Quintiles announced a strategic alliance with leading global pharmaceutical company Eisai Co., Ltd. (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 in order to bring therapies to market faster for the benefit of cancer patients worldwide.

The strategic alliance will be structured on a risk-sharing basis, with Quintiles funding, 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.”

“This is a significant business model and new strategy for development,” said Mr. Hideki Hayashi, Senior Vice President and Chief Product Creation Officer for Eisai. “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.”

Derek Winstanly, Executive Vice President of Strategic Business Partnerships for Quintiles, said: “We are delighted to ally with Eisai to transform and advance its drug development efforts. This is another example of how Quintiles can help biopharma companies around the world increase productivity and improve efficiency, helping to accelerate availability of drugs to patients.”

Quintiles brings a unique core strength in oncology product development to the partnership with Eisai. Since 2000, Quintiles has conducted 640 oncology studies, involving more than 131,000 patients at nearly 20,000 investigator sites in 68 countries. The company also helped develop or commercialize many of today’s most widely-prescribed anticancer drugs. To further support its deep clinical development experience in the 11 solid tumor indications covered by this agreement, Quintiles recently added further expertise in clinical oncology biomarker development through its acquisition of Targeted Molecular Diagnostics.

About Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide. Eisai concentrates its R&D activities in three key areas:

• Integrative Neuroscience, including Alzheimer’s disease, neuropathic pain and epilepsy.
• Integrative Oncology, including anticancer therapies, tumor regression, tumor suppression and antibodies; supportive cancer therapies include nausea and vomiting.
• Vascular/Immunological Reaction including acute coronary syndrome, atherothrombotic disease and sepsis.

Forward-Looking Statements

This press release contains “forward-looking statements,” based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Risks and uncertainties include, among other things, general industry conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products; inconsistency of treatment results among patients; the potential for product failures; potential difficulties in manufacturing; governmental laws and regulations affecting domestic and foreign operations and the ongoing success of the collaboration. The parties expressly disclaim any intent or obligation to update these forward-looking statements except as required to do so by law.