Moving beyond the traditional contract research organization model, Quintiles will collaborate with Eisai to perform 11 proof-of-concept trials on six oncology compounds in a deal announced Oct. 30.

The goal of the collaboration is to determine the potential efficacy of the compounds in the shortest time possible. The Japanese drug maker will be conducting 18 trials of its own on the six compounds from its pipeline as well.

For years, CROs have wanted to find a way to get access to other economic opportunities, rather than simply be work-for-hire shops. Most cannot afford the cost and risk of drug development - or their investors do not believe they can. They are valued on earnings growth - and investors do not like CROs to take big risks with their money.

Under a risk-sharing structure, Eisai will retain full ownership of the compounds being studied, while Quintiles will co-fund the design of and conduct its 11 trials in exchange for potential success-based milestone payments, said Geoff Owens, vice president of business development for NovaQuest, Quintiles' deal-making subsidiary. No financial details of the transaction were disclosed by either company.

Owens maintained that since Eisai and Quintiles will be working to advance the compounds simultaneously, and because Quintiles has significant experience with oncology trials, the deal should yield enough efficiencies to speed up the overall POC process. Since 2000, Quintiles has conducted 640 oncology studies involving more than 131,000 patients in 68 countries.

"We're going to capitalize on that experience to use every best practice to gain every efficiency possible to make these trials as productive, efficient and as quick as possible," he said. "Getting to a proof-of-concept answer as quickly as possible is really what this is all about."

"And Eisai is empowering us to do so in the operational aspect of the collaboration," Owens continued. "Eisai is going to take its very best people and they will collaborate with their Quintiles counterparts to wring every possible time savings and efficiency out of this. We think there is good opportunity there based on the capabilities and experience of both organizations."

Prior working relationship led to collaboration

The collaboration came about partly because Quintiles, which is based in Research Triangle Park, N.C., has performed work for Eisai along with most other major drug makers during its existence, Owens said.

"We [previously] had a significant and successful relationship in a traditional fee-for-service sense of a sponsor working with a CRO like Quintiles," he said. "And so this we view as a … next step to take the relationship to another level and we found a way to structure a very exciting partnership where we're sharing that financial risk."

Quintiles noted that its recent acquisition of Targeted Molecular Diagnostics gives it additional expertise in clinical oncology biomarker development ([See Deal]).

The compounds on which Quintiles will perform Phase Ib/II POC studies are:

eribulin mesylate (E7389) in non-small cell lung cancer and bladder cancer.
E7080 in melanoma and breast cancer.
Ontak (denileukin diftitox), a CD25 antagonist currently approved by FDA for persistent or recurrent cutaneous T cell lymphoma, in melanoma.
E7820 in colorectal cancer.
E6201 as combination therapy with two different chemotherapy regimens in breast cancer.
E7050 in hepatocellular carcinoma, head-and-neck cancer and gastric cancer.

In a release Hideki Hayashi, Eisai's senior vice president and chief product creation officer, said "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."

- Joseph Haas (j.haas@elsevier.com)

[Editor's note: This article also appeared in 'The Pink Sheet' DAILY - Oct. 30, 2009.]

Quintiles And Eisai Collaborate To Develop Cancer Compounds

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