Market Newsdesk

BEIJING, March 5, 2021 /PRNewswire/ — Luokung Technology Corp. (NASDAQ: LKCO) (“Luokung” or the “Company”), a leading interactive location-based services and big data processing technology company based in China, today announced that it has filed a complaint together with two U.S. shareholders with the U.S. Federal District Court for the District of Columbia (the “Court”), alleging that Luokung’s designation as a “Communist Chinese Military Company” (“CCMC”) by the Trump Administration is unlawful. Luokung is asking the Court to declare that Luokung’s CCMC designation is invalid and to enjoin the application of former President Trump’s relevant Executive Order to Luokung.

Background Information

As the Company previously announced, on January 14, 2021 the U.S. Department of Defense (“DoD”) placed the Company on a list of entities operating directly or indirectly in the United States and deemed to be a CCMC under Executive Order 13959, issued by former President Trump on November 12, 2020 (“EO 13959”). The DoD list is maintained under the authority of Section 1237 of the National Defense Authorization Act for Fiscal Year 1999 (“Section 1237”). The U.S. Department of the Treasury Office of Foreign Assets Control (“OFAC”) administers and enforces EO 13959.

Under EO 13959, U.S. persons, including both individuals and entities, will be prohibited from transacting in securities and derivatives of entities subject to EO 13959 starting 60 days after their designations as CCMCs, i.e., on March 15, 2021 for entities designated by DoD on January 14, 2021.

EO 13959, as amended by Executive Order 13974 issued on January 13, 2021, provides an exemption allowing for divestment transactions by U.S. persons within 365 days of the designation by DoD, and also mandates such divestment by U.S. persons within 365 days of the designation by DoD (i.e., by January 14, 2022 for entities designated by DoD on January 14, 2021).

Company Seeking Extension Following OFAC Designation

OFAC issued on January 26, 2021 General License 1A, which permits until May 27, 2021 trading of securities and derivatives of certain entities whose names “closely match” but are not an exact match with those on the Section 1237 List.  The name listed by the DoD on the Section 1237 List is not an exact match to Luokung’s correct legal name of “Luokung Technology Corp.”  Luokung therefore believes that it qualifies under General License 1A.  Luokung has sought confirmation of the applicability of General License 1A from OFAC, but has not received any such confirmation to date. 

Luokung Files Lawsuit in Defense of its Claims that the Company’s Designation is Unlawful

Luokung, together with two U.S. shareholders of the Company, filed a complaint today with the Court setting forth seven claims that Luokung’s designation as a CCMC under Section 1237 and EO 13959, as amended, is unlawful: 

• First, Luokung alleges that the designation under Section 1237 is arbitrary and capricious, an abuse of discretion, and otherwise not in accordance with law in violation of the Administrative Procedure Act, 5 U.S.C. § 551 et seq. (“APA”).
• Second, Luokung alleges that DoD exceeded its authority by failing to follow procedures in Section 1237 in violation of the APA.
• Third, Luokung alleges that DoD did not consult with other agencies as required by Section 1237, and therefore Luokung’s designation is in excess of DoD authority.
• Fourth, Luokung alleges that it is not a CCMC under the statutory definition in Section 1237 and, therefore, restrictions on trading of Luokung shares under EO 13959 cannot lawfully apply to Luokung.
• Fifth, Luokung alleges that its designation as a CCMC and the restrictions in EO 13959, as applied to Luokung, violate the Fifth Amendment of the U.S. Constitution, i.e., are an unconstitutional deprivation of property and other rights without due process of law.
• Sixth, Luokung alleges that Section 1237 fails to provide fair notice of what a CCMC is and therefore, in conjunction with restrictions that apply to CCMCs under EO 13959, is unconstitutionally vague.
• Finally, Luokung also asserts a seventh claim seeking a declaratory judgment from the Court that General License 1A applies to Luokung, and that the prohibitions in EO 13959, if applicable at all to Luokung, do not go into effect until May 27, 2021.

Luokung filed the complaint along with plaintiffs Mr. Baomin Li and Mr. Raymond Weiman Bai, both of whom are U.S. citizens and shareholders of Luokung.  Like the Company, the Company’s U.S. shareholders are adversely affected by the designation of Luokung under Section 1237 and EO 13959.  As relief, Luokung asks the Court, among other things, to declare that Luokung’s designation as a CCMC is invalid and enjoin the application of the prohibitions in EO 13959 as they apply to Luokung. 

Luokung looks forward to defending its and its U.S. shareholders’ interests in the Court, but notes there is no guarantee that its claims will prevail. 

Luokung will make further public announcements as warranted by future developments. Investors are kindly requested to pay attention to the Company’s announcements and beware of investment risks.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future and other statements that are other than statements of historical fact. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “plan”, “probable”, “potential”, “should”, “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination and analysis of the existing law, rules and regulations and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you the statement herein will be accurate. As a result, you are cautioned not to rely on any forward-looking statements.

CONTACT:

The Company:
Mr. Jay Yu
Chief Financial Officer
Tel: +86-10-5327-4727
Email: [email protected]

Investor Relations

Adam Prior

Senior Vice President
The Equity Group Inc.
Tel: 212-836-9606     
Email: [email protected]

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SOURCE Luokung Technology Corp.

COLORADO SPRINGS, Colo., March 5, 2021 /PRNewswire/ — Century Casinos, Inc. (Nasdaq Capital Market®: CNTY) announced today that the company will release its earnings for the fourth quarter and year-end of 2020 on Friday, March 12, 2021.

On Friday, March 12, 2021, Century Casinos will host its Q4 2020 Earnings Conference Call at 8:00 a.m. MST. Participants are advised to dial in 15 minutes in advance. US domestic and Canadian participants please dial +1 844-244-9160, all other international participants please use +1 330-931-4670 to dial in. The conference ID is ‘Quarter4’. To just follow the call, or a recording of the call, please visit our website at https://www.cnty.com/investor/financials/financial-results/ .

About Century Casinos, Inc.:
Century Casinos, Inc. is a casino entertainment company. The Company owns and operates Century Casino & Hotels in Cripple Creek and Central City, Colorado, and in Edmonton, Alberta, Canada; the Century Casino in Cape Girardeau and Caruthersville, Missouri, and in St. Albert, Alberta, Canada; Mountaineer Casino, Racetrack & Resort in New Cumberland, West Virginia; the Century Mile Racetrack and Casino (“CMR”) in Edmonton, Alberta, Canada; and Century Bets! Inc. (“CBS”). CBS and CMR operate the pari-mutuel off-track horse betting networks in southern and northern Alberta, respectively. Through its Austrian subsidiary, Century Resorts Management GmbH (“CRM”), the Company holds a 66.6% ownership interest in Casinos Poland Ltd., the owner and operator of eight casinos throughout Poland; and a 75% ownership interest in Century Downs Racetrack and Casino in Calgary, Alberta, Canada. The Company operates four ship-based casinos. The Company, through CRM, also owns a 7.5% interest in, and provides consulting services to, Mendoza Central Entretenimientos S.A., a company that provides gaming-related services to Casino de Mendoza in Mendoza, Argentina. The Company continues to pursue other projects in various stages of development.

Century Casinos’ common stock trades on The Nasdaq Capital Market® under the symbol CNTY. For more information about Century Casinos, visit our website at www.cnty.com.

This release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These statements are based on the beliefs and assumptions of the management of Century Casinos based on information currently available to management. Such forward-looking statements include, but are not limited to, statements regarding future results of operations, including the impact of the current coronavirus (COVID-19) pandemic, and plans for our casinos and our Company. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such forward-looking statements. Important factors that could cause actual results to differ materially from the forward-looking statements include, among others, the risks described in the section entitled “Risk Factors” under Item 1A in our Annual Report on Form 10-K for the year ended December 31, 2019, in Item 8.1 in our Current Report on Form 8-K filed on May 8, 2020, in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and in subsequent periodic and current SEC filings we may make. Century Casinos disclaims any obligation to revise or update any forward-looking statement that may be made from time to time by it or on its behalf.

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SOURCE Century Casinos, Inc.

BOSTON, March 5, 2021 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company, today announced that Company management will participate in the upcoming H.C. Wainwright Global Life Sciences Conference taking place virtually from March 9-10, 2021. 

Akash Bakshi, Senior Vice President and Chief Operating Officer of NeuroBo and Seth Reno, Commercial Advisor of NeuroBo, will present a corporate overview at the conference, including an update on the status of the ongoing phase 2/3 study of lead program, ANA001, in moderate and severe COVID-19 patients.

The presentation will be available beginning March 9, at 7:00 am ET. A webcast of the presentation will be available on the “Events and Presentations” section of NeuroBo’s website at: neurobopharma.com/events-presentations. An archived replay will be available for a period of 90 days after the conference.

About NeuroBo Pharmaceuticals

NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company’s recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. The company’s NB-01 candidate has been shown in a Phase 2 study to significantly reduce pain symptoms associated with painful diabetic neuropathy (PDN), with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study was postponed. In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo’s NB-02 drug candidate is focused on the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company’s fourth program, Gemcabene, was developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

For more information visit: https://www.neurobopharma.com.

Forward Looking Statements

Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the development timeline for niclosamide for the treatment of COVID-19, the market size for COVID-19-related therapeutics and the competitive advantages of ANA001, the potential benefits of ANA001 as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators), and potential milestone payments and royalties that may become due to the former equity holders of ANA under the acquisition agreement. Forward-looking statements are usually identified by the use of words, such as “believes,” “anticipates,” “expects,” “intends,” “plans,” “may,” “potential,” “will,” “could” and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. These factors, risks and uncertainties include, but are not limited to: the failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the acquisition agreement on the results of operations and financial position of NeuroBo; the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo’s business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo’s ability to continue as a going concern; the timing of completion of NeuroBo’s planned clinical trials, including with respect to ANA001; the timing of the availability of data from NeuroBo’s clinical trials, including with respect to ANA001;  the clinical utility, potential benefits and market acceptance of NeuroBo’s product candidates, including ANA001; ; and NeuroBo’s need for additional financing to fulfill its stated goals; and other factors discussed in the “Risk Factors” section of NeuroBo’s Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent NeuroBo’s views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo’s views as of any date subsequent to the date hereof.

Contacts:

Rx Communications Group

Michael Miller

+1-917-633-6086
[email protected]

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SOURCE NeuroBo Pharmaceuticals, Inc.

SUGAR LAND, Texas, March 5, 2021 /PRNewswire/ — Trecora Resources (NYSE: TREC), a leading provider of specialty hydrocarbons and specialty waxes, today announced its upcoming conference schedule: 

• G. research 12^th Annual Specialty Chemicals Virtual Conference
  Date and Time: Thursday, March 11, 2021 from 2:00 p.m. – 2:30 p.m. ET (11:00 a.m. – 11:30 a.m. PT)

Pat Quarles, CEO, and Sami Ahmad, CFO will participate in a live webcast for the G. research 12th Annual Specialty Chemicals Virtual Conference with replays available for 90 days. The slides that accompany the webcast will be available on the Company’s website: www.trecora.com. To listen to the webcast please click on the link below: 

https://wsw.com/webcast/gabellifunds3/trec/2819626

Management will also be available for one-on-one meetings throughout the day. Investors interested in scheduling a meeting should contact their G. research representative. 

About Trecora Resources (TREC)
TREC owns and operates a specialty petrochemicals facility specializing in high purity hydrocarbons and other petrochemical manufacturing and a specialty wax facility, both located in Texas, and provides custom processing services at both facilities.

Investor Relations Contact: 
Jason Finkelstein 
The Piacente Group, Inc. 
212-481-2050 
[email protected] 

 

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SOURCE Trecora Resources

VANCOUVER, BC, March 5, 2021 /PRNewswire/ –  Callinex Mines Inc. (the “Company” or “Callinex”) (TSXV: CNX) (OTC: CLLXF) announces that it has granted 160,000 stock options to its directors, officers and consultants.  The options are exercisable at $5.00 per share, subject to certain vesting requirements and expire five years from the date of grant.

About Callinex Mines Inc.

Callinex Mines Inc. (TSXV: CNX) (OTC: CLLXF) is advancing its portfolio of base and precious metals rich deposits located in established Canadian mining jurisdictions. The portfolio is highlighted by its Nash Creek and Superjack deposits in the Bathurst Mining District of New Brunswick. A 2018 PEA outlined a mine plan that generates a strong economic return with a pre-tax IRR of 34.1% (25.2% post-tax) and NPV8% of $230 million ($128 million post-tax). The projects have significant exploration upside over a district-scale land package that encompasses several high-grade mineral occurrences along a 20km trend. Click here to view a video overview of the Nash Creek Project.

Callinex has a project portfolio that also includes projects within the Flin Flon Mining District of Manitoba that are located 25km to an operating processing facility that requires additional ore.

Neither the 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.

Some statements in this news release contain forward-looking information. These statements include, but are not limited to, statements with respect to future expenditures. These statements address future events and conditions and, as such, involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the statements. Such factors include, among others, the ability to complete the proposed drill program and the timing and amount of expenditures. Except as required under applicable securities laws, Callinex does not assume the obligation to update any forward-looking statement.

View original content to download multimedia:http://www.prnewswire.com/news-releases/callinex-grants-stock-options-301241193.html

SOURCE Callinex Mines Inc.

TEL AVIV, Israel, March 5, 2021 /PRNewswire/ — SciSparc Ltd. (formerly known as Therapix Biosciences Ltd.) (OTCQB: SPRCY), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced that it has closed its previously announced private placement in which the Company sold an aggregate of 1,152,628 Units to certain institutional and accredited investors as follows: (a) 916,316 units at an offering price of $7.07 per unit, consisting of 1 American Depositary Share (“ADS”), a Series A Warrant to purchase an equal number of Units purchased and a Series B Warrant to purchase half the number of Units and (b) 236,312 pre-funded units at a price of $7.069 per unit, consisting of 1 pre-funded warrant to purchase one ADS, a Series A Warrant to purchase an equal number of Units purchased and a Series B Warrant to purchase half the number of Units. The Series A Warrants have an exercise price of $7.07, subject to adjustments therein. The Series B Warrants have an exercise price equal to $10.60, subject to adjustments therein. The Series A Warrants and the Series B Warrants are exercisable six months from the date of issuance and have a term of exercise equal to five years from the initial exercise date. The Pre-Funded Warrants have an exercise price of $0.001 per full ADS. The Pre-Funded Warrants will be exercisable at any time after the date of issuance upon payment of the exercise price. The aggregate gross proceeds from the offering were approximately $8.15 million, before deducting fees to the placement agent and other offering expenses payable by the Company.

 

 

Aegis Capital Corp. acted as Exclusive Placement Agent in the United States in connection with the offering.

The securities were sold in a private placement, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the Securities and Exchange Commission, for purposes of registering the resale of the securities issued or issuable in connection with the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

About SciSparc Ltd. (OTCQB: SPRCY):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 (formerly THX-110) for the treatment of Tourette syndrome and for the treatment of obstructive sleep apnea; SCI-160 (formerly THX-160) for the treatment of pain; and SCI-210 (formerly THX-210) for the treatment of autism spectrum disorder and epilepsy.

Logo – https://mma.prnewswire.com/media/1434686/SciSparc_Ltd_Logo.jpg

Investor Contact:
[email protected]
Tel: +972-3-6167055

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SOURCE SciSparc Ltd.

SUMMIT, N.J., March 5, 2021 /PRNewswire/ — Seqirus, a global leader in influenza prevention, today announced that the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX^® QUADRIVALENT (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older.¹ FLUCELVAX QUADRIVALENT was previously FDA-approved for use in persons four years of age and older. FLUCELVAX QUADRIVALENT will be available as a 0.5ml intramuscular (IM) vaccine per dose for the 2021/22 U.S. influenza season.

The expanded age indication is based on absolute efficacy data indicating that FLUCELVAX QUADRIVALENT was effective and produced a sufficient immune response against influenza in children and adolescents between ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator.² This represents the first absolute efficacy study of a cell-based influenza vaccine in this population.

“Young children are at a high risk of complications from influenza, which is why annual vaccination is critical,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “The absolute efficacy results for FLUCELVAX QUADRIVALENT that served as the basis for this approval indicate that the cell-based vaccine offers an important new option for children as young as two years of age.”

According to the Centers for Disease Control and Prevention (CDC), the best way to prevent influenza is by receiving an annual seasonal influenza vaccine.³ More than 52,000 hospitalizations occurred in children aged 18 years of age and younger during the 2019/20 U.S. influenza season, and there were over 434 influenza-related deaths in this age group.⁴ Children younger than five years of age are at high risk of developing serious flu-related complications.⁵ The CDC recommends everyone six months of age and older without contraindications receive an influenza vaccine annually.³

FLUCELVAX QUADRIVALENT utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing. There are several factors that can impact seasonal influenza vaccine effectiveness, which may include mismatch between circulating strains and the influenza strains contained within the seasonal influenza vaccine. Egg-based manufacturing requires a growth-inducing strain to ensure the influenza virus can grow successfully in eggs, which can cause the strain to mutate and result in an influenza virus that can be different from the intended strain.⁶ This may lead to a mismatch between the circulating strains and the inactivated influenza strains contained within the seasonal influenza vaccine.⁶ Cell-based influenza vaccines like FLUCELVAX QUADRIVALENT are designed to help avoid egg-adapted changes and may result in vaccine virus strains that are more closely matched to those selected by the World Health Organization.^6,7 Cell-based influenza vaccine technology may offer additional advantages over the standard influenza manufacturing process, including being more scalable and offering faster production in the event of an influenza pandemic.⁶

“While influenza vaccination has always offered a way to minimize the burden of disease on the healthcare system, it is more important than ever this season to minimize the burden on the healthcare system and preserve capacity for COVID-19 patients,” said Dave Ross, Vice President, North America Commercial Operations at Seqirus. “Especially now, we remain focused on our public health imperative to help protect as many people as possible against influenza, especially children.”

In the U.S., Seqirus operates a state-of-the-art cell-based manufacturing facility in Holly Springs, North Carolina, purpose-built in partnership with the Biomedical Advanced Research and Development Authority (BARDA) to increase cell-based vaccine manufacturing capacity and combat pandemic influenza threats.⁸

Seqirus plans to continue exploring other clinical research associated with FLUCELVAX QUADRIVALENT.

About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life- threatening complications in some people.⁹ Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.⁹ The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.³ Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.⁹ Preliminary estimates from the CDC report that from October 1, 2019, through April 4, 2020, there were an estimated 410,000 to 740,000 influenza-related hospitalizations in the U.S.¹⁰ Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.³ The CDC recommends that people get vaccinated by the end of October.¹¹ Getting vaccinated too early (for example, in July or August), can be associated with reduced protection against influenza infection later in the flu season.¹¹ However, getting vaccinated later can still be beneficial and vaccination should continue to be offered throughout the influenza season, even into January or later.¹¹

About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

About CSL
CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus – provides life- saving products to more than 100 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL Limited, visit www.csl.com.

For more information visit www.seqirus.com and www.csl.com.

Intended Audience
This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.

Forward-Looking Statements
This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

FLUCELVAX^® QUADRIVALENT (Influenza Vaccine)
IMPORTANT SAFETY INFORMATION

What is FLUCELVAX^® QUADRIVALENT (Influenza Vaccine)?

FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 2 and older from the flu. Vaccination with FLUCELVAX QUADRIVALENT may not protect all people who receive the vaccine.

Who should not get FLUCELVAX QUADRIVALENT?

You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine.

Before receiving FLUCELVAX QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:

• have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUCELVAX QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
• have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine
• have ever fainted when receiving a vaccine

What are the most common side effects of FLUCELVAX QUADRIVALENT?

• pain, redness, or a raised hardened area or swelling where the vaccine was given
• headache
• tiredness
• muscle aches
• feeling unwell (malaise)

Additional side effects seen in children include:

• tenderness or bruising where vaccine was given
• sleepiness
• irritability
• changes in eating habits

These are not all of the possible side effects of FLUCELVAX QUADRIVALENT. You can ask your healthcare provider for more information and for advice about any side effects that concern you.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1–855–358-8966 or VAERS at 1–800–822–7967 or www.vaers.hhs.gov.

You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.

Before receiving this vaccine, please see the full US Prescribing Information for FLUCELVAX QUADRIVALENT. The information provided here does not include all that is known about FLUCELVAX QUADRIVALENT. To learn more, talk with your healthcare provider or pharmacist.

FLUCELVAX^® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

USA-QIVc-21-0006

MEDIA CONTACT

Polina Miklush

+1 (908) 608-7170
[email protected]

REFERENCES

¹ FLUCELVAX^® QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: Seqirus Inc; 2021.

² Fortanier, A.C., Põder, A., Bravo, L.C., et al. (2020). Efficacy of Cell-Derived Quadrivalent Influenza Vaccine Against Clinical Influenza in Children 2 to <18 Years of Age.

³ The Centers for Disease Control and Prevention (CDC). (2020). Key Facts About Seasonal Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed March 2021.

⁴ CDC. (2020). Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States — 2019–2020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2019-2020.html. Accessed March 2021.

⁵ Centers for Disease Control and Prevention (CDC). (2020). Flu & Young Children. Retrieved from: https://www.cdc.gov/flu/highrisk/children.htm. Accessed March 2021.

⁶ CDC (2020). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.htm. Accessed March 2021.

⁷ Rajaram, S., Boikos, C., Gelone, et al. (2020). Influenza Vaccines: The Potential Benefits of Cell-Culture Isolation and Manufacturing.

⁸ This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I.

⁹ CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed March 2021.

¹⁰ CDC. (2020). 2019-2020 U.S. Flu season: Preliminary burden estimates. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed September 2020.Accessed March 2021.

¹¹ CDC. (2020). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed March 2021.

 

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