TRENDS & PERSPECTIVES
A partnership between a leading molecular diagnostics company and a major pharmaceutical company could help to promote further acceptance of personalized medicine. Celera (Rockville, MD) entered into a research collaboration with Merck & Company, Inc. (Whitehouse Station, NJ) to develop biomarker and pharmacogenomic tests for cancer patients. Under the terms of the agreement, Celera will evaluate the use of certain gene expression profiles identified by Merck, with the goal of developing diagnostic predictors for use in Merck’s clinical trials. Such predictors could potentially form the basis for commercial companion diagnostic tests for oncology therapies.
Celera will receive an undisclosed payment for this collaboration. The company would be eligible for an additional payment if Merck decides to transfer a Celera validated gene expression assay to a clinical reference laboratory upon completion.
Celera’s close ties with Merck are not new. According to Celera officials, the company’s relationship with Merck has unfolded over a long period of time. Celera has had a long-standing, multiyear exchange of information with Merck, which resulted in this research collaboration.
“The decision to pursue this collaboration is a reflection of the evolution and maturation of targeted medicine in which companies are developing diagnostic kits for clinical trials for various drugs,” says John Sninsky, PhD, vice president of discovery research at Celera. “So the time was right from the standpoint of matching up the drugs that Merck wanted to consider in the context of a relationship with capabilities and information that was available scientifically for a potential companion diagnostic.”
Celera officials said that one of the initial goals of the research collaboration is to gather information on messenger RNA levels that are associated with drug response. “Merck has done a large amount of work from a standpoint of messenger RNA profiling,” says Sninsky. “They have a long history of an investment into fundamental science, and they have the necessary information to take the next step and gather the information.”
The companies will focus their research efforts in oncology, which reflects cancer’s importance as a clinical area and the compelling science in this area that merits being followed up on by a more directed effort.
“In a general context, oncology has really led the way, whether it be for combination therapies or combining molecular markers with drug therapies,” says Sninsky. “Certainly there are examples, such as the use of Gleevec pairing up with IVDs in a very targeted way. From my perspective, the reason oncology is first is because it is the most active area in combining genomic information in a way that will further enhance our understanding and use of drugs.”
The agreement between Celera and Merck demonstrates the importance of such collaborations in developing personalized medicine’s full potential. For example, the discrete nature of the information that is available to pharmaceutical companies relative to diagnostics companies is being appreciated more. In the context of companion diagnostics, it is important to bring such knowledge bases together to go forward, since each of them separately does not have sufficient information to develop a clear and comprehensive strategy for targeted medicine. However, Celera officials believe that in order for personalized medicine to gain greater acceptance, IVD companies must do their part by conducting the proper research and presenting the appropriate data.
“IVD companies have to make a commitment to presenting timely, replicatable science,” says Sninsky. “In the end, that’s what’s going to convince patients, clinicians, and the reimbursement community that personalized medicine can help make the right decisions. So it’s an understanding of fundamental science, and it’s a gathering of compelling, statistically significant data.”
Other Celera officials added that IVD companies will also have to do a better job in educating pharmaceutical companies on the time that it takes to develop companion diagnostics products. “Very often, I get the impression that pharma companies only focus on drug development,” says Andrew Grupe, PhD, senior director of pharmacogenomics and director of central nervous system discovery research at Celera. “They don’t think about the development of a diagnostic product right away. So they need to keep in mind that it takes time to develop an IVD product that they may need at the same time when they get FDA approval.”
In other related developments, Celera signed an agreement to acquire substantially all of the assets of Atria Genetics (South San Francisco, CA) for approximately $33 million in cash. Atria has a line of human leukocyte antigen (HLA) testing products that are used for identifying potential donors in the matching process for bone marrow transplants.
Since January 2004, Atria’s HLA sequencing-based typing products have been marketed and distributed worldwide by Abbott Molecular (Pleasanton, CA) through its alliance with Celera. With this acquisition, Celera will retain 60% of these end-user revenues under the current distribution agreement with Abbott, and will also continue to receive a low, single-digit-percentage royalty on the total end-user revenues.
