Eisai links with SFJ in new outsourcing model for late-stage development

by | 8th Sep 2011 | News

Eisai has put the late-stage clinical development, as well as the associated funding, of a candidate compound for thyroid cancer in the hands of SFJ Pharma Ltd, wholly subsidiary of a US-based company that specialises in getting innovative drugs to market in Japan.

Eisai has put the late-stage clinical development, as well as the associated funding, of a candidate compound for thyroid cancer in the hands of SFJ Pharma Ltd, wholly subsidiary of a US-based company that specialises in getting innovative drugs to market in Japan.

The collaborative agreement with the SFJ Pharmaceutical subsidiary for the multi-kinase inhibitor E7080 (lenvatinib) is part of a broader partnership scheme Eisai is building up to accelerate late-stage clinical development of its new drug pipeline.

The scheme will complement Eisai’s existing strategic collaboration with drug development specialist Quintiles, under which the latter’s oncology development team conducts proof of concept studies with compounds from Eisai’s anticancer pipeline and the two companies share development costs.

Under the arrangement with SFJ Pharma, however, costs for Phase III studies with E7080 in thyroid cancer will be borne entirely by SFJ, while Eisai will conduct the clinical trials itself.

It will make milestone payments to SFJ only if E7080 secures regulatory approval. Moreover, if and when the compound is cleared for marketing, all commercial rights will remain with Eisai.

No further financial details of the agreement between Eisai and SFJ Pharma were disclosed.

Accelerated development

The arrangement will enable Eisai to pursue simultaneously multiple promising late-stage clinical development programmes, which the company expects will “further accelerate its product creation activities and allow new products to become available for patients more quickly”.

Explaining its broader strategy for a “rich” late-stage clinical pipeline, Eisai said it would effectively leverage internal resources as well as building “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 programmes simultaneously and as quickly as possible”.

By moving new drugs through development “swiftly and reliably” in accordance with its comprehensive product creation strategy, which encompasses both the strategic collaboration initiated with Quintiles in 2009 and the new agreement with SFJ, Eisai “seeks to bring new treatments to market as early as possible”, it stated.

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