Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes

PR Newswire

STOCKHOLM, Dec. 16, 2020 /PRNewswire/ — Diamyd Medical and the Critical Path Institute (C-Path) are proud to announce their collaboration to significantly improve the scientific community’s insight into type 1 diabetes (T1D) through Diamyd Medical’s contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Measures Initiative (TOMI) T1D integrated database.

The Phase III trial evaluated the use of the diabetes vaccine Diamyd®, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D. TOMI-T1D aims to create a clinical trial simulation tool (CTST) with large and diverse clinical datasets from the T1D community. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design. Contribution of these robust data sets from industry led trials is critical to TOMI-T1D’s work in developing innovative and quantitative tools that can facilitate clinical development efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials. 

“Progress towards the establishment of approved therapies for people with T1D is critically reliant on participation from our partners in industry with their data”, said Simi Ahmed and Elizabeth Robertson, on behalf of the charity partnership.

“This is indeed a right step in that direction”, said Colin Dayan, lead PI at Cardiff University.

“We are thrilled that Diamyd Medical is taking a leading role and championing precompetitive collaborations advancing type 1 diabetes regulatory science solutions”, said Inish O’Doherty Executive Director at C-Path. “Their data will help in the construction and evaluation of a clinical trial simulation tool to assist in the development of novel therapies for type 1 diabetes patients”.

“We are very honored to be part of this important collaboration -involving key stakeholders within the type 1 diabetes landscape, said Ulf Hannelius, President & CEO of Diamyd Medical. “As we are moving into an era of precision medicine in type 1 diabetes, we can expect to see significant therapeutic advances, and access to high quality data will be integral to maximizing these efforts”.

To learn more about the TOMI-T1D project visit: https://c-path.org/programs/tomi-t1d/

About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

About JDRF

JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent, and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact and uniting on a national stage to pool resources, passion and energy. We collaborate with academic institutions, policymakers and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

About Diabetes UK

1.     Diabetes UK’s aim is creating a world where diabetes can do no harm. Diabetes is the most devastating and fastest growing health crisis of our time, affecting more people than any other serious health condition in the UK – more than dementia and cancer combined. There is currently no known cure for any type of diabetes. With the right treatment, knowledge and support people living with diabetes can lead a long, full and healthy life. For more information about diabetes and the charity’s work, visit www.diabetes.org.uk  

2.     Diabetes is a condition where there is too much glucose in the blood because the body cannot use it properly. If not managed well, both type 1 and type 2 diabetes can lead to devastating complications. Diabetes is one of the leading causes of preventable sight loss in people of working age in the UK and is a major cause of lower limb amputation, kidney failure and stroke. 

3.     People with type 1 diabetes cannot produce insulin. About 10 per cent of people with diabetes have type 1. No one knows exactly what causes it, but it’s not to do with being overweight and it isn’t currently preventable. It’s the most common type of diabetes in children and young adults, starting suddenly and getting worse quickly. Type 1 diabetes is treated by daily insulin doses – taken either by injections or via an insulin pump. It is also recommended to follow a healthy diet and take regular physical activity.

4.     People with type 2 diabetes don’t produce enough insulin or the insulin they produce doesn’t work properly (known as insulin resistance). Around 90 per cent of people with diabetes have type 2. They might get type 2 diabetes because of their family history, age and ethnic background puts them at increased risk. They are also more likely to get type 2 diabetes if they are overweight. It starts gradually, usually later in life, and it can be years before they realise they have it. Type 2 diabetes is treated with a healthy diet and increased physical activity. In addition, tablets and/or insulin can be required. 

For more information on reporting on diabetes, download our journalists’ guide: Diabetes in the News: A Guide for Journalists on Reporting on Diabetes (PDF, 3MB).

About Diamyd Medical

Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown  in a genetically predefined patient group in a large-scale metastudy as well as in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB.

Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: [email protected]

CONTACT:

For further information, please contact:

Ulf Hannelius, President and CEO

Phone: +46 736 35 42 41

E-mail: [email protected]

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-and-critical-path-institute-announce-data-sharing-collaboration-to-develop-advanced-d,c3255392

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SOURCE Diamyd Medical AB

Victory Square Technologies Announces Completion of Asset Purchase from Techstars 2019 Alumni Company GameOn App Inc. and Appointment of Matt Bailey as Chief Executive Officer of V2 Games Inc.

VANCOUVER, British Columbia, Dec. 16, 2020 (GLOBE NEWSWIRE) — Further to the press release of Victory Square Technologies Inc. (“VictorySquare“) (CSE:VST) (OTC:VSQTF) (FWB:6F6) dated September 18, 2020, V2 Games Inc. (“V2 Games“), a portfolio company of Victory Square, is pleased to announce that on December 1, 2020, it closed a transaction to acquire substantially all of the assets (the “AssetPurchase“) of GameOn App Inc. (“GameOn“) pursuant to an asset purchase agreement between V2 Games and GameOn dated November 11, 2020, as amended by an amending agreement dated November 30, 2020 (the “APA“).

Prior to the sale of its assets to V2 Games, GameOn was a gaming company providing consumers, broadcasters, sportsbooks, venues and brand partners with interactive, social experiences around sports, television and live events. GameOn drove engagement and revenue through its suite of proprietary mobile and TV technologies, changing the way fans compete, watch and win through free and frictionless prediction games. After completing the Techstars accelerator program and launching last summer, GameOn landed distribution rights into Comcast homes and bars. GameOn’s television app, which has been acquired by V2 Games, overlays sports games to enable live prediction in venues throughout the United States, driving viewership, engagement and revenue. GameOn also worked with white-label partners including NBCUniversal, Bravo and Real Housewives.

“We are excited to welcome the GameOn team to the Victory Square family,” said Shafin Diamond Tejani, CEO of Victory Square. “This acquisition will strengthen the V2G management team, add new interactive and innovative products to the company’s portfolio and includes partnerships with major players including Comcast and NBCUniversal. The upcoming public listing of V2G will also unlock value for VST and our shareholders, as we follow in the footsteps of the successful public launch of Fansunite Entertainment earlier this year.”

As consideration for the Asset Purchase, V2 Games issued 3,123,288 common shares of V2 Games at a deemed price of $0.80 per share, assumed USD$274,400 in liabilities of GameOn, and issued a convertible note with a principal amount of USD$92,000 and a maturity date of December 1, 2022 (the “ConvertibleNote“), equivalent to a total purchase price of approximately $2,965,047 based on the Bank of Canada exchange rate for United States dollars to Canadian dollars as of December 14, 2020. No interest is payable on the principal amount of the Convertible Note, which is convertible into common shares of V2 Games at a price of $0.25 per share at the option of the holder.

Pursuant to the APA, V2 Games has agreed to use commercially reasonable efforts to complete a going public transaction and list its common shares on the Canadian Securities Exchange (the “CSE”) by February 28, 2021, or such other date as may be agreed by V2 Games and GameOn (the “GoingPublicTransaction“) and, immediately prior to the closing of the Going Public Transaction, V2 Games will issue such number of common shares of V2 Games as is equal to $150,000 divided by the deemed price per share determined in connection with the Going Public Transaction (the “GoingPublicSharePrice“) to such directors, employees and consultants of GameOn as GameOn may direct.

V2 Games has also agreed to use commercially reasonable efforts to complete a financing with gross proceeds of at least $1,500,000 at a price of $0.25 per share (the “V2 Games Financing“) prior to completion of the Going Public Transaction.

The board of directors of V2 Games (the “Board“) will be reconstituted to consist of five members, three of whom will be nominees of V2 Games and two of whom will be nominees of GameOn. The details of the reconstitution of the Board will be announced in due course.

Chief Executive Officer

In connection with the Asset Purchase, V2 Games has entered into an employment agreement dated December 1, 2020, with Matthew Bailey, a founder and the chief executive officer of GameOn, pursuant to which Mr. Bailey has agreed to serve as V2 Games’ chief executive officer.

Mr. Bailey has over a decade of experience, including executive roles with BSE Global – the owner of the Brooklyn Nets and Barclays Center – as well as CSM Sport & Entertainment, leading client accounts such as the Harlem Globetrotters. He has also developed revenue-generating partnerships with key brands including Ford Motor Company, T-Mobile, Burger King and Vita Coco, and has been featured in Forbes magazine.

“I am very excited to join the team at V2 Games and work towards our listing on the CSE in Q1 2021,” said Mr. Bailey. “V2 Games’ purchase of GameOn’s assets provides a path to growth and we have already made some significant moves, including hiring Santiago Jaramillo as Vice President of Product,” he continued. “Mr. Jaramillo brings extensive sports and game experience to V2 Games, having spent a decade building FIFA at EA Sports and also leading development of NBA Top Shot at Dapper Labs.”

“We continue to seek out new opportunities for additional acquisitions,” said Mr. Bailey. “The growing excitement around sports betting and gaming presents a key opportunity for V2 Games and I look forward to capitalizing on this in the days ahead.”

ABOUT V2 GAMES INC.

V2 Games is a video and mobile game ventures firm focusing on royalty investments in high-value gaming projects featuring globally-recognized intellectual properties. The company generates cash flow by streaming revenue share from recognizable gaming projects. Examples of these projects include: Pacific Rim: Breach Wars, Rune: Ragnarok, Men In Black and Hello Kitty. V2 Games previously developed the hit mobile game PAC-MAN Bounce, which got over 20 million downloads.

ABOUT VICTORY SQUARE TECHNOLOGIES INC.

Victory Square builds, acquires and invests in promising startups, then provides the senior leadership and resources needed to fast-track growth.

Our sweet spot is the cutting-edge tech that’s shaping the 4th Industrial Revolution. Our portfolio consists of 23 global companies using AI, VR/AR and blockchain to disrupt sectors as diverse as fintech, insurance, health and gaming.

What we do differently for startups

Victory Square isn’t just another investor. With real skin in the game, we’re committed to ensuring each company in our portfolio succeeds. Our secret sauce starts with selecting startups that have real solutions, not just ideas. We pair you with senior talent in product, engineering, customer acquisition and more. Then we let you do what you do best — build, innovate and disrupt. In 24-36 months, you’ll scale and be ready to monetize.

What we do differently for investors

Victory Square is a publicly traded company headquartered in Vancouver, Canada, and listed on the Canadian Securities Exchange (VST), Frankfurt Exchange (6F6) and the OTCQX (VSQTF).

For investors, we offer early-stage access to the next unicorns before they’re unicorns.

Our portfolio represents a uniquely liquid and secure way for investors to get access to the latest cutting-edge technologies while also tapping into emerging global trends with big upsides. For more information, please visit www.victorysquare.com.

On behalf of the board,

Shafin Diamond Tejani
Chief Executive Officer and Director
Victory Square Technologies Inc.
www.victorysquare.com

For further information about Victory Square, please contact:

Investor Relations Contact – Alex Tzilios
Email: [email protected]
Telephone: 778-867-0482

Media Relations Contact – Howard Blank, Director
Email: [email protected]
Telephone: 604-928-6066

Forward Looking Statement

This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the outlook of the business of Victory Square, including, without limitation, statements relating to future performance, execution of business strategy, future growth, business prospects and opportunities of Victory Square and its related subsidiaries, including V2 Games, and other factors beyond our control. Such forward-looking statements may, without limitation, be preceded by, followed by, or include words such as “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans”, “continues”, “project”, “potential”, “possible”, “contemplate”, “seek”, “goal”, or similar expressions, or may employ such future or conditional verbs as “may”, “might”, “will”, “could”, “should” or “would”, or may otherwise be indicated as forward-looking statements by grammatical construction, phrasing or context. All statements other than statements of historical facts contained in this news release are forward-looking statements. Forward-looking information is based on certain key expectations and assumptions made by the management of Victory Square. Although Victory Square believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on them because Victory Square can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. The statements contained in this news release are made as of the date of this news release. Victory Square disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. The CSE has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof.



Elbit Systems Awarded a $15 Million Contract to Supply XACT nv32 micro Night Vision Systems to the Netherlands Armed Forces

PR Newswire

HAIFA, Israel, Dec. 16, 2020 /PRNewswire/ — Elbit Systems Ltd. (NASDAQ: ESLT) (TASE: ESLT) (“Elbit Systems” or “the Company”) announced today that it was awarded an approximately $15 million initial contract from the Dutch Ministry of Defense to supply XACT nv32 micro night vision monocular systems for the Armed Forces of the Netherlands. The initial contract will be performed over a period of two-years, with the potential for additional follow-on orders over a period of seven-years.

This contract award joins previous contracts in the Netherlands in the fields of digital soldier systems and network-combat warfare systems, most notably for the VOSS program.

Compact and light weight, with a flip-up head/helmet adapter, XACT nv32 provides high resolution images under adverse conditions while minimizing Line-Of-Sight deviation and is suitable for mounted and dismounted soldiers, Special Forces and law-enforcement teams. Elbit Systems’ XACT product family is already operational with a number of NATO countries, including Germany, as well as with the Israeli and the Australian Armed Forces.


Elad Aharonson, General Manager of Elbit Systems ISTAR,
commented: “This contract award follows a number of important contracts awarded to Elbit Systems in recent years in the Netherlands. We see the Netherlands as a key market for Elbit Systems, and we intend to continue strengthening our local industrial cooperation and investments in the Netherlands in the years to come”.


About Elbit Systems

Elbit Systems Ltd. is an international high technology company engaged in a wide range of defense, homeland security and commercial programs throughout the world. The Company, which includes Elbit Systems and its subsidiaries, operates in the areas of aerospace, land and naval systems, command, control, communications, computers, intelligence surveillance and reconnaissance (“C4ISR”), unmanned aircraft systems, advanced electro-optics, electro-optic space systems, EW suites, signal intelligence systems, data links and communications systems, radios and cyber-based systems and munitions. The Company also focuses on the upgrading of existing platforms, developing new technologies for defense, homeland security and commercial applications and providing a range of support services, including training and simulation systems.

For additional information, visit: https://elbitsystems.com/, follow us on Twitter or visit our official Youtube Channel.


Contacts:

David Vaaknin

VP, Head of Corporate Communications

Tel:  972-77-2946691

Cell: 972-52-8000403


[email protected]

Dana Tal-Noyman

Manager, International  Corporate Communications

Tel: 972-77-2948809

Cell: 972-54-9998809


[email protected]

 

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SOURCE Elbit Systems Ltd.

BevCanna Focused on Burgeoning U.S. Market for Functional Beverages and Natural Health Products

BevCanna Focused on Burgeoning U.S. Market for Functional Beverages and Natural Health Products

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

The growing health and wellness products company to evaluate potential partnerships and acquisition targets with a view to expanding its growing portfolio

VANCOUVER, British Columbia–(BUSINESS WIRE)–
Emerging leader in infused cannabis beverages, BevCanna Enterprises Inc. (CSE:BEV, Q:BVNNF, FSE:7BC) (“BevCanna” or the “Company”) announced its intention today to further expand into the U.S. market, and is evaluating a list of potential strategic partnership and acquisition targets.

BevCanna is actively targeting strategic partnerships and M&A opportunities within the American market, as well as the potential to expand further into the U.S. through internal growth projects. The Company is specifically seeking strong beverage brands, manufacturers and distributors that have a wide range of capabilities and established distribution networks.

“The U.S. market for plant-based functional beverages and consumer products is exploding,” said Marcello Leone, CEO of BevCanna. “We’re seeing exceptionally strong year over year growth across a number of wellness categories, and as we evolve into a comprehensive health and wellness company focused on plant-based functional beverages and natural health products, we see unlimited opportunities to bring our products and expertise to this burgeoning market.”

The global functional beverages market anticipates a substantial 6.63 per cent CAGR during the 2018-2023 forecast period, with an estimated scaling of US $234.48B valuation. Market Research Future’s (MRFR) detailed report includes segments, competitions, and drivers for better predictive analysis of the future market. Functional beverages are gaining traction with consumers, who see benefits in their key ingredients, including minerals, vitamins, herbs, amino acids, antioxidants, and probiotics.

“BevCanna will now offer one of the most unique and diverse portfolios of beverage and wellness products within the cannabis, plant-based fulvic and humic, and natural health products categories,” added Mr. Leone. “We plan to bring this strength to global markets, including the expansive U.S. base.”

The global minerals supplements market is forecasted to grow at a more than 7.5 per cent CAGR between 2019-2026 and is anticipated to reach a total market value of approximately US $19.2B by 2026.

One of BevCanna’s key initiatives is accelerating the expansion of Naturo’s market-leading fulvic and humic mineral beverage TRACE into the U.S. market, along with BevCanna’s Anarchist Mountain all-natural ready to drink and ready to mix beverages.

BevCanna will also fully leverage its recently acquired Pure Therapy website, providing it with a proven e-commerce brand and platform to expand and launch proprietary plant-based natural products directly into the global health and wellness market, including the burgeoning U.S. CBD market.

As the Company identifies and forges additional strategic partnerships and acquisitions, it will continue to look for ways to leverage its strong and growing manufacturing, branding and distribution capabilities to capitalize on the increasing consumer demand for wellness-oriented products, by bringing new products to market and expanding upon the success of its current line-up.

About BevCanna Enterprises Inc.

BevCanna Enterprises Inc. (CSE:BEV, OTCQB:BVNNF, FSE:7BC) develops and manufactures cannabinoid–infused beverages and consumer products for in–house brands and white label clients. With decades of experience creating, branding and distributing iconic brands that have resonated with consumers on a global scale, the team demonstrates an expertise unmatched in the emerging cannabis beverage category. Based in British Columbia, Canada, BevCanna owns the exclusive rights to a pristine spring water aquifer, access to a world–class 40,000–square–foot, HACCP certified manufacturing facility, with a current bottling capacity of up to 210M bottles per annum. BevCanna also recently acquired US natural health and wellness e-commerce platform Pure Therapy. BevCanna’s vision is to be a global leader in infused innovations.

On behalf of the Board of Directors:

John Campbell, Chief Financial Officer and Chief Strategy Officer

Director, BevCanna Enterprises Inc.

Forward-Looking Information

This news release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of the Company. Forward-looking information is based on certain key expectations and assumptions made by the management of the Company, including the statements regarding: the Company’s intention to further expand into the U.S. market, and that it is evaluating a list of potential strategic partnership and acquisition targets; that BevCanna is actively targeting strategic partnerships and M&A opportunities within the American market, as well as the potential to expand further into the U.S. through internal growth projects; that the Company is specifically seeking strong beverage brands, manufacturers and distributors that have a wide range of capabilities and established distribution networks; that the U.S. market for plant-based functional beverages and consumer products is exploding; that the Company sees exceptionally strong year over year growth across a number of wellness categories, and as the Company evolves into a comprehensive health and wellness company focused on plant-based functional beverages and natural health products, the Company sees unlimited opportunities to bring its products and expertise to this burgeoning market; the global functional beverages market anticipates a substantial 6.63 per cent CAGR during the 2018-2023 forecast period, with an estimated scaling of US $234.48B valuation; that BevCanna will now offer one of the most unique and diverse portfolios of beverage and wellness products within the cannabis, plant-based fulvic and humic, and natural health products categories; the Company plans to bring this strength to global markets, including the expansive U.S. base; the global minerals supplements market is forecasted to grow at a more than 7.5 per cent CAGR between 2019-2026 and is anticipated to reach a total market value of approximately US $19.2B by 2026; that one of BevCanna’s key initiatives is accelerating the expansion of Naturo’s market-leading fulvic and humic mineral beverage TRACE into the U.S. market, along with BevCanna’s Anarchist Mountain all-natural ready to drink and ready to mix beverages; that BevCanna will also fully leverage its recently acquired Pure Therapy website, providing it with a proven e-commerce brand and platform to expand and launch proprietary plant-based natural products directly into the global health and wellness market, including the burgeoning U.S. CBD market; the Company will continue to look for ways to leverage its strong and growing manufacturing, branding and distribution capabilities to capitalize on the increasing consumer demand for wellness-oriented products, by bringing new products to market and expanding upon the success of its current line-up; and other statements regarding the business plans of the Company.

Forward-looking statements are based on certain assumptions regarding the issuances of licenses by Health Canada to the Company under the Cannabis Act; future positive legislative, tax and regulatory developments with respect to cannabis; a continued high regulatory barrier entry for cannabis-infused beverages; successful and timely commercialization of the company’s products; successful and timely negotiation of various agreements; the closing of the Company’s previously announced acquisition of Naturo Group Investments Inc.; and expectations with respect to the future growth of recreational cannabis products. While the Company considers these assumptions to be reasonable, based on information currently available, they may prove to be incorrect. Readers are cautioned not to place undue reliance on forward-looking statements. The assumptions of the Company, although considered reasonable by it at the time of preparation, may prove to be incorrect. In addition, forward-looking statements necessarily involve known and unknown risks, including, without limitation, the Company not being issued licenses by Health Canada; risks associated with general economic conditions; risks associated with climate and agriculture; changes in consumer preferences; adverse industry events; future legislative, tax and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; the inability to implement business strategies; competition; currency and interest rate fluctuations and other risks. Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. For more information on the risk, uncertainties and assumptions that could cause anticipated opportunities and actual results to differ materially, please refer to the public filings of the Company which are available on SEDAR at www.sedar.com. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law, and the Company does not assume any liability for disclosure relating to any other company mentioned herein.

For media enquiries or interviews, please contact:

Wynn Theriault, Thirty Dash Communications Inc.

416-710-3370

[email protected]

For investor enquiries, please contact:

Luca Leone, BevCanna Enterprises Inc.

604-880-6618

[email protected]

KEYWORDS: United States North America Canada

INDUSTRY KEYWORDS: Retail Alternative Medicine Health Food/Beverage

MEDIA:

Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe

Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe

— 93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus —

— Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe —

SANTA MONICA, Calif.–(BUSINESS WIRE)–
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.

The conditional marketing authorization is supported from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent, with 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent and 33 percent of patients, respectively.

“Significant gaps in treatment remain for patients with mantle cell lymphoma who progress following initial therapies,” said Professor John G. Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, London. “The availability of this first cell therapy for relapsed or refractory mantle cell lymphoma, following at least two lines of systemic therapy including a BTK inhibitor, provides an important option for patients in Europe.”

“Kite is committed to bringing the curative intent potential of CAR T-cell therapy to patients with hematological cancers,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. We are proud our second cell therapy has been approved for use in Europe, and I extend my thanks to the patients who participated in the clinical trial and their families and caregivers, clinical researchers, regulators and dedicated colleagues at Kite who helped make this approval possible for patients living with relapsed or refractory mantle cell lymphoma.”

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a BTK inhibitor have a poor prognosis, with a median overall survival of 6 to 10 months. In Europe, it is estimated that at least 7,400 people are diagnosed with mantle cell lymphoma each year.

Tecartus is a CAR T-cell therapy, an individualized method of treatment that harnesses the body’s own immune system to target cancer cells. The therapy uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature. In recognition of its potential to benefit patients with significant unmet medical need, Tecartus was granted Priority Medicines (PRIME) designation by the EMA.

Conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorisation after the submission and assessment of additional confirmatory data. Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. It requires additional monitoring and post-marketing data before full approval is granted.

For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

About ZUMA-2

ZUMA-2 is an ongoing, multinational, single arm, Phase 2 open-label pivotal trial. The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or acalabrutinib). The treatment was manufactured for 71 patients and administered to 68 patients. The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the European Commission may not extend or convert the conditional marketing authorization into an unconditional marketing authorization for Tecartus for the treatment of relapsed or refractory mantle cell lymphoma. In addition, physicians and patients may not see the potential benefits of Tecartus, and there is the possibility of unfavorable results from other ongoing and additional clinical studies involving Tecartus. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

Kite, the Kite logo, Tecartus, XLP and GILEAD are trademarks ofGilead Sciences, Inc., or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.comor call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Monica Tellado, Investors

(650) 219-3882

Nathan Kaiser, Media

(650) 522-1853

KEYWORDS: California Europe United States North America

INDUSTRY KEYWORDS: Biotechnology Hospitals Health Pharmaceutical Oncology

MEDIA:

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Kellogg Employees on Six Continents Rise Up and Rally to Feed People in Need for World Food Day

PR Newswire

BATTLE CREEK, Mich., Dec. 16, 2020 /PRNewswire/ — Kellogg Company (NYSE: K) today announced the results of its employee-driven program to help address food security in recognition of World Food Day.

Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8668551-kellogg-company-world-food-day/

Kellogg and its employees reached more than 4.1 million people through food donations, volunteerism and giving campaigns – as well as those who participated in company-sponsored activities, such as online or in-store promotions and digital events to learn more about the issue of food security.

The number of people experiencing hunger is at an all-time high in 2020 because of the COVID-19 pandemic. It’s expected that an additional 83 to 132 million people will go hungry – and that’s on top of the 690 million people who already face hunger worldwide.

World Food Day was observed Oct. 16, but Kellogg sponsored activities in the weeks before and after it.

Thousands of Kellogg employees, from the U.S. to Latin America to Europe and across Asia, rolled up their sleeves to ensure more children and families were being fed and fulfilled through virtual food drives, fundraisers, socially distanced in-person food collections and various other activities. 

“As a leading global food company that addresses food insecurity, Kellogg employees around the world have once again stepped up to put their heart and soul on display to create Better Days for people in need,” said Steve Cahillane, Kellogg Company Chairman and CEO. 

“And they did it in creative ways due to the limitations of the pandemic. It was incredibly inspiring to see our people come together from regions around the world and rally for a common purpose. This work has never been more important as we strive for a good and just world, where people are not just fed, but fulfilled.”

  • In Europe, employees in Belgium, Germany, France, Italy, Spain, Ireland, the UK and Russia participated in food drives, held fundraising events, and tuned in to virtual discussions about the issue of food insecurity. Kellogg partnered with retailers in Belgium and Germany on promotions to donate food and raise money for local food banks. In Russia, colleagues at the company’s Kutno manufacturing facility donated food and funds to support a local orphanage. And in the UK, the Wrexham plant team helped deliver 1,000 kilograms of food to local hunger relief organizations.
  • In AMEA, employees in South Africa mobilized to create #MyBetterDays moments by assembling more than 13,000 hampers filled with meals and face masks to distribute to families in need in their communities. One Kellogg manufacturing manager from the Springs facility shared how the hampers helped to provide some much-needed relief to families struggling with the effects of the pandemic. You can read more about his story in this Social K blog. Pringles Asia Pacific collaborated with e-commerce customer RedMart, on a ‘buy a box, give a box’ campaign to support frontline COVID-19 healthcare workers. Kellogg Korea, in partnership food and beverage company, Nongshim, collectively donated food and funds to the non-profit organization, Child Fund Korea.
  • In Latin America, employees participated in virtual volunteering events, donated food and funds to charity partners and created face masks and bags made of t-shirts for local food banks to deliver their donations. In Mexico, employees volunteered at a school to teach children how to avoid food waste. The Latin America team also created a “Heart & Soul” podcast that featured external partners discussing food insecurity.
  • In Canada, the team rallied from coast to coast to create #KCIBetterDays by safely delivering hampers filled with cereal, masks and a note of encouragement to Canadians in need in their communities. Kellogg also partnered with its largest customer, Loblaws, for an in-store activation whereby for every box of cereal sold on World Food Day at Loblaws Market & Discount banners, Kellogg donated $1.00 (up to a maximum of $50,000) to President’s Choice Children’s Charity to help fight childhood hunger. 
  • In the United States, employees donated to United Way and other charitable partners through Kellogg’s Better Days campaign and contributed to a number of activities, including virtual fundraisers where company leaders and Kellogg’s Business/Employee Resource Groups competed for greatest funds raised. Kellogg also partnered once again with Amazon and Feeding America, this year hosting a “Stream It Forward” promotion where Amazon donated $1 for every hour of content streamed in the Food Network Kitchen app on Fire TV, tablet and Echo Show. Plus, for every participating Kellogg food purchased on Amazon.com during the promotion period, Kellogg donated 10 meals to Feeding America.

These efforts contribute to Kellogg’s Better Days global purpose platform and commitment to create better days for 3 billion people around the world by 2030.


About Kellogg Company


At Kellogg Company (NYSE: K), we strive to enrich and delight the world through foods and brands that matter. Our beloved brands include Pringles®, Cheez-It®, Special K®, Kellogg’s Frosted Flakes®, Pop-Tarts®, Kellogg’s Corn Flakes®, Rice Krispies®, Eggo®, Mini-Wheats®, Kashi®, RXBAR®, MorningStar Farms® and more. Net sales in 2019 were approximately $13.6 billion, comprised principally of snacks and convenience foods like cereal and frozen foods. Kellogg brands are beloved in markets around the world. We are also a company with Heart & Soul, committed to creating Better Days for 3 billion people by the end of 2030 through our Kellogg’s® Better Days global purpose platform. Visit

www.KelloggCompany.com or www.OpenforBreakfast.com.


 

Kellogg partnered with our brands and retail customers to host online food drives.

 

In Poland, our Kutno manufacturing plant team donated food and funds to a local food bank and orphanage.

 

In South Africa, employees packed 13.000 hampers filled with meals and face masks to distribute to families in need.

 

Kellogg Company World Food Day program logo

 

In the U.K., employees from our Wrexham plant helped deliver 1,000 kilograms of food to benefit local hunger relief organizations.

 

In Canada, the team rallied from coast to coast to create #KCIBetterDays by safely delivering hampers filled with cereal, masks and a note of encouragement to Canadians in need in their communities.

 

kellogg_company_Logo

 

 

Cision View original content:http://www.prnewswire.com/news-releases/kellogg-employees-on-six-continents-rise-up-and-rally-to-feed-people-in-need-for-world-food-day-301193773.html

SOURCE Kellogg Company

BioNTech and Fosun Pharma to Supply China with mRNA-based COVID-19 Vaccine

  • Supply agreement reflects both companies’ shared commitment and efforts to achieve vaccine accessibility and affordability in China
  • A local Phase 2 clinical trial of mRNA COVID-19 vaccine candidate BNT162b2 is on-going in Jiangsu, China

MAINZ, GERMANY, and SHANGHAI, CHINA, December 16, 2020 (GLOBE NEWSWIRE) BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) today announced an agreement to supply Mainland China with an initial 100 million doses of their BNT162 mRNA-based vaccine candidate against COVID-19 in 2021, subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany. 

“We would like to thank the Chinese government and National Medical Products Administration for their commitment and trust in our vaccine development efforts to help address this global pandemic threat,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “This joint development effort with Fosun Pharma is a testament to the importance of global cooperation and reflects our strategy to supply our vaccine globally. This agreement is an important step toward our shared goal of bringing a safe and efficacious vaccine to people worldwide.”

“Since the outbreak of the COVID-19 epidemic, we have been working closely with BioNTech. With the support of the Joint Prevention and Control Mechanism of the State Council, especially the National Medical Products Administration, the National Health Commission, the Ministry of Science and Technology and other relevant authorities, the R&D and clinical trial of our COVID-19 mRNA vaccine in China has been moved forward rapidly. On the premise of ensuring the safety and effectiveness of the vaccine, we actively support the marketing of the vaccine in China. The BNT162b2 mRNA vaccine is a successful model of international R&D collaboration,” Wu Yifang, Chairman and CEO of Fosun Pharma said. “We are pleased to reach the supply agreement with BioNTech, which is an important step in Fosun Pharma and BioNTech’s efforts to achieve vaccine accessibility and affordability in China.”

In March 2020, BioNTech and Fosun Pharma announced their strategic collaboration to work jointly on the development and commercialization of a potential COVID-19 vaccine based on BioNTech’s mRNA technology platform.

On November 24, 2020, the companies initiated a Phase 2 clinical trial of vaccine candidate BNT162b2 in Jiangsu Province, China. The trial commenced with the recruitment of 960 healthy participants, between 18 to 85 years old, to assess the safety and immunogenicity of the vaccine candidate and to support future Biologic License Application (BLA) in China.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare group in China. Fosun Pharma has built a strong root in China and developed a global operation strategy, with pharmaceutical manufacturing and R&D being the largest and core business segment, together with strong presences in medical devices and diagnostics, healthcare services, pharmaceutical distribution and retail.

With R&D innovation as core driving factor, Fosun Pharma continues to optimize its pharmaceutical operations across both innovative and generic drugs. The company has established international R&D centers for excellence in areas such as innovative small molecule drugs, high-value generic drugs, biologics, and cell-therapy.

Under guidance of our 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma follows the brand concept of Innovation for Good Health and strives to be a leading enterprise in the global pharmaceutical and healthcare markets.

For more information, please visit: www.fosunpharma.com

Forward-looking Statements of BioNTech

This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Fosun Pharma to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected time point for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf-life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

BioNTech’s Media Relations

Jasmina Alatovic
Director Global External Communications
+49 89 62 81 75 46
E-mail: [email protected]

Fosun Pharma’s Media Relations

Barney Liu
Deputy Director of Media and Public Relations
Tel: +86 21-3398 7123
E-mail: [email protected]



CallTower Appoints New Channel Director for Illinois

Bryan Green joins the CallTower Channel Sales Team

South Jordan, Utah, Dec. 16, 2020 (GLOBE NEWSWIRE) — CallTower, a global leader in delivering cloud-based enterprise-class unified communications and collaboration solutions, is proud to announce Bryan Green, a seasoned channel professional, has joined their team. With nearly twenty years of strategic, result-oriented Channel experience and a record of excellence in leading business-growth initiatives, Bryan will deliver his expertise as CallTower’s Channel Director of Illinois. 

As an effective communicator and presenter with excellent interpersonal, analytical, and negotiation skills, Bryan has held long-term key UCaaS Sales Leadership roles at Access One, Inc. and Globalcom. 

“I am excited to join the CallTower team and empower our partners and their customers to be more successful,” said Green. “I am thrilled to be joining an organization that delivers turnkey Cisco and Microsoft Teams UCaaS solutions – all tailored to meet the needs to today’s competitive global environment.” 

According to CallTower Chief Revenue Officer, William Rubio, “Bryan is a channel innovator, and we are thrilled that he will champion our Illinois Channel Program. CallTower is growing at an unprecedented rate and Bryan is joining our team at the perfect time to continue our momentum and support our partners. Bryan has an impeccable reputation, and his motivation to get things done fits perfectly into our culture.” 

 

About CallTower 

Since its inception in 2002, CallTower has become a leading provider of cloud-based, enterprise-class Unified Communications solutions for growing organizations worldwide. CallTower provides, integrates and supports industry-leading, cloud-based, Unified Communications and Collaboration solutions, including Cisco® HCS, Webex, Microsoft® Teams Direct Routing, Office 365, Enterprise Hosted Skype for Business, CT Cloud Voice, CT Cloud Boost, CT Cloud Meeting powered by Zoom and Cloud Contact Center for business customers. 

For more information, contact [email protected].

Attachment



Kade Herbert
CallTower, Inc.
8003475444
[email protected]

First-in-class cholesterol-lowering treatment NILEMDO® * (bempedoic acid) tablet and its combination with ezetimibe NUSTENDI® * (bempedoic acid and ezetimibe) tablet approved in Switzerland

– NILEMDO

®

(bempedoic acid) is the first oral, once-daily treatment approved in almost two decades to lower low-density lipoprotein cholesterol (LDL-C) for indicated patients –

– Bempedoic acid and its fixed combination drug product with ezetimibe both deliver significant reductions in LDL-C when added to a statin or other lipid-lowering therapies

1,2

– Two-thirds of patients in Switzerland with very high cardiovascular risk do not achieve LDL-C target values set out by the European Society of Cardiology,

3

indicating a need for additional treatment options –

MUNICH, Germany, and ANN ARBOR, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) — Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics (NASDAQ: ESPR) announced today Swissmedic approval for NILEMDO®* (bempedoic acid) tablet and NUSTENDI®* (bempedoic acid and ezetimibe) tablet, offering new treatment options for people with high low-density lipoprotein cholesterol (LDL-C) in Switzerland.

Bempedoic acid is the first oral, once-daily treatment option approved in the last two decades for patients who have difficulty reaching their cholesterol-lowering goals. In a recent observational study, two-thirds of patients in Switzerland with very high cardiovascular risk did not achieve LDL-C target values set out by the European Society of Cardiology.3 Patients who do not reach their LDL-C lowering goals are at increased risk for heart attack and stroke.4 Diagnosis of high cholesterol has increased among older adults in Switzerland in the past 20 years.5

“Cardiovascular disease remains a leading cause of death in Switzerland. In 2017 it accounted for over 30% of deaths across the country, highlighting a critical need for new treatment options for the many people who are having difficulty reaching their LDL-C goals with existing lipid-lowering therapies,” said Dr. Lucas Schalch, Country Manager at Daiichi Sankyo Switzerland. “Today’s approval of NILEMDO® and NUSTENDI® is a pivotal milestone for patients in secondary prevention, offering them new, convenient treatment options and demonstrating another step forward in our commitment to reduce the risk of atherosclerotic cardiovascular disease.”

“Bempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. This unique mechanism of action allows it to work alongside existing treatments,” said Ashley Hall, Chief Development Officer of Esperion. “Our focus is finding convenient, affordable ways for appropriate patients to manage LDL-C. That is why we also developed a single-tablet combination of bempedoic acid and ezetimibe, to help reduce pill burden.”

Bempedoic acid and its fixed combination drug product with ezetimibe were approved in the European Union and the United States earlier this year with different labels and indications.1,6,7,8 In Europe, the products are marketed as NILEMDO® and NUSTENDI®, and in the U.S. as NEXLETOL® and NEXLIZET® (respectively).1,6,7,8 The Esperion team discovered and developed bempedoic acid, drawing on its deep expertise in developing cholesterol-lowering medicines. With strong commercial capabilities, particularly in cardiovascular medicine, Daiichi Sankyo has licensed exclusive commercialization rights to bempedoic acid and the fixed combination drug product of bempedoic acid and ezetimibe in the European Economic Area, Turkey and Switzerland from Esperion. Marketing Authorization for both products in Switzerland will be transferred to Daiichi Sankyo.

Swissmedic approved bempedoic acid for the treatment of adults with clinically manifesting atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolaemia (HeFH) who need additional LDL-C lowering, as an adjunct to diet and in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies.9 The fixed combination drug product of bempedoic acid and ezetimibe is indicated as an adjunct to diet in adults with clinically manifesting ASCVD or HeFH for patients unable to reach LDL-C goals with the maximum tolerated dose of a statin combined with ezetimibe or bempedoic acid, or patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.10 Both approvals were supported by data from the CLEAR trial program, which included more than 3,600 high- and very-high-risk patients.9,10 The effect of bempedoic acid on cardiovascular morbidity and mortality is currently being investigated in 14,014 patients across 32 countries as part of the CLEAR Outcomes study.11

Bempedoic acid was generally well-tolerated in clinical studies. The most commonly reported adverse reactions with bempedoic acid during pivotal trials were hyperuricaemia, pain in extremity and anaemia. The majority of adverse reactions reported with bempedoic acid were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo.1,6-10

Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centred around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.

Esperion Therapeutics

Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Esperion’s commercialization plans for bempedoic acid tablet, its expectations for the market for medicines to lower LDL-C and the impact of bempedoic acid tablet in such market, including the commercial launch and the market adoption of bempedoic acid tablet in the United States and European Union. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, delays or failures in Esperion’s clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

References

* This medicinal product is subject to additional monitoring in the European Union

(1) European Medicines Agency. NILEMDO® Summary of Product Characteristics. 27 Nov 2020: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf.

(2) Pinkosky SL, et al. Liver- specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature Communications. 2016; 7:13457. DOI:10.1038/ncomms13457.

(3) Rachamin Yael, et al. “Statin treatment and LDL target value achievement in Swiss general practice – a retrospective observational study,” 27 May 2020. Swiss Med Wkly. 2020;150:w20244: https://smw.ch/article/doi/smw.2020.20244

(4) WHO. Cardiovascular diseases (CVDs) Factsheet. 2017. Available online at: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds). Last accessed December 2020.

(5) Swiss Federation Federal Statistical Office report, Gesundheitsstatistik 2019, 29 Oct 2019: https://www.bfs.admin.ch/bfsstatic/dam/assets/10227275/master;

(6) European Medicines Agency. NUSTENDI® Summary of Product Characteristics. 27 Nov 2020: https://www.ema.europa.eu/en/documents/product-information/nustendi-epar-product-information_en.pdf.

(7) U.S. Food and Drug Administration. NEXLETOL® Prescribing Information. 27 Nov 2020: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf.

(8) U.S. Food and Drug Administration. NEXLIZET® Prescribing Information. 27 Nov 2020: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf.

(9) Swissmedic. NILEMDO® (bempedoic acid) Product Information for Human Medicinal Products. December 2020.

(10) Swissmedic. NUSTENDI® (bempedoic acid and ezetimibe) Product Information for Human Medicinal Products. December 2020.

(11) Stephen J Nicholls et al, Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance, American Heart Journal (2020), https://doi.org/10.1016/j.ahj.2020.10.060

Contacts:

Daiichi Sankyo Europe GmbH
Dr. Wolfgang Schiessl (Europe)
Director Product PR and Communications, Cardiovascular Europe
+49 151 1714 7317

Esperion
[email protected]



Rio Tinto advances climate partnership with China Baowu Steel with US$10 million investment

Rio Tinto advances climate partnership with China Baowu Steel with US$10 million investment

MELBOURNE, Australia–(BUSINESS WIRE)–
Rio Tinto has committed to invest $10 million with the world’s largest steel producer China Baowu Steel Group over the next two years in low-carbon steelmaking projects and research. This investment is the next step in advancing the partnership formed between Rio Tinto, China Baowu and Tsinghua University in 2019 to develop and implement new methods to reduce carbon emissions and improve environmental performance across the steel value chain.

Rio Tinto’s investment will fund the joint establishment of a Low Carbon Raw Materials Preparation R&D Centre, which will initially prioritise the development of lower carbon ore preparation processes. This will include creating two ore preparation pilot plants, one to use biomass and the other exploring using microwave technology. The investment will also support work on carbon dioxide utilisation and conversion at the China Baowu Low Carbon Metallurgical Innovation Centre, which is a Baowu-led open platform for advancing metallurgical technologies to support the low-carbon transformation of the steel industry.

These investments will advance technologies that will be crucial in reducing emissions from China’s prevalent iron and steel making process, and will support both the short and long-term decarbonisation goals of the steel industry. As the world’s largest steel producer, China Baowu’s leadership in advancing low-carbon steel solutions is an important pillar in supporting China’s target of striving to be carbon neutral by 2060.

Rio Tinto chief executive J-S Jacques said “This investment with our partners at China Baowu is an important step in our climate partnership. We have been able to identify research and development projects which have the potential to significantly reduce the carbon emissions associated with existing steelmaking processes, as well as developing technologies for the future of steelmaking to support the transition to a low-carbon economy.

“The initial priority areas identified by the partnership for investment show the value of working together to share resources and utilise the strengths of the respective teams to make progress towards a low-carbon steel value chain.”

China Baowu chairman Chen Derong said “To deal with global climate change and achieve green transformation through cooperation has become the consensus and common practices of the global steel value chain. It requires collective action of the steel enterprises, as well as upstream and downstream players. We highly appreciate Rio Tinto’s commitment to advancing a low-carbon future, and we hope to strengthen our partnership with Rio Tinto in contributing our joint efforts.”

About Rio Tinto

Rio Tinto produces materials that are essential to human progress. We have publicly acknowledged the reality of climate change for over two decades and have reduced our emissions footprint by over 30 per cent in the decade to 2020.

We have set ambitious emissions targets to reduce our carbon intensity by a further 30% and our absolute emissions by a further 15% by 2030, alongside establishing a $1 billion fund to invest in climate related projects. These targets will bring us a step closer to achieving our long-term goal of becoming net zero emissions by 2050.

In 2018, we completed the divestment of our coal assets, becoming the only major mining company not producing fossil fuels. In the same year, we also entered into the Elysis joint venture with Alcoa, with investments from the Government of Quebec and Apple, which is developing a revolutionary process to make aluminium that eliminates all direct greenhouse gas emissions from smelting.

In 2019, we entered into a partnership with the world’s largest steel producer, China Baowu Steel Group and Tsinghua University to develop and implement new methods to reduce carbon emissions and improve environmental performance across the steel value chain.

About China Baowu Steel Group

The vision of China Baowu is to become a leader in the global steel industry, with a mission to build up a high-quality steel ecosphere together. Its core values of integrity, innovation, synergy, and sharing informs its commitment to advancing a green, high-quality and intelligent steel manufacturing industry, with coordinated effort across related industries including new materials, modern trade logistics, industrial services, urban services, and industrial finance, leveraging its leadership in technology, efficiency and scale.

The overall approach of China Baowu’s low-carbon metallurgical technology innovation is to explore and adopt key low-carbon technologies by continuously innovating and improving the existing steelmaking process in the short term, and to lead technology of the future in the longer term. China Baowu is building an open platform to work with partners to explore technology solutions and roadmaps to reinvent the steel-making process and reshape the low-carbon value chain for the steel industry’s low-carbon transformation.

Rio Tinto

[email protected]

riotinto.com

Follow @RioTinto on Twitter

Media Relations, United Kingdom

Illtud Harri

M +44 7920 503 600

David Outhwaite

T +44 20 7781 1623

M +44 7787 597 493

Media Relations, Americas

Matthew Klar

T +1 514 608 4429

Media Relations, Asia

Grant Donald

T +65 6679 9290

M +65 9722 6028

Media Relations, Australia

Jonathan Rose

T +61 3 9283 3088

M +61 447 028 913

Matt Chambers

T +61 3 9283 3087

M +61 433 525 739

Jesse Riseborough

T +61 8 6211 6013

M +61 436 653 412

Investor Relations, United Kingdom

Menno Sanderse

T: +44 20 7781 1517

M: +44 7825 195 178

David Ovington

T +44 20 7781 2051

M +44 7920 010 978

Clare Peever

M: +44 7788 967 877

Investor Relations, Australia

Natalie Worley

T +61 3 9283 3063

M +61 409 210 462

Amar Jambaa

T +61 3 9283 3627

M +61 472 865 948

Group Company Secretary

Steve Allen

Rio Tinto plc

6 St James’s Square

London SW1Y 4AD

United Kingdom

T +44 20 7781 2000

Registered in England

No. 719885

Joint Company Secretary

Tim Paine

Rio Tinto Limited

Level 7, 360 Collins Street

Melbourne 3000

Australia

T +61 3 9283 3333

Registered in Australia

ABN 96 004 458 404

Category: general

KEYWORDS: Australia/Oceania China Australia Asia Pacific

INDUSTRY KEYWORDS: Mining/Minerals Environment Manufacturing Alternative Energy Natural Resources Energy Steel

MEDIA:

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