- Acorda will focus on new opportunities for growth, including the potential launch of its next drug Inbrija, executives said on a second quarter investor call, as problems continue with defending patents for its best-selling drug.
- Inbrija, which is meant to treat off episodes of Parkinson's disease, is currently under review with the Food and Drug Administration, and has a user fee action date of Oct. 5.
- This time last year the FDA issued a Refusal To File letter to Acorda for the Inbrija New Drug Application, saying it was incomplete due to a lack of certain details about its manufacturing process.
Last year, a court invalidated four of five patents covering Ampyra (dalfampridine), a multiple sclerosis drug that helps patients walk. The drug makes up about 95% of Acorda's revenues, and the entrance of generic versions would spell disaster for the company.
While the biotech continues to fight off the entrance of generics in court battles, the future of Ampyra does not look bright. In July, a Federal Circuit court denied Acorda's motion for an injunction against at-risk launches of generic Ampyra.
Acorda hopes the approval of Inbrija and its entrance to the market will be its saving grace. Ampyra is expected to bring in $300 to $350 million this year, but Acorda says the market opportunity for Inbrija (levodopa inhalation powder) is more than $800 million.
"The FDA is reviewing that NDA and our Acorda team is preparing for launch," said Acorda CEO Ron Cohen on a second quarter earnings call with investors. "This includes discussions with payers, pharmacy benefit managers, increasing disease state awareness among a range of audiences and expanding our social media and online presences. And that includes our 'Many Faces of OFF' Facebook page and our 'Live Well, Do Tell' campaign, which we recently launched for the Parkinson's disease community."
The company is currently training its sales force and mapping territories, as well as preparing promotional materials. "Our market research also continues and reinforces our conviction that off periods represent a large unmet need in the Parkinson's community," added Cohen.
In market research conducted by the company that included 226 neurologists, 175 primary care physicians and 150 patients with Parkinson's disease, "89% of physicians stated that they would include inhaled levodopa in their treatment regimen for their patients and 79% of people with Parkinson's stated that they would ask their doctors to prescribe inhaled levodopa."
"Based on this and extensive additional work to date, we believe that there would be strong demand and market receptivity to Inbrija," said Cohen.
Not looking to get into the same issues it is having with Ampyra, the company emphasized on the call that its patent portfolio for Inbrija extends into the 2030s. "In addition, we have a large body of trade secrets and know-how, which, we believe, gives a particularly long tail to the exclusivity on this technology," added the CEO.
The company had $392 million in cash and equivalents at the end of the quarter, which will help support the launch of Inbrija.
Last year, however, Acorda laid off 20% of its staff, or about 100 employees, in order to cut costs.