Impax Pharma ($IPXL) announced that the European Commission has approved its modified-release combination of carbidopa and levodopa to treat Parkinson's disease, dubbed Numient.
Hayward, CA's Impax already sells the drug in the U.S. as Rytary. The med is a clear drug delivery play.
The company said it was approved in EU countries and Iceland, Lichtenstein and Norway following three Phase III randomized studies of its safety and efficacy, including two that compare it to other formulations of levodopa-carbidopa.
One trial of 393 patients with advanced Parkinson's found that Numient reduced the percentage of "off" time--during which the patient is in a state of severely limited mobility--from 36.9% to 23.8% compared with a reduction from 36% to 29.8% for the immediate-release formulations, equivalent to a reduction in "off" time of nearly 1.2 hours. In addition, Numient increased "on" time without troublesome dyskinesia during waking hours by 1.9 hours, compared to an increase of 0.8 hours for immediate-release levodopa-carbidopa.
Another study of 91 patients compared Numient to levodopa-carbidopa plus entacapone and found similar results. At the end of the treatment phase, Numient patients had 3.8 hours of off time (or 24% of waking hours) while they were awake, compared with 5.2 hours (or 32.5% of waking hours) for those on the alternative formulation.
Numient is Impax's first branded drug approved outside the U.S., and the company hopes it will pave the way for worldwide adoption, said Numient CEO Fred Wilkinson in a statement, adding, "Numient addresses one of the most significant unmet needs for patients living with this disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled."
Besides a longer release profile, Numient has other drug delivery tricks up its sleeve. For patients with difficulty swallowing (a symptom that often accompanies Parkinson's), the med's capsule can be opened so that the immediate- and extended-release beads within can be sprinkled on applesauce.
The FDA's approval of Rytary helped propel Impax's specialty pharma revenues to $40.4 million in Q3, up $28 million year over year. The approval of Numient in Europe will help Impax compete in a therapeutic arena abounding with various delivery and administration methods, approved or in the pipeline.
In January, the FDA approved not only Rytary but also AbbVie's ($ABBV) Duopa, which is delivered straight into the patient's small intestine over 16 consecutive hours using an infusion pump and a procedurally placed tube.
But both medications may someday be supplanted by NeuroDerm's ($NDRM) version of levodopa/carbidopa, which delivers the medication via a wearable belt or patch pump.
Meanwhile, in June, Acorda Therapeutics ($ACOR) moved a step closer to collecting the payoff from its $525 million acquisition of Civitas, maker of an inhaled levodopa, when it presented strong Phase II results. Also in June, Cynapsus ($CYNA) kicked off patient enrollment in its Phase III clinical trial of sublingual apomorphine for Parkinson's patients who suffer from "off episodes," such as those for whom levodopa alone is inadequate.
Rytary suffered from a complete response rejection letter in 2013, before winning approval in 2015, and others are facing challenges as well. Earlier in November, NeuroDerm received written confirmation from the FDA that it can file for approval of its Parkinson's disease treatment on the strength of data from one clinical trial, freeing it of the need to run a second, 360-person study. But the FDA also demanded additional Good Manufacturing Practice documents from NeuroDerm's device supplier, leaving investors unsure whether the update was good or bad news.
Finally, in August, Israel's Intec Pharma raised a less-than-hoped-for $30 million from its IPO on Nasdaq, designed to fund its Phase III trial of its Accordion Pill delivery platform for levodopa-carbidopa, which hasn't been commercialized since the company's founding in 2000.
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