After cutting deep into its R&D operations, Merck KGaA's drug development group has partnered up with Quintiles, tapping the global CRO as an exclusive clinical trial provider for the next 5 years. In the pact, investigators at Merck Serono will join hands with experts at Quintiles to shape and guide the company's R&D strategy while the CRO manages trial planning and execution from Phase I through post-marketing studies.
Over the last few years a number of Big Pharma companies like Sanofi ($SNY) and Eli Lilly ($ELY) have divvied up their clinical trial business among a few key, exclusive CRO providers. That strategy has fit well with pharma companies' efforts to do more outsourcing as they try to economize on research. And it's helped drive a consolidation of the CRO business, with a few big rivals angling for much of the market share.
But Quintiles says this new pact goes much further than the standard outsourcing agreements the industry has been seeing. "There are a number of unique aspects to this collaboration, but most notably, Quintiles will be a standing member of a collaborative clinical operations team that will be responsible for clinical operations decisions related to the Merck Serono development portfolio," notes a Quintiles spokesperson to FierceBiotech. "In this capacity, Quintiles has the opportunity to be involved in clinical development activities--from strategic input in clinical development plan definition and trial concept sheet design to leading and coordinating the execution of most clinical operations activities, including clinical trials for the drug candidates."
Quintiles has been growing rapidly in recent years, building a network for clinical studies that now reaches around the globe. The CRO and its top investors recently raised close to a billion dollars from a highly successful IPO. In this new pact with Merck, Quintiles boasts it can bring its global operation to bear to speed up studies for Merck KGaA while keeping costs in check.
|Quintiles CEO Tom Pike|
Merck could use some expert assistance in trial design and execution. Like many of its rivals, the company has eliminated a major research hub--Serono's big facility near Geneva--after some bitter clinical setbacks. The most notable of the failures includes the Phase III disaster for cladribine, once considered a top prospect for multiple sclerosis. Poor Phase III planning was considered a major factor in that failure, which was followed by the appointment of Annalisa Jenkins, a Bristol-Myers ($BMY) vet, as the new R&D chief. Merck is now focused on neurology, oncology, immuno-oncology and immunology.
"We are excited about the opportunities this collaboration provides as we work with Merck Serono in a new and innovative manner that leverages the best of our combined capabilities," says Quintiles CEO Tom Pike. "We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve."
- here's the press release