Business Wire

Samsung Bioepis Announces Results of Additional One-Year Follow-up Study on SB3 Trastuzumab Biosimilar Candidate at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

Del

Samsung Bioepis Co., Ltd. today announced additional one-year follow-up study results on SB3, a biosimilar candidate referencing Herceptin® 1 (trastuzumab). The data was made available as an abstract publication at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 1-5, 2018 in Chicago.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180601005020/en/

Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)

“The additional one-year follow-up study demonstrates the long-term safety profile of SB3,” said Chul Kim, Head of Clinical Sciences Division, Samsung Bioepis. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”

Patients with HER2-positive early breast cancer were randomly assigned to receive eight cycles of SB3 or reference trastuzumab (TRZ) in neoadjuvant setting concurrently with chemotherapy. Patients then underwent surgery, followed by 10 cycles of adjuvant SB3 or TRZ. After completion of therapy, 367 patients (SB3, n=186; TRZ, n=181) consented to participate in a five-year follow-up study. The median follow-up duration from initiation of study treatment was 30.1 months in SB3 and 30.2 months in TRZ. The aim of this study was to observe the incidence of symptomatic congestive heart failure (CHF), asymptomatic significant left ventricular ejection fraction (LVEF) decrease, incidence of other cardiac events, event-free survival (EFS), and overall survival (OS).

Throughout the additional one-year treatment-free follow-up period, the study results showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to TRZ in the SB3 treatment group.

SB3 is under regulatory review by the US Food and Drug Administration (FDA). The Biologics License Application (BLA) for SB3 was accepted for review in December 2017.

Details on the abstract publication are as follows:

  • ‘Additional one-year follow-up study to evaluate safety and survival in patients who have completed neoadjuvant-adjuvant treatment with SB3 (trastuzumab biosimilar) or reference trastuzumab in HER2-positive early or locally advanced breast cancer’

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six late-stage candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

1 Herceptin ® is a registered trademark of Genentech

Contact information

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.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

9 in 10 Enterprises Report Gaps Between the Cybersecurity Culture They Have and the One They Want15.10.2018 13:35Pressemelding

With cybersecurity threats continuing to escalate worldwide, the ISACA/CMMI Institute Cybersecurity Culture Report found that just 5 percent of employees think their organization’s cybersecurity culture is as advanced as it needs to be to protect their business from internal and external threats. More than 4,800 business and technology professionals shared their insights in the global research study, conducted via online polling in June 2018. Results were released today at ISACA’s CSX North America cybersecurity conference in Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005149/en/ New global research from ISACA and the CMMI Institute shows 95% of organizations say there is a gap between the cybersecurity cultures they have and the ones they want. (Graphic: Business Wire) Cybersecurity culture is a workplace culture in which security awareness and behaviors are integrated into everyone’s daily operations, a

AirFit F30, ResMed’s First Minimal-Contact Full Face CPAP Mask, Now Available in the U.S., Canada15.10.2018 13:05Pressemelding

ResMed (NYSE: RMD, ASX: RMD) today announced the availability of its first minimal-contact full face CPAP mask, AirFit F30, the latest addition to its AirFit mask portfolio, which helps sleep apnea patients reduce facial marks, wear glasses in bed and curl up closer to their bed partner. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005185/en/ AirFit F30 full face CPAP mask: Side View (Photo: Business Wire) Availability AirFit F30 is available for sale now in the United States and Canada, and will be on display at the Medtrade Fall conference this week in Atlanta; visit ResMed’s Booth #2116. AirFit F30 fits 93 percent of patients,1 and features a minimal-contact cushion that sits just below the nose, preventing top-of-the-nose red marks and irritation, plus reducing feelings of claustrophobia for some full face wearers. It also has ResMed’s QuietAir vent, making the mask quieter than ambient noise in the bedroom. New

Dole Launches Refreshed Brand15.10.2018 13:00Pressemelding

Dole Food Company announced today the launch of a refreshed logo and brand identity for the iconic 160-year old produce company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005069/en/ Dole strives to more thoughtfully connect and understand consumers, and their preferences and desires when it comes to shopping for fresh produce. Insights gained through this discovery process have helped influence the development decisions of this robust reimaging of the DOLE Brand. The new visual identity reflects: Dole’s values as an organization around freshness, transparency and responsibility. An evolution in the logo treatment inspired by nature and its earth-given benefits. A new visual representation of the vibrant character attributes surrounding the DOLE Brand. Refinement of true nature-based color and texture pallets and font typography. The refreshed DOLE Trademark evolves from living in the fresh air and harkens to the g

Scanlog Strengthens its Position at the Cutting Edge of Logistics Innovation by Embracing Robotic Process Automation from Softomotive15.10.2018 12:08Pressemelding

Scandinavian Logistics Partners AB (Scanlog), a rapidly expanding Scandinavian logistics company specializing in international transports, is using ProcessRobot from Softomotive to help transform its order booking process and develop a smarter workflow. ProcessRobot is a leading enterprise Robotic Process Automation (RPA) platform, including enterprise grade security and controls, with links to best-of-breed AI technologies. With ProcessRobot handling increasing numbers of customer orders, Scanlog has fortified its position as a technology leader in the logistics sector, and can deliver a speedier shipping service for its clients. Mattias Ljungberg , CEO of Scanlog, explains: “With ProcessRobot, we have reduced the time it takes to process each customer order by 89 percent. Previously it took a human employee up to four minutes to enter the booking details to our systems: now, the robot completes the task within 20 seconds.” Scanlog has ambitious plans to automate many other processes

MAXON Announces Senior Leadership Appointments15.10.2018 12:00Pressemelding

MAXON, the leading developer of professional 3D software solutions, today announced leadership appointments to make it a globally-focused software development company. The executive leadership team changes, effective immediately, reflect the strategic goals of David McGavran, Chief Executive Officer, for the future of MAXON and its acclaimed 3D software application, Cinema 4D. “This is an exciting and transformational time in the evolution of MAXON and I’m eager to work with our new leadership team that represents the very best talent across our offices poised to take MAXON to the next level,” stated McGavran. “With proven track records of delivering strong results, I am pleased to have these talented and passionate executives join me in streamlining operational initiatives to best serve global customers and partners, anticipate the ever-changing needs of the 3D digital landscape, and maintain Cinema 4D’s standing as a best-in-class market leader in 3D content creation.” Executive Team

PotNetwork Holdings, Inc. Files Form 10 To Become SEC Reporting Company15.10.2018 12:00Pressemelding

PotNetwork Holdings, Inc. (OTC Pink: POTN) announced today that it has filed a Registration Statement on Form 10 with the U.S. Securities and Exchange Commission (SEC) to register its common stock under the Securities Exchange Act of 1934, as amended (the Act) including its audited financial statements for the year ended December 31, 2017 and unaudited interim financial statements through June 30, 2018. POTN had engaged PCAOB member firm Manohar, Chowdhry & Associates, in July 2017 to replace its former auditor. The Company’s voluntary filing of the Form 10 will make the Company subject to the periodic reporting requirements of the Act which includes annual, quarterly and current report filings. Additionally, the filing will enable the Company’s management to move forward with its application to OTC Markets to uplist to the OTCQB market tier. As a result of investor feedback and management’s plan for a new, broadened strategic direction, the Company has rescinded the previously announc