Business Wire

EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union

Share

Celltrion Group today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). The CHMP recommends that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.1

Under Article 5 (3) of Regulation 726/2004, the CHMP’s scientific opinion provides a harmonised EU- level opinion on the efficacy, quality and safety of antibodies. The scientific opinion can be considered by EU member states when making decisions on the possible use of monoclonal antibody therapies at a national level prior to a marketing authorisation.

The EMA has also initiated a rolling review of regdanvimab based on data from animal studies (non- clinical data) and clinical trials, in addition to data on the quality of the medicine. The EMA uses its rolling review process to accelerate the assessment of a promising medicine during a public health emergency and once finalised it will provide the basis of an EU marketing authorisation for the monoclonal antibody treatment.

“Today’s CHMP positive scientific opinion by the EMA takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 worldwide. Based on clinical data and CHMP’s positive scientific opinion, regdanvimab has been adopted and contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We believe the CHMP’s positive opinion will accelerate reviews and authorisations by national authorities who may take evidence-based decisions on the use of our therapy. We will also continue to work in close collaboration with the EMA to complete the rolling review and marketing authorisation process.”

Regarding mutations, the Korea Disease Control and Prevention Agency (KDCA) has independently confirmed that CT-P59 successfully neutralised the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants.

Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, commented, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.”

- ENDS -

Notes to Editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.

About CT-P59 (regdanvimab)

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre-clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralize the wild type and mutant viruses of concern including the UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

FORWARD LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

References

1 EMA issues advice on use of regdanvimab for treating COVID-19 | European Medicines Agency (europa.eu). Last accessed 26 March 2021.

2 Celltrion Data on file

Contact information

Holly Barber
hbarber@hanovercomms.com
+44 (0) 07759 301620

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Advanced Eye Protection Against Covid-19 For Healthcare Professionals – an Exclusive Bollé Safety Technology16.4.2021 23:00:00 EEST | Press release

Bollé Safety, world leader in the design and manufacture of protective eyewear, presents its Healthcare division dedicated to all healthcare professionals. Its range of protective eyewear with anti-fog and anti-scratch PLATINUM® coating provides highly exposed employees with the highest levels of protection, clarity, and vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210416005009/en/ @BolléSafety - A.Childeric Viruses & infections’ protection Bollé Safety offers certified products compliant with the most stringent international standards. Its anti-fog PPE product range is tailored to protect professionals who are at high risk of being exposed to bodily fluids when providing care to patients. It is the company’s shared commitment to provide the highest quality protection for all healthcare workers. The importance of a clear vision Bollé Safety’s unique and exclusive permanent double sided anti-fog and anti-scratch PLA

Zeepay Ghana Acquires Mangwee Mobile Money in Zambia16.4.2021 20:55:00 EEST | Press release

Zeepay, the leading African Challenger Fintech with operations in over 10 African countries today acquired a 51 percent stake in Mangwee Mobile Money in Zambia. In a private placement Zeepay and Mangwee agreed to a sale of 51 percent of Mangwee shares to Zeepay. The deal makes Zeepay Ghana the majority shareholder of the entity. Mangwee has been in operations since 2018, and was initially set up to operate as an alternative wallet targeting university students in Zambia with the aim of assisting to drive the cost of mobile money services downward. Zeepay is the leading African challenger fintech with operations across 20 African countries and 30 day active in 10 of them. The company specializes in paying remittances into mobile money wallets across Africa and is regulated by both Bank of Ghana as an EMI issuer and in the UK as a Money Transfer Operator, by the Financial Conduct Authority. The merger is the first of its kind; that two Indigenous African fintechs into Mobile Money operat

CGTN: Leading With Action: China in the Fight for Carbon-Neutral Future16.4.2021 19:29:00 EEST | Press release

Climate change is not taking a break from wreaking havoc in 2020, with the joint highest global temperatures on record, rampant bushfires, the faster rates of sea level rise and the extinction of some species. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210416005435/en/ Under this circumstance, Chinese President Xi Jinping, French President Emmanuel Macron, and German Chancellor Angela Merkel held a virtual meeting Friday on climate change, ahead of the Leaders' Climate Summit on Earth Day convened by the U.S., scheduled next week. Emphasizing that he always advocates building a community with a shared future for mankind, the Chinese president voiced his willingness to strengthen cooperation with France and Germany on climate change. "Tackling climate change is a common cause for all mankind and it should not become a geopolitical bargaining chip, a target for attacking other countries, or an excuse for trade barriers," h

Colicity Inc. Announces the Separate Trading of its Class A Common Stock and Warrants, Commencing on or about April 16, 202116.4.2021 16:30:00 EEST | Press release

Colicity Inc. (the “Company”) announced that holders of the units sold in the Company’s initial public offering of 34,500,000 units, including the underwriters’ exercise of their full over-allotment option for 4,500,000 units, completed on February 26, 2021 (the “Offering”) may elect to separately trade the Class A common stock and warrants included in the units commencing on or about April 16, 2021. Any Units not separated will continue to trade on The Nasdaq Capital Market under the symbol “COLIU,” and the Class A common stock and warrants will separately trade on The Nasdaq Capital Market under the symbols “COLI” and “COLIW,” respectively. No fractional warrants will be issued upon separation of the units and only whole warrants will trade. Holders of units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company’s transfer agent, in order to separate the units into Class A common stock and warrants. This press release shall not constitute an o

Evobrutinib is the First and Only BTK Inhibitor to Demonstrate Reduction of a Key Biomarker of Neuronal Damage and Inflammation in Patients with MS16.4.2021 11:00:00 EEST | Press release

Merck, a leading science and technology company, will present data from a Phase II placebo-controlled randomized trial at the 2021 American Academy of Neurology (AAN) Annual Meeting showing that the investigational Bruton’s tyrosine kinase (BTK) inhibitor evobrutinib significantly reduced blood neurofilament light chain (NfL) levels, a key biomarker of neuronal damage and inflammation, in patients with multiple sclerosis (MS). Elevated blood NfL levels have been shown to be associated with damage to neurons and inflammation and may predict future brain atrophy and disease progression. “Blood NfL is a biomarker that may allow monitoring of disease activity and treatment response, which could be less burdensome and more sensitive than other standard clinical measures for MS patients,” said Prof. Jens Kuhle, MD, PhD, Head Multiple Sclerosis Centre, University Hospital Basel. “These data provide key insights into the role evobrutinib may play in modulating the clinical course of MS and fur

IFF Presents “Learning Labs” Video Series to Demonstrate Potential of New Company15.4.2021 23:15:00 EEST | Press release

IFF (NYSE: IFF) today introduced a new “Learning Labs” video series, featuring in-depth discussions with the leadership of the company’s segments and R&D function. Each video provides a comprehensive overview of IFF’s robust portfolio and enhanced capabilities following its recently completed merger with DuPont’s Nutrition and Biosciences (“N&B”) business. The complete “Learning Labs” series can be found here: ir.iff.com/events-presentations. In addition, IFF has also provided segment-level financial detail based on 2020 pro forma results. “As a global industry leader of high-value consumer ingredients, we are pleased to provide a closer look into our capabilities, operational model and future growth potential,” said Andreas Fibig, IFF Chairman and CEO. “Stakeholder communication remains essential to IFF’s continued growth, and since combining with N&B, we have continued to explore new ways to meaningfully connect with our investors. The insights shared through our ‘Learning Labs’ seri

Algorand and BridgeTower Capital Announce Strategic Partnership15.4.2021 23:14:00 EEST | Press release

BridgeTower Capital, a global private equity firm, focusing on traditional private equity investments and blockchain and DeFi markets, announced today a partnership with Algorand. Algorand, the creator of the world’s first pure proof-of-stake foundational blockchain, is a leading blockchain technology company accelerating the convergence of decentralized and traditional finance. BridgeTower will use Algorand’s technology as the underlying blockchain solution to issuance of the BridgeTower Capital tokenized digital security. It will also use Algorand as a preferred blockchain for BridgeTower products and services. Beyond the elementary requirement of an open, public network, Algorand’s technology enables a set of high performing Layer-1 blockchains that provide security, scalability, complete transaction finality, built in privacy, Co-Chains, and advanced smart contracts. “Algorand was a clear choice given their technology, team and leadership position in the digital marketplace,” said

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom