US-based biopharmaceutical services company Quintiles has formed alliances with two pharmaceutical multinationals, spanning clinical pharmacology studies and oncology product development.

The clinical pharmacology alliance is with AstraZeneca and closely follows the announcement that Quintiles will team up with Eisai to conduct Phase II trials with six oncology product candidates in the Japanese company’s research and development pipeline.

Both agreements are further evidence of strategic outsourcing by cost-conscious pharmaceutical companies that should benefit larger and more diversified players in a contract research industry feeling the knock-on effects of stalled drug development programmes in a constrained economic climate.

As Ron Wooten, executive vice-president, Quintiles Corporate Development, commented on the Eisai deal: “Quintiles and Eisai are using the power of partnerships to manage risk and enable transformation in a rapidly evolving industry where the rules are changing on all fronts”.

Under its alliance with AstraZeneca, Quintiles will assume operational responsibility for delivering the “majority” of AZ’s clinical pharmacology needs as a sole provider, working globally and across multiple therapy areas, the US company said.

The arrangement, which includes a simple, standardised pricing model, will encompass the clinical conduct and medical oversight of clinical pharmacology studies, as well as “a range of activities across the end-to-end study process”, Quintiles added.

The company has a network of clinical pharmacology facilities across Europe and the US, connected via integrated data platforms that use advanced electronic data capture and reporting to facilitate early go-no go decisions, it noted. The plan is to supplement this network with a facility in Asia next year.

The two partners will “work together, focusing their efforts on leveraging leading-edge science and establishing operational efficiency and consistency to support AstraZeneca’s goal to shorten delivery timelines and bring innovative medicines more quickly to patients”, Quintiles commented.

Proof of concept

The tie-up with Eisai involves Phase II proof-of-concept studies in 11 solid tumour indications. A key goal of the alliance, Quintiles said, is to “determine the efficacy of the products in the shortest possible time in order to bring therapies to market faster for the benefit of cancer patients worldwide”.

This strategic alliance will be structured on a risk-sharing basis, with Quintiles partly funding the design and conduct of the clinical trials in exchange for success milestone payments.

The agreement will enable Eisai to extend its oncology programme, increasing the number of indications under evaluation for the six product candidates – eribulin (E7389), E7080, Ontak (denileukin difitox), E7820, E6201 and E7050. These assets will remain the property of Eisai, while Quintiles will have development accountability for them throughout the Phase II proof-of-concept stage.

“Quintiles has first-hand experience in working with partners to rebalance operational portfolio and resource risk,” Wooten pointed out. “This goes beyond the traditional boundaries of the pharma business model, offering a more nimble, modular and variable way of leveraging resources to increase the value of assets.”

Since 2000, Quintiles has conducted 640 oncology studies involving more than 131,000 patients in 68 countries. Last December, the company boosted its capabilities in the fast-growing market for targeted cancer therapies by acquiring oncology biomarker specialist Targeted Molecular Diagnostics.