Pipeline: The company has one key product in development and two on the market through a partnership with Allergan (AGN).
ADS-5102 This is the company’s most advanced and most important wholly owned drug in the pipeline. This compound is being developed for the treatment of levodopa-induced dyskinesia {LID} that comes with the most common Parkinson's disease treatment “levodopa” as well as for the treatment of multiple sclerosis in patients with walking impairment. There are approximately one million individuals with Parkinson’s in the United States and around 60,000 newly diagnosed cases annually.
This drug has successfully completed several late stage trials for use in Parkinson’s. Since ADS-5102 is an extended-release formulation of Parkinson's disease drug amantadine, approval chances should be higher and streamlined when the company submits its NDA for the treatment of Parkinson by the end of the year. The extended release feature of ADS-5102 offers advantages over amantadine by achieving higher concentrations earlier in the day when it is most needed and lower concentrations in the evening when it isn’t. Higher dosages might also be able to be given enhancing the positive effects of the drug. ADS-5102 should be a first-line therapy for LID if/when approved.
The company completed a Phase II trial for the treatment of MS in the second quarter. The key metric was the timed 25-foot walking test where treated patients showed a ~15% improvement in walking speed versus a placebo. The company will meet with the FDA to put together the design for a Phase III trial.
Adamas has two approved products on the U.S. market in partnership with Forest Laboratories, an indirect wholly-owned subsidiary of Allergan. The first is Namzaric™ (memantine HCl extended release and donepezil HCl) capsules and the second is Namenda XR® (memantine HCI) extended release capsules.