Acorda Therapeutics (ACOR) is trading nicely higher today (+5%) after the FDA approved INBRIJA for intermittent treatment of OFF episodes in people with Parkinson's disease treated with carbidopa/levodopa. It's expected to be available by prescription in 1Q19.
Just so readers understand, Parkinson's is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons in the brain. These neurons are responsible for producing dopamine and that loss causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson's progresses, people are likely to experience OFF periods, which are characterized by the return of Parkinson's symptoms, which can occur despite underlying baseline therapy. It is estimated that approximately 40% of people with Parkinson's in the US experience OFF periods.
INBRIJA is the first and only inhaled levodopa for intermittent treatment of OFF episodes in patients with Parkinson's disease. INBRIJA uses Acorda's ARCUS platform for inhaled therapeutics. The ARCUS Technology Platform allows systemic delivery of medication through inhalation, by transforming molecules into a light, porous dry powder. This allows delivery of substantially higher doses of medication than can be delivered via conventional dry powder technologies. It's not just INBRIJA. ARCUS has the potential to be used in a variety of inhaled medicines. Acorda acquired the ARCUS technology platform as part of the acquisition of Civitas Therapeutics in 2014.
Acorda sees today's approval of INBRIJA as a major milestone for both Acorda and the Parkinson's community. Despite being on treatment, patients may experience OFF periods as Parkinson's progresses, which can be disruptive. The Michael J. Fox Foundation provided funding for the early clinical development of INBRIJA because patients told them that OFF periods were one of their most serious issues. It provides a new option to manage these gaps in symptom control.
In sum, this was good news for Acorda. The stock took a tumble in September when the company announced a couple of negative items. First, a federal appeals court upheld a lower court's decision to invalidate four AMPYRA patents. AMPYRA is one of two FDA-approved therapies marketed by Acorda. It's a treatment to improve walking in patients with multiple sclerosis. Second, the FDA had extended the review period for the INBRIJA .Those two event plus some negative sell side commentary has taken a toll on the stock in recent months.
Today's news is certainly a positive. Acorda's has said its highest priority is preparing for the expected launch of Inbrija. OFF periods, or the re-emergence of Parkinson's symptoms, is seen as one of the most significant unmet needs in Parkinson's and there is enthusiasm for an inhaled formulation of levodopa as a treatment option. The stock is down from its initial highs at the open, but is up for the day. The weak overall market is probably weighing on the stock. Also, the approval may have been somewhat expected. Regardless, this was a positive step forward for Acorda.