Diamyd receives compensation from Apoteket AB

Diamyd Medical announces today that the company has executed a settlement agreement with Apoteket AB regarding a clinical study in LADA patients, which was invalidated in 2007. The cause of the invalidation was contradictory data, which gave reason to suspect a mix-up of active drug and placebo.

Diamyd contracted Apoteket AB in 2004 for handling of blinding, randomization and labeling of the study drug for a clinical study with 160 LADA patients. As the study was unblinded and reported during summer 2007, the data was found to be inconclusive. An inspection at the pharmacy, that had handled the study drug, revealed insufficiencies in routines and documentation, which made it impossible to conclude which patients had received active drug and which patients had received placebo. The study was invalidated on these grounds. Diamyd has claimed damages from Apoteket AB for unnecessary costs related to the invalidated study. The settlement agreement includes a payment of SEK 11 million to Diamyd as compensation for the insufficiencies in Apoteket’s routines and documentation causing Diamyd to invalidate the study. “We have now agreed on a settlement with Apoteket AB and we are looking forward to, in new LADA studies, confirm earlier positive results that have been reported in this patient group after treatment with the diabetes vaccine Diamyd®”, says Elisabeth Lindner, President of Diamyd Medical.

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