Rumors that Acorda was considering a sale drove company stock up about 12 percent on Friday, Jan. 5, to hit $23.55.
Rumors that Acorda Therapeutics was considering a sale drove company stock up about 12 percent on Friday, Jan. 5, to hit $23.55. The Wall Street Journal reported that Acorda had brought in advisers to assist in exploring an auction.
The company has been struggling recently. On Nov. 15, 2017, the company reported it had halted enrollment in its Phase III clinical trial of tozadenant for Parkinson’s disease because of several patient deaths. A few days later it announced it was discontinuing clinical development of the drug altogether.
In both the Phase IIb study and the Phase III study, about 890 patients received tozadenant and 234 received placebo. There were five deaths out of seven patients with sepsis, all in the tozadenant group. Agranulocytosis is an absence of white blood cells, which are key immune cells. Four of the cases of sepsis were related to agranulocytosis, two had no white blood cell counts at the time of the event and one patient had a high white blood cell count.
This became a major problem for the company. Its primary source of revenue is Ampyra, which faces patent expiration this summer, depending on how the courts decide on a patent case. In March, a district court judge invalidated four out of five patents that cover Ampyra. Ampyra is prescribed to patients with multiple sclerosis (MS) to improve walking ability. The company has been unsuccessful in getting the drug approved for other indications. The single remaining patent expires in the middle of 2018.
John Carroll, with Endpoints News, writes, “The initial plan was to hustle the levodopa drug CVT-301 and positive Phase III data to regulators, looking for an approval that would allow for the seamless switch to a new lead therapy. But that path was temporarily blocked by regulators who kicked back the application, asking for Acorda to fill in some blanks. Now Cohen and the team, who strongly resisted a push to the sales block last year, may see a sale and a handoff as the best new strategy for 2018.”
On Dec. 7, 2017, the company resubmitted a New Drug Application (NDA) for Inbrija to the U.S. Food and Drug Administration (FDA) for symptoms of OFF periods in Parkinson’s patients taking a carbidopa/levodopa regimen. The resubmission dealt with two problems raised in a previous rejection.
Today, the company released information at the J.P. Morgan Healthcare Conference regarding 2017 Ampyra sales and provided financial guidance for 2018. In the fourth quarter, Ampyra had net sales of $166 million, totaling net sales of $542 million for the year. Its cash and cash equivalents at the end of the year were $300 million. The company’s expected sales of Ampyra for 2018 are $330 to $350 million. And the company expects combined 2018 research-and-development and SG&A non-GAAP operating expenses of $270 to $290 million, which if the math is correct, will have the company remain solvent, if not dramatically profitable. It projects a cash balance by the end of 2018 to be $300 million.
“In response to the challenges we faced in 2017, we streamlined Acorda to focus on our most important and valuable initiatives,” Ron Cohen, Acorda’s president and chief executive officer, said in a statement. “Based on the Company’s proven track record of commercial success in the specialty neurology space, an NDA submitted for a major product and a continued commitment to fiscal responsibility, 2018 will be a transformative year for Acorda.”
Cohen went on to say, “We are preparing for potential approval and launch of Inbrija, our investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking carbidopa/levodopa. We look forward to working with the FDA during the NDA review process, and to bringing this new treatment option to the PD community to help address an important unmet need. Based on our continued market research we have increased our projection for Inbrija’s U.S. market opportunity to greater than $800 million.”
