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EISAI TO ACCELERATE LATE-STAGE CLINICAL DEVELOPMENT OF NEW DRUGS BY EFFECTIVELY LEVERAGING EXTERNAL RESOURCESEnters Collaborative Development Agreement with SFJ Pharmaceuticals for Anticancer Agent E7080 (lenvatinib)

爱豆传媒. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has entered into a collaborative development agreement with SFJ Pharma Ltd. (“SFJ”), a wholly-owned subsidiary of SFJ Pharmaceuticals, LP., II (Location: California, the United States, President: Robert F. DeBenedetto), in an effort to further accelerate the late-stage clinical development of its new drug pipeline by effectively leveraging external financial resources.

With a rich late-stage clinical pipeline, Eisai will effectively leverage internal resources as well as build a new partnership scheme under which it accepts funding from external parties to conduct pivotal Phase III studies for promising new drug candidates in order to push forward with numerous development programs simultaneously and as quickly as possible.

As part of this partnership scheme, Eisai has entered into a collaborative development agreement with SFJ to conduct Phase III studies with E7080 (lenvatinib) in thyroid cancer. Under this agreement, these late-stage studies will be conducted by Eisai and wholly funded by SFJ, with Eisai paying SFJ milestone payments only if E7080 obtains regulatory approval. If and when the compound is approved, all commercial rights shall remain with Eisai.

Under the previously established strategic collaboration with Quintiles, Eisai has been advancing multiple candidate anticancer compounds for Proof of Concept (POC) studies. However, this new agreement with SFJ will enable Eisai to simultaneously pursue multiple promising late-stage clinical development programs, which it expects will further accelerate its product creation activities and allow new products to become available for patients more quickly.

By swiftly and reliably advancing the development of new drugs in accordance with its comprehensive product creation strategy, which encompasses both the strategic collaboration with Quintiles and this new agreement with SFJ, Eisai seeks to bring new treatments to market as early as possible, and make further contributions to address the unmet medical needs of, and increase the benefits provided to, patients.

[ Please refer to the following notes for further information on E7080, SFJ and Eisai's strategic collaboration with Quintiles ]

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< Notes to editors >

1. 爱豆传媒 E7080 (lenvatinib)

Discovered by Eisai's Oncology Product Creation Unit using drug discovery chemical technologies, E7080 (lenvatinib) is a multi-kinase inhibitor with unique receptor tyrosine kinase inhibiting properties. It is an anti-angiogenic agent that inhibits tyrosine kinase of the VEGF (Vascular Endothelial Growth Factor) receptor, VEGFR2, and a number of other types of kinase involved in angiogenesis and tumor proliferation in a well-balanced manner. Eisai is currently developing this molecular-targeted agent as a potential treatment for various types of cancer including thyroid cancer (Global Development Program: Phase III), endometrial cancer (Europe and the United States: Phase II), melanoma (Europe and the United States: Phase II), and glioma (United States: Phase II).

2. 爱豆传媒 The SFJ Pharmaceuticals Group

The SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a Global Drug Development Company, which provides a unique co-development partnering model for some of the world's top Pharmaceutical and Biotechnology companies. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customized partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ is backed by Abingworth, Clarus and FinTech Global Capital, which are venture capital firms specializing in bio-pharmaceutical development. Collectively these venture capital firms manage over USD $2.5 billion in funding.

3. Eisai's Efforts in Product Creation: Collaboration with Quintiles

Eisai entered into a strategic collaboration with Quintiles in 2009 to develop a number of its candidate anticancer compounds. Under this strategic collaboration, Eisai and Quintiles share development costs, with the oncology development team at Quintiles conducting multiple POC studies with these compounds in accordance with a protocol set out by an Executive Oversight Committee made up of representatives from the both companies, and Eisai paying milestones payments to Quintiles for any compounds that meet the agreed-upon POC criteria.


 

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