HORSHAM, Pa. and KENILWORTH, N.J., Dec. 21 /CNW/ -- Centocor, Inc. and
Schering-Plough Corporation (NYSE: SGP) today announced they have revised
their 1998 distribution agreement regarding the development, commercialization
and distribution of both REMICADE(R) (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
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.
Centocor is harnessing the power of world-leading research and
biomanufacturing to deliver innovative biomedicines that transform patients'
lives. Centocor 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 has brought critical biologic therapies to patients suffering from
debilitating immune disorders. Centocor, Inc. is a wholly owned subsidiary of
Johnson & Johnson.
JOHNSON & JOHNSON DISCLOSURE NOTICE: This press release contains
"forward- looking statements" as defined in the Private Securities Litigation
Reform Act of 1995. These statements are based on current expectations of
future events. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from
Centocor's expectations and projections. Risks and uncertainties include
general industry conditions and competition; economic conditions, such as
interest rate and currency exchange rate fluctuations; technological advances
and patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approvals; domestic and foreign
health care reforms and governmental laws and regulations; and trends toward
health care cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December 31,
2006. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.
Centocor does not undertake to update any forward-looking statements as a
result of new information or future events or developments.
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough 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 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'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. The company is based in Kenilworth, N.J., and its
Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
includes certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements
relating to the timing of filing applications for golimumab. Forward-looking
statements relate to expectations or forecasts of future events. Schering-
Plough does not assume the obligation to update any forward-looking statement.
Many factors could cause actual results to differ materially from Schering-
Plough's forward-looking statements, including market forces, economic
factors, product availability, patent and other intellectual property
protection, current and future branded, generic or over-the-counter
competition, the regulatory process, and any developments following regulatory
approval, among other uncertainties. For further details about these and
other factors that may impact the forward-looking statements, see Schering-
Plough's Securities and Exchange Commission filings, including Part II, Item
1A. "Risk Factors" in the Schering-Plough's third quarter 2007 10-Q.
For further information:
For further information: Alex Kelly, +1-908-298-7436 Web Site: