KENILWORTH, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Addressing analysts and portfolio managers at the research headquarters of Schering-Plough Corporation , Fred Hassan, chairman and CEO, reviewed the progress achieved in the company's Action Agenda since new management team members first joined the company in 2003. He examined the company's and industry's operating environment, and highlighted efforts to broaden Schering-Plough's research pipeline and product portfolio to achieve long-term growth and high performance.
Other members of the Schering-Plough management team reviewed the company's discovery process and early R&D pipeline, discussed strategies for capturing the full value of molecules discovered and developed at Schering- Plough, and highlighted the company's strategies of investing for long-term high performance in areas across the company.
"We are working to build breadth and depth in our product and research portfolio both by capturing the full value of our internal innovations and actively seeking external licensing and partnering opportunities," said Hassan. "These actions support our goal of achieving a more diverse product mix to support long-term growth. As we begin the Turnaround phase in our Action Agenda, we are maintaining a science-centered focus and continue to build strength in our company. We are also beginning the actions that will drive the next period of development of Schering-Plough - the period when we aspire to begin to deliver on our long-term goal of sustainable high performance."
Capturing the Value of R&D Investment
In reviewing the company's current portfolio, presenters highlighted strategies designed to maximize the value of internal discoveries and innovations by extending the value of current products through investment in new indications, and by leveraging prescription assets across the company's consumer and animal health businesses. Examples included:
* ZETIA (ezetimibe), a first-in-class therapy for high cholesterol discovered by Schering-Plough scientists, and VYTORIN (ezetimibe/simvastatin), offering a dual mechanism to treat high cholesterol; both are important treatments marketed in partnership with Merck & Co., Inc. Studies are ongoing to expand the clinical profile of ezetimibe. * NOXAFIL (posaconazole), discovered at Schering-Plough and recently approved in the European Union (EU) for treating certain invasive fungal infections in patients with refractory disease or who are intolerant of other therapies, representing a serious unmet medical need. In addition, new data were reviewed showing that NOXAFIL prophylactic (preventive) treatment significantly reduced the incidence of aspergillosis and serious fungal infections overall in certain high-risk patients. It is anticipated that these data will support a new drug application in the United States and Europe for the prophylactic use of NOXAFIL. * REMICADE (infliximab), recently approved for treating plaque psoriasis in the EU. The medicine is also used to treat a wide range of immune- mediated inflammatory disorders, including Crohn's disease, psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis. It continues to be studied in other diseases. * TEMODAR (temozolomide), approved in the United States and the EU for the treatment of certain types of brain tumors. An application has been filed in Japan for approval to treat malignant glioma. Japanese authorities have agreed to conduct a priority review of the application, reflecting the potential importance of temozolomide to satisfy an unmet medical need in Japanese patients. * ASMANEX (mometasone furoate inhalation powder), a new treatment for asthma. Both mometasone and its novel delivery system were discovered and developed at Schering-Plough. Approved for U.S. marketing in March 2005, the therapy reflects ongoing efforts to further the potential utility of internal innovations. Mometasone is the active ingredient in several other treatments, including NASONEX, ELOCON and an animal health therapy. * CLARITIN (loratadine) OTC, extending the commercial value of a successful prescription asset through leadership in taking prescription products to over-the-counter (OTC) status. In continuing to leverage this innovation, seven new line extensions are under development. R&D Pipeline and Discovery Highlights
Reviewing the discovery process at Schering-Plough and early research compounds in development, management discussed discovery capabilities, new technologies and strategic actions designed to continue to improve the company's discovery efforts and build on its expertise in small molecule development and biotechnology. Schering-Plough has continued to enhance its research capabilities through the integration of new technologies, including genomics, high-throughput screening and structure-based drug design.
The company discussed the integration earlier this year of its two research facilities in California into a new unit, Schering-Plough BioPharma. The consolidation is designed to build on the company's discovery expertise in biologics research and to build "critical scientific mass" to support the discovery of novel biologics and the emergence of new molecules. The company also noted the acquisition in February of most of NeoGenesis Pharmaceuticals' assets. The acquisition built on a long-term collaboration utilizing novel screening technologies for lead identification and compound optimization.
Looking at the research pipeline, a range of therapies under development was reviewed, including:
* Vicriviroc (CCR5 receptor antagonist) - Phase II studies under way in treatment-experienced patients living with HIV; * CNTO 148 (golimumab) - a fully human monoclonal antibody, being developed under an agreement with Centocor, Inc. as a therapy for rheumatoid arthritis and other immune-mediated diseases, which is anticipated to begin Phase III studies in early 2006; * HCV protease inhibitor, for treating hepatitis C, now in Phase II; * Thrombin receptor antagonist, a potential oral therapy for acute coronary syndrome now in Phase II; * Pleconaril, in development as an intranasal formulation for treating the common cold in certain high-risk patient populations, in Phase II development; and * Two novel compounds with different mechanisms of action for the treatment of cough, both in early phase development.
Hassan and other members of management also reviewed improvements in the company's product flow capability since mid-2003. They said clear improvements in the company's product flow capability and early stage pipeline have been achieved in the past two years. Since July 2004, there have been five "first cycle" approvals received in the United States, including the on- time approval in July 2004 of VYTORIN for the treatment of high cholesterol and the approval in March 2005 of TEMODAR, following priority review, as a treatment for adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer.
Turning to business development and licensing, management reviewed several recent previously announced transactions, including CNTO 148, and said the company is actively looking to strengthen its competitive position and broaden the product pipeline through external agreements.
Webcast Information
A replay of the live audio webcast of this meeting will be available by going to the Investor Relations section of the Schering-Plough corporate Web site, www.schering-plough.com, and clicking on the "Presentations/Webcasts" link. A replay of the webcast will be available starting at approximately 6 p.m. today through 5 p.m. on Dec. 1.
Disclosure Notice
The information in this press release includes certain "forward-looking" statements within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the company's plans, strategy, and long-term goals; its progress under the Action Agenda and anticipated timing regarding future performance of the Action Agenda; business prospects; trends in performance; the anticipated growth and potential of certain products including VYTORIN, ZETIA, CNTO 148, NOXAFIL and CLARITIN; and the potential of its product pipeline. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. 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. A number of risks and uncertainties could cause results to differ from forward-looking statements, including the regulatory process for new products and new indications; the market viability of the company's (and the cholesterol joint venture's) marketed and pipeline products; possible changes in business strategies and the ability to successfully implement those business strategies; general market and economic factors; regulations and legislation; label/use changes and concerns of prescribers or patients relating to Schering-Plough products, other companies' products or pharmaceutical products generally; existing and new manufacturing issues that may arise; trade buying patterns; and patent positions. 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 under the heading "Disclosure Notice," including the company's third quarter 10-Q. The company does not assume any obligation to update any forward- looking statement.
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
Schering-Plough CorporationCONTACT: Media - Steve Galpin, Jr., +1-908-298-7415, or Denise K. Foy,+1-908-298-7616; Investor - Alex Kelly, +1-908-298-7436, all for Schering-Plough
Web site: http://www.schering-plough.com/
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