Backed by a strong line of existing market-leading pharmaceutical products, Schering-Plough is committed to continually discovering and developing new pharmaceuticals that can save lives, improve patients' health and reduce overall treatment costs. Using the latest tools of chemical synthesis, molecular biology, cell-signaling, gene targeting, combinatorial chemistry, X-ray crystallography, biotechnology, bioinformatics, genomics and high-throughput screening, our researchers and scientists around the world are pursuing new leads in targeted therapeutic areas, giving Schering-Plough a strong pipeline of promising therapeutic agents that have substantial human and market potential. These targeted therapeutic areas for our research include:
Respiratory
Since the 1940s Schering-Plough has been a leader in discovering and developing respiratory therapies. Our current asthma product lines -- beta antagonists, inhaled steroids and theophyllines -- fulfill many of the recommended asthma treatment guidelines developed by the National Heart, Lung and Blood Institute (NHLBI). As a result of our ongoing research into new and more effective agents to prevent or block effects of the body's allergic and immunological responses, we are currently in the process of developing novel formulations of mometasone, an anti-inflammatory steroid with a very competitive safety and efficacy profile.
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NASONEX, a once-daily nasal spray for allergic rhinitis, is currently in development for both European and US marketing clearance. Also in development are non-CFC oral dry powder and metered-dose inhalers for bronchial asthma that may offer superior pharmacology relative to other inhaled corticosteroids, as well as the convenience of a once-daily dose with an environmentally-friendly propellant.
In collaboration with Celltech Group, plc in the UK, SPRI is developing a potentially breakthrough product for treating asthma and inflammatory and allergic disorders -- a monoclonal antibody to the cytokine interleukin 5 (IL-5). This novel drug is nearing clinical phase and may offer a unique prophylactic therapy by blocking the cytokine involved in the migration of inflammation-producing eosinophils to the lungs.
Oncology
Our tremendous efforts in this area follow a multi-pronged approach using cytokines, cytotoxics and hormonal and genetic therapies. Drugs for the treatment of lung, breast and prostate cancers, as well as malignant melanoma and brain tumors, are among the targets of research efforts and existing products developed by Schering-Plough researchers. One example is a farnesyl protein transferase inhibitor that may offer a novel mechanism to block the function of the RAS oncogene, commonly implicated in breast, colon and pancreatic solid tumors. This program is nearing the clinical phase. We also continue to develop new indications for INTRON A and EULEXIN anti-cancer agents.
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SPRI's Canji, Inc. is rapidly advancing new cancer treatments based on proprietary scientific discoveries with p53 tumor suppressor gene therapy technology. The therapy has application in 50 percent of all human tumors and is now in clinical trials.
At SPRI's DNAX Research Institute, researchers have cloned and expressed the genes of a number of promising lymphokines, including interleukin-4 (IL-4) and interleukin-10 (IL-10). IL-4 is in clinical trials for non-small-cell lung cancer, and in an early phase trial for gastrointestinal carcinoma. (In addition, IL-10 is in clinical trials for Crohn's disease and ulcerative colitis, and early-stage trials for rheumatoid arthritis.)
Numerous collaborative and licensing efforts augment our substantial in-house efforts as well:
- Interleukin-11 (IL-11), currently in Phase III clinical studies, has been licensed from Genetics Institute, Inc. for marketing in most countries. This blood cell growth factor has the potential to restore blood platelet levels and may be used as adjunctive therapy in cancer chemotherapy and bone marrow transplantation.
- TEMODAL (temozolomide), licensed from Cancer Research Campaign Technology, is a cytotoxic agent in late-stage trials for the treatment of brain tumors and malignant melanoma.
- A novel pure anti-estrogen agent for breast cancer is being developed in collaboration with the Laval University Medical Center, promising more complete and longer-lasting regression of breast cancer and other estrogen sensitive tumors than current therapies.
Infectious Disease
This is a very active area within SPRI, covering fungal, bacterial and viral diseases. Advanced molecular and cellular biology techniques, as well as bioinformatics, are used to study molecular mechanisms underlying disease processes. Targets for therapeutic intervention are identified and analyzed based on the potential for successful drug discovery.
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A major area of present research focus is hepatitis C. INTRON A (alpha-interferon) has proven to be a successful antiviral agent and is the only therapeutic currently approved for hepatitis C.
An oral anti-fungal agent began clinical trials in 1996, and may offer the broadest spectrum of activity of any systemic antifungal on the market, with a profile superior to fluconazole and itraconazole, and stronger potencies for several indications.
ZIRACIN (everninomicin), an injectable antibiotic highly active against gram positive methicillia-resistant and vancomycin-resistant bacteria, is in the clinic, offering hope for a major therapeutic concern where alternative therapies are currently lacking. Namely, on the emerging problem of drug-resistant bacterial infections.
In addition to intensive in-house research and development efforts, collaborative efforts and licensing agreements are in effect with:
- Alkermes, Inc., Enzon, Inc. and ICN Pharmaceuticals, including combination therapy of INTRON A with ribavirin, offering the possibility of improving sustained response rates in hepatitis C patients. Exciting advances in dosing and delivery systems for INTRON A are in development, reducing the frequency of dosing and allowing for self-administration of this versatile drug.
- Genome Therapeutics Corp. -- to discover novel anti-infective agents active against drug-resistant organisms found in various infectious diseases.
Central Nervous System
We are experiencing tremendous growth in the therapeutic area of Central Nervous System (CNS) disorders. Utilizing our expertise in chemical synthesis and molecular biology, Schering-Plough is taking steps to advance research efforts in the neurosciences. Our current research targets include analgesics and drugs for the treatment of Alzheimer's disease, stroke, obesity and schizophrenia. In exploring new pharmaceutical agents, we have also entered into collaboration agreements with:
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- Neurogen Corp. -- to develop a new generation of pharmaceuticals that are more effective and have fewer side effects than currently marketed products. A D4 antagonist has been identified as a development candidate and is slated for clinical trials in 1997.
- Cephalon, Inc. -- to develop protease inhibitors to block the neuritic plaques that cause neuronal death in Alzheimer's patients.
Cardiovascular
In the early 1980's Schering-Plough was virtually unknown in the cardiovascular arena. Now, more than a decade later, cardiovascular disease has become a key therapeutic area as our researchers explore new compounds for treating arteriosclerosis and other circulatory disorders. Current research targets include an oral cholesterol absorption inhibitor.
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Development of new cardiovascular therapies is primarily being achieved through collaborative agreements with:
- COR Therapeutics -- giving Schering-Plough co-marketing rights to INTEGRILIN, a novel cardiovascular agent that inhibits platelet aggregation, a crucial event in the formation of arterial blood clots.
- Corvas International -- to develop oral inhibitors of thrombin, a key enzyme in the blood-clotting process.
Beyond our Key Therapeutic Areas
Through continued substantial investments in research and development, and aggressively pursuing licensing and co-development programs, Schering-Plough Research Institute maintains the knowledge and flexibility to pursue scientific advances in other areas that fit our long-term strategic goals and strengthen our worldwide competitiveness, including genetic engineering, biotechnology and gene therapy.