Schering-Plough, Johnson and Johnson revise Remicade and golimumab agreement

Schering-Plough and Centocor – a Johnson & Johnson company – have announced a revision to their agreement regarding the development, commercialisation and distribution of Remicade (infliximab) and golimumab.

The companies originally signed the agreement for the anti-tumour necrosis factor (TNF) therapies in 1998. Remicade is an anti-TNF alpha therapy for chronic inflammatory disorders, while golimumab is currently in phase III of clinical development.

Under the revised agreement, the rights of Schering-Plough to exclusively market Remicade outside the United States will be extended beyond 2014 to equal the duration of its rights over golimumab.

“Remicade is approved to treat such indications as rheumatoid arthritis, early rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, plaque psoriasis and ulcerative colitis,” the companies report.

They firms plan to file applications for marketing authorisation for golimumab for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis indications with the US Food and Drug Administration and European Medicines Agency in 2008.

Last month, Schering-Plough, Centocor and Mitsubishi Tanabe Pharma announced that one million patients have been treated with Remicade.

J Spiegel, chief medical officer and senior vice-president of Schering-Plough Research Institute, said that the compound had transformed the treatment of patients with inflammatory diseases.