News Release FOR IMMEDIATE RELEASE Media Contacts: Investor Contacts: Centocor Centocor Michael Parks Louise Mehrotra
Exhibit 99.1
News Release | ||||
FOR
IMMEDIATE RELEASE |
||||
Media Contacts: | Investor Contacts: | |||
Centocor | Centocor | |||
Xxxxxxx Xxxxx | Xxxxxx Xxxxxxxx | |||
000-000-0000 | 000-000-0000 | |||
cell: 000-000-0000 | Xxxx Xxxxx | |||
000-000-0000 | ||||
Schering-Plough | Schering-Plough | |||
Xxxxxxxxx Xxxxxxxx | Xxxxx Xxxxx | |||
000-000-0000 | 000-000-0000 |
CENTOCOR, SCHERING-PLOUGH REVISE AGREEMENT
COVERING REMICADE, GOLIMUMAB
COVERING REMICADE, GOLIMUMAB
HORSHAM, PA and KENILWORTH,
NJ, Dec. 21, 2007 — 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 REMICADEÒ
(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 commersilization 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.
About Centocor
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 Xxxxxxx & Xxxxxxx.
XXXXXXX
& XXXXXXX 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 Xxxxxxx & 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 xxx.xxx.xxx, xxx.xxx.xxx or on request from Xxxxxxx & Xxxxxxx. Centocor does not undertake to update any forward-looking statements as a result of new information or future events or developments.
About Schering-Plough
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 xxx.xxxxxxxx-xxxxxx.xxx.
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-Xxxxxx’s third quarter 2007 10-Q.
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