Microsoft word - egi120614er01e.doc

EXTRAORDINARY INFORMATION
on the clinical trial results of biosimilar infliximab product
Egis Pharmaceuticals PLC announces the positive results of clinical trials conducted on biosimilar infliximab which is developed and manufactured by its partner, Celltrion, a leading biotechnological company in South Korea, and is to be marketed by Egis. As communicated earlier, Egis Pharmaceuticals PLC had concluded a cooperation agreement with Celltrion to market 8 biosimilar medicines (monoclonal antibodies). According to the agreement Egis will have exclusive rights in 5 countries of the CIS region (incl. Russia), and semi-exclusive rights in further 12 countries in CEE region to sell these products. The partner of Egis successfully completed clinical studies conducted on the first product among those specified in the cooperation agreement. Positive results had been announced at the Annual Congress of the European League Against Rheumatism (EULAR; Berlin, Germany) on June 8, 2012. Celltrion’s biosimilar infliximab demonstrated equivalence with the original product (Remicade®) in pharmacokinetics, safety, and efficacy in treatments of ankylosing spondylitis throughout a randomized, double-blind phase 1 study. Furthermore it produced proof of equivalence with the original product (Remicade®) in a randomized, double-blind phase 3 clinical study when co-administered in both cases with methotrexate in patients with active rheumatoid arthritis. The results show clear evidence of quality, safety and efficacy of the biosimilar infliximab whose application for marketing authorization has been validated for assessment as the first biosimilar monoclonal antibody by the European Medicine Agency (EMA) as early as March 2012. The above represent another big milestone for Egis in quickly and successfully entering the market of biologicals. About Celltrion

Celltrion, Inc. is a leading biopharmaceutical company in Korea specializing in monoclonal
antibody capabilities to develop, manufacture and distribute biologics that contribute to human
life. Based on its world-class technology in monoclonal antibody manufacturing, Celltrion
achieves strategic collaboration with a number of global pharmaceuticals. In addition, Celltrion
is in preparation to be an initiative on newly emerging world mAb biosimilar market with its
advanced development technology and state-of-the-art facility. Now Celltrion develops large
portfolio of biosimilar products with blockbuster biologics.
About Egis

Egis Pharmaceuticals Public Limited Company, headquartered in Budapest, Hungary, is one
of the leading pharmaceutical companies operating principally in Central Europe. The
company focuses on research, development and commercialization of pharmaceuticals and
active pharmaceutical ingredients for the treatment of cardiovascular, central nervous system,
respiratory and digestive system disorders. The company sells its products in many countries
across the world through business partners and strong subsidiary companies network.
Remicade® is the trademark of Centocor Ortho Biotech Inc./Janssen Biotech, Inc.
Budapest, June 14, 2012

Source: http://www.egispraha.cz/download/egi120614er01e.pdf