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Schering-Plough Highlights R&D Pipeline Progress, Innovation and Breadth of Research Projects

KENILWORTH, N.J., Nov. 24 /PRNewswire-FirstCall/ -- Leaders of Schering-Plough Corporation (NYSE: SGP) today provided an update for investors on the company's research pipeline, highlighting a rich and innovative portfolio that includes 46 new entities in clinical trials or under regulatory review and 29 in preclinical studies.

"Research and development is adding strength and breadth to Schering-Plough as we continue our transformation," said Fred Hassan, chairman and CEO. "Our scientists have built a pipeline that we believe is the best in our history and one of the best in the industry, with nine new molecular entities (NMEs) in Phase III plus three in pre-registration." He said the new medicines that emerge from this pipeline will join a geographically diverse portfolio, with expected market exclusivity for most key prescription products continuing well into the next decade.

"Our goal remains the same: Deliver high performance for the long term," said Hassan. "We believe that having this robust pipeline, including several potential first-in-class and/or best-in-class compounds, is a key step toward achieving that goal."

Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute, said, "Our R&D innovation is visible in our pipeline projects, six of which have been designated 'fast track' by the U.S. Food and Drug Administration." He added, "We are pleased that R&D now has the potential to add enormous value to the company's already well-protected marketed product portfolio."

R&D Pipeline and Discovery Highlights

In reviewing the company's portfolio, presenters highlighted the following projects in the company's pipeline:

  • Thrombin Receptor Antagonist (TRA), a novel antiplatelet agent that can potentially prevent the formation of deadly blood clots without adding a significant bleeding risk (in Phase III); approximately 13,000 patients have been enrolled in its Phase III program targeted to include 30,000 patients;
  • SIMPONI(TM)* (golimumab), a once-monthly subcutaneous anti-TNF agent for inflammatory and autoimmune disorders (under review in EU for rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and in Phase III for ulcerative colitis); Schering-Plough has exclusive marketing rights to golimumab outside the U.S. except in Japan and certain other Asian markets;
  • SAPHRIS(TM)** (asenapine), a novel psychopharmacologic agent (under U.S. review for schizophrenia and acute manic or mixed episodes associated with bipolar I disorder); pivotal relapse-prevention data were presented showing that only 12 percent of patients receiving asenapine relapsed at the specified endpoint versus 47 percent of patients receiving placebo;
  • BRIDION(R) (sugammadex), the first and only selective relaxant binding agent for reversing neuromuscular blockade in anesthesia (approved in EU; under review in U.S. and Japan);
  • Boceprevir, an oral protease inhibitor for treating hepatitis C with peginterferon and ribavirin combination therapy (in Phase III); 24-week sustained viral response (SVR) data were presented showing that 75 percent of patients achieved SVR; in addition, a next-generation protease inhibitor in Phase II for treating hepatitis C was unveiled, with the potential to offer once-daily dosing and having 10 times the in vitro potency of current protease inhibitors in late-phase development;
  • Mometasone furoate and formoterol (MFF), an inhaled combination therapy for asthma and COPD (completing Phase III); pivotal data from Phase III trials in asthma were presented showing that MFF met its primary endpoints; and
  • Preladenant, a novel and selective adenosine2a receptor antagonist for Parkinson's disease (completing Phase II); results of a Phase II dose-finding trial in patients suffering from moderate to severe Parkinson's disease were reported showing that preladenant met the primary endpoint.

Presenters reviewed a range of other therapies in various stages of development in the company's six therapeutic areas: allergy/respiratory; cardiovascular/metabolic; central nervous system; immunology/infectious disease; oncology; and women's health.

Several earlier-stage research projects were also unveiled for the first time, including:

  • Two monoclonal antibodies for oncology -- robatumumab (anti-IGF-1R) in Phase II and anti-HGF in Phase I;
  • Two projects for Alzheimer's -- a beta secretase inhibitor and a gamma secretase inhibitor; and
  • A novel anti-inflammatory agent, anti-IL-23, in Phase I for chronic inflammatory conditions.

In Animal Health, the company highlighted its global leadership position and diverse portfolio and pipeline, with more than 120 small-molecule projects and 140 biological projects under way. The company also highlighted three growth corridors for Schering-Plough: companion animal; parasiticides; and geographic expansion in the U.S., Japan and emerging markets.

Webcast Information

A replay of the webcast of Schering-Plough's "R&D Update" meeting is available by going to the Investor Relations section of the Schering-Plough corporate Web site,, and clicking on the "Presentations/Webcasts" link. The replay will be available starting on Nov. 24 through 5 p.m. on Dec. 24.

Disclosure Notice

DISCLOSURE NOTICE: The information in this press release, the comments of Schering-Plough speakers during the R&D Update meeting and webcast on Nov. 24, 2008, beginning at 8:30 a.m. (EST), and other written reports and oral statements made from time to time by the company may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements do not relate strictly to historical or current facts and are based on current expectations or forecasts of future events. You can identify these forward-looking statements by their use of words such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "project," "intend," "plan," "potential," "will," and other similar words and terms. In particular, forward-looking statements include statements relating to the company's plans; its strategies; its progress under the Action Agenda and anticipated timing regarding future performance of the Action Agenda; business prospects; anticipated growth; timing and level of savings achieved from the Productivity Transformation Program, including the ongoing integration of OBS; prospective products or product approvals; trends in performance; anticipated timing of clinical trials and its impact on R&D spending; anticipated exclusivity periods; actions to enhance clinical, R&D, manufacturing and post-marketing systems; and the potential of products and trending in therapeutic markets, including the cholesterol market. Actual results may vary materially from the company's forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering-Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. A number of risks and uncertainties could cause results to differ materially from forward-looking statements, including, among other uncertainties, market viability of the company's (and the cholesterol joint venture's) marketed and pipeline products; market forces; economic factors such as interest rate and exchange rate fluctuations; the outcome of contingencies such as litigation and investigations; product availability; patent and other intellectual property protection; current and future branded, generic or over-the-counter competition; the regulatory process (including product approvals, labeling and post-marketing actions); scientific developments relating to marketed products or pipeline projects; and media and societal reaction to such developments. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. "Risk Factors" in the third quarter 2008 10-Q, filed October 29, 2008.

* SIMPONI is a trademark owned by Centocor, Inc. and licensed to Schering-Plough for use (subject to regulatory approval) with golimumab products in its territory (including the EU); the SIMPONI trademark is under regulatory review in the U.S.

** The SAPHRIS trademark is under regulatory review in the U.S.

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, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is

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