AstraZeneca's news that nitric oxide donator AZD 3582 had failed to reach a primary end-point in a Phase II trial sent originator NicOx's shares plummeting, as investors lost faith in the biotech's entire platform. NicOx is disputing the data's accuracy in an attempt to salvage investor confidence--and to survive. The events highlight the tension between Big Pharma's duties to investor transparency and to protect its biotech partners. They're also a reminder to biotechs that there's more to deals than just royalties.

Recent concerns over the cardiovascular risk profile of Cox-2 inhibitors strengthen the case for pain compound AZD 3582, a new formulation of naproxen in Phase II trials at AstraZeneca. For the compound's originator, NicOx, forthcoming trial results will be critical in validating the firm's founding concept: grafting a nitric oxide molecule onto existing generic drugs.

International Pharmaceutical Excipients Council of the Americas supports the maximum daily exposure limit but suggests FDA retain potency limit field until it finishes adding MDE information to avoid causing confusion.