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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

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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]



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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]

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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]



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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.

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Rio Tinto confirms development capital and timeline for Oyu Tolgoi underground

Rio Tinto confirms development capital and timeline for Oyu Tolgoi underground

LONDON–(BUSINESS WIRE)–
Rio Tinto today unveiled a pathway for the ongoing development of the underground project at Oyu Tolgoi in Mongolia, one of the largest known copper and gold deposits in the world. The definitive estimate details how Oyu Tolgoi underground will achieve sustainable production for Panel 0 by October 2022 for development capital of $6.75 billion.

Rio Tinto and its partners, the Government of Mongolia and Turquoise Hill Resources (TRQ), need to continue to work together to finalise three other milestones – the outstanding government approvals, funding and a power solution – in order to ensure that the project can commence caving operations in 2021. This will unlock the most valuable part of Oyu Tolgoi, delivering significant benefits for the shareholders of Oyu Tolgoi and the people of Mongolia.

At peak production, Oyu Tolgoi is expected to operate in the first quartile of the copper cash cost curve1 and by 2030 is expected to be the fourth largest copper mine in the world.

Oyu Tolgoi is expected to produce 480,000 tonnes2 of copper per year on average from 2028 to 2036 from the open pit and underground, compared with 146,300 tonnes3 in 2019 from the open pit. The underground Ore Reserve has an average copper grade of 1.52 per cent, which is more than three times higher than the open pit Ore Reserve, and contains 0.31 grammes per tonne of gold.4 The size and quality of this Tier 1 asset provides additional expansion options, which could see production sustained for many decades.

Arnaud Soirat, Chief Executive of Copper & Diamonds said, “We now have a pathway to bring the underground project into production, which will unlock the most valuable part of Oyu Tolgoi. We will continue to work together with the Government of Mongolia and TRQ to progress the project, including finalising all necessary approvals and agreeing a solution on power and funding.”

This is a summary. The full notice is available here:https://www.riotinto.com/-/media/Content/Documents/News/RT-development-OT-underground-2020.pdf

Note to editors

Oyu Tolgoi is jointly owned by the Government of Mongolia (34 per cent) and Turquoise Hill Resources (66 per cent, of which Rio Tinto owns a controlling interest of 50.8 per cent). Rio Tinto has been the manager of the Oyu Tolgoi project since 2010.

The open-pit mine was completed in less than 24 months and production started in 2013. Since then, more than 240 million tonnes of ore have been milled, with over one million tonnes of copper in concentrate sold.

This announcement is authorised for release to the market by Rio Tinto’s Group Company Secretary.

1 WoodMackenzie copper equivalent cash cost curve (Q3 2020).

2 This production target (stated as recovered metal) for the Oyu Tolgoi underground and open pit mines is underpinned 22 per cent by Proved Ore Reserves and 78 per cent by Probable Ore Reserves for the years 2028-2036, which have been scheduled from current mine designs by Competent Persons in accordance with the requirements of the Australasian Code for Reporting of Exploration Results, Minerals Resources and Ore Reserves, 2012 Edition (the JORC code).

3 Rio Tinto Fourth Quarter Operations Review, published 17 January 2020

4 The Ore Reserves for Hugo Dummett North and Hugo Dummett North Extension are reflected in Table A below.

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Lipidor signs cooperation agreement with contract manufacturer to offer licensees the opportunity for GMP production

PR Newswire

STOCKHOLM, Dec. 16, 2020 /PRNewswire/ — Lipidor AB (Nasdaq First North: LIPI) announced today that the Company has signed a new cooperation agreement with Aurena Laboratories AB. Over a five-year period, Lipidor will invest up to SEK 15 million in the new collaboration. Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. This will enable Lipidor to offer potential licensees the opportunity for large-scale commercial production. This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.

Aurena Laboratories has already met the requirements of the U.S. Food and Drug Administration (FDA) for commercial drug production. Through the new cooperation, the parties will jointly ensure that the production meets all requirements for registration application within the EU. According to the first target milestone, the production unit shall be ready to manufacture so-called stability batches for registration documentation during the first half of 2021. This is followed by a number of activities and sub-milestones to ensure the unit’s capacity up to full-scale commercial production. The collaboration will also ensure that the processes and manufacturing otherwise meet current requirements for CMC (Chemistry, Manufacturing and Controls) and GMP (Good Manufacturing Practices) for commercial production of prescription drugs based on Lipidor’s formulation platform AKVANO®.

“We look forward to further strengthening our cooperation with Aurena Laboratories. The new cooperation involves an intensive and increased transfer of knowledge between the companies, and the implementation of a development plan for the production facility. The goal is to facilitate the registration process and to be able to offer licensees the opportunity for a high-quality and large-scale manufacture of Lipidor’s prescription drug candidates for upcoming commercialization,” says Ola Holmlund, CEO of Lipidor.

“Being able to demonstrate that the infrastructure is in place, that the production meets all regulatory requirements, and that the plant has capacity for commercial production are all strategically important for ongoing discussions with potential licensees.”

“We look forward to working side by side with Lipidor to be able to offer manufacturing to their future licensees. Aurena will invest in this project for several years and our view is that it is both commercially and strategically important,” says Magnus Hedman, Chairman of the Board, Aurena Laboratories.

Lipidor has already cooperated with the contract manufacturer Aurena Laboratories regarding hand and skin disinfection sprays and veterinary care products. Production takes place at Aurena Laboratories’ production facility in Karlstad, Sweden and products are distributed from there to customers in Sweden and internationally. Aurena Laboratories is a leader in contract manufacturing of aerosol and spray products for the pharmaceutical industry and is one of Lipidor’s two strong industrial principal owners. All in all, this contributes to Lipidor’s ability to more rapidly develop and commercialize ever more competitive drug candidates.

This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 16-12-202008:15 CET.

CONTACT:

For more information, please contact

Ola Holmlund, CEO
Phone: +46 72 50 70 369
E-mail: [email protected]

Certified Adviser

Erik Penser Bank AB
Telefon: 08-463 83 00
E-post: [email protected]

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201216_EN_PR Lipidor signs cooperation agreements to offer licensees option of GMP-production

 

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SOURCE Lipidor

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Lucerne Capital Issues Statement Regarding Revised Offer From Next Private To Acquire Altice Europe

PR Newswire

GREENWICH, Conn. and AMSTERDAM, Dec. 16, 2020 /PRNewswire/ — Lucerne Capital Management (“Lucerne”), a registered investment adviser managing funds that own approximately EUR 106 million of shares of Altice Europe N.V. (ATC.AS) (“Altice Europe” or the “Company”), today issued the following statement regarding the revised all-cash offer of EUR 5.35 per share for all common shares A and common shares B of Altice Europe by Next Private B.V. (the “Revised Offer”): 

This Revised Offer represents a significant increase in price, demonstrating that the Company and its independent directors recognize the inherent value of Altice Europe stock.  We appreciate the support we have received from other Altice Europe shareholders and are pleased to reach this outcome, which we believe provides fair value to minority shareholders and represents a positive outcome for all stakeholders in the Company. 

As previously announced, Lucerne sent letters to the Altice Europe Board of Directors on October 1 and November 30 opposing the original offer of EUR 4.11.  Subsequently, Lucerne filed a petition with the Enterprise Chamber in Amsterdam on December 7 asking the court to order an inquiry into Altice Europe, to appoint three independent non-executive directors to assess and supervise the original offer, and to prohibit a vote on the “pre-wired restructuring measures.”

About Lucerne Capital Management

Lucerne Capital Management, founded in 2000 and co-managed by Pieter Taselaar and Thijs Hovers, is an investment firm specializing in bottom-up stock selection with a focus on European markets.

Contacts

Lucerne Capital Management

Claudia Taselaar

+1 914 819 3746

[email protected]

 

Media Contacts

Steve Bruce/Taylor Ingraham

ASC Advisors

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SOURCE Lucerne Capital Management

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Castellum strengthens its presence in Slakthusetområdet area with acquisition for SEK 298 million

PR Newswire

GOTHENBURG, Sweden, Dec. 16, 2020 /PRNewswire/ — Castellum acquires the lease hold to the Sandhagen 9 property in the Slakthusområdet area at an acquisition price of SEK 298 million, including overheads of approximately SEK 2 million.

“The area is one of Stockholm’s most interesting development areas. Through this deal, we increase our opportunities to build and offer office volume in a strategic development cluster”, says Henrik Saxborn, CEO of Castellum AB.

The lease hold to the Sandhagen 9 property is acquired from the seller Humlegården Fastigheter. The house was built in 1989 at the address Rökerigatan 19 in direct connection to Arenavägen which will be developed into an urban main street through the area. The former slaughterhouse area is one of Stockholm’s most exciting areas where a new modern district is developed with the right mix of offices, housing, trade, culture and business. Castellum actively participates in realizing the vision for the area; to create Stockholm’s sharpest district. This is done by adding more attractive and modern workplaces to long for as the area develops.

“There is a great demand and interest, with many tenants eager to come in from the start in modern premises to become part of the new Slakthusområdet area. Now we are ready to develop premises that meet that demand in every way”, says Martin Bjöörn, CEO of Castellum Region Stockholm-North.

“We know how to create successful workplaces that meet today’s demands for technical solutions, while the premises also take people’s needs into account. There is a great demand and interest, with many tenants wanting to come in from the get-go. Now we are ready to develop premises that meet that demand in every way”, says Martin Bjöörn, CEO of Castellum Region Stockholm-North.

The transaction in brief:

Castellum acquires the lease hold to the office property Sandhagen 9 from Humlegården Holding III AB

Acquisition price: SEK 298 million including overheads of approximately SEK 2 million

Closing: Jan 2021

Rental area (sqm): 5,669

Major tenant: Profina Holding

Economic occupancy rate: 97%

Average contract duration (years): 1,7

For further information please contact:

Henrik Saxborn, CEO Castellum AB, +46.706.947450

Ulrika Danielsson, CFO Castellum AB, +46.31.607474

About Castellum:

Castellum is one of Sweden’s largest listed real estate companies with a property value of SEK 98 billion. We are active in 17 Swedish growth regions as well as in Copenhagen and Helsinki. Every day, 250,000 people go to work in our premises. We develop flexible workplaces and logistics solutions in close proximity to city centres and with a lettable area of 4.3 million square meters. One of our sustainability goals is to be completely climate neutral by 2030. Castellum is the only Nordic real estate company selected by the Dow Jones Sustainability Index (DJSI). The Castellum share is listed on the Nasdaq Stockholm Large Cap.

Beyond expectations.

www.castellum.se

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