Market Newsdesk

TAIPEI and MILPITAS, Calif., Nov. 17, 2020 /PRNewswire/ — Silicon Motion Technology Corporation (NasdaqGS: SIMO) (“Silicon Motion”), a global leader in designing and marketing NAND flash controllers for solid-state storage devices, today announced the SM8266, a complete enterprise-grade 16-channel PCIe 4.0 NVMe hardware plus firmware turnkey SSD controller solution.  Customers can rapidly develop and bring to market enterprise SSDs for data centers by using our complete development platform that includes a turnkey NVMe firmware stack and hardware reference design kit.

“Our solution is the only complete PCIe Gen4 turnkey solution available today from an established merchant controller supplier,” said Nelson Duann, Silicon Motion’s Senior Vice President of Marketing and R&D.  “Since the introduction of our PCIe Gen3 turnkey solution, we have established a longer track record of supplying turnkey solutions in terms of customer adoption and sale volume than any other company.  Our Shannon Systems team is already custom designing enterprise-grade NVMe, Open-Channel and Key-Value SSDs using SM8266 for hyperscale customers’ data centers with production expected in 2021.”

Advanced turnkey enterprise SSD controller solution

The SM8266 controller solution features Silicon Motion’s state-of-the-art firmware and hardware technology to provide consistent, low latency QoS domains.  Offering capacity up to 16TB with 16 NAND flash channels, the SM8266 is designed to support the latest 3D TLC and QLC NAND flash technologies.  To ensure enterprise level reliability, data integrity and retention at PCIe Gen4 performance, the SM8266 is equipped with Silicon Motion’s proprietary technologies including:

• 6^th generation NANDXtend™ technology, which incorporates machine learning algorithms supporting Silicon Motion’s proprietary high-performance LDPC error correction code (ECC) engine with RAID, ensuring better data integrity even in extreme operating environments.
• End-to-end data path protection, which applies ECC to the SSD’s SRAM and DRAM buffers as well as to the primary NAND flash memory array. This maintains data integrity as data is transmitted between the host and the SSD, and between buffer memories and NAND flash.
• Power loss protection, which eliminates the risk of data loss in the event of an unexpected power outage.

Other features of SM8266 include:

• High performance PCIe Gen4 x4 & NVMe 1.4 compliance
• Turnkey stacks enable standard NVMe SSD as well as proprietary Open-Channel and Key-Value SSD implementations
• Support for up to 16TB of physical NAND capacity
• Low and consistent latency enabled by physical and logical isolation
• Ultra-high sequential read performance of up to 6.5GB/s and 950K sustained random read IOPS
• Data security with AES 256-bit hardware supporting SED, Secure Boot and TCG Opal

Silicon Motion will showcase SM8266 at SC Virtual from November 17 to 19. https://cdmcd.co/5YAKp6 

SM8266 video: https://www.youtube.com/watch?v=GM_OLtymubw

About Silicon Motion:

We are the global leader in supplying NAND flash controllers for solid state storage devices and the merchant leader in supplying SSD controllers.  We have the broadest portfolio of controller technologies and our controllers are widely used in storage products such as SSDs and eMMC+UFS devices, which are found in data centers, PCs, smartphones, and commercial and industrial applications. We have shipped over six billion NAND controllers in the last ten years, more than any other company in the world.  We also supply customized high-performance hyperscale data center and industrial SSD solutions.  Our customers include most of the NAND flash vendors, storage device module makers and leading OEMs.  For further information on Silicon Motion, visit us at www.siliconmotion.com.

Corporate Media Contact:  

Minnie Lin    
Director of Marketing Communication      
Tel: +886 2 2219 6688 x3010    
E-mail: [email protected]

Sales & Marketing Communications Contact:

Robert Fan

President of SMI USA
Tel: +1 408 519 7219
E-mail: [email protected]

Investor Contact:

Chris Chaney

Director, Investor Relations & Strategy
Tel: +1 561 866-9173
E-mail: [email protected]

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SOURCE Silicon Motion Technology Corporation

TEL AVIV, Israel and RALEIGH, N.C., Nov. 17, 2020 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat)[1] in patients with symptomatic COVID-19 who do not require hospitalization.

“This is a significant milestone in our efforts to combat the effects of the COVID-19 pandemic. The ability to treat patients earlier in the course of COVID-19 disease, using an oral therapy that enables treatment outside of a hospital setting, is of critical importance given the large proportion of patients that are not hospitalized but are still very much at risk of disease progression,” said Terry F. Plasse MD, Medical Director at RedHill. “With RHB-107 and opaganib[2], RedHill has two novel, late-stage, oral therapeutic candidates with potential to reduce the impact of COVID-19 disease, both of which target host cell components, potentially minimizing the likelihood of resistance due to emergence of viral mutations.”

RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make it a promising candidate for evaluation as a treatment for COVID-19 disease. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial cell model and its safety profile has been demonstrated in approximately 200 people, including in Phase 2 studies in oncology indications. RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma AG (FWB: HPHA, formerly Wilex AG).

The randomized, parallel-group double-blind Phase 2/3 study is expected to start enrolling patients early next year. The study will enroll patients with symptomatic diagnostically confirmed COVID-19 who do not require inpatient care. RHB-107 will be administered once daily for 14 days, with patients receiving follow-up for eight weeks from first dosing. The primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.

The late-stage development program for RedHill’s other COVID-19 candidate, opaganib, in patients with severe COVID-19 pneumonia includes: The U.S. Phase 2 study (NCT04414618) is now fully enrolled and expected to report topline data in the coming weeks; and the global Phase 2/3 study (NCT04467840) which is more than 50% enrolled and is on track to enroll up to 270 patients and report topline data in support of potential emergency use applications in the first quarter of 2021. Both studies are randomized, double-blind, parallel-arm, placebo-controlled trials with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

About RHB-107 (upamostat)

RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make it a strong candidate for evaluation as a treatment for COVID-19 disease. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases, and has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany’s Heidelberg Pharmaceuticals (formerly WILEX AG) for all indications.

About RedHill Biopharma    

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik^® for opioid-induced constipation in adults with non-cancer pain^[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults^[4], and Aemcolo^® for the treatment of travelers’ diarrhea in adults^[5]. RedHill’s key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva^®), a first–in–class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (iv) RHB-102 (Bekinda^®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB–106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

 This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that enrollment in the company’s Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, the risk that the Company’s Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia^®; (v) the Company’s ability to successfully commercialize and promote Movantik^®, Talicia^® and Aemcolo^®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

[1] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

[2] Opaganib is an investigational new drug, not available for commercial distribution

[3] Full prescribing information for Movantik^® (naloxegol) is available at: www.Movantik.com.  

[4] Full prescribing information for Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

[5] Full prescribing information for Aemcolo^® (rifamycin) is available at: www.Aemcolo.com.

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SOURCE RedHill Biopharma Ltd.

INDIANAPOLIS and INCHEON, South Korea, Nov. 17, 2020 /PRNewswire/ — Samsung Biologics’ partnership with Eli Lilly and Company is expected to greatly accelerate the global supply for Lilly’s COVID-19 antibody therapies through a long-term manufacturing agreement, with the ultimate goal of making antibody treatments more globally accessible for patients.

Lilly’s success in developing neutralizing antibodies against COVID-19, augmented with Samsung Biologics’ manufacturing scale, signals a major move forward in delivering important treatments to patients suffering from the deadly pandemic.  

“Neutralizing antibodies are proving to be a potentially important tool in the fight against COVID-19, and the biopharmaceutical industry is collaborating quickly and effectively to increase the global manufacturing supply,” said David A. Ricks, Lilly’s chairman and CEO. “This agreement with Samsung supplements Lilly’s own internal manufacturing capacity and greatly expands our ability to deliver Lilly antibody therapies to patients around the world.”

Lilly and Samsung Biologics entered into the manufacturing partnership agreement in May of 2020 to address the increasingly urgent demand for COVID-19 treatments worldwide. Despite the global challenges of securing stable supply of raw materials amid the pandemic, Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) meeting Good Manufacturing Practices (GMP) and regulatory expectations within 5 months of contract signing by leveraging the full force of both companies’ collaborative efforts. In addition, the timeline for tech transfer was reduced dramatically to less than 3 months, due in large part to close communications and coordination between technical, quality, supply chain, and regulatory experts from both companies.

“We are very pleased to deliver this product to our client Lilly in record breaking speed to aid in the war against the COVID-19 pandemic,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “Thanks to Lilly’s ongoing scientific efforts, patients suffering from this devastating disease are gaining new hope. Samsung Biologics is proud to be Lilly’s CDMO partner and will continue to work relentlessly and collaboratively with them to bring COVID-19 treatments to patients who need them the most, wherever they are.”

About Eli Lilly and Company
 

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity at a single site, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.

Lilly Forward Looking Statements

This press release contains forward-looking statements about the supply and use of Lilly antibodies to treat or prevent COVID-19 and reflects Lilly’s current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Lilly antibodies will prove to be safe and effective to treat or prevent COVID-19, that Lilly antibodies will receive regulatory approval, or that Lilly can provide an adequate supply of Lilly antibodies in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Samsung Biologics Forward Looking Statements

This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics’ objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.

Media Contacts:

Eli Lilly
 and Company

Mark E. Taylor; [email protected] 

Samsung Biologics

Claire Kim; [email protected] 

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SOURCE Samsung Biologics

ARLINGTON, Va., Nov. 17, 2020 /PRNewswire/ — The AES Corporation (NYSE: AES) today announced an agreement with Alberta Investment Management Corporation (AIMCo) to merge the sPower development platform, a leading independent solar developer in the US, with AES’ US-based clean energy development business to accelerate the safe, reliable transition to cleaner energy solutions in the country. AES’ wholly-owned clean energy development business includes AES Distributed Energy and a wind development team formerly part of Advance Energy. The merged business will represent one of the top renewables growth platforms. 

As states, communities and organizations of all types make commitments and plans to reduce their carbon footprints, renewables are on track to be the fastest-growing source of electricity generation in the US in 2020. AES is working with its customers to co-create and deliver the smarter, greener energy solutions that meet their needs, including 24/7 carbon-free energy.

“We share our customers’ commitments to a more sustainable energy future. Together, we can create a safe, resilient and carbon-free grid,” said Andrés Gluski, AES President and Chief Executive Officer. “The merger of sPower with AES’ clean energy business will benefit customers by providing access to a broader portfolio of product offerings as well as an expanded highly skilled and experienced team to drive innovation at scale.”  

“sPower has been one of our key infrastructure platforms since our initial investment made in partnership with AES in 2017,” stated Kevin Uebelein, Chief Executive Officer of AIMCo. “Our experience working with AES has shown that they are a world leader in delivering on customers’ sustainable energy needs, and the formation of this new renewables platform in the US will take that capability to an even higher level. On behalf of our clients and consistent with our investment mandate, we are excited about the value the next phase of our partnership will bring to our many stakeholders.”

The merged renewables platform will bring together sPower’s and AES’ differentiated capabilities in solar, wind and energy storage to accelerate our customers’ energy transitions.

“This platform will bring tremendous value to our customers as they pursue their business objectives and climate commitments,” said Leo Moreno, AES Clean Energy President.  “Our expanded portfolio of innovative solutions based on cutting-edge technologies will enable us to work together with our customers to power their energy transitions while making a carbon-free future possible.”

Future projects developed from the combined 12 gigawatts (GW) development pipeline will be owned 75% by AES and 25% by AIMCo, leveraging our successful partnership at sPower. Although there is no change in ownership of operating assets and backlog, the newly formed platform will manage the 2.5 GW of operating assets and the existing 2.6 GW contracted backlog. The transaction is expected to close in the next few months upon successful completion of customary closing conditions. 

More information about the available jobs in AES’ clean energy business is available at aesrenewablejobs.com.

About AES
The AES Corporation (NYSE: AES) is a Fortune 500 global energy company accelerating the future of energy. Together with our many stakeholders, we’re improving lives by delivering the greener, smarter energy solutions the world needs. Our diverse workforce is committed to continuous innovation and operational excellence, while partnering with our customers on their strategic energy transitions and continuing to meet their energy needs today. For more information, visit www.aes.com.

About AIMCo
AIMCo is one of Canada’s largest and most diversified institutional investment managers with more than $115 billion of assets under management. AIMCo was established on January 1, 2008 with a mandate to provide superior long-term investment results for its clients. AIMCo operates at arms-length from the Government of Alberta and invests globally on behalf of 31 pension, endowment and government funds in the Province of Alberta.

AIMCo’s Infrastructure and Renewable Resources group manages a portfolio of nearly $10 billion in infrastructure investments, comprised primarily of long-term equity positions in OECD-based infrastructure assets. These assets typically provide essential services to the public and are either regulated or have highly contracted revenues with the potential for long-term capital appreciation. AIMCo infrastructure investments are intended to match long duration real return asset characteristics with inflation-indexed pension liabilities.

For more information on AIMCo please visit www.aimco.ca.

About sPower
Headquartered in Salt Lake City, Utah, sPower is a leading independent power producer (IPP) that owns and operates a wind, solar, and storage portfolio. sPower is owned by a joint venture partnership between The AES Corporation (NYSE: AES), a Fortune 500 global power company, and the Alberta Investment Management Corporation (AIMCo), one of Canada’s largest and most diversified institutional investment managers.

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SOURCE The AES Corporation

TORONTO, Nov. 17, 2020 /PRNewswire/ – Corus Entertainment Inc. (TSX: CJR.B) announced today that its Board of Directors has declared quarterly dividends of $0.06 per Class B Share and $0.05875 per Class A Share payable on December 30, 2020, to shareholders of record at the close of business on December 15, 2020.

The foregoing dividends are designated as “eligible” dividends for the purpose of the Income Tax Act (Canada) and any similar provincial legislation.

Corus’ Board of Directors reviews the dividend on a quarterly basis. Shareholders are entitled to receive dividends only when any such dividends are declared by Corus’ Board of Directors and there is no entitlement to any dividend prior thereto.

Registered shareholders who are residents of Canada and who are not currently participating in Corus’ Dividend Reinvestment Plan (“the Plan”) may elect to participate in the Plan through the completion of an enrollment form which can be obtained from the Company’s plan administrator, AST Trust Company (Canada), on their website at www.astfinancial.com/ca-en or by calling 1.800.387.0825. The Plan allows eligible holders of Class A Shares and Class B Shares to acquire additional Class B Shares through reinvestment of the cash dividends paid on their respective shareholdings. Non-registered beneficial shareholders who are residents of Canada and who wish to join the Plan should consult their broker, financial institution or other intermediary through which they hold Class A Shares or Class B Shares.

Corus’ Board of Directors confirms that the Company will distribute shares purchased on the open market at no discount from the average market price to the Plan participants of record, as determined pursuant to the terms of the Plan.

There were 3,412,392 Class A Voting Shares and 204,954,666 Class B Non-Voting Shares outstanding on October 31, 2020.

Corus Entertainment Inc. reports in Canadian dollars.

About Corus Entertainment Inc.
Corus Entertainment Inc. (TSX: CJR.B) is a leading media and content company that develops and delivers high quality brands and content across platforms for audiences around the world.  Engaging audiences since 1999, the company’s portfolio of multimedia offerings encompass 34 specialty television services, 39 radio stations, 15 conventional television stations, a suite of digital assets, animation software, technology and media services. Corus is an established creator of globally distributed content through Nelvana animation studio, Corus Studios, and children’s book publishing house Kids Can Press. The company also owns innovative full-service social digital agency so.da, and lifestyle entertainment company Kin Community Canada. Corus’ roster of premium brands includes Global Television, W Network, HGTV Canada, Food Network Canada, HISTORY®, Showcase, Adult Swim, National Geographic, Disney Channel Canada, YTV, Global News, Globalnews.ca, Q107, Country 105, and CFOX. Visit Corus at www.corusent.com.

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SOURCE Corus Entertainment Inc.

ATLANTA, Nov. 17, 2020 /PRNewswire/ — UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VIMPAT^® (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older.¹ PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes.²

“These approvals underscore UCB’s commitment to people living with epilepsy and our focus on finding solutions for specific unmet needs within the epilepsy community,” said Mike Davis, Head of U.S. Neurology at UCB. “We are pleased that VIMPAT is now available as a treatment option for people living with primary generalized tonic-clonic seizures on their journey to seizure control.”

The PGTCS approval is based, in part, on results of a Phase 3 study recently published in the Journal of Neurology, Neurosurgery & Psychiatry.³  Adjunctive treatment with VIMPAT resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment period, with the corresponding risk reduction being 45% (p=0.001), and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo (31.3% vs 17.2%, p=0.011).

People living with generalized tonic-clonic seizures have an increased risk of injury⁴ and those who experienced three or more in one year had a fifteen-fold increased risk of sudden unexpected death in epilepsy.⁵

“The treatment of primary generalized tonic-clonic (convulsive) seizures is challenging, with about one-third of patients still being refractory while on therapy,” said David Vossler, MD, FAAN FACNS FAES, Department of Neurology, University of Washington, Seattle, USA. “Bolstered by a wealth of data demonstrating the efficacy and safety of VIMPAT, this new indication gives people suffering from PGTCS a chance at freedom from these seizures, which many have never experienced.”

Results from the Phase 3 study showed that VIMPAT was generally tolerated in patients with Idiopathic Generalized Epilepsy (IGE) and PGTCS. The most common adverse reactions (≥10%) reported in patients treated with VIMPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo.

Regarding the expanded pediatric population, VIMPAT tablets and oral solution were already approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy. VIMPAT injection was previously approved for the treatment of partial-onset seizures only in adult patients (17 years of age and older).

In October 2020, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIMPAT  as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy.⁶ Regulatory reviews for use of VIMPAT in the treatment of PGTCS are also underway in Japan and Australia.

About Epilepsy

Epilepsy is the main symptom of a variety of chronic disorders of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.⁷

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies, and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About UCB

UCB, Brussels, Belgium (www.ucb-usa.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or the central nervous system. With more than 7,600 people in approximately 40 countries, the company generated revenue of €4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

About VIMPAT^® (lacosamide) CV in the U.S.

¹

VIMPAT^® was approved in the U.S. in 2008 as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. VIMPAT was approved as monotherapy for adults in August 2014, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2017. VIMPAT is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.

INDICATION

VIMPAT^® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

• Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including VIMPAT, increase the risk of suicidal behavior and ideation. Monitor patients taking VIMPAT for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to the healthcare provider.
• Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia in adult and pediatric patients. In adult clinical trials for partial-onset seizures, the onset of dizziness and ataxia was most commonly observed during titration. Advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they are familiar with the effects of VIMPAT on their ability to perform such activities.
• Cardiac Rhythm and Conduction Abnormalities

PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrhythmia

Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in adult patients and in healthy volunteers. When VIMPAT is given with other drugs that prolong the PR interval, further PR prolongation is possible.

In the postmarketing setting, there have been reports of cardiac arrhythmias in patients treated with VIMPAT, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death. Most, although not all, cases have occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval. These events have occurred with both oral and intravenous routes of administration and at prescribed doses as well as in the setting of overdose.

VIMPAT should be used with caution in patients with underlying proarrhythmic conditions such as known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block, and sick sinus syndrome without pacemaker), severe cardiac disease (such as myocardial ischemia or heart failure, or structural heart disease), and cardiac sodium channelopathies (e.g., Brugada Syndrome).

VIMPAT should also be used with caution in patients on concomitant medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval. In such patients, obtaining an ECG before beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenance dose, is recommended. In addition, these patients should be closely monitored if they are administered VIMPAT through the intravenous route. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away.

Atrial Fibrillation and Atrial Flutter

VIMPAT administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.

• Syncope: VIMPAT may cause syncope in adult and pediatric patients.
• Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential of increased seizure frequency.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also known as multi- organ hypersensitivity, has been reported with antiepileptic drugs, including VIMPAT. Some of these events have been fatal or life-threatening. If signs or symptoms are present, immediately evaluate the patient. Discontinue VIMPAT if an alternative etiology for the signs and symptoms cannot be established.
• Risks in Patients with Phenylketonuria: VIMPAT oral solution contains aspartame, a source of phenylalanine, which can be harmful in patients with phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Adverse Reactions

• Partial-Onset Seizures: In the adult adjunctive therapy placebo-controlled clinical trials for partial-onset seizures, the most frequently seen adverse reaction with VIMPAT was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in ≥10 percent of VIMPAT-treated patients, and greater than placebo, were headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%).
• Primary Generalized Tonic-Clonic Seizures: In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizure placebo-controlled trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.
• Pediatric Patients: Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 years of age were similar to those seen in adult patients.
• Injection: In adult adjunctive therapy clinical trials for partial-onset seizures, adverse reactions with intravenous administration generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia, may be higher with 15-minute administration than over a 30- to 60-minute period. The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial-onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults. Infusion times less than 30 minutes were not adequately studied in pediatric patients.

Dosing Considerations

VIMPAT injection is for intravenous use only when oral administration is temporarily not feasible. The loading dose for adult patients should be administered with medical supervision considering the VIMPAT pharmacokinetics and increased incidence of CNS adverse reactions. The use of a loading dose in pediatric patients has not been studied. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Perform dose titration with caution in all patients with renal and/or hepatic impairment.

VIMPAT is a Schedule V controlled substance.

Please refer to full Prescribing Information.

For further information, UCB:

U.S. Neurology Communications
Erica Puntel,
U.S. Communications, UCB
T 404.938.5359, [email protected] 

Investor Relations

Antje Witte,
Investor Relations, UCB 
T +32.2.559.94.14, [email protected] 

Isabelle Ghellynck,
Investor Relations, UCB
T+32.2.559.9588, [email protected]

VIMPAT^® is a registered trademark used under license from Harris FRC Corporation.

©2020 UCB, Inc., Smyrna, GA 30080. All rights reserved.

Forward looking statements – UCB

This press release contains forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal  models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’ efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

References:

1. VIMPAT^® (lacosamide) CV. U.S. Prescribing Information

2. NIHR: National Institute for Health Research. Lacosamide for primary generalised tonic-clonic seizures – adjunctive therapy. http://www.io.nihr.ac.uk/wp-content/uploads/2019/07/27110-Lacosamide-for-Primary-Generalized-Tonic-Clonic-Seizures-V1.0-JULY2019-NON-CONF.pdf

3. Vossler DG, et al. Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomized, placebo-controlled trial. Neurol Neurosurg Psychiatry 2020; 91(10):1067-1075

4. Asadi-Pooya AA, Nikseresht A, Yaghoubi E, et al. Physical injuries in patients with epilepsy and their associated risk factors. Seizure 2012;21:165–8. 5

5. DeGiorgio CM, et al. Ranking the leading risk factors for sudden unexpected death in epilepsy. Front Neurol. 2017;8:473

6.  European Medicine Agency: Committee for Medicinal Products for Human Use (CHMP). https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vimpat-ws/1782_en.pdf

7. Epilepsy Foundation. Who gets epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Date Accessed 10 November 2020

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SOURCE UCB, Inc.

DUBLIN, Nov. 17, 2020 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder. Following a remote review of manufacturing records, FDA stated that resolution of certain conditions related to the tablet coating process at the company’s Wilmington, OH facility is required before ALKS 3831 may be approved. The CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

The observations noted in the CRL were specific to certain development batches of ALKS 3831. The company believes this issue has since been resolved and that sufficient data is available to address these observations. Alkermes is preparing those data for submission and plans to work closely with the Agency to resolve these items in a timely manner and complete labeling discussions for the application.

Consistent with FDA’s August 2020 Guidance for Industry related to manufacturing inspections during the COVID-19 global pandemic, the Agency did not conduct an on-site Pre-Approval Inspection (PAI) at the company’s Wilmington, OH manufacturing facility during its review of the NDA, and instead conducted a remote review of records under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. FDA confirmed receipt of the requested records provided by Alkermes on Sept. 11, 2020 and, since that date, no report or feedback from this records review was provided to Alkermes until receipt of the CRL.

“We will continue to work closely with the Agency in an expeditious manner to support approval of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder and believe we have a clear path to resolution. Importantly, there were no clinical issues identified in the CRL pertaining to ALKS 3831’s efficacy or safety, and no new studies were requested for approval of the application,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

The NDA submission for ALKS 3831 was based on data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone, and pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA^®. Throughout the clinical development program, ALKS 3831 demonstrated a consistent antipsychotic efficacy, safety, and tolerability profile in patients with schizophrenia.

In October 2020, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee appointed by the FDA jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes, 3 no, 1 abstention). The committees also jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan (11 yes, 6 no).

Conference Call

Alkermes will host a conference call for analysts and investors on Tuesday, Nov. 17, 2020, at 8:00 a.m. ET (1:00 p.m. GMT). The webcast player may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. To participate in the question and answer session, please dial in to the conference call, which may be accessed by dialing +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13713465. The conference call replay will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Tuesday, Nov. 17, 2020 through Tuesday, Nov. 24, 2020.

About Schizophrenia
 
Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).¹ An estimated 2.4 million American adults have schizophrenia,² with men and women affected equally.

About Bipolar I Disorder


Bipolar disorder is a brain disorder that causes shifts in a person’s mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year.³

About ALKS 3831


(olanzapine/samidorphan)


ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

About Alkermes plc

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; the company’s expectations regarding next steps for the NDA for ALKS 3831, including its plans to engage with the FDA to resolve any outstanding FDA requests; and the company’s belief in its ability to expeditiously complete labeling discussions with the FDA and resolve any outstanding items required by the FDA to support approval of the NDA for ALKS 3831. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company will be able to sufficiently resolve all FDA requests to meet the FDA’s requirements for approval in a timely manner or at all; whether data from the company’s manufacturing processes may be interpreted by the FDA in different ways than the company interprets it; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program following receipt of the FDA’s CRL; whether the FDA will approve the NDA for ALKS 3831 in a timely manner or at all; if approved, whether the FDA will impose conditions on the marketing of ALKS 3831, such as a risk evaluation and mitigation strategy; whether future clinical trials for ALKS 3831, if any, will be completed on time or at all; unanticipated impacts of the COVID-19 pandemic on the operations of the company and on the operations of the regulatory agencies involved in the review and potential approval of ALKS 3831; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

ZYPREXA^® is a registered trademark of Eli Lilly & Company.

¹American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5^th ed. Washington, DC: American Psychiatric Publishing; 2013.

² National Institutes of Health. Schizophrenia. Accessed on Nov. 16, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

³ Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543-552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/ 

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SOURCE Alkermes plc

ARMONK, N.Y., Nov. 17, 2020 /PRNewswire/ — IBM (NYSE: IBM) today announced that P-TECH, a groundbreaking public education model to strengthen education equity and career development opportunities in primarily underserved communities, is now in 28 countries and regions. China is the most recent country to adopt the model, bringing the total of countries so far with P-TECH schools to 28. IBM also added Italian, Korean, Polish, and Turkish languages to the free Open P-TECH online career readiness platform, making technology and professional competencies more accessible to even more young people around the world.

Especially when socioeconomic disparities are exacerbated by the pandemic, P-TECH provides students with a pathway to college and career by enabling students to graduate with high school diplomas, no-cost college associates degrees aligned to industry needs, and workplace experiences, including paid mentorship and internships. Together, the private and public sectors adjust training and education practices to prioritize pathways and skills that allow people to access today’s most in-demand jobs. 

The first P-TECH school opened in Brooklyn, NY, in 2011 with IBM as its industry partner, in collaboration with New York City Public Schools and The City University of New York. There are now more than 240 P-TECH schools in operation, working with nearly 200 community colleges and more than 600 industry partners, including GLOBALFOUNDRIES, Thomson Reuters, Volkswagen and others. The industry partnerships are crucial in the P-TECH model to bring insight into the skills and qualities needed in prospective employees and also to foster those skills and qualities in students.

The P-TECH model helps to strengthen regional economies and underserved populations with a workforce better prepared for “new collar” jobs — highly skilled and fast growing careers in areas like cybersecurity, design, mainframe administration and more that don’t require traditional college degrees.

P-TECH is proving effective.  For example, in the U.S. alone:

• Initial graduates earned associates degrees four times faster than the on-time national community college graduation rate.
• Student populations in IBM P-TECH schools are at least 40% young women and 90% African American or Hispanic. These numbers will help diversify the tech industry and spur innovation with more inclusive economic growth.
• Interim MDRC study results show that the first seven New York City’s P-TECH schools are increasing the number of CTE credits that students earn without sacrificing other academic coursework.  

“P-TECH responds to one of the greatest needs of every country: to bridge the gap between schools and work in ways that promote education equity,” said Grace Suh, IBM Vice President of Education. “These solid public-private partnerships around the globe help create a long-term socioeconomic shift and new vision to build a more inclusive and innovative society.”

“P-TECH generates excitement about career opportunities in advanced manufacturing. The model forges important partnerships that bring industry and education closer together,” said Tara McCaughey, Lead, Education and Workforce Development, GLOBALFOUNDRIES. “GF is proud to be an industry partner to four P-TECHs in the New York State’sHudson Valley and Greater Capital District regions, providing an important opportunity to talk to students about professional skills and participate in panel discussions about the advanced manufacturing field. The students that complete P-TECH programs are a critical part of the next generation of technicians, future engineers and leaders.”

To bring some of the benefits of P-TECH schools to a broader audience, IBM has also created Open P-TECH, a free digital learning platform which extends important components of the P-TECH workplace learning, professional and technical skills curriculum to learners and teachers. More than 130,000 learners and teachers are making use of the platform in more than 130 countries. It is now available in Chinese, English, French, Italian, Korean, Polish, Portuguese, Spanish and Turkish languages.

For more information, please visit https://newsroom.ibm.com/ibm-corporate-social-responsibility, or https://www.ibm.org/initiatives/p-tech

Media Contact:
Katie Leasor
IBM External Relations
[email protected]

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SOURCE IBM

NEW YORK, Nov. 17, 2020 /PRNewswire/ — Shutterstock, Inc. (NYSE:SSTK) a leading global creative platform offering full-service solutions for brands, businesses and media in need of high-quality content, tools and services, today announced its 2021 Color Trends report. By analyzing pixel data from the year’s top downloads and mapping each pixel color to a HEX code, the report reveals the three fastest-growing colors that will tell the story of 2021, as well as local favorites from around the world. 

The top three 2021 colors include:

• Set Sail Champagne (#FAEBD7): a soft, glowing tint of white evoking an escapist desire to embark on a new journey.
• Fortuna Gold (#DAA520): a rich shade of gold representing the chance happenings and happy coincidences found in life’s moments.
• Tidewater Green (#2F4F4F): a deep teal with touches of yellow and blue—just like the constant ebb and flow of ocean tides, this color is a reminder that change is a given.

“For years, brands and agencies have used bold colors to stand out in a crowded content landscape; however, 2020 has forced creatives to be more purposeful in their strategies. We see them turning to optimistic colors that inspire a sense of hope—a sense that positive change is coming,” said Flo Lau, Creative Director at Shutterstock. “With nearly 2 million global customers leveraging Shutterstock’s library to create innovative, fresh and timely content for their campaigns and projects, their recent download choices are reflecting a shift in creative thought. They’re leaving behind the bright, saturated hues that defined 2020 and moving towards 2021 with a rich, natural palette that speaks to new opportunities, and more simply, a desire to get outside and get away.”

Dive into Shutterstock’s 2021 Color Trends report to explore the top trending colors around the world.

About Shutterstock
Shutterstock, Inc. (NYSE: SSTK), directly and through its group subsidiaries, is a leading global provider of high-quality licensed photographs, vectors, illustrations, videos and music to businesses, marketing agencies and media organizations around the world. Working with its growing community of over 1 million contributors, Shutterstock adds hundreds of thousands of images each week, and currently has more than 350 million images and more than 20 million video clips available.

Headquartered in New York City, Shutterstock has offices around the world and customers in more than 150 countries. The company’s brands also include Bigstock, a value-oriented stock media offering; Shutterstock Custom, a custom content creation platform; Offset, a high-end image collection; PremiumBeat, a curated royalty-free music library; and Shutterstock Editorial, a premier source of editorial images and videos for the world’s media.

For more information, please visit www.shutterstock.com and follow Shutterstock on Twitter and on Facebook.

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SOURCE Shutterstock, Inc.

CALGARY, AB, Nov. 17, 2020 /PRNewswire/ – Vermilion Energy Inc. (“Vermilion”, “We”, “Our”, “Us” or the “Company”) (TSX: VET) (NYSE: VET) announces changes to its senior leadership team. Mr. Michael Kaluza has stepped down as Executive Vice President and Chief Operating Officer (“COO”), effective immediately. We would like to thank Mr. Kaluza for his many contributions to Vermilion over the past seven years.

Mr. Dion Hatcher has been appointed to the newly created position of Vice President, North America. Mr. Hatcher has been with Vermilion since 2006 and most recently held the position of Vice President of the Canadian Business Unit, a position he has held since 2016. In his new role, Mr. Hatcher will be responsible for all of Vermilion’s operations in Canada and the United States.

Mr. Darcy Kerwin has been appointed to the newly created position of Vice President, International & HSE where he will oversee Vermilion’s Health, Safety and Environment efforts and be responsible for all of Vermilion’s international operations. Mr. Kerwin has been with Vermilion since 2005 and has worked in our Canada, France, Australia and Ireland business units and most recently in the Calgary Head Office as Vice President, Strategic Planning.

We would like to congratulate Mr. Hatcher and Mr. Kerwin on their new roles and look forward to their ongoing contributions to Vermilion. These promotions are in alignment with Vermilion’s objectives of promoting from within to develop internal succession candidates and maintaining continuity in our business while retaining our focus on efficient, effective operations.

In lieu of filling the role of COO we will rely on Mr. Hatcher and Mr. Kerwin to jointly fulfill the duties and continue to emphasize our focus on cost-control and safe, efficient, profitable operations. 

As previously announced, Mr. Hatcher and Mr. Kerwin are also members of Vermilion’s Executive Committee. The Executive Committee is proving to be very successful in managing the company by utilizing the collective knowledge of the eight Committee members to collaborate on strategic decisions for the Company.

About Vermilion

Vermilion is an international energy producer that seeks to create value through the acquisition, exploration, development and optimization of producing properties in North America, Europe and Australia. Our business model emphasizes organic production growth augmented with value-adding acquisitions, along with returning capital to investors when economically warranted. Vermilion is targeting growth in production primarily through the exploitation of light oil and liquids-rich natural gas conventional resource plays in Canada and the United States, the exploration and development of high impact natural gas opportunities in the Netherlands and Germany, and through oil drilling and workover programs in France and Australia. Vermilion holds a 20% working interest in the Corrib gas field in Ireland.

Vermilion’s priorities are health and safety, the environment, and profitability, in that order. Nothing is more important to us than the safety of the public and those who work with us, and the protection of our natural surroundings. We have been recognized as a top decile performer amongst Canadian publicly listed companies in governance practices, as a Climate Leadership level (A-) performer by the CDP, and a Best Workplace in the Great Place to Work® Institute’s annual rankings in Canada, the Netherlands and Germany. In addition, Vermilion emphasizes strategic community investment in each of our operating areas.

Employees and directors hold approximately 5% of our fully diluted shares and are committed to delivering long-term value for all stakeholders. Vermilion trades on the Toronto Stock Exchange and the New York Stock Exchange under the symbol VET.

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SOURCE Vermilion Energy Inc.