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Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19

– Randomized, placebo-controlled, multicenter, global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalized adults with COVID-19 –

SAN FRANCISCO and LONDON, Dec. 17, 2020 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) investigational monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs (one of the major sites of infection).

ACTIV-3 is one of several ongoing trials in the NIH’s ACTIV program, an NIH led public-private partnership designed to accelerate development of the most promising treatments and vaccine candidates for COVID-19. ACTIV-3 has been designed as a “master protocol” that allows for the simultaneous evaluation of multiple investigational therapeutics as they become available, but within the same clinical trial structure, across multiple trial sites.

George Scangos, Ph.D., chief executive officer of Vir, said: “Recent data suggest that the neutralizing activity of antibodies may be insufficient to protect hospitalized adults from the most severe consequences of COVID-19. We are hopeful that the differentiating factors and broad anti-coronavirus activity of VIR-7831 may allow it to help those patients and add to our preparedness for related coronaviruses that could emerge in the future.”

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: “With new infection and hospitalization rates reaching record highs, the world needs multiple options to help combat this pandemic. We are developing solutions to fight this virus, from prevention through treatment, to provide relief from COVID-related illness. Our treatment option, VIR-7831, which has a high barrier to resistance and has the potential to neutralize the virus and kill infected cells, could allow this treatment to be effective for patients in hospital settings, where other antibodies have so far not shown an impact.”

In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization. The Phase 3 part of the COMET-ICE trial is assessing the safety and efficacy of a single intravenous (IV) infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of adults who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. The COMET clinical development program for VIR-7831 also includes a planned Phase 3 trial for the prevention of symptomatic infection.

ACTIV-3 Clinical Trial Design
The ACTIV-3 trial arm evaluating VIR-7831 will initially compare 300 participants who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms, who will receive either VIR-7831 or placebo. Participants also will receive standard care for COVID-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants’ clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care. If the VIR-7831 treatment arm appears to have a positive benefit:risk profile, the trial will enroll an additional 700 participants, including those who are more severely ill (i.e., adults with organ failure requiring mechanical support, or COVID-19-associated dysfunction of organs other than the lungs). Trial participants will be followed for 90 days following enrollment to analyze their response to treatment. The primary efficacy endpoint is the participants’ sustained recovery for 14 days after release from the hospital.

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is a monoclonal antibody for which preclinical data suggest its ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

About the Vir and GSK Collaboration
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-7831 in treating hospitalized patients with COVID-19, the potential benefits of participating in the ACTIV-3 trial, the ability of using a combination of a potent effector function and neutralization capabilities in enhancing the efficacy of monoclonal antibodies to treat hospitalized patients, the efficacy and safety of a single intravenous (IV) infusion of VIR-7831, Vir’s plans around the evaluation of interim analyses and the expected timing of clinical study results for VIR-7831, the ability of VIR-7831 to prevent symptomatic infection, the clinical trial design around ACTIV-3 as well as statements around the potential benefits of Vir and GSK’s collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

GSK Cautionary Statement Regarding Forward-Looking Statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk Factors” in the company’s Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road
Brentford, Middlesex
TW8 9GS



Vir Biotechnology Contacts:

Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
[email protected] 
+1 415 506 5256

Media
Cara Miller
VP, Corporate Communications
[email protected]
+1 415 941 6746 

GSK Contacts:

Media:
Simon Steel  +44 (0) 20 8047 5502  (London)
Tim Foley  +44 (0) 20 8047 5502  (London)
Kristen Neese  +1 804 217 8147  (Philadelphia)
Kathleen Quinn  +1 202 603 5003  (Washington DC)

Analysts/Investors:
Sarah Elton-Farr  +44 (0) 20 8047 5194  (London)
Sonya Ghobrial  +44 (0) 7392 784784  (Consumer)
Danielle Smith  +44 (0) 20 8047 0932  (London)
James Dodwell  +44 (0) 20 8047 2406  (London)
Jeff McLaughlin  +1 215 751 7002  (Philadelphia)
Frannie DeFranco  +1 215 751 4855  (Philadelphia)

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Aurora Spine Plans A Major Multicenter Study of its ZIP™ Interspinous Fixation Device for Relief of Back Pain

Company announces initiation of new clinical study beginning Q1 2021

CARLSBAD, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG), a designer and manufacturer of innovative medical devices, today announced plans to commence a multicenter study of its ZIP™ Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease.

Aurora recently conducted an advanced training session and cadaver lab that introduced leading neurosurgical, orthopedic and pain management physicians to the ZIP™ implant. With more than 5,000 procedures already completed worldwide, ZIP™ is safe and effective in an outpatient setting. The company is launching a multicenter, prospective clinical study to investigate the efficacy of the ZIP™ device managing low back pain and improving quality of life in patients suffering from symptomatic degenerative disc.

“The ZIP study is an important milestone for Aurora as we are committed to helping patients experiencing chronic back pain by advancing the benefits of the ZIP-Screwless™ procedure through vigorous clinical research,” said Trent J. Northcutt, President and CEO of Aurora Spine, Inc. “This multicenter study is designed to demonstrate reproducible outcomes in the real world through vigorous science and attention to quality of life. We are excited to pursue this evidence-based pathway. We continue to be very pleased with the enthusiasm of our clinical investigators,” said Northcutt. “Site selection has commenced, and we are appreciative of all the support from our stellar group of physicians across the country to bring this pivotal, minimally invasive technology to market. We believe there is a significant population of patients who will benefit from the ZIP-Screwless procedure once this important study is completed.”

“This therapy is a great opportunity to continue to bridge the gap between spine surgeons and pain management for our patients,” said Steven Falowski, M.D., Director of Functional Neurosurgery at Argires-Marotti Neurosurgical Associates of Lancaster, PA. “The launch of this collaborative study will give the ability to produce published clinical outcomes utilizing a minimally invasive option to treat spinal pathology, potentially preventing a more invasive open surgical approach in the future or even give a viable treatment option to those who were not invasive surgical candidates.”

Vipul Mangal, M.D., an interventional pain specialist from National Spine & Pain Centers, has adopted this therapy in his patients as a minimally invasive alternative approach. Dr. Mangal commented, “This device has been revolutionary in my practice as a minimally invasive device to significantly improve function and pain for my patients with back pain. I am excited to be part of the study and to train others so that we can continue to advance therapies that relieve pain and restore function.”

About Aurora Spine

Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

Contact:

Aurora Spine Corporation

Trent Northcutt
President and Chief Executive Officer
(760) 424-2004

Chad Clouse
Chief Financial Officer
(760) 424-2004

www.aurora-spine.com



www.aurorapaincare.com 

Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
[email protected]



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VistaGen Therapeutics Announces Proposed Underwritten Public Offering

SOUTH SAN FRANCISCO, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) — VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today announced that it commenced an underwritten public offering of units consisting of its common stock, par value $0.001 per share (the “Common Stock”), and its Series D convertible preferred stock (the “Series D Preferred Stock”). All securities to be sold in the offering are to be sold by VistaGen. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Series D Preferred Stock will be initially convertible into a specified number of shares of Common Stock at any time at the option of the holder, provided that no such conversion will be permitted until VistaGen’s stockholders approve an amendment to its articles of incorporation increasing the number of authorized shares of Common Stock in an amount sufficient to permit the conversion in full of the Series D Preferred Stock.

VistaGen intends to use the net proceeds from the offering for research, development and manufacturing and regulatory expenses associated with continuing development of PH94B, PH10, AV-101, and potential drug candidates to expand its CNS pipeline and for other working capital and general corporate purposes.

Jefferies LLC and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-234025), previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective on October 7, 2019. The securities may be offered only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: Jefferies LLC by mail at Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022 or by telephone at +1 877-547-6340, or by email at [email protected] or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606 or by email at [email protected] or by telephone at +1 800-621-0687.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About VistaGen

VistaGen Therapeutics, Inc. is a biopharmaceutical company committed to developing and commercializing innovative medicines with potential to go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of VistaGen’s three drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date and has therapeutic potential in multiple CNS markets.

Forward-Looking Statements

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to our expectations regarding the completion of the proposed public offering. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to whether or not we will be able to raise capital through the sale of shares of Common Stock and preferred stock, market and other conditions and the impact of the COVID-19 pandemic, general economic, industry or political conditions in the United States or internationally. There can be no assurance that we will be able to complete the proposed public offering on the anticipated terms, or at all. We will need to raise additional capital to fund our operations and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. Other risks and uncertainties include, but are not limited to, issues related to: adverse healthcare reforms and changes of laws and regulations; manufacturing and marketing risks, including risks related to the COVID-19 pandemic, which may include, but are not limited to, unavailability of or delays in delivery of raw materials for manufacture of its CNS drug candidates and difficulty in conducting clinical trials; inadequate and/or untimely supply of one or more of its CNS drug candidates to meet demand; entry of competitive products; and other technical and unexpected hurdles in the development, manufacture and commercialization of its CNS drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended March 31, 2020, and in our most recent Quarterly Report on Form 10-Q for the quarter and six months ended September 30, 2020, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the SEC. Our SEC filings are available on the SEC’s website at www.sec.gov. In addition, any forward-looking statements represent our views only as of the issuance of this release and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Company Contact

Mark A. McPartland VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: [email protected]

Source: VistaGen Therapeutics, Inc.

 



Posted on

Texas Roadhouse Appoints Jerry Morgan President

LOUISVILLE, Ky., Dec. 17, 2020 (GLOBE NEWSWIRE) — Texas Roadhouse, Inc. (NasdaqGS: TXRH) announced today that Regional Market Partner Jerry Morgan has been promoted to President of the Louisville-based restaurant company, effective January of 2021.

Morgan, who will relocate to Louisville, will report directly to Kent Taylor who will continue to serve as Chief Executive Officer and Chairman of the Board. Taylor had assumed the role of President when the role was vacated in June of 2019.

Taylor commented, “Going from three jobs to two, will allow me to focus my additional time, energy, and creativity on our future growth, such as establishing Bubba’s 33 and Jaggers as segment leaders and expanding our retail initiatives, including Butcher Shop and our new Margarita Mix. I also want to expand our To-Go operations and have several other ideas that I think will propel Texas Roadhouse into the next decade.”

A 23-year veteran of Texas Roadhouse, Morgan has more than 35 years of restaurant management experience with Texas Roadhouse, Bennigan’s and Burger King.

Morgan started his Texas Roadhouse career in 1997 as Managing Partner of the company’s first restaurant in Texas. He earned the company’s most prestigious award, Managing Partner of the Year, in 2001 and was promoted to Market Partner later that year.

In 2015, Morgan was named Regional Market Partner, where he was responsible for overseeing more than 120 restaurants in 14 states.

Taylor continued, “Jerry brings great operational focus and leadership to an already stellar executive leadership team and is a perfect balance to our awesome field operations led by our Chief Operating Officer, Doug Thompson, and our Regional Market Partners.”

Both Morgan and Thompson along with Chief Financial Officer Tonya Robinson and a few other Louisville-based executives will report to Taylor. 

Taylor added, “Jerry will spend his first few months listening, learning and serving alongside our folks at the Support Center in Louisville.”

Morgan commented, “I look forward to joining the amazing Support Center family, which does such an outstanding job of serving our operators. I have learned firsthand that hospitality just happens to be the name of our industry. It’s not just what we do. What we do best is to be great teammates, build relationships, and have a passion for serving others. Let’s go Roadhouse.”

About the Company
Texas Roadhouse is a casual dining concept that first opened in 1993 and today has grown to over 630 restaurants system-wide in 49 states and ten foreign countries. For more information, please visit the Company’s Web site at www.texasroadhouse.com.

Contacts:

Investor Relations

Michael Bailen
(502) 515-7298

Media

Travis Doster
(502) 638-5457



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CareTrust REIT Announces Quarterly Dividend of $0.25 per Share; Strong Q4 Collections

SAN CLEMENTE, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) — CareTrust REIT, Inc. (NASDAQ:CTRE) announced today that its Board of Directors has declared a quarterly common stock cash dividend of $0.25 per common share.

Greg Stapley, CareTrust’s Chairman and Chief Executive Officer, reported that CareTrust collected 99.7% of its contractual cash rents for the fourth quarter. “Despite the ongoing COVID-19 pandemic, our outstanding tenants are finding ways to adapt and thrive,” he said. He noted that the company expects to pay the quarterly dividend on or about January 15, 2021, to common stockholders of record as of the close of business on December 31, 2020.

About CareTrust REIT™

CareTrust REIT, Inc. is a self-administered, publicly-traded real estate investment trust engaged in the ownership, acquisition, development and leasing of skilled nursing, seniors housing and other healthcare-related properties. With a nationwide portfolio of long-term net-leased properties, and a growing portfolio of quality operators leasing them, CareTrust REIT is pursuing both external and organic growth opportunities across the United States. More information about CareTrust REIT is available at www.caretrustreit.com.

Contact:

CareTrust REIT, Inc.
(949) 542-3130
[email protected]



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TD Asset Management Inc. Announces Estimated Annual Reinvested Distributions for certain TD ETFs

Canada NewsWire

TORONTO, Dec. 17, 2020 /CNW/ – TD Asset Management Inc. (“TDAM”) today announced the estimated 2020 reinvested distributions for certain TD Exchange-Traded Funds (the “TD ETFs”) listed below. These annual reinvested distributions generally represent realized capital gains within the TD ETFs. 

Unitholders of record on December 31, 2020 will receive the actual 2020 reinvested distributions which may vary from the estimated amounts disclosed below. The actual taxable amounts of reinvested distributions for 2020, will be reported in late December or early 2021. The tax characteristics of the distributions will be reported in early 2021.

Cash distributions will be reported separately.

Details of the per-unit reinvested distribution are as follows:


Fund Name


Fund
Ticker


Estimated Annual
Reinvested
Distribution ($)

TD Active High Yield Bond ETF

TUHY

$0.31818

TD Active Global Income ETF

TGFI

$0.27603

TD Canadian Long Term Federal Bond ETF

TCLB

$0.21635

TD U.S. Long Term Treasury Bond ETF

TULB

$1.69410

TD Income Builder ETF

TPAY

$0.16839

TD Q U.S. Small Mid-Cap Equity ETF

TQSM

$0.00000

TD Morningstar ESG Canada Equity Index ETF

TMEC

$0.00000

TD Morningstar ESG U.S. Equity Index ETF

TMEU

$0.00000

TD Morningstar ESG International Equity Index ETF

TMEI

$0.00000

For more information regarding TD ETFs, visit TDAssetManagement.com

Commissions, management fees and expenses all may be associated with investments in exchange-traded funds (ETFs). Please read the prospectus and ETF Facts before investing. ETFs are not guaranteed, their values change frequently and past performance may not be repeated. ETF units are bought and sold at market price on a stock exchange and brokerage commissions will reduce returns.

Morningstar® Canada Sustainability Extended IndexSM, Morningstar® US Sustainability Extended IndexSM and Morningstar® Developed Markets ex-North America Sustainability Extended IndexSM are service marks of Morningstar, Inc. and have been licensed for use for certain purposes by TD Asset Management Inc. The TD Morningstar ESG Canada Equity Index ETF, TD Morningstar ESG International Equity Index ETF and TD Morningstar ESG U.S. Equity Index ETF (collectively, the “TD ETFs”) are not sponsored, endorsed, sold or promoted by Morningstar Research Inc. (“Morningstar”), and Morningstar makes no representation regarding the advisability of investing in the TD ETFs.

TD ETFs are managed by TD Asset Management Inc., a wholly-owned subsidiary of The Toronto-Dominion Bank.

®The TD logo and other trademarks are the property of The Toronto-Dominion Bank or its subsidiaries.

About TD Asset Management Inc.

TD Asset Management (TDAM), a member of TD Bank Group, is a North American investment management firm. Operating through TD Asset Management Inc. in Canada and TDAM USA Inc. in the U.S., TDAM brings new thinking to investors’ most important challenges. TDAM offers investment solutions to corporations, pension funds, endowments, foundations and individual investors. Additionally, TDAM manages assets on behalf of almost 2 million retail investors and offers a broadly diversified suite of investment solutions including mutual funds, professionally managed portfolios and corporate class funds. Asset management businesses at TD manage $396 billion in assets as at September 30, 2020. Assets under management include TD Asset Management Inc., TDAM USA Inc. and Epoch Investment Partners Inc. All entities are wholly-owned subsidiaries of The Toronto-Dominion Bank.

SOURCE TD Asset Management Inc.

Posted on

FDA Approves Amgen’s RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan® (rituximab)

Fifth FDA Approval From Amgen’s Biosimilars Portfolio

PR Newswire

THOUSAND OAKS, Calif., Dec. 17, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis (MPA). RIABNI will be made available in the U.S. in January 2021.

“The approval of RIABNI represents an important milestone across our biosimilar and oncology portfolios,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. “Following the proven success of KANJINTI® (trastuzumab-anns) and MVASI® (bevacizumab-awwb) in the U.S. marketplace, RIABNI reaffirms Amgen’s long-term commitment to providing high quality biosimilars that can potentially offer more affordable, effective treatment options for cancer and other serious diseases and that contribute to the sustainability of healthcare systems.”

RIABNI, a CD20-directed cytolytic antibody, was proven to be highly similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study and a comparative clinical study.

The randomized, double-blind, comparative clinical study evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity of RIABNI compared to Rituxan in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. There were 256 patients enrolled and randomized (1:1) to receive 375 mg/m2 intravenous infusion of either RIABNI or Rituxan, once weekly for 4 weeks followed by dosing at weeks 12 and 20. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for RIABNI compared to Rituxan, showing clinical equivalence. PK, PD, safety and immunogenicity of RIABNI were similar to Rituxan.

The Wholesale Acquisition Cost (WAC or “list price”) of RIABNI in the U.S. will be 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% less than the WAC for Rituxan, 15.2% less than the WAC for Truxima® (biosimilar to Rituxan) and matching the WAC for Ruxience® (biosimilar to Rituxan). At launch, RIABNI will be priced 16.7% below the current Rituxan Average Selling Price (ASP). RIABNI will be available from both wholesalers and specialty distributors.

Amgen has a total of 10 biosimilars in its portfolio, five of which have been approved in the U.S., and three that are approved in the European Union (EU).

About 
RIABNI™
 
(rituximab-arrx) in the U.S.
RIABNI is a biosimilar to Rituxan, an anti-CD20 monoclonal antibody. The active ingredient of RIABNI is a monoclonal antibody that has the same amino acid sequence as Rituxan. RIABNI also has the same strength as Rituxan, and the dosage form and route of administration are identical to the IV formulation of Rituxan.

RIABNI is currently not yet available commercially. This is not an offer for sale. The following information is derived from the approved label in the U.S.

In the U.S., RIABNI is approved for:

Non-Hodgkin’s Lymphoma (NHL)
RIABNI (rituximab-arrx) is indicated for the treatment of adult patients with:

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.


Chronic Lymphocytic Leukemia (CLL)

RIABNI, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.

Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
RIABNI, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA).

Important Safety Information

BOXED WARNINGS:
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Infusion-Related Reactions: Rituximab product administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RIABNITM infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions.
  • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products. Discontinue RIABNITM in patients who experience a severe mucocutaneous reaction. The safety of readministration of RIABNITM to patients with severe mucocutaneous reactions has not been determined.
  • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RIABNITM. Discontinue RIABNITM and concomitant medications in the event of HBV reactivation.
  • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products. Discontinue RIABNITM and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Infusion-Related reactions (IRR)

  • Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes.
  • Rituximab-product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.
  • Premedicate patients with an antihistamine and acetaminophen prior to dosing. For patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA), methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g., glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue RIABNITM. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved.
  • Closely monitor the following patients: those with preexisting cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3).

Severe Mucocutaneous Reactions

  • Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis.
  • The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue RIABNITM in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined.

Hepatitis B Virus Reactivation

  • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive).
  • HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases, increase in bilirubin levels, liver failure, and death can occur.
  • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RIABNITM. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during RIABNITM treatment.
  • Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following RIABNITM therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy.
  • In patients who develop reactivation of HBV while on RIABNITM, immediately discontinue RIABNITM and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming rituximab product treatment in patients who develop HBV reactivation. Resumption of RIABNITM treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

Progressive Multifocal Leukoencephalopathy (PML)

  • JC virus infection resulting in multifocal leukoencephalopathy (PML) and death can occur in rituximab-product -treated patients with hematologic malignancies or with autoimmune diseases. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. The patients with autoimmune diseases had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.
  • Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue RIABNITM and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Tumor Lysis Syndrome

  • Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within 12−24 hours after the first infusion of RIABNITM in patients with non-Hodgkin’s lymphoma (NHL). A high number of circulating malignant cells (≥25,000/mm3), or high tumor burden, confers a greater risk of TLS.
  • Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

Infections

  • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure).
  • New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue RIABNITM for serious infections and institute appropriate anti-infective therapy.
  • RIABNITM is not recommended for use in patients with severe, active infections.

Cardiovascular Adverse Reactions

  • Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of RIABNITM for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

Renal Toxicity

  • Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience TLS and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and RIABNITM is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue RIABNITM in patients with a rising serum creatinine or oliguria.

Bowel Obstruction and Perforation

  • Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab products in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1−77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

Immunization

  • The safety of immunization with live viral vaccines following rituximab product therapy has not been studied, and vaccination with live virus vaccines is not recommended before or during treatment.
  • For patients treated with RIABNITM, physicians should review the patient’s vaccination status and patients should, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating RIABNITM; administer non-live vaccines at least 4 weeks prior to a course of RIABNITM.

Embryo-Fetal Toxicity

  • Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed in utero. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception with RIABNITM and for at least 12 months after the last dose.

Concomitant Use with Other Biologic Agents and Disease Modifying Antirheumatic
Drugs (DMARDs) in GPA and MPA

  • Limited data are available on the safety of the use of biologic agents or DMARDs. Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly. Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products.

Adverse Reactions

  • The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and chronic lymphocytic leukemia (CLL) were infusion-related reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials.
  • The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion-related reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials.

Nursing Mothers

  • There are no data on the presence of rituximab products in human milk, the effect on the breastfed child, or the effect on milk production. Because of the potential of serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with RIABNITM and for at least 6 months after the last dose.

Clinical Trials Experience in GPA and MPA

  • Adverse reactions reported in ≥15% of rituximab-treated patients were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema (other important adverse reactions include infusion-related reactions).

Induction Treatment of Patients with Active GPA/MPA (GPA/MPA Study 1)

Infusion-Related Reactions

  • In GPA/MPA Study 1, 12% vs 11% (rituximab-treated vs cyclophosphamide-treated, respectively) of patients experienced at least one infusion-related reaction. Infusion-related reactions included cytokine release syndrome, flushing, throat irritation, and tremor. In the rituximab group, the proportion of patients experiencing an infusion reaction was 12%, 5%, 4%, and 1% following the first, second, third, and fourth infusions, respectively. Patients were premedicated with antihistamine and acetaminophen before each rituximab infusion and were on background oral corticosteroids, which may have mitigated or masked an infusion-related reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion-related reactions.

Infections

  • In GPA/MPA Study 1, 62% vs 47% (rituximab-treated vs cyclophosphamide-treated, respectively) of patients experienced an infection by Month 6. The most common infections in the rituximab group were upper respiratory tract infections, urinary tract infections, and herpes zoster. The incidence of serious infections was 11% vs 10% (rituximab-treated vs cyclophosphamide-treated, respectively), with rates of approximately 25 and 28 per 100 patient-years, respectively. The most common serious infection was pneumonia.

Hypogammaglobulinemia

  • Hypogammaglobulinemia (IgA, IgG, or IgM below the lower limit of normal) has been observed in patients with GPA and MPA treated with rituximab in GPA/MPA Study 1. At 6 months, in the rituximab group, 27%, 58%, and 51% of patients with normal immunoglobulin levels at baseline had low IgA, IgG, and IgM levels, respectively, compared to 25%, 50%, and 46% in the cyclophosphamide group.

Immunogenicity

  • A total of 23/99 (23%) rituximab-treated adult patients with GPA or MPA tested positive for anti-rituximab antibodies by 18 months in GPA/MPA Study 1. The clinical relevance of anti-rituximab antibody formation in rituximab-treated adult patients is unclear.

Treatment of Patients with GPA/MPA Who Have Achieved Disease Control with Induction Treatment (GPA/MPA Study 2)

  • In GPA/MPA Study 2, the safety profile was consistent with the known safety profile of rituximab in immunologic indications.

Infusion-Related Reactions (IRR)

  • In GPA/MPA Study 2, 7/57 (12%) patients in the non-US-licensed approved rituximab arm reported infusion-related reactions. The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (<4%). One patient had two serious IRRs; two IRRs led to a dose modification; and no IRRs were severe, fatal, or led to withdrawal from the study.

Infections

  • In GPA/MPA Study 2, 30/57 (53%) patients in the non-US-licensed approved rituximab arm and 33/58 (57%) in the azathioprine arm reported infections. The incidence of all-grade infections was similar between the arms. The incidence of serious infections was similar in both arms (12%). The most commonly reported serious infection in the group was mild or moderate bronchitis.

Attention Healthcare Provider: Provide Medication Guide to patient prior to RIABNITM infusion and advise patients to read guide.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436. 

Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

About Amgen Biosimilars
Amgen is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

About Amgen Oncology
Amgen is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do. 

For more information, follow us on www.twitter.com/amgenoncology.

About Amgen
 
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration’s, or Amgen’s, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen’s business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen’s manufacturing activities, the distribution of Amgen’s products, the commercialization of Amgen’s product candidates, and Amgen’s clinical trial operations, and any such events may have a material adverse effect on Amgen’s product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

Rituxan® is a registered trademark of Biogen.
Truxima® is a registered trademark of Celltrion Inc.
Ruxience® is a trademark of Pfizer Inc.

CONTACT: Amgen, Thousand Oaks 
Kelley Davenport, 202-585-9637 (media)
Trish Rowland, 805-447-5631 (media) 
Arvind Sood, 805-447-1060 (investors) 

 

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Latest Release of Lattice sensAI Solutions Stack Delivers up to 6X Performance Boost on Award-Winning CrossLink-NX FPGAs

Latest Release of Lattice sensAI Solutions Stack Delivers up to 6X Performance Boost on Award-Winning CrossLink-NX FPGAs

Upgraded CNN Engine, NN Compiler, and New Reference Designs Enable 60 Frames-Per-Second Video Streams While Consuming Mere Milliwatts of Power

HILLSBORO, Ore.–(BUSINESS WIRE)–Lattice Semiconductor Corporation (NASDAQ: LSCC), the low power programmable leader, today announced performance enhancements and additional reference designs for its award-winning Lattice sensAI™ solutions stack. Lattice sensAI helps developers rapidly create high-performance AI/ML solutions running on flexible, low power Lattice FPGAs for use in Edge devices. The enhancements include optimizations to the stack’s programmable CNN Plus engine and NN compiler software and leverage other innovations in AI/ML technology that capitalize on the capabilities of the Lattice Nexus™ FPGA platform. The updated stack also features reference designs that use these enhancements to boost application performance while keeping power consumption low, including a new object detection application running on the Lattice CrossLink™-NX FPGA, Lattice’s flagship device for vision processing.

“By taking advantage of the hardware programmability of FPGAs and tracking the latest innovations in AI and ML technology, we’ve extended the performance capabilities of our sensAI solutions stack to new levels,” said Hussein Osman, Market Segment Manager, Lattice Semiconductor. “With these enhancements, Lattice can deliver a smart vision solution capable of analyzing incoming video data streams at up to 60 frames-per-second while consuming only a few milliwatts of power, enabling more accurate smart vision performance in industrial automation, smart home, and security and surveillance applications.”

The latest enhancements to the Lattice sensAI solution stack (v3.1) include:

  • Optimized CNN engine IP – optimizations to the way DSPs are used in the IP block and other architectural features of CrossLink-NX FPGAs deliver heightened CNN performance to the sensAI stack. For example, when running the stack on a CrossLink-NX FPGA, the Mobilenet CNN model (version 1) can process video data at 60 frames-per-second at a resolution of 224×224, a 6x increase in performance from the prior release. Lattice offers an object detection reference design that can enable similar performance in applications like automated defect detection on an industrial assembly line or presence detection in security cameras.
  • Updated CNN compiler – the software compiler used in the sensAI stack is specifically optimized for DSPs implemented on a Lattice FPGA fabric to reduce operations-per-cycle by 50 percent. Additional NN model compression innovations include removal of duplicate weights to reduce memory usage while preserving accuracy.
  • More development board options – a new sensAI development board featuring the CrossLink-NX 40K FPGA, an image sensor, microphones, and expansion connectors for interfacing with additional sensors. This board supports the reference designs referred to above and is intended to speed time-to-market for AI/ML applications.
  • New end-to-end reference designs and hardware – a low power gesture detection reference design to accelerate customer implementation of contactless human/machine interface (HMI) systems that are gaining popularity in the post-COVID-19 marketplace. The application uses an ultra-low-power Lattice iCE40™ UltraPlus FPGA so developers can implement it in a small form factor using minimal power. The reference design could be a compelling option for developers looking to add HMI to an industrial robot or a battery-powered smart toy.

For More Information

To learn more about the Lattice technologies mentioned above, please visit:

About Lattice Semiconductor

Lattice Semiconductor (NASDAQ: LSCC) is the low power programmable leader. We solve customer problems across the network, from the Edge to the Cloud, in the growing communications, computing, industrial, automotive, and consumer markets. Our technology, long-standing relationships, and commitment to world-class support lets our customers quickly and easily unleash their innovation to create a smart, secure and connected world.

For more information about Lattice, please visit www.latticesemi.com. You can also follow us via LinkedIn, Twitter, Facebook, YouTube, WeChat, Weibo or Youku.

Lattice Semiconductor Corporation, Lattice Semiconductor (& design) and specific product designations are either registered trademarks or trademarks of Lattice Semiconductor Corporation or its subsidiaries in the United States and/or other countries. The use of the word “partner” does not imply a legal partnership between Lattice and any other entity.

GENERAL NOTICE: Other product names used in this publication are for identification purposes only and may be trademarks of their respective holders.

MEDIA CONTACTS:

Bob Nelson

Lattice Semiconductor

408-826-6339

[email protected]

INVESTOR CONTACT:

Rick Muscha

Lattice Semiconductor

408-826-6000

[email protected]

KEYWORDS: United States North America Oregon

INDUSTRY KEYWORDS: Semiconductor Consumer Electronics Technology Other Technology Software Hardware

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Sierra Bancorp Names Susan M. Abundis and Julie Castle to its Board of Directors

Sierra Bancorp Names Susan M. Abundis and Julie Castle to its Board of Directors

PORTERVILLE, Calif.–(BUSINESS WIRE)–
Sierra Bancorp (NASDAQ: BSRR), the holding company for Bank of the Sierra, announced today that it has named Susan M. Abundis and Julie Castle to the Board of Directors of both Sierra Bancorp and Bank of the Sierra. Abundis and Castle will join the boards immediately. In addition, the board of Sierra Bancorp has appointed both Ms. Abundis and Ms. Castle to the Governance and Nominating Committee. Also, the respective boards appointed Ms. Abundis to the Senior Loan Committee while Ms. Castle has been appointed to the Audit Committee and the Risk Committee.

Susan M. Abundis has 40 years of banking experience and is currently on the Board of Trustees at Community Medical Center, California Health Sciences University, and Tesoro Viejo Conservancy. Most recently, she was Chief Operating Officer at California Health Sciences University in Clovis. Her last banking role was as Managing Director–Division Credit Manager at Bank of the West–BNP, where she started as an Area Manager and Senior Vice President. Abundis also held several jobs at Bank of America culminating in her position as Market President, Area Manager and Senior Vice President. Originally from Arroyo Grande, she currently resides in Fresno, earned her bachelor’s degree at Fresno State, and attended Pacific Coast Banking School. Among her many professional awards, Abundis was named Woman of the Year by both Soroptimist of Ventura and Girl Scouts of America–Tres Condados of Ventura County and made the Marjoree Mason Center’s list of Top Ten Women of the Year.

Julie Castle was most recently a Member of the Board for Rabobank, N.A. She was also previously a Board Member for Pacific Coast Banking School (PCBS) and First Interstate Bank. Castle’s financial experience spans over 35 years, and includes managing and leadership positions at Wells Fargo, E.F. Hutton, Bank of America, First Interstate Bancsystem, Zions Bancorporation, and Cannon Financial Institute, where she served as Executive Vice President and Managing Consultant. She earned a bachelor’s degree at the University of California, Davis and a Graduate Degree of Banking at the University of Washington, PCBS. She is also a Certified Financial Planner (CFP).

“We are excited for Susan and Julie, two great leaders and incredibly talented individuals, to join our Board of Directors,” said Kevin McPhaill, President and Chief Executive Officer. “It’s yet another sign of the ongoing growth of our Bank as we strive to provide value for our shareholders and continue to help the communities we serve.”

Sierra Bancorp’s Board of Directors include Chairman Morris A. Tharp, Vice-Chairman James C. Holly, President and CEO Kevin J. McPhaill, and Directors Albert L. Berra, Gordon T. Woods, Lynda B. Scearcy, Robb Evans, Vonn R. Christenson, Laurence S. Dutton, Ph.D., Susan M. Abundis, Julie Castle, and Director Emeritus Robert L. Fields.

About Sierra Bancorp

Sierra Bancorp is the holding company for Bank of the Sierra, which since its founding in 1977, has grown to become the largest independent bank headquartered in California’s southern San Joaquin Valley, with over $3 billion in assets. Bank of the Sierra is a community-centric regional bank, which offers a full range of retail and commercial banking services with full-service branches located within the counties of Tulare, Kern, Kings, Fresno, Los Angeles, Ventura, San Luis Obispo and Santa Barbara. The bank also maintains a loan production office and an online branch and provides specialized lending services through an agricultural credit center and an SBA center. Bank of the Sierra is recognized as one of the strongest and top-performing community banks in the country with a 5-star rating from Bauer Financial.

Category: Financial

Source: Sierra Bancorp

Mitchell Lee, Communications Specialist

Matthew Hessler, SVP, Director of Marketing

(559) 782-4900 or (888) 454-BANK

www.bankofthesierra.com

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Banking Professional Services Finance

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Wayne Savings Bancshares, Inc. Declares Quarterly Dividend

WOOSTER, Ohio, Dec. 17, 2020 (GLOBE NEWSWIRE) — Wayne Savings Bancshares, Inc. (OTCQX:WAYN), (the “Company”), the holding company parent of Wayne Savings Community Bank (the “Bank”), has declared a cash dividend of $0.20 per share of the Company’s common stock for the quarter ending December 31, 2020. The quarterly cash dividend will be paid on January 20, 2021 to stockholders of record as of January 6, 2021.

Established in 1899, Wayne Savings Community Bank, the wholly owned subsidiary of Wayne Savings Bancshares, Inc., has twelve full-service banking locations in the communities of Wooster, Ashland, Millersburg, Rittman, Lodi, North Canton, Creston and Fredericksburg, Ohio. At September 30, 2020, Wayne Savings Bancshares, Inc. reported total assets of $550.7 million, deposits of $451.6 million, and stockholders’ equity of $50.9 million, or 9.2% of total assets.

Statements contained in this news release which are not historical facts may be forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from those currently anticipated due to a number of factors. Factors which could result in material variations include, but are not limited to, changes in interest rates which could affect net interest margins and net interest income, competitive factors which could affect net interest income and noninterest income, changes in demand for loans, deposits and other financial services in the Company’s market area; changes in asset quality, general economic conditions as well as other factors discussed in documents filed by the Company from time to time. The Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.

Contact:

Wayne Savings Bancshares, Inc.
James R. VanSickle, II
President and Chief Executive Officer
330-264-5767