In further evidence of a shift toward more fundamental risk-sharing in drug development between biopharmaceutical companies and CROs, Quintiles is making a significant investment in Swiss biotech Kareus Therapeutics as part of a broad strategic alliance to move two of Kareus’ pre-clinical programs through clinical trials, according to PharmaTimes.

Quintiles will make an undisclosed investment in Kareus, a privately owned biotechnology company focused on developing novel therapeutics to address high unmet medical need in areas such as central nervous system disorders, metabolic diseases and cardiovascular conditions.

The investment will be split between an equity stake and access to clinical services on a shared-risk basis. In June 2010, Quintiles said it would invest up to $2 million in Australia’s Prana Biotechnology to help support a planned phase II study with PBT2, a compound for Alzheimer’s disease.

Kareus plans to file an investigational new drug (IND) application in the U.S. for KU-046, a “first-in-class” new chemical entity discovered in-house for the treatment of Alzheimer’s disease. 

Kareus also has identified a lead series of molecules that demonstrate potent, long-lasting insulin sensitization with a broad therapeutic window for the treatment of Type-2 diabetes, the company said. It will select a clinical candidate from this lead series for development later this year. 

Quintiles will conduct phase I proof-of-relevance trials for both KU-046 and the selected diabetes candidate.

The deal “is an example of how leading biotechnology companies are building partnerships that extend beyond the traditional licensing model to manage risk, increase productivity and increase value to stakeholders,” said Tom Perkins, Quintiles’ senior vice president of corporate development.

Perkins said in leveraging Quintiles’ suite of drug development services, Kareus will be able to use the company’s new phase I research unit in Hyderabad, India.

“With Quintiles as our partner, Kareus is now ideally placed to accelerate the development of our novel drug pipeline and advance the first product candidates generated by our innovative discovery platform into clinical studies,” said Patrick Doyle, head of corporate and business development at Kareus.