Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect

Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. With Amneal hitting its third-quarter filing goal, the company is on track to bring the therapy to market around the middle of next year.

The drug candidate, IPX203, is an oral formulation of carbidopa/levodopa (CD/LD) that features a mix of immediate-release CD/LD granules and extended-release LD coated beads. Amneal has deployed a set of drug delivery technologies to create a release profile that increased "on" time without troublesome dyskinesia in a phase 3 clinical trial.

“The RISE-PD data indicate IPX203 can offer patients a new and important treatment option that will enable them to have more ‘Good On’ time during the day, which we believe would be a significant new benefit for Parkinson’s patients. We are working with the FDA to bring this treatment to market,” Chintu Patel, co-CEO at Amneal, said in a statement. 

IPX203 features a disintegrant polymer to enable rapid dissolution of the immediate-release granules. The LD beads are coated with a sustained release polymer for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer and an enteric coating to prevent the beads from disintegrating prematurely in the stomach.

Amneal received FDA approval for an extended-release CD/LD formulation, Rytary, in 2015, but it is a fairly niche product, racking up sales of $83 million over the first half of the year. IPX203 will open up a bigger opportunity. 

The company is targeting peak U.S. annual net sales of $300 million to $500 million, making IPX203 the biggest opportunity in its branded specialty pipeline. Amneal is aiming to launch at least one new branded drug per year through to 2026 and sees its Grande and Kronotec drug delivery technologies providing a stream of  505(b)(2) opportunities.