US orphan designation for Addex' dipraglurant

Swiss biotech firm Addex Therapeutics (SIX: ADXN) says that the US Food and Drug Administration has granted orphan drug designation to dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID).

Orphan drug status provides Addex with a number of benefits including reduced development costs and seven years US market exclusivity from launch. Dipraglurant is a novel small molecule inhibitor of the metabotropic glutamate receptor 5 (mGluR5) that has successfully completed Phase II proof-of-concept testing in Parkinson's disease (PD) patients suffering from debilitating levodopa-induced dyskinesia (LID), an indication that has no approved treatment options. Addex is currently conducting an mGlu5 receptor occupancy clinical trial and is preparing to start a Phase III pivotal trial in PD-LID.

$900 million annual sales forecast by the company

Last year, when it announced the filing for US orphan status (The Pharma Letter August 5, 2015), Addex said it sees sales of up to $900 million from its drug candidate to treat involuntary movements induced by prolonged intake of treatment of levodopa in Parkinson's patients. Also last year, Addex entered into a collaboration with the Dystonia Medical Research Foundation to explore the use of dipraglurant to treat dystonia.