A generic drug has long been used to manage the involuntary movements that are a side effect of Parkinson’s medication
Late last week, Adamas Pharmaceuticals Inc. hailed its newly-approved drug Gocovri as “the first and only medicine approved by the FDA” for the involuntary movements that are a side effect of Parkinson’s disease medication.
That’s technically true. But a generic drug, amantadine, has long been used off-label by doctors for those involuntary movements, called dyskinesia. Generic amantadine can be bought for as little as 64 cents per pill, according to the price comparison website GoodRx. At two pills a day, a yearly supply costs under $500.
Adamas Pharma’s ADMS, +6.96% Gocovri is a new formulation of amantadine, at a new price: between $10,000 and $30,000 a year. (Those numbers refer to the wholesale acquisition cost of the drug, or the price a drugmaker offers middleman wholesalers, from which significant discounts may be taken.)
Even if the new product provides incrementally more value to patients, that doesn’t justify its too-high price tag, said one critic.
Adamas Pharma concedes that Gocovri is high-dose amantadine that can be taken once a day.
But in a Monday conversation with MarketWatch, Chief Executive Greg Went and Chief Medical Officer Rajiv Patni emphasized that there are other important differences. Gocovri is “not a convenience play” but rather a new chemical entity that is designed to be more effective, they said; moreover, the product represents 13 years and “well over” $100 million in investment.
About one million individuals in the U.S. have the progressive movement disorder Parkinson’s disease. The drug levodopa is commonly used to manage Parkinson’s disease symptoms, but it has a common side effect: dyskinesia, which an estimated 150,000 to 200,000 patients experience to some extent, according to Adamas.
Gocovri is designed to be taken before bedtime; the dose releases slowly overnight so as to moderate sleep disruption, a common amantadine side effect, and achieve a high concentration by waking hours, Adamas’ Went and Patni said.
In clinical trials, Parkinson’s patients got on average between 3.6 and 4 hours more a day of functional time as compared with a placebo’s 0.8 to 2.1 hour increase. The 3.6 to 4 hours included less time with dyskinesia and less time when their main medication wasn’t working, known as OFF periods.
In fact, Adamas Pharma’s central mission is making drugs more effective by understanding timing, management said, which may well make it unique. The company is also behind the extended release Alzheimer’s medication Namenda XR, which Allergan AGN, -0.16% commercializes in the U.S.; the company is also working with Allergan on the dementia medication Namzaric, which combines two therapeutic agents that are often co-prescribed into one capsule.
“If you’ve ever been a coffee drinker... you’re actually very familiar with timing patterns affecting the way you live or function,” Went said. “At Adamas, we’ve shown just how profoundly we can impact patients’ lives through an understanding of timing.”
But how does Gocovri compare to amantadine? Evidence from a small study of about 30 patients who were still experiencing dyskinesia on amantadine suggested that Gocovri does better, Adamas management said. After being switched to Gocovri, those patients experienced a statistically significant reduction in dyskinesia and OFF time, the company said.
Still, that doesn’t substitute for a direct comparison of the two therapies, and it followed only a small number of patients, said Dr. Walid Gellad, an associate professor at University of Pittsburgh and an internist who has patients with Parkinson’s disease. (The company said it couldn’t compare the two therapies directly in trials because amantadine isn’t approved by the FDA for dyskinesia.)
In addition, Adamas got an orphan drug designation for Gocovri from the FDA, making the therapy eligible for various development incentives, including tax credits for clinical tests, he noted.
And although generic amantadine will continue to be available, Gellad said it’s likely that co-pay coupons could be used to sway patients to the more expensive product.He also said he’s concerned that “the company will engage in some behavior to limit access to the generic.”
Adamas said there will be a co-pay assistance component as part of its program aimed at ensuring patient access to Gocovri. The program will “in no way block a physician or patient’s ability to choose or gain access to amantadine,” the company said.
“I think it’s great if [Gocovri] reduces side effects and is easier to take. The question is, how much is it worth to us, given that money’s not unlimited?” Gellad said. “If you have Parkinson’s or your family member has Parkinson’s, it’s obviously worth it to you. But everybody pays for these things, it’s not only the patient who has the condition. And so society has to decide where it wants to put its investment.”
Adamas shares have surged 33.2% over the last three months, compared with a 1.1% rise in the S&P 500 SPX, +0.08% . Shares surged 40.1% on Friday on news of Gocovri’s approval.
http://www.marketwatch.com/story/adamas-pharma-says-its-new-parkinsons-drug-isnt-just-a-more-expensive-long-acting-version-of-generic-2017-08-29
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