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Takeda signs Alzheimer's deal for Actos

Japan's Takeda has entered into a partnership aimed at developing its diabetes medication Actos as a treatment for Alzheimer's disease

Japan's Takeda has entered into a partnership aimed at developing its blockbuster diabetes medication Actos (pioglitazone) as a treatment for Alzheimer's disease.

Actos, a once-daily pill with annual sales of about $4bn, goes off-patent this month.  A major new indication for the drug such as Alzheimer's disease could help revitalise sales in the face of competition from lower-cost generic versions in the diabetes space.

The rationale for exploring diabetes drugs as Alzheimer's disease treatments is that patients with Alzheimer's often have poor insulin function in their brains. However, last year, GlaxoSmithKline's (GSK) similar diabetes drug Avandia (rosiglitazone) failed an early clinical trial in Alzheimer's disease.

Under the partnership deal, Takeda has licensed the rights to an assay from the small US company Zinfandel Pharmaceuticals that it plans to use to identify high-risk older adults who would be good candidates for clinical trials of pioglitazone in Alzheimer's disease, possibly giving the drug a better shot at demonstrating efficacy.

The deal gives Takeda exclusive worldwide rights to Zinfandel's TOMM40 assay as a biomarker for the risk of Alzheimer's disease in high-risk older adults with normal cognitive function. The biomarker is being developed by Zinfandel to identify healthy people at high risk of developing Alzheimer's within five years.

The companies will work together to study pioglitazone in connection with the TOMM40 biomarker and Alzheimer's disease, and they will attempt to validate the biomarker as a test of individual risk.

The agreement calls for Takeda to make an upfront payment of $9m as well as payments tied to development milestones that could total up to $78m. The deal also includes commercial milestones and royalties on sales. Takeda's exclusive licence includes rights to sublicense, develop, make, use and commercialise the biomarker assay.

Actos, which is currently Takeda's top-selling product, is undergoing a safety review by the US Food and Drug Administration (FDA). In September, the agency announced that it would review a possible increased risk in bladder cancer associated with long-term use of the drug.

11th January 2011

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