% for the quarter ended March 31, 2021 to 3.85% for the quarter ended March 31, 2022. Also we continue to benefit from the repricing of maturing certificates of deposit (CDs). The average rates paid on CDs declined 42 basis points from 1.33% for the first quarter of 2021 to 0.91% for the first quarter of 2022. When compared to the fourth quarter of 2021, the first quarter 2022 net interest margin declined five basis points from 3.51%.

 

Loan Loss Provision

For the three months ended March 31, 2022, we recorded a provision to the allowance for loan losses (“allowance”) of $300 thousand compared to $240 thousand for the three months ended March 31, 2021. Net recoveries were $137 thousand for the first quarter of 2022 compared to $142 thousand for the first quarter of 2021. The allowance as a percentage of total loans was 1.37% as of March 31, 2022 compared to 1.38% as of December 31, 2021 and 1.32% as of March 31, 2021.

 

Non-interest Income

Non-interest income for the first quarter of 2022 was $1.5 million, a decrease of $1.1 million, or 43%, from $2.6 million for the first quarter of 2021. Income from the origination and sales of residential mortgages declined $1.1 million, or 56%, from the first quarter in 2021 due to a $22.3 million, or 30%, decline in originations. Additionally, we retained in our loan portfolio $21.5 million, or 42%, of the $51.0 million in mortgage originations in the first quarter of 2022 compared to $9.2 million, or 13%, of the first quarter of 2021 originations. Mortgage activity was impacted by a drop in refinancing transactions and a lack of inventory in the purchase market. During the first quarter of 2022, we earned $347 thousand in gains on the sale of SBA loans compared to $335 thousand for the comparable 2021 period.

 

When compared to the fourth quarter of 2021, non-interest income for the first quarter of 2022 declined $653 thousand from $2.1 million. Income from the sales of SBA loans and the origination and sales of residential mortgages declined $349 thousand and $347 thousand, respectively, from their amounts for the fourth quarter of 2021. Mortgage originations declined $4.0 million from $55.0 million for the fourth quarter of 2021 and the loans retained in our loan portfolio grew $4.5 million, or 26% from $17.0 million in the fourth quarter of 2021.

 

Non-interest Expense

Non-interest expense was $4.6 million for the quarter ended March 31, 2022, representing a $228 thousand decline, or 4.7%, from $4.8 million for the quarter ended March 31, 2021. Reductions in professional fees and impaired loan expenses were the primary causes for the improvement in non-interest expenses.

 

When compared to the fourth quarter of 2021, non-interest expense for the first quarter of 2022 declined $517 thousand from $5.1 million. Reductions in professional fees, lending expenses and impaired loan expenses were the primary cause for the improvement in non-interest expenses.

 

Income Taxes

For the first quarter of 2022, income tax expense was $707 thousand compared to $662 thousand for the first quarter of 2021. A $101 thousand decline in tax-free interest income on our municipal investments negatively impacted income tax expense.

 

Financial Condition

Assets

As of March 31, 2022, total assets were $697.8 million and grew $15.0 million from $682.8 million as of December 31, 2021.

 

Total loans were $535.2 million as of March 31, 2022, an increase of $33.3 million, or 6.6%, from $501.9 million as of December 31, 2021. During the first quarter, commercial loans, including commercial real estate and construction and excluding PPP loans, grew $23.1 million. Residential mortgages and home equity loans and lines of credit increased $20.8 million. PPP loans declined $10.3 million to $3.7 million as of March 31, 2022. Residential mortgages held for sale grew $1.4 million from $10.0 million as of December 31, 2021 to $11.4 million as of March 31, 2022.

 

Liabilities

Total deposits were $626.0 million as of March 31, 2022, and grew $15.5 million, or 2.5%, from $610.5 million as of December 31, 2021. Municipal deposits and interest checking accounts increased $33.0 million and $2.0 million, respectively. Certificates of deposit and demand deposits declined $9.6 million and $8.7 million, respectively.

 

Shareholder’s Equity

Total shareholders’ equity was $56.6 million as of March 31, 2022, compared to $57.8 million as of December 31, 2021. During the first quarter of 2022, the net unrealized loss in our investment portfolio caused a $2.8 million decline in accumulated other comprehensive income (“AOCI”) from $272 thousand as of December 31, 2021 to an accumulated other comprehensive loss of $2.5 million as of March 31, 2022. The decline in AOCI was caused by higher interest rates and the widening spreads in our government agency sponsored bonds and mortgage-backed securities. We have minimal credit risk in the investment portfolio. As a result of the decrease in shareholders’ equity, tangible book value per share decreased $0.22, or 1.8%, from $12.23 as of December 31, 2021 to $12.01 as of March 31, 2022.

 

Asset Quality

Non-performing assets as of March 31, 2022 were $3.3 million compared to $3.5 million as of December 31, 2021. The ratio of non-performing assets to total assets as of March 31, 2022 was 0.48% compared to 0.52% as of December 31, 2021. As of March 31, 2022, the allowance was $7.3 million, or 1.37% of total loans. The allowance to non-accrual loans was 220.9% as of March 31, 2022, compared to 195.9% as of December 31, 2021.

 

Income Statement and Other Highlights:

Highlights as of March 31, 2022 and December 31, 2021, and a comparison of the three months ended March 31, 2022 to the three months ended March 31, 2021 include the following:

1st COLONIAL BANCORP, INC.

CONSOLIDATED INCOME STATEMENTS

(Unaudited, dollars in thousands, except per share data)

For the three months

ended March 31,

2022

2021

Interest income

$

6,421

$

5,546

Interest expense

650

773

Net Interest Income

5,771

4,773

Provision for loan losses

300

240

Net interest income after provision for loan losses

5,471

4,533

Non-interest income

1,480

2,595

Non-interest expense

4,585

4,813

Income before taxes

2,366

2,315

Income tax expense

707

662

Net Income

$

1,659

$

1,653

Earnings Per Share – Basic

$

0.35

$

0.33

Earnings Per Share – Diluted

$

0.34

$

0.33

SELECTED PERFORMANCE RATIOS:

For the three months

ended March 31, 2022

For the three months

ended March 31, 2021

Return on Average Assets

0.96

%

1.04

%

Return on Average Equity

11.69

%

12.43

%

Book value per share

$

12.01

$

11.04

As of March 31, 2022

As of December 31, 2021

Bank Capital ratios:

Tier 1 Leverage

9.60

%

9.22

%

Total Risk Based Capital

14.45

%

15.37

%

Common Equity Tier 1

13.20

%

14.11

%

1st COLONIAL BANCORP, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands)

As of March 31, 2022

As of December 31, 2021

Cash and cash equivalents

$

26,128

$

40,877

Total investments

106,864

111,807

Mortgage loans held for sale

11,418

9,957

Total loans

535,224

501,883

Less allowance for loan losses

(7,343

)

(6,906

)

Loans and leases, net

527,881

494,977

Bank owned life insurance

16,263

16,160

Premises and equipment, net

993

1,072

Accrued interest receivable

1,680

1,664

Other assets

6,558

6,320

Total Assets

$

697,785

$

682,834

Total deposits

$

625,984

$

610,477

Subordinated debt

10,449

10,440

Other liabilities

4,778

4,100

Total Liabilities

641,211

625,017

Total Shareholders’ Equity

56,574

57,817

Total Liabilities and Shareholders’ Equity

$

697,785

$

682,834

1st COLONIAL BANCORP, INC.

NET INTEREST INCOME AND MARGIN

(Unaudited, in thousands, except percentages)

For the three months ended

For the three months ended

March 31, 2022

March 31, 2021

Average

Balance

Interest

Yield

Average

Balance

Interest

Yield

Cash and cash equivalents

$

41,227

$

15

0.15

%

$

27,625

$

7

0.10

%

Investment securities

110,342

378

1.39

%

135,255

461

1.38

%

Mortgage loans held for sale

11,016

81

2.98

%

22,255

120

2.19

%

Loans

513,770

5,947

4.69

%

435,271

4,958

4.62

%

Total interest-earning assets

676,355

6,421

3.85

%

620,406

5,546

3.63

%

Non-interest earning assets

22,633

21,370

Total average assets

$

698,988

$

641,776

Interest-bearing deposits

NOW and money markets

$

283,404

$

86

0.12

%

$

250,347

$

117

0.19

%

Savings

129,219

92

0.29

%

117,507

84

0.29

%

Certificates of deposit

122,900

275

0.91

%

114,454

375

1.33

%

Total interest-bearing deposits

535,523

453

0.34

%

482,308

576

0.48

%

Borrowings

10,535

197

7.58

%

12,735

197

6.27

%

Total interest-bearing liabilities

546,058

650

0.48

%

495,043

773

0.63

%

Non-interest bearing deposits

91,335

88,649

Other liabilities

4,026

4,142

Total average liabilities

641,419

587,834

Shareholders’ equity

57,569

53,942

Total average liabilities and equity

$

698,988

$

641,776

Net interest income

$

5,771

$

4,773

Net interest margin

3.46

%

3.12

%

Net interest spread

3.37

%

3.00

%

1st Colonial Community Bank, the subsidiary of 1st Colonial Bancorp, provides a range of business and consumer financial services, placing emphasis on customer service and access to decision makers. Headquartered in Collingswood, New Jersey, the Bank has branches in Westville, New Jersey and Limerick, Pennsylvania. The bank also has a loan production office in Haddonfield, New Jersey and administrative offices in Cherry Hill, New Jersey. To learn more, call (877) 785-8550 or visit www.1stcolonial.com.

This release contains forward-looking statements that are not historical facts and include statements about management’s strategies and expectations about our business. There are risks and uncertainties that may cause our actual results and performance to be materially different from results indicated by these forward-looking statements. Factors that might cause a difference include the extent of the adverse impact of the current global coronavirus outbreak on our customers, prospects and business, as well as the impact of any future pandemics or other natural disasters; economic conditions including rising inflation and supply chain shortages; civil unrest, rioting, acts or threats of terrorism, or actions taken by the local, state and Federal governments in response to such events, which could impact business and economic conditions in our market area; unanticipated loan losses; inability to close loans in our pipeline; lack of liquidity; varying and unanticipated costs of collection with respect to nonperforming loans; an inability to dispose of real estate owned; changes in interest rates, changes in FDIC assessments, deposit flows, loan demand, and real estate values; changes in relationships with major customers; operational risks, including the risk of fraud by employees, customers or outsiders; competition; changes in accounting principles, policies or guidelines; changes in laws or regulations and in the manner in which the regulators enforce same; new technology and other factors affecting our operations, pricing, products and services.

Contacts

Mary Kay Shea, 856‑885‑2391

Categories
Business Science

ENHERTU® granted Breakthrough Therapy Designation in U.S. for patients with HER2 low metastatic breast cancer

  • Based on DESTINY-Breast04 results where Daiichi Sankyo and AstraZeneca’s ENHERTU demonstrated significant improvement in both progression-free survival and overall survival
  • ENHERTU has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers

 

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Patients with hormone receptor (HR) positive breast cancer should additionally have received or be ineligible for endocrine therapy.

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

 

The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

 

The FDA granted the BTD based on data from the pivotal DESTINY-Breast04 phase 3 trial where ENHERTU demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer with HR positive or HR negative disease versus physician’s choice of chemotherapy, which is the current standard of care. The positive topline results of DESTINY-Breast04 were recently announced and these data will be presented at an upcoming medical meeting.

 

The safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. Overall interstitial lung disease (ILD) rates were consistent with that observed in late-line HER2 positive breast cancer trials of ENHERTU with a lower rate of grade 5 ILD observed, as determined by an independent adjudication committee.

 

“Historically, only patients with HER2 positive metastatic breast cancer were shown to benefit from HER2 directed therapy. DESTINY-Breast04, in which ENHERTU showed a clinically meaningful survival benefit in patients with HER2 low metastatic breast cancer, is the first trial to demonstrate that selecting patients for treatment based on low expression of HER2 has the potential to change the diagnostic and treatment paradigms for these patients,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This Breakthrough Therapy Designation acknowledges the potential of ENHERTU to fulfill an unmet medical need and we look forward to working closely with the FDA to bring the first HER2 directed therapy to patients with metastatic breast cancer whose tumors have lower levels of HER2 expression.”

 

“Today’s news is a significant validation of the potential we see for the historic DESTINY-Breast04 trial to enable a paradigm shift in how breast cancer is classified by targeting the full spectrum of HER2 expression,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “ENHERTU continues to show transformative potential, and this milestone represents an important advance for patients with HER2 low metastatic breast cancer who are in urgent need of new treatment options and better outcomes.”

 

This is the third BTD for ENHERTU in breast cancer. ENHERTU previously received BTDs for the treatment of second-line HER2 positive metastatic breast cancer in 2021 and later-line HER2 positive metastatic breast cancer in 2017. Two additional BTDs for ENHERTU also have been granted in 2020 for HER2 mutant metastatic non-small cell lung cancer (NSCLC) and HER2 positive metastatic gastric cancer.

 

About DESTINY-Breast04

DESTINY-Breast04 is a global, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR positive (n=480) or HR negative (n=60), unresectable and/or metastatic breast cancer with low HER2 expression previously treated with one or two prior lines of chemotherapy. Patients were randomized 2:1 to receive either ENHERTU or chemotherapy.

 

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomized patients (HR positive and HR negative disease), OS in patients with HR positive disease and OS in all randomized patients (HR positive and HR negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety.

 

DESTINY-Breast04 enrolled approximately 540 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

 

About Breast Cancer and HER2 Expression

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the U.S.1,2 More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 In the U.S., more than 290,000 new cases are expected to be diagnosed in 2022, resulting in more than 43,000 deaths.3

 

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers, and is one of many biomarkers expressed in breast cancer tumors.4

 

HER2 expression is currently defined as either positive or negative, and is determined by an IHC test which measures the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.4,5 HER2 positive cancers are defined as IHC 3+, IHC 2+/ISH+.4 HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.4 Up to half of all patients with breast cancer have tumors with a HER2 IHC score of 1+, or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2 targeted therapy.6,7,8,9 Low HER2 expression occurs in both HR positive and HR negative disease.10

 

HER2 testing is routinely used to determine appropriate treatment options for patients with metastatic breast cancer. Targeting the lower range of expression in the HER2 spectrum may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.11 Currently, chemotherapy remains the only treatment option both for patients with HR positive tumors following progression on endocrine (hormone) therapy.12 Few targeted options are available for those who are HR negative.13

 

About ENHERTU

ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

 

ENHERTU (5.4 mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens based on the results from the DESTINY-Breast01 trial.

 

ENHERTU (6.4 mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

 

ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity. For more information, please see the accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

 

About the ENHERTU Clinical Development Program

A comprehensive global development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

 

Regulatory applications for ENHERTU are currently under review in Europe, Japan, U.S. and several other countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

 

ENHERTU also is currently under review in the U.S. for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy based on the results from the DESTINY-Lung01 trial, and in Europe for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2 based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

 

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan.

 

U.S. Important Safety Information for ENHERTU

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

  • Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

    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 a confirmatory trial.

  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY
  • Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
  • Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Metastatic Breast Cancer

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

Locally Advanced or Metastatic Gastric Cancer

In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Metastatic Breast Cancer

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7% of patients.

Locally Advanced or Metastatic Gastric Cancer

In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.

Adverse Reactions

Metastatic Breast Cancer

The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (79%), white blood cell count decreased (70%), hemoglobin decreased (70%), neutrophil count decreased (62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate aminotransferase increased (41%), alanine aminotransferase increased (38%), platelet count decreased (37%), constipation (35%), decreased appetite (32%), anemia (31%), diarrhea (29%), hypokalemia (26%), and cough (20%).

Locally Advanced or Metastatic Gastric Cancer

The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months (range: 0.5 to 13.1) in the irinotecan/paclitaxel group.

Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%).

ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (75%), white blood cell count decreased (74%), neutrophil count decreased (72%), lymphocyte count decreased (70%), platelet count decreased (68%), nausea (63%), decreased appetite (60%), anemia (58%), aspartate aminotransferase increased (58%), fatigue (55%), blood alkaline phosphatase increased (54%), alanine aminotransferase increased (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), blood bilirubin increased (24%), pyrexia (24%), and alopecia (22%).

Use in Specific Populations

  • Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
  • Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
  • Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
  • Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
  • Geriatric Use: Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.

Contacts

Global:
Victoria Amari

Daiichi Sankyo, Inc.

vamari@dsi.com
+1 908 900 3010 (mobile)

US:
Don Murphy

Daiichi Sankyo, Inc.

domurphy@dsi.com
+1 917 817 2649 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Read full story here

Categories
Business Regulations & Security

Seoul Semiconductor files patent infringement lawsuits against Philips TV and Filament LED bulbs in Europe and U.S.

ANSAN, South Korea — (BUSINESS WIRE) — #Acrich—Seoul Semiconductor Co., Ltd. “(Seoul),” a leading global innovator of LED products and technology, announced that, in April 2022, it has launched patent infringement lawsuits against Ace Hardware, a global retail company, in the U.S., and, in Europe, against a distributor of Conrad Electronic’s sales platform.


In the two cases, which are pending in the U.S. District Court for the Eastern District of Virginia and the German District Court of Düsseldorf, Seoul asserted infringement of its patents by Philips brand TVs, filament LED bulbs, and premium lighting products. Seoul also sought a recall of infringing products as well as the destruction of those products in the German case.

 

In these lawsuits, Seoul’s patents cover phosphor technology for high-quality color gamut and WICOP technology.

 

Seoul has developed its phosphor technology together with a Japanese company (“M”) over 15 years and has succeeded in producing LED lights that are the closest spectrum to natural light. Based on the quality of these lights, which is recognized in the industry, Seoul’s phosphor technology can be found in premium lighting products requiring more than CRI (color rendering index) 90, as well as display products.

 

WICOP is a revolutionary patented technology that is compactly designed without wire bonding or packaging, thus enabling LEDs to be mounted directly in a PCB assembly. WICOP technology has been adopted in over 100 car models, which is approximately 10% of the global automobile market. It is also widely used in about 20% of the global TV market as of 2020.

 

Seoul has already successfully obtained permanent injunctions against various infringing products several times in Europe and the U.S. In September 2020, the German District Court of Düsseldorf issued permanent injunctions, an order of recall and destruction against filament LED bulbs manufactured by a Phillips brand affiliate. In 2019 and 2021, the U.S. District Court for the Central District of California and the New Jersey District Court issued permanent injunctions against the sales of a Philips TV product and 13 automotive lighting brand LED products respectively.

 

“While global companies emphasize corporate responsibility, such as ESG, many companies still use copycat products that stole others’ hard-earned technology in order to gain short-term profits,” said Myeong-Ki Hong, CEO of Seoul. “It is a pity that there are unethical companies that seek profits at the expense of others’ sweat and tears,” he added.

 

About Seoul Semiconductor

Seoul Semiconductor is the world’s second-largest global LED manufacturer, a ranking excluding the captive market, and has more than 10,000 patents. Based on a differentiated product portfolio, Seoul offers a wide range of technologies, and mass produces innovative LED products for indoor and outdoor lighting, automotive, IT products, such as mobile phones, computer displays, and other applications, as well as the UV area. The company’s world’s first development and mass production products are becoming the LED industry standard and leading the global market with a package-free LED, WICOP; a high-voltage AC-driven LED, Acrich; an LED with 10X the output of a conventional LED, nPola; a cutting edge ultraviolet clean technology LED, Violeds; an all direction light emitting technology, filament LED; a natural sun spectrum LED, SunLike; and more. For more information, please visit www.seoulsemicon.com/en.

Contacts

Seoul Semiconductor Co., Ltd.
Jinseop Jung

Tel: +82-70-4391-8555

Email: jjs8732@seoulsemicon.com

Categories
Business Lifestyle Local News Science

BeiGene breaks ground on new manufacturing and clinical R&D center at the Princeton West Innovation Campus in New Jersey

Flagship U.S. Facility Will Include Biologic Manufacturing and Late Stage Research and Clinical Development of Innovative Cancer Medicines

 

Sixth U.S. Location Adds to Global Expansion and Brings New Jobs to New Jersey

 

HOPEWELL, N.J. & CAMBRIDGE, Mass. & BASEL, Switzerland & BEIJING — (BUSINESS WIRE) — $BGNE #BeiGene—BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced the groundbreaking of its flagship U.S. manufacturing and clinical R&D center at the Princeton West Innovation Campus in Hopewell, N.J.

“Our planned flagship U.S. R&D and manufacturing center supports our commitment to fight for life for people living with cancer around the world, through state-of-the-art commercial-stage biologic pharmaceutical manufacturing, late-stage research and clinical development capabilities,” said John Oyler, Co-Founder, Chairman and CEO of BeiGene. “The Princeton-Hopewell area is an excellent location for BeiGene and the thriving life science community, with a deep talent pool as we continue to advance our pipeline of innovative cancer medicines and work to diversify our global supply chain.”

 

The initial phase of construction is expected to include approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing space, with capacity for up to 16,000 liters of biologics formula. BeiGene intends to recruit hundreds of new hires from the area’s attractive talent market to support its continued growth and its commitment to producing life-saving oncology medicines.

 

“BeiGene’s plans for hundreds of new jobs in New Jersey speak to our efforts to grow our state’s business-friendly environment and to our commitment to fostering innovation,” said Governor Phil Murphy. “We are proud to welcome BeiGene to the Princeton area and look forward to the company manufacturing innovative cancer medicines in its new state-of-the-art facility.”

 

In November 2021, BeiGene acquired the Hopewell property from Lincoln Equities Group and has retained DPR Construction as its construction management firm and IPS-Integrated Project Services, LLC as its architectural and engineering firm. The property has more than one million square feet of developable real estate for future potential expansion.

 

Added Oyler: “At BeiGene, we are committed to not only delivering innovative and affordable medicines but also to upholding the highest standards of ethics and integrity, operational excellence, and environmental stewardship. This commitment applies to everything we do, including the development of BeiGene’s Hopewell project.”

 

“As a leader with a long history in New Jersey’s biotech industry, Hopewell Township welcomes BeiGene to our community,” said Hopewell Mayor Courtney Peters-Manning “We are pleased that BeiGene will bring their state-of-the-art technologies, manufacturing, and R&D center to Hopewell, whose products will help countless people all over the world. We look forward to continuing to work with BeiGene and are excited about what will be produced here in Hopewell.”

 

BeiGene currently has five offices in the U.S., in San Mateo and Emeryville, Calif., Cambridge, Mass., Ridgefield Park, N.J. and Fulton, Md. Globally, the company has more than 30 offices across five continents.

 

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

 

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

 

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

 

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s plans to establish a new manufacturing and clinical R&D center in New Jersey and to manufacture commercial-stage medicines and drug candidates at the site and to diversify its global supply chain, the expected timing for construction, the expected size and capacity of the site and potential for future expansion, BeiGene’s anticipated investment in and recruiting and hiring of talent for the new manufacturing and R&D center, BeiGene’s commitment to upholding the highest standards of ethics and integrity, operational excellence, and environmental stewardship, and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Contacts

Investors

Kevin Mannix

+1 240-410-0129

ir@beigene.com

Media
Kyle Blankenship

+1 667-351-5176

media@beigene.com

Categories
Business News Now! Perks

New Jersey’s leading retail destination gives small businesses a leg up

Westfield Garden State Plaza Partners with the NJ Small Business Development Center Bringing Main Street Proprietors to the Main Stage


PARAMUS, N.J. — (BUSINESS WIRE) — #smallbusiness — Westfield Garden State Plaza is launching an initiative that gives small, locally-owned businesses, especially minority- and women-owned businesses, the opportunity to showcase their goods and services alongside America’s most recognized brands. Well-known as a destination for uber-shoppers on both sides of the Hudson River, Garden State Plaza has joined forces with the NJ Small Business Development Center at Ramapo College to provide mom and pop retailers with something that until now was unattainable – retail space in one of the country’s busiest malls.

 

“Special leasing terms like a 3-month lease vs. the typical 10–15-years that larger retailers generally commit to are just some of big benefits for small business,” says Chris Neidhardt, Director of Leasing for Westfield Garden State Plaza. “Our goal for the program is to elevate awareness for mom and pop businesses and in addition, to shine a spotlight on women and minority-owned businesses. The way we see it, it’s like bringing main street to the main stage.”

 

The value of such an opportunity is multi-faceted with Garden State Plaza offering exposure to continuous foot traffic, ample parking, internal security and available inventory that is move- in ready.

 

According to Vincent Vicari, regional director of the New Jersey Small Business Development Center, based at Ramapo College, “We may be two separate entities, but our shared vision to see entrepreneurial businesses thrive and prosper is what’s led us to join forces. A key objective of the partnership is to mentor these businesses to a point where they’ll be able to sign longer leases as their viability and profitability allow.” Participants in the program will receive the valuable support that the NJ Small Business Development Center can provide including assistance with strategic marketing, development and execution of a sound business plan, and counseling regarding available funding resources.

 

Chic Sugars is currently open and is the first business to debut as a result of the program. Tonnie’s Minis will be opening in early May and several other leases are under review. Erika Oldham, proprietor of Chic Sugars, is known for her cake creations to the stars with celebrity clients like Jay-Z, Missy Elliott, and Nicki Minaj, to name a few. She recently appeared on Food Network’s “Winner Cake All” and had this to say as she anticipates her presence at the mall, “I’m looking forward to expanding my customer base beyond my storefront bakery in Englewood, while also diversifying my product offerings to more bite-sized items that mall shoppers can enjoy on-the-go.”

 

Tonnie Rozier is the proprietor of Tonnie’s Minis currently with locations in Newark and Edgewater. “This is a sign of positive growth for me and my brand as it not only signals a second location, but also an expanded demographic that will be exposed to my signature cupcakes.” Tonnie’s is known for its unique bakery concept, offering customers the opportunity to first select a cupcake flavor, then customize the final product by choosing from an array of icing and topping options. “It’s so rewarding to observe the customer satisfaction that comes from participating in the creation of your own personalized confection.” Tonnie’s Minis has been featured on Food Network’s Cupcake Wars and The Wendy Williams Show.

 

“For many small businesses, this is an opportunity to transform a lifelong dream into reality, by debuting a concept or expanding an existing one alongside the biggest names in retail,” said Tiffany Ramirez, marketing manager at Westfield Garden State Plaza. “We hope that this program can be successfully replicated at other Westfield centers around the country.” Unibail-Rodamco-Westfield currently operates 24 malls across the US.

 

About Westfield Garden State Plaza

Westfield Garden State Plaza (GSP) is the ultimate destination for fashion, dining and entertainment located just minutes from Manhattan. Anchored by Neiman Marcus, Nordstrom and Macy’s, the property features the Luxury Collection of Shops and premium fashion district alongside the best brands in every retail category and includes Louis Vuitton, Gucci, Tiffany & Co., Salvatore Ferragamo, Burberry, Versace, Tory Burch, BOSS, Design Within Reach, Tesla, ZARA, NARS, Fabletics, and Apple. Approximately 20 million shoppers per year enjoy an unparalleled shopping and dining experience, personalized services and amenities at GSP.

Contacts

Lisa Hermann

Senior Director of Marketing

201-843-2121

Lisa.Hermann@urw.com

Tiffany Ramirez

Marketing Manager

201-221-0414

Tiffany.Ramirez@urw.com

Categories
Business Culture

Golden Peak Media names Farrell McManus Chief Sales Officer

Executive brings deep media experience

 

GOLDEN, Colo. — (BUSINESS WIRE) — #leadership — Jeffrey Litvack, CEO of Golden Peak Media, today announced the appointment of Farrell McManus to Chief Sales Officer. Farrell will lead the sales, success and support teams focused on building deeper relationships with the company’s community of crafters, artists, and partners serving this community. Farrell’s appointment parallels the company’s upmarket trajectory and evolving business opportunities for Golden Peak Media.

 

Before joining Golden Peak Media, Farrell held executive positions with media, technology and professional service companies. Most recently, he led business development and marketing teams at law firms Norris McLaughlin and Stroock & Stroock & Lavan LLP, bringing innovation to their client engagement and vendor management efforts. In addition, he spearheaded diversity efforts at both firms pushing for more inclusive hiring and client outreach efforts. As Associate Publisher at ALM Media he oversaw the New York Law Journal, New Jersey Law Journal, and the Connecticut Law Tribune and was integral in the transformation of ALM’s regional brands’ offerings from predominantly print programs to digital, face-to-face, and research-based initiatives that grew revenue and profitability.


“We’ve seen sustained growth over the past three years and are continuing to accelerate our move upmarket and are excited to add Farrell, a leader with a deep understanding of what it takes to transform sales processes and organizations,” Golden Peak Media CEO Jeff Litvack said.

 

“This is an unprecedented time in the world of creators and makers. Over the last two years, we have seen a surge of people around the world finding their creative side in a range of pursuits. I’m looking forward to working with Jeff and the team at Golden Peak to increase and diversify our offerings, awareness and reach in these rapidly growing communities of creators and makers,” McManus said.

 

About Golden Peak

Golden Peak Media is one of the largest media and education companies serving Art and Craft enthusiasts in the U.S. The Company publishes 15 magazines, including Love of Quilting and Artists Magazine, and has more than 5000 digital videos and 15,000 digital patterns. More information can be found at www.goldenpeakmedia.com.

Contacts

Kimberly Greenlee, kgreenlee@goldenpeakmedia.com

Categories
Business Education Sports & Gaming

Clifford ‘Big Cliff’ Omoruyi signs with IPZ for NIL representation

TEWKSBURY, N.J. — (BUSINESS WIRE) — Clifford “Big Cliff” Omoruyi, a 6’11″ student athlete at Rutgers University, has signed with IPZ under the NCAA’s NIL rules.

Omoruyi is originally from Benin City, Nigeria, and came to New Jersey as a 14-year-old old seeking an education and a college degree. Basketball was a tool that he hoped would help him achieve his goal. He began his high school career at Queen of Peace (North Arlington) and ended it by leading Roselle Catholic to a 22-7 record and an NJSIAA Non-Public B North title in a season that was cut short due to the Covid shutdown.

 

Omoruyi was a consensus four-star prospect in high school and became the first New Jersey Gatorade Player of the Year to commit to Rutgers University. He was also the first top-50 High School prospect to commit to Rutgers since 2010. In the 2020-21 season he became the first Rutgers freshman since 2008 to record a double-double in his debut, while, in the classroom, making the Dean’s List for academic excellence.

 

Omoruyi had a breakout campaign as a sophomore. As the starting center for the entire season, he led NCAA Division 1 basketball in dunks, while averaging 11 points, 7.9 rebounds, and 1.3 blocks per game.

 

“I saw Cliff play in high school and was immediately drawn to his smile…his love for his teammates…and of course his game,” said Robert Zito, IPZ managing partner. “This is a young man who exhibits discipline, loyalty, teamwork and ‘getting it done’ in the classroom and on the court. With a 3.5 GPA and his work representing Rutgers and New Jersey on the basketball court, Cliff has been a phenomenal asset to both the school and the state.”

 

In 2021 the NCAA officially announced a new NIL policy that allows athletes to be compensated for their name, image, and likeness. However, the law remains unclear as it translates to international students in the United States on F-1 student visas.

 

Prominent New Jersey attorney Peter Till has been engaged to navigate the complexity of the F-1 student visa issues as it relates to Cliff and other New Jersey and United States college athletes.

 

“‘This law firm could not be prouder to preserve and protect all of Cliff’s opportunities that are only available in America,” said Till. “There is a clear and unmistakable reason why so many students come to these shores because of the unparalleled opportunities for greatness that can only happen in this country. We will seek and explore every opportunity to obtain the benefits of hard work available to student athletes today, including the foreign student-athletes who are unquestionably and utterly accomplished on behalf of their respective colleges and universities.”

 

“I sincerely appreciate the work that IPZ and Mr. Till are doing on my behalf,” said Cliff Omoruyi. “I know that they have met with Rutgers and that my school is supportive. I hope to have the ability to use my personality, knowledge, work as a student in the classroom and my basketball acumen to help brands in New Jersey…the United States…and the world.”

 

About IPZ: IPZ represents clients in sports, media, and entertainment, providing management, contract negotiations, consulting, public relations and marketing communications support. The company, an alliance with Zito Partners, is built on the integrity of its professionals, maintains a family focus, and provides whole life solutions for its clients. For more information, visit www.ipzusa.com

Contacts

Robert Duggan

rduggan@ipzusa.com
917-243-3406

Categories
Business Culture Lifestyle

Samsung Solve for Tomorrow National Winners tackle food waste, crowd stampedes and bus driver shortages

New Jersey, Texas, and Virginia schools awarded $100,000 each in technology in 12th annual $2 million STEM competition

 

RIDGEFIELD PARK, N.J. — (BUSINESS WIRE) — After a two-year virtual hiatus resulting from the COVID-19 global pandemic, Samsung Electronics America, Inc. announced the three National Winners of the 12th annual $2 million* Samsung Solve for Tomorrow Contest during an in-person event at Samsung 837 in Manhattan. Students from across the country convened both in-person, virtually and in the metaverse via 837x to present how they used STEM (science, technology, engineering and math) skills to address local issues and inspire change in their communities. Selected from 10 finalists, the National Winners will receive $100,000 in Samsung technology and classroom supplies.


Over the course of the school year, middle and high students have worked to develop sustainable projects using problem-based learning to address issues in their local community from climate change to public transportation and mobility. These innovations, developed by bright young minds, demonstrate how STEM learning can take an idea and transform a community, while empowering students to make a difference despite the adversities they may face.

 

“We are thankful to have the opportunity to recognize such a remarkable group of inspiring and innovative Solve for Tomorrow students in person after a two-year virtual hiatus,” said Ann Woo, Senior Director of Corporate Citizenship at Samsung Electronics America. “These students continue to tackle problems of national importance with extraordinary solutions. We look forward to seeing our Samsung Solve for Tomorrow students continue to make a difference in our world in the years to come.”

 

The three National Winners in the 12th annual Samsung Solve for Tomorrow Contest and their grand prize-winning STEM innovations are:

 

1. Princeton High School – Princeton, New Jersey

Food waste is the third-largest contributor to greenhouse gas emissions and Princeton, NJ does not have any specialized municipal collection of organic waste. Therefore, most of the food that is not consumed within the community is thrown into the garbage and ultimately winds up in landfills. To combat the overproduction of greenhouse gas emissions in landfills, the students utilized technology, and the black soldier fly to bioremediate food waste into usable products such as protein for animal feed and as a substitute for palm oil in cosmetics like soap.

 

Princeton High School was also named the Samsung Employee Choice Award Winner, winning an additional $10,000, bringing their total to $110,000 in technology for their school.

 

View Princeton High School’s project video here: https://youtu.be/VmYo5etiWII

 

2. Porter High School – Porter, Texas

To help get students to safety and prevent crowd panic caused by an active shooter, or the threat of one, students from Porter High School developed an evacuation system to address crowd stampedes. First, a mesh network of microcontrollers will detect if there is an active shooter and relay that information. Second, if an evacuation is necessary, the microcontrollers will activate a color-coded system of lights and arrows located along the floor and walls of the hallways that will convey the most expedient and safest route out of the area to help reduce panic.

 

View Porter High School’s project video here: https://youtu.be/wcbbE-mirAA

 

3. Great Bridge High School – Chesapeake, Virginia

When faced with an unreliable public transportation system, students from Great Bridge High School developed AcceleRoute, a system to help bus drivers construct personalized and efficient routes determined by the students they are transporting on a given day. As the students board the bus, they scan a programmed card that connects to an app that will determine the most efficient route to transport all students to their homes.** The system increases efficiency and bus ridership while reducing greenhouse gas emissions.

 

Great Bridge High School was also named the Community Choice Award Winner, winning an additional $10,000 bringing their total to $110,000 in technology for their school.

 

View Great Bridge High School’s project vide here: https://youtu.be/hRYP3k1S8iM

 

New this year, Samsung partnered with the North American Association for Environmental Education (NAAEE) for the first Solve for Tomorrow Sustainability Innovation award, furthering Samsung’s commitment to sustainability. This year, Central Falls High School from Central Falls, Rhode Island, was selected as the winner by a committee of judges for addressing environmental justice and redeveloping abandoned areas to increase urban greenery.. The school was awarded a $10,000 in energy efficient Samsung technology prize package of products to help bring their project idea to life.

 

“NAAEE is proud to collaborate with Samsung for the Solve for Tomorrow Contest to select a Sustainability Innovation Award Winner,” said Judy Braus, Executive Director NAAEE. “The students at Central Falls High School exemplified the thoughtful and community-focused innovation we need to create an equitable and sustainable future for all. It was inspirational to see how so many of the projects tackled environmental challenges and highlighted the power of teamwork, creative problem solving, and passion in creating positive community change.”

 

As part of Samsung’s guiding vision of ‘Together for Tomorrow! Enabling People’, Solve for Tomorrow launched in 2010 to encourage innovative thinking, creative problem-solving and teamwork to address the most pressing issues impacting society. Today, the competition fosters critical thinking and creative problem solving, anchored in problem-based learning. For the past decade, Samsung has awarded $20 million in technology and classroom materials to more than 2,500 public schools in the United States.

 

To learn more about the National Finalist schools, please visit www.samsung.com/solve or follow on Instagram @SolveForTomorrow. For official rules and judging criteria, click here.

 

*$2 million prize is based on an estimated retail value.

**The school is responsible for ensuring the proper handling and security of all data potentially shared and/or collected as part of their project. Samsung takes privacy very seriously and encourages all Semi-Finalists to consider how information that is part of their project is being handled.

 

About Samsung Electronics America, Inc.

Headquartered in Ridgefield Park, N.J., Samsung Electronics America, Inc. (SEA) is a leader in mobile technologies, consumer electronics, home appliances and enterprise solutions. The company pushes beyond the limits of today’s technology to provide groundbreaking connected experiences across its large portfolio of products and services, including mobile devices, home appliances, home entertainment, 5G networks, and digital displays. As EPA’s ENERGY STAR® Corporate Commitment Partner, SEA is dedicated to making a positive impact on the environment through its eco-conscious products, practices and operations. To learn more and to get involved, visit Samsung.com. For the latest News visit news.samsung.com/us and follow @SamsungNewsUS. SEA is a wholly owned subsidiary of Samsung Electronics Co., Ltd.

 

About Samsung Electronics Co., Ltd.

Samsung inspires the world and shapes the future with transformative ideas and technologies. The company is redefining the worlds of TVs, smartphones, wearable devices, tablets, digital appliances, network systems, and memory, system LSI and LED solutions. For the latest News please visit the Samsung Newsroom at http://news.samsung.com.

Contacts

Cat Lyons

Allison+Partners for Samsung

SamsungSFT@allisonpr.com

Categories
Business Lifestyle

Premier Specialties, Intarome and Fragrance Solutions unite as OnScent

MIDDLESEX, N.J. — (BUSINESS WIRE) — Premier Specialties, Intarome and Fragrance Solutions—companies with solid reputations for innovation and customer-centricity—are joining forces under a new name, OnScent.

 

 

As OnScent, the unification expands the companies’ abilities to provide the fragrance solutions, expertise, responsiveness, and infrastructure that innovative Consumer Package Goods (CPG) brands, contract manufacturers and private-label manufacturers need to accelerate success.

 

“The combined strengths, talent and long-standing customer relationships of Premier Specialties, Intarome and Fragrance Solutions will enable us to become a disruptive force in the industry,” said Bertrand Lemont, OnScent CEO. “We provide the creativity, science, market intelligence and regulatory expertise our customers need to deliver authentic solutions that differentiate their brands, delight their customers and enable category leadership.”

 

OnScent will maintain fragrance research, creation, production, and distribution through two state-of-the-art facilities in Middlesex, NJ (formerly Premier Specialties) and Norwood, NJ (formerly Intarome).

 

“OnScent is passionately devoted to creating unique and authentic fragrance and natural cosmetic solutions that are consistently on brand, on brief and on trend,” said Lemont. “Our team has the expertise, creativity, and commitment to operational excellence that product innovators need. We deliver solutions through a partnership model that is based on trust, transparency, and mutual success.”

 

About OnScent

OnScent partners with product innovators to create fragrance and natural cosmetic solutions that accelerate your success. Our multi-disciplinary team of fragrance industry experts combine creativity, science, market intelligence and regulatory expertise to deliver authentic solutions that differentiate your brands, delight your customers, and enable product leadership. Visit OnScent.com.

Contacts

Contact: Rosita Presti, OnScent

Phone: 201.450.1691

Email: rpresti@OnScent.com