- The Food and Drug Administration has given the green light to a first-of-its-kind medicine for Parkinson's disease patients, in turn handing its developer, Adamas Pharmaceuticals Inc., a big stock boost.
- Gocovri is now the only drug approved to treat the involuntary movements, called dyskinesia, that Parkinson's patients experience when they're on levodopa-based therapy — the standard of care for the neurological disorder.
- Adamas plans to make Gocovri available during the fourth quarter and conduct an official launch in January. In prepping for commercializing, the company has made job offers to six regional business directors who will oversee the drug's rollout, and wants to bring on 59 neurology sales specialists by Thanksgiving.
Adamas executives didn't disclose the exact price they have in mind for Gocovri (amantadine), but they did note in an Aug. 24 investor call that the wholesale acquisition cost (WAC) would likely fall in the range of $10,000 to $30,000.
The pricetag did raise some eyebrows, though, since Gocovri is an extended-release version of an already generic drug that was originally approved in 2006.
Though there aren't any other FDA-approved drugs for the Parkinson's disease dyskinesia indication, recently approved treatments for Parkinson's disease and other types of dyskinesia may offer some context for Gocovri's potential price tag.
Teva Pharmaceutical Industries Ltd., for instance, priced its medicine for involuntary movements in Huntington's disease patients, Austedo (deutetrabenazine), at $60,000 annually. Neurocrine Biosciences Inc.'s tardive dyskinesia drug Ingrezza (valbenazine) is $5,275 per a 30-count bottle, putting it also around $60,000 for a year's supply. Acadia Pharmaceuticals Inc.'s Nuplazid (pimavanserin), a treatment for hallucinations associated with Parkinson’s disease psychosis, clocks in at $25,600 for a year's worth of the drug.
Ken Cacciatore, an analyst at Cowen & Co., said the investment bank is modeling a $15,000 annual cost for Gocovri, but believes that anything within the $10,000 to $30,000 range " should be reasonable and secure broad coverage/access, especially given the severe unmet need that this product addresses."
Even if the drug's price tag doesn't gain favor with payers, Adamas has been working on other means to secure pickup of its drug. The company has already locked down a partnership with a "prominent U.S. pharmacy organization via their specialty pharmacy group" to increase patient access to Gocovri, said Richard King, Adamas' chief operating officer, during the call.
Adamas also anticipates its sales force will be able to reach 95% of the neurologists that could prescribe Gocovri. In a pre-market survey, the company found that physicians showed intent to use the drug in 54% of their Parkinson's patients with dyskinesia — broken down into 24% coming from both untreated dyskinesia patients and those on other therapies, such as dopamine agonists or monoamine oxidase B (MAO-B) inhibitors, and 6% from patients who were on reduced levodopa or carbidopa regimens.
A main goal from the sales end is to "educate neurologists that Gocovri is associated with a familiar and manageable adverse event profile," King said. "Based on our quantitative market research, this product profile will be a welcome addition to neurologist tool kit and help people with Parkinson's disease, reflective of an anticipated use of Gocovri in over half of their patients with dyskinesia."
The approval, as well as Adamas' plan of attack for rolling out Gocovri, appears to have resonated well with investors. The company's stock opened at $20.41 per share on Aug. 25, up nearly 44% from close of market Wednesday.
"The bottom line is that patients who are reaching the later stage of Parkinson's disease are in serious need of treatment options for LID and Gocovri is currently the only therapeutic now available to directly address this condition," Cacciatore wrote in his Aug. 25 investor note.
"Our consultants have remained consistent in their belief that this product profile is differentiated and will be a very welcome addition to the treatment paradigm for the significant number of patients struggling with LID and its effects," he added.
Those consultants also indicated that 25% of the Parkinson's disease population have moderate-to-severe lepodova-induced dyskinesia (LID), equating to at least 200,000 patients.
Gocovri is a once-daily, 274 mg oral medication taken at night (so as to provide adequate concentrations of during the following day). The drug's approval was based on a series of mid-to-late stage investigations, namely EASE LID and EASE LID 3.
In EASE LID, patients receiving Gocovri demonstrated a 37% reduction in dyskinesia as measured by the Unified Dyskinesia Rating Scale (UDysRS) by week 12, whereas those on placebo had a 12% reduction over that period. In EASE LID 3, patients receiving Gocovri had a 46% reduction in dyskinesia versus a 16% reduction for those on placebo, also after 12 weeks of investigation.
To enroll in the studies, patients must have had at least one hour of troublesome dyskinesia each day and experience at least mild functional impairment due to their dyskinesia. Patients additionally needed to be on a stable dose of levodopa, which couldn't change during the double-blind experiments.
"This is an essential point because, before the FDA approval of Gocovri, the primary way to manage dyskinesia was levodopa dose decrease and or fractionation. This may no longer be necessary," Rajiv Patni, Adamas' chief medical officer, said in the Aug. 24 investor call.
What's more, Gocovri-treated patients in the EASE LID study reported an added 3.6 hours of functional time each day, meaning they had more time where their medication was adequately abetting troublesome dyskinesia, compared to 0.8 hours for patients on placebo. In EASE LID 3, Cogovri-treated patients gained an additional four hours of functional time daily versus 2.1 hours for patients on placebo.
As for safety, Patni said "there has been no surprises during clinical development." Rate of discontinuation due to any adverse reaction was 20% versus 8% for placebo, "indicating that most adverse drug reactions did not constitute significant morbidity ..."
Adverse events from Gocovri treatment included falling asleep during daily activities, suicidality and hallucinations.