Quintiles has entered into a strategic alliance with AstraZeneca. The contract research organization (CRO)-clinical pharmacology alliance with AstraZeneca was formed to deliver the sponsor’s clinical pharmacology studies across multiple therapy areas and around the globe.
Quintiles will assume the operational responsibilities for the majority of AstraZeneca’s clinical pharmacology delivery. The alliance involves a sole provider for clinical pharmacology delivery, and a simple, standardized pricing model.
In addition to clinical conduct and medical oversight of studies, the agreement covers a range of activities across the end-to-end study process. Ron Wooten, executive vice president, Quintiles Corporate Development, said, “This is an industry-leading alliance and demonstrates how, at Quintiles, we’re helping the industry seize opportunities as the industry transforms in response to the changing environment.”
Commenting on the alliance, Anders Ekblom, executive vice president for Global Drug Development, AstraZeneca, said, “This model gives us access to the right scientific and medical expertise plus the quality, flexibility and capacity we need to work efficiently and cost-effectively to deliver these studies. Finding more efficient ways to do our work, whilst maintaining the highest quality, is one of AstraZeneca’s key priorities.”
Quintiles also signed a strategic alliance with global pharmaceutical company Eisai, based in Tokyo, Japan, to develop six potential oncology products in Eisai’s R&D pipeline. Under the terms of the agreement, Quintiles’ oncology experts will conduct phase II proof-of-concept studies for 11 solid tumor indications.
A key goal of the alliance is to determine the efficacy of the products in the shortest possible time to bring therapies to market faster for the benefit of cancer patients worldwide. The strategic alliance will be structured on a risk-sharing basis. Quintiles will fund, in part, the design and conduct of the clinical studies in exchange for success milestone payments. Other financial terms were not disclosed.
The agreement is designed to enable Eisai to extend its oncology program, increasing the number of indications investigated for the six potential products, including eribulin (E7389), E7080, Ontak(denileukin diftitox), E7820, E6201 and E7050. These assets will remain the property of Eisai, with Quintiles having development accountability through the phase II proof-of-concept stage. In addition to projects covered under the agreement with Quintiles, Eisai will continue ongoing development of 18 additional indications for the same six compounds. “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,” said Ron Wooten, executive vice president, Quintiles Corporate Development. “Quintiles has first-hand experience in working with partners to rebalance operational, portfolio and resource risk. 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.”
Hideki Hayashi, senior vice president and chief product creation officer for Eisai, added, “This is a significant business model and new strategy for development. We are maximizing the potential of Eisai’s oncology compounds. I am pleased that Quintiles and Eisai share the same goals and our incentives are aligned for speed, quality and efficiency. We will explore multiple indications in parallel so that we can deliver our compounds as fast, widely and appropriately as possible for cancer patients’ benefit.”