Centocor, Schering-Plough Revise Agreement Covering REMICADE, Golimumab
Friday December 21, 2:40 pm ET
HORSHAM, Pa. and KENILWORTH, N.J., Dec. 21 /PRNewswire-FirstCall/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP - News) today announced they have revised their 1998 distribution agreement regarding the development, commercialization and distribution of both REMICADE® (infliximab), an anti-tumor necrosis factor (anti-TNF) alpha therapy for chronic inflammatory disorders, and golimumab, Centocor's next-generation, human, anti-TNF alpha therapy, which is currently in Phase 3 trials. Effective upon regulatory approval of golimumab in the EU, the revised agreement will extend the duration of Schering-Plough's rights to exclusively market REMICADE in its current marketing territories outside the United States beyond 2014 to match the current duration of its exclusive marketing rights for golimumab product. Schering-Plough's marketing rights to both products will now extend for 15 years after the first golimumab commercial sale.
In addition, Centocor will receive a progressively increased share of profits on Schering-Plough's distribution of both products in the Schering-Plough marketing territory between 2010 and 2014, and remaining fixed thereafter for the remainder of the term.
The revised agreement will also allow Schering-Plough to independently develop and market golimumab for the Crohn's disease indication in its territories, with an option for Centocor to participate in the program.
The parties have also agreed to utilize an autoinjector device developed by Centocor affiliate Cilag GmbH International in the commercialization of golimumab in their respective territories and have further agreed to share the autoinjector development costs. The autoinjector would allow patients to self-administer golimumab subcutaneously. The revised agreement provides for Schering-Plough to make an upfront payment of $20.5 million in the 2007 fourth quarter for rights to the autoinjector device.
Centocor exclusively markets REMICADE and upon approval will market golimumab in the United States. Schering-Plough has held exclusive marketing rights to REMICADE outside of the United States, Japan and certain Asian countries. In 2005, Schering-Plough exercised an option under the 1998 agreement with Centocor for license rights to develop and commercialize golimumab in the same territories as REMICADE.
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. Golimumab is currently in Phase 3 trials for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and is being investigated for administration by either monthly subcutaneous injection or every 12-week intravenous (IV) infusion. The companies anticipate filing applications with the U.S. Food and Drug Administration and the European Medicines Agency in 2008 seeking approval for golimumab in these therapeutic areas. |
