Schwarz Pharma, which is in the process of being taken over by Belgium’s UCB, is celebrating after US regulators gave the go-ahead to the firm’s Parkinson’s disease treatment Neupro.
The US Food and Drug Administration has approved Neupro (rotigotine transdermal patch) for the treatment of symptoms of early-stage idiopathic Parkinson's disease, and Schwarz Pharma noted that the patch, with its once daily dosing, is the first non-ergolinic dopamine agonist transdermal system capable of delivering medication over a 24-hour period. Neupro will be available in the USA in three strengths (2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours).
In Europe, Neupro is approved for all stages of Parkinson's disease and Schwarz Pharma’s chief scientific officer Iris Loew-Friedrich said that the firm intends to submit a supplemental New Drug Application for the treatment of advanced Parkinson's disease to the FDA by the end of 2007."
Analysts were impressed and UBS issued a note saying that US peak sales should reach 120 million euros in the early-stage Parkinson's indication, but added that while studies show that Neupro appears effective and well-tolerated compared with placebo, it failed to show non-inferiority to GlaxoSmithKline’s rival product Requip (ropinirole), “hence we expect it will not be as successful as that drug."
UBS said that "Neupro has the advantage of being a once-daily transdermal patch, although we see that advantage disappearing once GSK gains approval of its once-daily extended release formulation, expected 2007.” Schwarz Pharma itself has said that sales of the drug could reach as much as 350 million euros annually, but this figure could be boosted by an additional 300 million euros per year if it is also successful in developing the compound for restless legs syndrome.