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Hospira Shares Results From Two Open-label Extension Studies for Biosimilar Infliximab in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis
Date:10/31/2013

pleted the Phase I PLANETAS study entered into the open-label extension phase. Of these, 88 were continuously treated with Inflectra (maintenance group) and 86 were switched from Remicade to Inflectra (switch group) for one additional year. The maintenance group and the switch group at weeks 78 and 102 were similar as measured by ASAS20/ASAS40, ASAS partial remission, and ASDAS-CRP rates. In this study, the adverse event profile for CT-P13 was generally consistent with the originator.

"We're very pleased with the findings of the two-year extension studies," said Dr. Stan Bukofzer, corporate vice president and chief medical officer, Hospira. "We are committed to continuing to build on our biosimilars experience."

Full results of the extension studies, conducted by South Korean-based biopharmaceutical company, Celltrion, were shared as a late-breaker oral presentation at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego on Oct. 29.

In 2009, Hospira entered into an agreement with Celltrion, which is developing eight monoclonal antibody biosimilars. Under the terms of the agreement, Hospira obtained the rights to Inflectra in Europe and certain CIS (Commonwealth of Independent States) countries, the United States, Canada, Australia and New Zealand. Inflectra will be launched throughout Europe at the earliest opportunity taking into account any relevant patent protection.

View the full results of the studies at:
http://www.acrannualmeeting.org/Content/images/pdf/2013%20ACR%20Late-Breaking%20Accepted%20Abstracts.pdf.

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SOURCE Hospira, Inc.
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