Navigation Links
Centocor, Schering-Plough Revise Agreement Covering REMICADE, Golimumab
Date:12/21/2007

HORSHAM, Pa. and KENILWORTH, N.J., Dec. 21 /PRNewswire-FirstCall/ -- 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 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.

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 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 http://www.sec.gov, http://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.

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 http://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.


'/>"/>
SOURCE Schering-Plough Corporation; Centocor, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
2. Schering-Plough Schedules Conference Call and Webcast for 2007 Third Quarter Earnings
3. Schering-Plough Reports Financial Results for Third Quarter of 2007
4. Schering-Plough CEO Calls for Four-Pronged Approach to Improving Current Health Care Environment
5. Schering-Plough Reports U.S. District Court for District of Massachusetts Finds No Liability for Subsidiary in AWP Case
6. Schering-Plough to Webcast CFO Robert J. Bertolinis Presentation at 2007 Credit Suisse Health Care Conference
7. Schering-Plough Receives Clearance From U.S. Federal Trade Commission for Planned Acquisition of Organon Biosciences N.V.
8. Schering-Plough Declares Quarterly Dividends on Common Shares and 2007 Mandatory Convertible Preferred Stock
9. PreViser Launches New Website and Enhanced Version of Its Oral Disease and Risk Assessment Software
10. NUCRYST and Smith & Nephew Revise Agreements
11. Isis Favorably Revises Financial Guidance and Introduces Mipomersen as Generic Name for ISIS 301012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... 24, 2016 , ... Dr. Amanda Cheng, an orthodontist ... has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be used ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Medical Market Analysis 2016 - Forecast to 2022" report ... The report contains up to date financial data derived from ... of major trends with potential impact on the market during ... market segmentation which comprises of sub markets, regional and country ...
Breaking Medicine Technology: