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J&J ends diabetes drug deal

J&J's Ortho-McNeil-Janssen Pharmaceuticals unit has terminated a diabetes partnership with Arena Pharmaceuticals

Johnson & Johnson's Ortho-McNeil-Janssen Pharmaceuticals unit has terminated a partnership with Arena Pharmaceuticals that had been aimed at developing new therapies to treat type 2 diabetes. The termination is effective as of December 28.

Ortho-McNeil made the decision to end the alliance in spite of the recent completion of a phase I clinical trial programme showing that the drug, APD597 (JNJ-38431055), may have utility as both monotherapy and combination therapy in diabetes.

APD597 is an orally delivered GPR119 agonist discovered by Arena that is intended to stimulate insulin production in response to increases in blood glucose. GPR119 is expressed in beta cells in the pancreas, which are responsible for producing insulin when blood glucose increases.

Rights to the drug will revert to Arena on the December termination date, as will the rights to other compounds and intellectual property associated with the partnership.

The phase I programme for APD597, which included multiple studies in healthy volunteers and type 2 diabetes patients, showed that the experimental therapy was well tolerated and had dose-proportional pharmacokinetics, according to Arena. The studies also provided evidence for the desired incretin stimulation and reductions in post-meal glucose spikes in overweight and obese non-diabetic volunteers, as well as in diabetic subjects.

"Results of the phase I programme suggest that APD597 may have utility both alone and in combination with a DPP-4 inhibitor for the treatment of type 2 diabetes," Arena president and CEO Jack Lief said in a statement.

Arena said it intends to move forward with APD597, as well as with the development of other compounds and technology discovered during the research portion of the collaboration, which ended in October 2007.

Under the worldwide collaboration and licensing agreement the two companies signed in 2004, Arena received an upfront payment of $17.5m and could have received up to $295m in milestone payments tied to development, approval and sales goals for each compound developed under the collaboration.

In addition, the agreement called for Arena to receive research funding of $4.8m over the initial two years of the partnership. In 2006, Ortho-McNeil exercised an option to extend the research term of the partnership by a year and provided another $2.4m in research funding.

Following the research phase, Johnson & Johnson Pharmaceutical Research & Development LLC would have been responsible for development and expenses for products resulting from the collaboration had the deal not been terminated. Arena also would have received double-digit royalties on sales had marketed products resulted from the collaboration.

8th November 2010

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