Business Wire

Celltrion Receives EU Approval for Trastuzumab Biosimilar

Del

Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC) approved Herzuma® (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017.

“The development of biosimilar is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal against a variety of diseases and to increase patients’ accessibility to innovative drugs at a more affordable price,” said Woosung Kee, Chief Executive Officer of Celltrion. “We have already seen many benefits of biosimilars in Europe from our experience with Remsima® and Truxima®1. Our experience has shown that biosimilars not only reduce individual patient’s out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies.”

The European Commission’s approval of Herzuma® marks an important milestone for Celltrion, providing more treatment options for patients. Herzuma® is the third biosimilar from Celltrion’s portfolio approved by the EC.

This decision by the European Commission means that Herzuma® is now approved for marketing in the 28 member states of the European Union (EU), in addition to Norway, Liechtenstein and Iceland.

About Herzuma®

Herzuma® is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat breast cancer and gastric cancer. Similarity of Herzuma® to the reference product, Herceptin®2, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. In 2017, Celltrion launched Herzuma® in Korea.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for Inflectra® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received EC’s approval for Truxima® (CT-P10, a mAb biosimilar to MabThera®3 (rituximab)) in February 2017. For more information, visit www.celltrion.com.

1 Celltrion’s mAb products Remsima® (infliximab biosimilar) and Truxima® (rituximab biosimilar) were approved by the EC in September 2013 and February 2017, respectively.

2 Herceptin® is a registered trademark of Genentech, Inc.

3 MabThera® is a registered trademark of F. Hoffmann-La Roche AG.

Contact information

Celltrion, Inc.
Gunn Lee, +82 32 850 5168
Gunhyuk.lee@celltrion.com
or
Heewon Park, +82 32 850 5356
Heewon.park@celltrion.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

SOTIO’s DCVAC/OvCa Significantly Improves Survival in Patients with Recurrent Ovarian Cancer19.3.2019 20:00:00 CETPressemelding

SOTIO, a biotechnology company owned by the PPF Group, presented results from SOV02, its Phase II clinical trial evaluating DCVAC/OvCa, an active cellular immunotherapy product, in patients with recurrent ovarian cancer at 2019 SGO’s 50 th Annual Meeting on Women's Cancer today. Final analysis of SOV02 shows that DCVAC/OvCa decreased the risk of death significantly compared to patients who did not receive DCVAC/OvCa. Clinical trial results were presented during today’s SGO 2019 Plenary Session by SOV02 principal investigator David Cibula, MD, PhD from General University Hospital in Prague (Czech Republic). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190319005837/en/ In the randomized, open label SOV02 clinical trial, patients with recurrent ovarian cancer received DCVAC/OvCa in combination with platinum-based chemotherapy. Compared to patients who did not receive DCVAC, it decreased the risk of death by 62%. The combinati

OCP Announces Date of Fourth Quarter and Full Year 2018 Earnings19.3.2019 19:00:00 CETPressemelding

OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its fourth quarter and full year 2018 results on Monday, March 25, 2019. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 9:00 a.m. EDT, 2:00 p.m. Morocco time (GMT+1), and 1:00 p.m. London time (GMT). OCP senior management will host a conference call to discuss fourth quarter and full year 2018 results at 10:00 a.m. EDT, 3:00 p.m. Morocco time (GMT+1), and 2:00 p.m. London time (GMT) on Monday, March 25, 2019 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma About OCP OCP is a global leader in the fertilizer industry, backed by almost a century’s

HCL and Xerox Expand Strategic Partnership to Accelerate Operational Transformation19.3.2019 16:51:00 CETPressemelding

HCL Technologies (HCL), a leading global technology company, announced that it signed a managed services agreement with Xerox (NYSE: XRX). Under the terms of the agreement, HCL will manage portions of Xerox’s shared services, including global administrative and support functions, including, among others, selected information technology and finance functions (excluding accounting). Leveraging HCL’s global scale and capabilities, Xerox will strategically evolve its shared services into process-first, technology-led digital operations. This seven-year agreement for an incremental $1.3 billion continues to build on the success of the Xerox-HCL relationship, which began in 2009 with product engineering and support services. Under that agreement, HCL currently manages aspects of Xerox’s mechanical, electrical and software engineering activities for printer and imaging product lines. Together, HCL and Xerox have delivered 215 U.S. patents and have created world-class R&D labs that are tightly

Abzena and Lipum AB Sign Integrated CMC Agreement to Produce a Novel Biologic for Autoimmune Inflammatory Diseases19.3.2019 15:18:00 CETPressemelding

Abzena, the global biologics gene to GMP partner research organization, announced it has signed an agreement to support an integrated CMC program with Lipum, a company developing treatments for chronic inflammatory diseases. Abzena will support Lipum’s anti-BSSL antibody IND program to help develop a novel therapeutic option for autoimmune inflammatory diseases, including juvenile idiopathic arthritis. The 18-month program includes: development of a research cell bank using Abzena’s proprietary cell line and ambr® 15 automated high throughput bioreactors, generation of master cell banks, scale up using an ambr® 250 during process development, followed by cGMP manufacturing in Sartorius 500 L single use stirred tank bioreactors for clinical material. The work will take place at Abzena’s sites in Cambridge, UK and San Diego, USA. Jonathan Goldman, CEO of Abzena, said: “Autoimmune inflammatory diseases such as juvenile idiopathic arthritis represent significant unmet medical need. We are

Guardsquare now Protects JavaScript Hybrid Mobile Apps19.3.2019 15:00:00 CETPressemelding

Guardsquare, the global reference in mobile protection, announces that DexGuard now protects JavaScript hybrid mobile applications for Android. The latest version of their state-of-the-art mobile security software, DexGuard 8.4, extends the existing code hardening capabilities with JavaScript obfuscation to provide superior protection to Android apps built with frameworks such as Cordova, Ionic and ReactNative. DexGuard currently provides its cutting-edge security solutions to the full-range of coding languages used for the Android platform, including JavaScript, Kotlin, Java and Native code (C/C++). Guardsquare’s technology answers to a growing global problem for enterprises rapidly undergoing digital transformation. As they quickly innovate and deploy more and more complex applications on increasingly powerful mobile devices, they often struggle with making these applications —running outside their corporate firewalls— secure. Still, for many companies and their mobile-centric custom

Saudi Arabia Takes Another Step Forward in Its Transformation Drive19.3.2019 14:00:00 CETPressemelding

King Salman bin Abdulaziz of Saudi Arabia today launched four wellbeing projects for the kingdom’s capital Riyadh, which will significantly improve the lives of its citizens, transform the city into an attractive destination and make it one of the world’s most livable cities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190319005574/en/ The four wellbeing projects - King Salman Park, Sports Boulevard, Green Riyadh and Riyadh Art – complement the Saudi Vision 2030’s “Quality of Life” Program and are aligned with the U.N. Sustainable Development Goals, to create sustainable cities and communities, while driving urgent action against climate change. Developed with a government investment of US$23 billion, the four projects will offer opportunities worth US$15 billion for the private sector to invest in the residential, commercial, recreational and wellness areas. In addition to providing tens of thousands of new jobs, they wi