- Acorda Therapeutics on Friday secured an earlier-than-expected U.S. approval for its Parkinson's disease treatment Inbrija, boosting the company's fortunes three months after a damaging court ruling that invalidated patents protecting the biotech's sole marketed drug.
- Inbrija, which delivers the mainstay Parkinson's therapy levodopa via an inhaler, is designed for on-demand use to treat "off periods" in people with the neurodegenerative disorder already on background treatment with carbidopa/levodopa.
- Shares in Acorda rose by more than 6% in shortened trading on Dec. 24 on the news, which could also spur speculation of potential takeover interest in the biotech. Still, Acorda will face crimped revenue in the near term due to September's patent decision on the company's multiple sclerosis medicine Ampyra.
While Acorda's stock perked up following the new approval, shares in the company remain down by more than 30% on the year, which has turned sour for much of the biotech sector.
The Food and Drug Administration's decision to OK Inbrija (levodopa inhalation powder) comes several weeks ahead of its rescheduled target action date of January 5. Originally, Acorda was set to secure a green light in early October, but regulators informed the company they would need more time to evaluate the company's application.
Approval in hand, Acorda will now have to build a market for its drug-device combination treatment.
Most people with Parkinson's disease are treated with levodopa, a now-generic drug that helps improve motor symptoms associated with the condition. Over time, however, people given levodopa can experience "off periods," or times when symptoms return despite baseline treatment.
Inbrija is designed to help address those periods of increased symptoms, which Acorda estimates affect about 350,000 Americans.
"Oral levodopa is the gold standard treatment for Parkinson's disease and Inbrija is intended to be used to address gaps in control of a person's symptoms that can occur even in the presence of this oral regimen," explained Acorda CEO Ron Cohen in a Dec. 24 call with analysts.
Acorda has said it will announce Inbrija's price at launch. Analysts expect the drug to cost between $5,000 to $10,000 per year, while the company projects peak annual sales of Inbrija could eventually reach more than $800 million.
But getting there could take some doing. For starters, regulators included a caution — not a full warning — against use of Inbrija in patients with asthma or other chronic lung conditions. Raymond James analyst Laura Chico wrote in a Dec. 24 note to investors that the warning spurred some moderation to the bank's market share assumptions.
In clinical testing, more patients given Inbrija experienced respiratory side effects than those on the control arm. Of the 17 reported cases of cough among Inbrija-treated patients, eleven were classified as mild and 6 as moderate. Two patients discontinued treatment.
And while levodopa is familiar to physicians and patients alike, Acorda will spend time to train healthcare professionals on use of the inhalation device prior to launch, expected in the first quarter of next year.
"Taking some time upfront to do this before putting drug in the channel will pay substantial dividends later as the healthcare professionals and patients alike become familiar with the product," said Cohen.
Acorda could face fresh competition, too. Sunovion hopes to win approval by late January for an under-the-tongue version of apomorphine, which is currently used to treat off periods via an injection.
In a recent earnings call, Acorda's Cohen acknowledged Sunovion would compete, but expressed confidence Acorda would be able to secure a majority share of the market.
Raymond James' Chico noted Acorda will benefit from an experienced field force, but cautioned "the road ahead remains challenging."