Lundbeck acquires European commercialization rights for Flurizan from Myriad, USA

New drug in final phase III development for the treatment of Alzheimer's disease.

26-May-2008

H. Lundbeck A/S and Myriad Genetics, Inc. announced that Lundbeck has acquired European commercialization rights to Myriad's Flurizan® (tarenflurbil). Flurizan® might have the potential to delay disability in patients suffering from Alzheimer's disease.

Myriad and Lundbeck have entered into a European commercialization agreement under which Lundbeck will have rights to market and sell Flurizan® in the European Union and several associated non-EU countries and will manage the regulatory process. Lundbeck has agreed to pay Myriad an initial USD 100 million and will pay up to USD 250 million in connection with regulatory approvals. Furthermore, Lundbeck has agreed to pay attractive commercialization milestones and will purchase bulk pharmaceutical material from Myriad. Lundbeck has also agreed to pay escalating royalties of 20 - 39% on sales less the amount paid for the bulk drug.

More than 200 patients have been treated in the clinical phase II trials with Flurizan®. Overall, the results support the hypothesis that Flurizan® may delay the disability of Alzheimer's disease. Flurizan® has an attractive therapeutic and safety profile in patients with mild Alzheimer's treated for 1 year. In addition to the reported significant benefit observed in patients with mild Alzheimer's in activities of daily living (p=0.033), global function (p=0.042) and a positive trend in cognition, the phase II data revealed a significant reduction (p=0.020) in the number of and a delay in time to psychiatric events (p=0.011). In a 24-month follow up study Flurizan® demonstrates an increasing response rate (absolute risk reduction) over time in subjects with mild Alzheimer's disease treated with Flurizan®. These long-term and increasing response rates have not been observed previously in clinical studies of drugs in Alzheimer's disease. However, as with all clinical phase 2 results these data are preliminary and needs to be confirmed in larger clinical phase 3 trials. Flurizan® is now being studied in two final phase 3 clinical trials.

https://www.bionity.com/en/news/82525/lundbeck-acquires-european-commercialization-rights-for-flurizan-from-myriad-usa.html