Kareus Therapeutics SA (Kareus), the company focused on the development of novel therapeutics to address high unmet medical need,  announced a broad strategic alliance with Quintiles to progress the development of two of Kareus' pre-clinical programmes through clinical trials.

Under the terms of the alliance, Quintiles will make an investment in Kareus in the US $ seven figure range, apportioned between an equity investment and access to clinical service on a shared-risk basis. Following the investment by Quintiles, Kareus plans to submit an Investigational New Drug (IND) application for KU-046, a first-in-class new chemical entity discovered by Kareus for the treatment of Alzheimer's disease. Kareus has also identified a lead series of molecules demonstrating potent, long-lasting insulin sensitisation with a broad therapeutic window for the treatment of type-2 diabetes and will select a clinical candidate for development later in 2011. Quintiles will conduct phase I proof-of-relevance clinical trials for both KU-046 and the chosen diabetes candidate.

Tom Perkins, senior vice president of Corporate Development for Quintiles said: “This agreement 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. We are pleased that Kareus has chosen to leverage Quintiles' suite of comprehensive services, including our new Phase I research unit in Hyderabad, India.”

Patrick Doyle of Kareus Therapeutics said: “We are delighted to have signed this alliance with Quintiles, a leading global provider of clinical services. 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, Karlect, into clinical studies.”

Kareus has developed a pipeline of novel molecules targeting diseases of the central nervous system based on its proprietary Karlect chemistry and drug discovery platform which targets molecular and gene expression pathways. KU-046, discovered using the Karlect platform, targets pathways upstream from the increased abeta peptide production found in Alzheimer's disease and has demonstrated significant improvement in cognition in a number of pre-clinical models.

Kareus will also seek to develop novel small molecule candidates in metabolic diseases, including diabetes, and inflammation. In addition, the leadership team of Kareus has an extensive background in cardiovascular disease and has applied this know-how to the development of 505(b)(2) filings for lipid lowering and cardiovascular disease.

Kareus Therapeutics SA is a private biotechnology company focused on the development of novel therapeutics to address high unmet medical need.

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. It helps bio pharmaceutical companies navigate risk and seize opportunities in an environment where change is constant.