Centocor Inc., Schering-Plough Corporation Revise Agreement Covering REMICADE®, Golimumab
Horsham, PA And Kenilworth, NJ. – Centocor, Inc., and Schering-Plough Corporation Corporation (NYSE: SGP), 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 Inc.’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 Corporation’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 Corporation’s marketing rights to both products will now extend for 15 years after the first golimumab commercial sale.
In addition, Centocor Inc. will receive a progressively increased share of profits on Schering-Plough Corporation’s distribution of both products in the Schering-Plough Corporation marketing territory between 2010 and 2014, and remaining fixed thereafter for the remainder of the term.
The revised agreement will also allow Schering-Plough Corporation to independently develop and market golimumab for the Crohn’s disease indication in its territories, with an option for Centocor Inc. to participate in the program.
The parties have also agreed to utilize an autoinjector device developed by Centocor Inc. 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 Corporation to make an upfront payment of $20.5 million in the 2007 fourth quarter for rights to the autoinjector device.
Centocor Inc. exclusively markets REMICADE® and upon approval will market golimumab in the United States. Schering-Plough Corporation has held exclusive marketing rights to REMICADE® outside of the United States, Japan and certain Asian countries. In 2005, Schering-Plough Corporation exercised an option under the 1998 agreement with Centocor Inc. 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.
About Centocor Inc.
Centocor Inc. is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients’ lives. Centocor Inc. has already brought innovation to the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn’s disease and psoriasis.
The world leader in monoclonal antibody production and technology, Centocor Inc. has brought critical biologic therapies to patients suffering from debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of Johnson & Johnson.
About Schering-Plough Corporation
Schering-Plough Corporation is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough Corporation creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough Corporation acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company’s ongoing transformation. Schering-Plough Corporation’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world.
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