Discovering and developing novel medicines that make a real difference in the lives of the people we serve has always been complex, time-consuming and challenging. But we never forget that every step we take to increase the speed at which we are able to discover and develop new medicines and vaccines means less suffering for the patients who are waiting for them. That vital consideration drives us to continue to find new ways to accelerate the process of discovery, while still safeguarding our unwavering commitment to patient safety and scientific excellence.
At Merck Research Laboratories, we are employing a wide variety of strategies that increase the speed at which we can identify and move forward our most promising candidates. For example, molecular profiling, or forecasting, lets us evaluate the effectiveness of a molecule in treating disease and its possible side effects at an earlier stage than ever before. “Biomarkers,” a kind of pharmacological readout, enable us to predict the benefits or harm of a potential medicine well in advance of early-stage clinical trials. Gene-expression array experiments can help identify critical patterns more quickly.
Our efforts have made Merck a world leader in these methods. Last year, our scientists carried out about 40,000 gene-expression array experiments. In each of these experiments, the levels of activation of approximately 25,000 genes were monitored. We know of no other organization in the world that performs more of these cutting-edge experiments.
We are also bringing an increased number of new mechanisms into the pipeline through our own research and through external licenses and alliances. In 2004, we concluded 50 such transactions.
(See chart on research pipeline page.)
The result of one of these collaborations is muraglitazar, a new kind of treatment for Type 2 diabetes that Merck will co-promote with Bristol-Myers Squibb. This past December, an application was submitted to the FDA. In addition to muraglitazar and Arcoxia, Merck now has the following product candidates in late-stage development:
- RotaTeq, to protect against rotavirus, a highly contagious virus that causes gastroenteritis. (see above right)
- Our new vaccine for zoster, or shingles. (see above right)
- Gardasil, our vaccine to protect against HPV infection and related cervical cancer and genital warts.
- ProQuad, our new childhood vaccine that adds a chickenpox component to the existing measles, mumps and rubella vaccine, for which we are awaiting FDA approval.
- MK-431 for the treatment of Type 2 diabetes.
- Gaboxadol, a compound licensed from Lundbeck, using a new mechanism which shows in trials to date the potential to improve sleep quality with a low risk of abuse.
“SAHA,” our Phase II cancer compound for the treatment of cutaneous T-cell lymphoma, is in clinical trials. We plan to submit it to the FDA for approval in 2006.
For more than a century, Merck has built an extraordinary record of accomplishment driven by our commitment to scientific excellence. Our ability to leverage and lead the revolution taking place in science will help drive our future success.
Molecular profiling and gene-expression array experiments are just two ways we are accelerating drug discovery and development in Merck labs. We have accelerated the filing of two new vaccines, which are intended to help prevent disease from occurring in the first place.
The first vaccine–RotaTeq–helps prevent rotavirus, a highly contagious virus which causes the hospitalization of nearly 50,000 children under age 5 in the United States, plus an estimated 500,000 deaths worldwide each year.
The second vaccine is designed to prevent shingles and the long-term pain associated with it. Shingles, the reactivation of the chickenpox virus in adults, affects approximately 800,000 Americans annually. People over the age of 50 are most commonly affected. As the population continues to age, the occurrence of shingles is likely to increase.