In further evidence of a shift towards more fundamental risk-sharing in drug development between biopharmaceutical companies and the contract research sector, Quintiles is making a significant investment in Swiss biotech Kareus Therapeutics as part of a broad strategic alliance to move two of Kareus’ preclinical programmes through clinical trials.

Under the alliance with 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, Quintiles will make an investment in Kareus “in the US$ seven-figure range”, the companies said.

The investment will be split between an equity stake and access to clinical services on a shared-risk basis. This is not the first time the US-based biopharmaceutical services provider has taken a piece of an outsourcing partner. In June 2010, Quintiles announced it would invest up to US$2 million in Australia’s Prana Biotechnology to help support a planned Phase II study with PBT2, the latter’s lead compound for Alzheimer’s disease.

Once Quintiles has made its investment in Kareus, the Swiss company aims to file an investigational new drug (IND) application in the US for KU-046, a “first-in-class” new chemical entity discovered in house for the treatment of Alzheimer’s disease. 

Kareus has also identified a lead series of molecules that demonstrate potent, long-lasting insulin sensitisation 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. 

As part of the alliance, Quintiles will conduct Phase I proof-of-relevance trials for both KU-046 and the selected diabetes candidate.

Beyond licensing

The agreement with Kareus “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”, commented Tom Perkins, Quintiles’ senior vice president of corporate development.

In leveraging Quintiles suite of drug development services, Kareus will be able to draw on the company’s new Phase I research unit in Hyderabad, India, Perkins noted.