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Developing true advances in patient care
Dr. Ranabir Sinha Roy, research fellow, is working in Merck Research Laboratories in Rahway, N.J., on a DP-IV inhibitor that may help diabetic patients manage their disease. By using new technologies, we expect to advance our DP-IV candidate from preclinical development to Phase III in just over two years, compared to an industry average of over four.

At Merck, breakthrough research is the focus and passion that drives everything we do. For more than 100 years, Merck researchers have pioneered innovations for treating serious disease—a tradition that produced such major advances as cortisone for rheumatoid arthrtis, streptomycin for tuberculosis, statins for cholesterol management and Crixivan for HIV/AIDS, to name a few. That record of achievement continues today as we develop breakthrough medicines and vaccines.

In 2003, Merck/Schering-Plough Pharmaceuticals filed for FDA approval of Vytorin, which contains the active ingredients of both Zetia and Zocor. If approved, this therapy would be the first single tablet containing the dual inhibition provided by a combination of two highly effective cholesterol-lowering medicines—Zetia, which limits cholesterol absorption in the intestine, and Zocor, which reduces cholesterol production in the liver.

Building on our successful experience in advancing arthritis and pain care, we resubmitted an expanded application in 2003 for FDA approval of Arcoxia, our new coxib. The FDA will determine whether to accept Merck's application as submitted. In clinical studies, Arcoxia was highly effective in the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, including menstrual pain, and other painful conditions such as acute gouty arthritis and ankylosing spondylitis, a fusion of bones in the spine. No other coxib currently has indications for ankylosing spondylitis, acute gouty arthritis or chronic low back pain.

The momentum behind our research is demonstrated by our late-stage pipeline, where Merck has four vaccine candidates. The first, ProQuad—a pediatric combination vaccine for measles, mumps, rubella and chickenpox—is expected to reduce the number of injections a child must receive. We intend to submit a Product License Application (PLA) for ProQuad to the FDA in the second half of 2004.

We plan to file PLAs in 2005 for three novel vaccine candidates that address compelling health needs:

  • A vaccine for human papillomavirus (HPV) has the potential to be the first vaccine to prevent the infection that is a leading cause of cervical cancer, the second most-common cancer among women worldwide. Cervical cancer strikes approximately 470,000 women each year and results in more than 200,000 deaths worldwide. An estimated 30 million adolescent and adult females in the United States are at risk for HPV infection.
  • A new Merck vaccine has the potential to be the first vaccine to prevent the pain and discomfort associated with shingles, a debilitating condition caused by the reactivation of the chickenpox virus in adults, affecting as many as 1 million Americans each year.
  • The vaccine, RotaTeq, seeks to prevent rotavirus, a highly contagious virus that is the most common cause of severe gastroenteritis in infants and young children. Rotavirus leads to at least 50,000 hospitalizations in the United States and causes more than 400,000 infant deaths in the developing world each year.

Our pipeline also includes a treatment for Type II diabetes, which affects more than 40 million people in major markets worldwide, with that number expected to more than double by 2015. If trials are successful, in 2006 we expect to file for FDA approval for the new glucose-lowering drug, a DP-IV inhibitor. Early tests have demonstrated that the product does not lead to weight gain and does not produce edema. Additional studies to confirm these findings are under way. As our labs continue to produce such breakthroughs, we are also improving the process of innovation, using new technologies that give us the ability to move compounds into later stages of development faster and improve the probability of success.

We are also leveraging the cutting-edge work at other pharmaceutical and biotechnology companies through external alliances. In 2003 alone, we completed 47 significant transactions, including research collaborations, preclinical and clinical compounds, and technology transactions, compared to 10 in 1999. Merck's ability to address significant unmet medical needs is well-reflected in the early-stage research in our labs in such critical areas as diabetes, obesity, Alzheimer's disease, respiratory disease, coronary heart disease, rheumatoid arthritis and a range of vaccines. These compelling needs and challenges drive all of us at Merck, and keep us focused on research that makes a genuine difference in the quality of people's lives.
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